Medelan

Medelan may be available in the countries listed below.

Ingredient matches for Medelan

Cimetidine

Cimetidine is reported as an ingredient of Medelan in the following countries:

• Greece

International Drug Name Search

Pantol

Pantol may be available in the countries listed below.

Ingredient matches for Pantol

Dexpanthenol

Dexpanthenol is reported as an ingredient of Pantol in the following countries:

• Japan


• Oman

International Drug Name Search

Indolgina

Indolgina may be available in the countries listed below.

Ingredient matches for Indolgina

Indometacin

Indometacin is reported as an ingredient of Indolgina in the following countries:

• Costa Rica


• El Salvador


• Guatemala


• Honduras


• Nicaragua


• Panama


• Spain

International Drug Name Search

Cinalid

Cinalid may be available in the countries listed below.

Ingredient matches for Cinalid

Azithromycin

Azithromycin is reported as an ingredient of Cinalid in the following countries:

• Bangladesh

International Drug Name Search

Carboplatin Merck

Carboplatin Merck may be available in the countries listed below.

Ingredient matches for Carboplatin Merck

Carboplatin

Carboplatin is reported as an ingredient of Carboplatin Merck in the following countries:

• Tunisia

International Drug Name Search

Infectoroxit

Infectoroxit may be available in the countries listed below.

Ingredient matches for Infectoroxit

Roxithromycin

Roxithromycin is reported as an ingredient of Infectoroxit in the following countries:

• Germany

International Drug Name Search

Glicina + Mannitolo Galenica

Glicina + Mannitolo Galenica may be available in the countries listed below.

Ingredient matches for Glicina + Mannitolo Galenica

Glycine

Glycine is reported as an ingredient of Glicina + Mannitolo Galenica in the following countries:

• Italy

Mannitol

Mannitol is reported as an ingredient of Glicina + Mannitolo Galenica in the following countries:

• Italy

International Drug Name Search

Fluoxetina Northia

Fluoxetina Northia may be available in the countries listed below.

Ingredient matches for Fluoxetina Northia

Fluoxetine

Fluoxetine is reported as an ingredient of Fluoxetina Northia in the following countries:

• Argentina

International Drug Name Search

Ethacridine

In some countries, this medicine may only be approved for veterinary use.

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0000442-16-0

Chemical Formula

C15-H15-N3-O

Molecular Weight

253

Therapeutic Categories

Antiseptic

Disinfectant

Chemical Name

3,9-Acridinediamine, 7-ethoxy-

Foreign Names

• Ethacridinum (Latin)
• Ethacridin (German)
• Ethacridine (French)
• Etacridina (Spanish)

Generic Names

• Ethacridine (OS: BAN)
• Éthacridine (OS: DCF)
• Ethacridine Lactate (OS: BANM)
• Acrinoli lactas (IS)
• Aethacridinum lacticum (IS)
• Ethodin (IS)
• Acrinol Hydrate (PH: JP XV)
• Ethacridine Lactate Monohydrate (PH: BP 2010, Ph. Eur. 6)
• Ethacridini lactas monohydricus (PH: Ph. Eur. 6)

Brand Names

• Pyorex
  Bailly-Creat, Tunisia



• Acridinpulver (veterinary use)
  WDT, Germany



• Acridinsalbe (veterinary use)
  WDT, Germany



• Acrinol
  Yakuhan Seiyaku, Japan



• Aethacridin Bichsel
  Bichsel, Switzerland



• Emcredil
  Unichem, India



• Liverall
  Daito, Japan



• Metifex
  Cassella-med, Germany



• Neochinosol
  Dermapharm, Germany



• Rivanol Galen
  Galen Pharma, Bulgaria



• Rivanol
  Dermapharm, Germany; Prolab, Poland



• Rivanolum roztwór
  Amara, Poland



• Rivanolum
  ICN, Poland



• Rivel
  EMO, Poland



• Rywanol
  Hasco, Poland



• Solution Ethacridine lactate
  Thalloderma, Bulgaria



• Vecredil
  Jagson Pal, India

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
DCF	Dénomination Commune Française
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Pralip

Pralip may be available in the countries listed below.

Ingredient matches for Pralip

Pravastatin

Pravastatin is reported as an ingredient of Pralip in the following countries:

• Romania


• Slovenia

Pravastatin sodium salt (a derivative of Pravastatin) is reported as an ingredient of Pralip in the following countries:

• Poland

International Drug Name Search

Funet

Funet may be available in the countries listed below.

Ingredient matches for Funet

Ketoconazole

Ketoconazole is reported as an ingredient of Funet in the following countries:

• Indonesia

International Drug Name Search

Betahistine Actavis

Betahistine Actavis may be available in the countries listed below.

Ingredient matches for Betahistine Actavis

Betahistine

Betahistine dihydrochloride (a derivative of Betahistine) is reported as an ingredient of Betahistine Actavis in the following countries:

• Malta


• Slovakia

International Drug Name Search

Prescaina Llorens

Prescaina Llorens may be available in the countries listed below.

Ingredient matches for Prescaina Llorens

Oxybuprocaine

Oxybuprocaine hydrochloride (a derivative of Oxybuprocaine) is reported as an ingredient of Prescaina Llorens in the following countries:

• Spain

International Drug Name Search

Tautax

Tautax may be available in the countries listed below.

Ingredient matches for Tautax

Docetaxel

Docetaxel is reported as an ingredient of Tautax in the following countries:

• Russian Federation

International Drug Name Search

Bromhexin ACO

Bromhexin ACO may be available in the countries listed below.

Ingredient matches for Bromhexin ACO

Bromhexine

Bromhexine hydrochloride (a derivative of Bromhexine) is reported as an ingredient of Bromhexin ACO in the following countries:

• Sweden

International Drug Name Search

Funazole

Funazole may be available in the countries listed below.

Ingredient matches for Funazole

Ketoconazole

Ketoconazole is reported as an ingredient of Funazole in the following countries:

• India

International Drug Name Search

Fenticonazole

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

D01AC12,G01AF12

CAS registry number (Chemical Abstracts Service)

0072479-26-6

Chemical Formula

C24-H20-Cl2-N2-O-S

Molecular Weight

455

Therapeutic Category

Antifungal agent

Chemical Name

1H-Imidazole, 1-[2-(2,4-dichlorophenyl)-2-[[4-(phenylthio)phenyl]methoxy]ethyl]-

Foreign Names

• Fenticonazolum (Latin)
• Fenticonazol (German)
• Fenticonazole (French)
• Fenticonazol (Spanish)

Generic Names

• Fenticonazole (OS: DCF, BAN)
• Fenticonazolo (OS: DCIT)
• Fenticonazole Nitrate (OS: BANM, USAN)
• Rec 15/1476 (IS: Recordati)
• Fenticonazole (nitrate de) (PH: Ph. Eur. 6)
• Fenticonazole Nitrate (PH: BP 2010, Ph. Eur. 6)
• Fenticonazoli nitras (PH: Ph. Eur. 6)
• Fenticonazolnitrat (PH: Ph. Eur. 6)

Brand Names

• Lomexin
  Algorithm, Oman; Pharmaplan, South Africa; Recordati, Taiwan



• Falvin
  Recordati, Italy



• Fenizolan
  Merckle Recordati, Germany



• Fentikol
  Zorka, Serbia



• Fentizol
  Aché, Brazil



• Gyno-Lomexin
  Organon, Turkey; Recordati, Luxembourg



• Gynoxin
  Organon, Luxembourg; Recordati, Poland



• Laurimic Vaginal
  Effik, Spain



• Laurimic
  Effik, Spain



• Lomexin Vaginal
  Recordati, Spain



• Lomexin
  Altana, Brazil; Altana, Mexico; Decafarma, Portugal; Effik, France; Fournier, Romania; Galenica, Greece; Gerot, Austria; Merckle Recordati, Germany; Orivas, Latvia; Pierre Fabre Medicament, Slovakia; Recordati, Bulgaria; Recordati, Czech Republic; Recordati, Spain; Recordati, Italy; Recordati, Lithuania; Recordati, Serbia; Recordati, Vietnam



• Lorenil
  Effik, Italy



• Terlomexin
  Effik, France

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Lysomucil Junior

Lysomucil Junior may be available in the countries listed below.

Ingredient matches for Lysomucil Junior

Acetylcysteine

Acetylcysteine is reported as an ingredient of Lysomucil Junior in the following countries:

• Belgium

International Drug Name Search

Antotalgin

Antotalgin may be available in the countries listed below.

Ingredient matches for Antotalgin

Phenazone

Phenazone is reported as an ingredient of Antotalgin in the following countries:

• Poland

International Drug Name Search

Glimepirid Orion

Glimepirid Orion may be available in the countries listed below.

Ingredient matches for Glimepirid Orion

Glimepiride

Glimepiride is reported as an ingredient of Glimepirid Orion in the following countries:

• Finland

International Drug Name Search

Giludop

Giludop may be available in the countries listed below.

Ingredient matches for Giludop

Dopamine

Dopamine hydrochloride (a derivative of Dopamine) is reported as an ingredient of Giludop in the following countries:

• Austria


• Greece


• Sweden

International Drug Name Search

Guajacuran

Guajacuran may be available in the countries listed below.

Ingredient matches for Guajacuran

Guaifenesin

Guaifenesin is reported as an ingredient of Guajacuran in the following countries:

• Czech Republic


• Slovakia

International Drug Name Search

Cefs-S

Cefs-S may be available in the countries listed below.

Ingredient matches for Cefs-S

Ceftriaxone

Ceftriaxone is reported as an ingredient of Cefs-S in the following countries:

• India

Sulbactam

Sulbactam is reported as an ingredient of Cefs-S in the following countries:

• India

International Drug Name Search

Erkacin

Erkacin may be available in the countries listed below.

Ingredient matches for Erkacin

Amikacin

Amikacin sulfate (a derivative of Amikacin) is reported as an ingredient of Erkacin in the following countries:

• Myanmar

International Drug Name Search

Butapirazol

Butapirazol may be available in the countries listed below.

Ingredient matches for Butapirazol

Phenylbutazone

Phenylbutazone is reported as an ingredient of Butapirazol in the following countries:

• Poland

International Drug Name Search

Laidlomycin

In some countries, this medicine may only be approved for veterinary use.

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0056283-74-0

Chemical Formula

C37-H62-O12

Molecular Weight

698

Therapeutic Categories

Antiprotozoal: Agent against coccidiosis

Growth stimulant

Chemical Name

Monensin, 16-deethyl-3-O-demethyl-16-methyl-3-O-(1-oxopropyl)-

Foreign Names

• Laidlomycinum (Latin)
• Laidlomycin (German)
• Laidlomycine (French)
• Laidlomycina (Spanish)

Generic Names

• Laidlomycin (OS: BAN)
• Laidlomycin Propionate Potassium (OS: BANM, USAN)
• RS 11988 (IS: Syntex)

Brand Names

• Aureomycin (Laidlomycin and Chlortetracycline (veterinary use))
  Alpharma Animal Health, United States



• Cattlyst (Laidlomycin and Chlortetracycline (veterinary use))
  Alpharma Animal Health, United States



• Cattlyst (veterinary use)
  Alpharma Animal Health, United States

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Calsal

Calsal may be available in the countries listed below.

Ingredient matches for Calsal

Calcitonin

Calcitonin is reported as an ingredient of Calsal in the following countries:

• Greece

International Drug Name Search

Erytrowet

Erytrowet may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Erytrowet

Erythromycin

Erythromycin is reported as an ingredient of Erytrowet in the following countries:

• Poland

International Drug Name Search

I-Caps

I-Caps may be available in the countries listed below.

Ingredient matches for I-Caps

Ascorbic Acid

Ascorbic Acid is reported as an ingredient of I-Caps in the following countries:

• Peru

International Drug Name Search

Methylscopolamine

Scheme

DCF

ATC (Anatomical Therapeutic Chemical Classification)

A03BB03,S01FA03

CAS registry number (Chemical Abstracts Service)

0013265-10-6

Chemical Formula

C18-H24-N-O4+

Molecular Weight

318

Therapeutic Categories

Ophthalmic agent

Gastrointestinal agent

Chemical Names

N-Methyl-O-tropoylscopinium

(1R,2R,4S,7S)-7-{[(2S)-3-hydroxy-2-phenylpropanol]oxy}-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.0²,⁴]nonane (IUPAC)

(8r)-6ß,7ß-Epoxy-3α-hydroxy-8-methyl-1αH,5αH-tropanium (-)-tropate

[7(S)-(1α,2ß,4ß,5α,7ß)]-7-(3-Hydroxy-1-oxo-2-phenylpropoxy)-9,9-azoniatricyclo[3.3.1.0²,⁴]nonane

3-Oxa-9-azoniatricyclo(3.3.1.0²,⁴)nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9,9-dimethyl-, (7(S)-(1α,2ß,4ß,5α,7ß))-

Foreign Names

• N-Methylscopolamin Kation (German)
• Méthylscopolamine (French)

Generic Names

• Méthylscopolamine (OS: DCF)
• Methscopolamine (IS)
• N-Methylscopolamine (IS)
• N-Methylscopolamine Methylsulfate (OS: JAN)
• N-Methylscopolamin mesilat (IS)
• CERM 1290 (IS)
• DD 234 (IS)
• N-Methylhyoscine methyl sulfate (IS)
• N-Methylscopolamine methosulfate (IS)

Brand Names

• Daipin
  Daiichi Sankyo, Japan



• Kuinlon
  Tatsumi Kagaku, Japan



• Meporamin
  Taiyo Pharmaceutical, Japan

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
IUPAC	International Union of Pure and Applied Chemistry
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym

Click for further information on drug naming conventions and International Nonproprietary Names.

Reliezen

Reliezen may be available in the countries listed below.

Ingredient matches for Reliezen

Diazepam

Diazepam is reported as an ingredient of Reliezen in the following countries:

• Japan

International Drug Name Search

Pediacort

Pediacort may be available in the countries listed below.

Ingredient matches for Pediacort

Prednisolone

Prednisolone 21-steaglate (a derivative of Prednisolone) is reported as an ingredient of Pediacort in the following countries:

• Venezuela

International Drug Name Search

Acéclofenac EG

Acéclofenac EG may be available in the countries listed below.

Ingredient matches for Acéclofenac EG

Aceclofenac

Aceclofenac is reported as an ingredient of Acéclofenac EG in the following countries:

• France

International Drug Name Search

Anwu

Anwu may be available in the countries listed below.

Ingredient matches for Anwu

Fluvoxamine

Fluvoxamine maleate (a derivative of Fluvoxamine) is reported as an ingredient of Anwu in the following countries:

• Taiwan

International Drug Name Search

Captopril Best

Captopril Best may be available in the countries listed below.

Ingredient matches for Captopril Best

Captopril

Captopril is reported as an ingredient of Captopril Best in the following countries:

• Colombia

International Drug Name Search

Alprazolam CF

Alprazolam CF may be available in the countries listed below.

Ingredient matches for Alprazolam CF

Alprazolam

Alprazolam is reported as an ingredient of Alprazolam CF in the following countries:

• Netherlands

International Drug Name Search

Clopin

Clopin may be available in the countries listed below.

Ingredient matches for Clopin

Clozapine

Clozapine is reported as an ingredient of Clopin in the following countries:

• Switzerland

International Drug Name Search

Ceporexin

Ceporexin may be available in the countries listed below.

Ingredient matches for Ceporexin

Cefalexin

Cefalexin is reported as an ingredient of Ceporexin in the following countries:

• Argentina

International Drug Name Search

Evitex A + E

Evitex A + E may be available in the countries listed below.

Ingredient matches for Evitex A + E

Retinol

Retinol palmitate (a derivative of Retinol) is reported as an ingredient of Evitex A + E in the following countries:

• Spain

Tocopherol, α-

Tocopherol, α- nicotinate (a derivative of Tocopherol, α-) is reported as an ingredient of Evitex A + E in the following countries:

• Spain

International Drug Name Search

Alfacalcidol ratiopharm

Alfacalcidol ratiopharm may be available in the countries listed below.

Ingredient matches for Alfacalcidol ratiopharm

Alfacalcidol

Alfacalcidol is reported as an ingredient of Alfacalcidol ratiopharm in the following countries:

• Germany

International Drug Name Search

Ratio-Bisacodyl

ratio-Bisacodyl may be available in the countries listed below.

Ingredient matches for ratio-Bisacodyl

Bisacodyl

Bisacodyl is reported as an ingredient of ratio-Bisacodyl in the following countries:

• Canada

International Drug Name Search

Ibucodone

Ibucodone may be available in the countries listed below.

Ingredient matches for Ibucodone

Hydrocodone

Hydrocodone tartrate (a derivative of Hydrocodone) is reported as an ingredient of Ibucodone in the following countries:

• Canada

Ibuprofen

Ibuprofen is reported as an ingredient of Ibucodone in the following countries:

• Canada

International Drug Name Search

Anprociclina

Anprociclina may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Anprociclina

Oxytetracycline

Oxytetracycline is reported as an ingredient of Anprociclina in the following countries:

• Italy

International Drug Name Search

Captopril Ranbaxy

Captopril Ranbaxy may be available in the countries listed below.

Ingredient matches for Captopril Ranbaxy

Captopril

Captopril is reported as an ingredient of Captopril Ranbaxy in the following countries:

• Spain

International Drug Name Search

Fluconazol Infarmasa

Fluconazol Infarmasa may be available in the countries listed below.

Ingredient matches for Fluconazol Infarmasa

Fluconazole

Fluconazole is reported as an ingredient of Fluconazol Infarmasa in the following countries:

• Peru

International Drug Name Search

Clorazepaatdikalium CF

Clorazepaatdikalium CF may be available in the countries listed below.

Ingredient matches for Clorazepaatdikalium CF

Dipotassium Clorazepate

Dipotassium Clorazepate is reported as an ingredient of Clorazepaatdikalium CF in the following countries:

• Netherlands

International Drug Name Search

Tersigan

Tersigan may be available in the countries listed below.

Ingredient matches for Tersigan

Oxitropium Bromide

Oxitropium Bromide is reported as an ingredient of Tersigan in the following countries:

• Japan

International Drug Name Search

Amoxicillin plus Heumann

Amoxicillin plus Heumann may be available in the countries listed below.

Ingredient matches for Amoxicillin plus Heumann

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicillin plus Heumann in the following countries:

• Germany

Clavulanate

Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Amoxicillin plus Heumann in the following countries:

• Germany

International Drug Name Search

Glurenor

Glurenor may be available in the countries listed below.

Ingredient matches for Glurenor

Gliquidone

Gliquidone is reported as an ingredient of Glurenor in the following countries:

• Bahrain


• Cyprus


• Egypt


• Iraq


• Italy


• Jordan


• Kuwait


• Lebanon


• Libya


• Morocco


• Qatar


• Saudi Arabia


• Spain


• Sudan


• Syria


• Thailand


• Tunisia


• United Arab Emirates


• Yemen

International Drug Name Search

Tansulosina Mepha

Tansulosina Mepha may be available in the countries listed below.

Ingredient matches for Tansulosina Mepha

Tamsulosin

Tamsulosin hydrochloride (a derivative of Tamsulosin) is reported as an ingredient of Tansulosina Mepha in the following countries:

• Portugal

International Drug Name Search

Amlodipina Ilab

Amlodipina Ilab may be available in the countries listed below.

Ingredient matches for Amlodipina Ilab

Amlodipine

Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Amlodipina Ilab in the following countries:

• Argentina

International Drug Name Search

Pamipro

Pamipro may be available in the countries listed below.

Ingredient matches for Pamipro

Pamidronic Acid

Pamidronic Acid disodium salt (a derivative of Pamidronic Acid) is reported as an ingredient of Pamipro in the following countries:

• Netherlands

International Drug Name Search

Risdonal

Risdonal may be available in the countries listed below.

Ingredient matches for Risdonal

Risperidone

Risperidone is reported as an ingredient of Risdonal in the following countries:

• Croatia (Hrvatska)


• Russian Federation

International Drug Name Search

Gen-Nizatidine

Gen-Nizatidine may be available in the countries listed below.

Ingredient matches for Gen-Nizatidine

Nizatidine

Nizatidine is reported as an ingredient of Gen-Nizatidine in the following countries:

• Canada

International Drug Name Search

Pronor

Pronor may be available in the countries listed below.

Ingredient matches for Pronor

Finasteride

Finasteride is reported as an ingredient of Pronor in the following countries:

• Bangladesh

International Drug Name Search

Tri-Levlen

In the US, Tri-Levlen (ethinyl estradiol/levonorgestrel systemic) is a member of the drug class contraceptives and is used to treat Abnormal Uterine Bleeding, Birth Control, Endometriosis, Gonadotropin Inhibition, Ovarian Cysts and Polycystic Ovary Syndrome.

US matches:

• Tri-Levlen

Ingredient matches for Tri-Levlen

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Tri-Levlen in the following countries:

• United States

Levonorgestrel

Levonorgestrel is reported as an ingredient of Tri-Levlen in the following countries:

• United States

International Drug Name Search

Progro S

Progro S may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Progro S

Estradiol

Estradiol 3-benzoate (a derivative of Estradiol) is reported as an ingredient of Progro S in the following countries:

• Australia

Progesterone

Progesterone is reported as an ingredient of Progro S in the following countries:

• Australia

International Drug Name Search

Arcalion

Arcalion may be available in the countries listed below.

Ingredient matches for Arcalion

Sulbutiamine

Sulbutiamine is reported as an ingredient of Arcalion in the following countries:

• Bahrain


• Brazil


• Chile


• Colombia


• Costa Rica


• Dominican Republic


• Egypt


• El Salvador


• France


• Ghana


• Guatemala


• Guyana


• Honduras


• Hong Kong


• India


• Iraq


• Jordan


• Kuwait


• Lebanon


• Luxembourg


• Malaysia


• Malta


• Mexico


• Nicaragua


• Nigeria


• Oman


• Panama


• Peru


• Philippines


• Portugal


• Qatar


• Saudi Arabia


• Singapore


• Spain


• Sudan


• Switzerland


• Syria


• Thailand


• Turkey


• United Arab Emirates


• Venezuela


• Vietnam


• Yemen

International Drug Name Search

Meptin Air

Meptin Air may be available in the countries listed below.

Ingredient matches for Meptin Air

Procaterol

Procaterol hydrochloride (a derivative of Procaterol) is reported as an ingredient of Meptin Air in the following countries:

• Indonesia

International Drug Name Search

Alendron Winthrop

Alendron Winthrop may be available in the countries listed below.

Ingredient matches for Alendron Winthrop

Alendronic Acid

Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Alendron Winthrop in the following countries:

• Germany

International Drug Name Search

Ramipril 5mg Tablet

1. Name Of The Medicinal Product

Ramipril 5mg tablet

2. Qualitative And Quantitative Composition

Ramipril 5mg tablets contain 5mg ramipril per tablet

For excipients, see 6.1

3. Pharmaceutical Form

Tablet

Ramipril 5mg: oblong shaped tablet (15 x 6.5mm), light pink speckled, scoreline on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

- Treatment of hypertension.

- Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with:

	• manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or
	• diabetes with at least one cardiovascular risk factor (see section 5.1).

- Treatment of renal disease:

	• Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria,
	• Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1),
	• Manifest glomerular non diabetic nephropathy as defined by macroproteinuria

- Treatment of symptomatic heart failure.

- Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction.

4.2 Posology And Method Of Administration

Oral use.

It is recommended that Ramipril is taken each day at the same time of the day.

Ramipril can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2). Ramipril has to be swallowed with liquid. It must not be chewed or crushed.

Adults

Diuretic-Treated patients

Hypotension may occur following initiation of therapy with Ramipril; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume and/or salt depleted.

If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with Ramipril (see section 4.4).

In hypertensive patients in whom the diuretic is not discontinued, therapy with Ramipril should be initiated with a 1.25 mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of Ramipril should be adjusted according to blood pressure target.

Hypertension

The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.

Ramipril may be used in monotherapy or in combination with other classes of antihypertensive medicinal products.

Starting dose

Ramipril should be started gradually with an initial recommended dose of 2.5 mg daily.

Patients with a strongly activated renin-angiotensin-aldosterone system may experience an excessive drop in blood pressure following the initial dose. A starting dose of 1.25 mg is recommended in such patients and the initiation of treatment should take place under medical supervision (see section 4.4).

Titration and maintenance dose

The dose can be doubled at interval of two to four weeks to progressively achieve target blood pressure; the maximum permitted dose of Ramipril is 10 mg daily. Usually the dose is administered once daily.

Cardiovascular prevention

Starting dose

The recommended initial dose is 2.5 mg of Ramipril once daily.

Titration and maintenance dose

Depending on the patient's tolerability to the active substance, the dose should be gradually increased. It is recommended to double the dose after one or two weeks of treatment and - after another two to three weeks - to increase it up to the target maintenance dose of 10 mg Ramipril once daily.

See also posology on diuretic treated patients above.

Treatment of renal disease

In patients with diabetes and microalbuminuria:

Starting dose:

The recommended initial dose is 1.25 mg of Ramipril once daily.

Titration and maintenance dose

Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the once daily dose to 2.5 mg after two weeks and then to 5 mg after a further two weeks is recommended.

In patients with diabetes and at least one cardiovascular risk

Starting dose:

The recommended initial dose is 2.5 mg of Ramipril once daily.

Titration and maintenance dose

Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the daily dose to 5 mg Ramipril after one or two weeks and then to 10 mg Ramipril after a further two or three weeks is recommended. The target daily dose is 10 mg.

In patients with non- diabetic nephropathy as defined by macroproteinuria

Starting dose:

The recommended initial dose is 1.25 mg of Ramipril once daily.

Titration and maintenance dose

Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the once daily dose to 2.5 mg after two weeks and then to 5 mg after a further two weeks is recommended.

Symptomatic heart failure

Starting dose

In patients stabilized on diuretic therapy, the recommended initial dose is 1.25 mg daily.

Titration and maintenance dose

Ramipril should be titrated by doubling the dose every one to two weeks up to a maximum daily dose of 10 mg. Two administrations per day are preferable.

Secondary prevention after acute myocardial infarction and with heart failure

Starting dose

After 48 hours, following myocardial infarction in a clinically and haemodynamically stable patient, the starting dose is 2.5 mg twice daily for three days. If the initial 2.5 mg dose is not tolerated a dose of 1.25 mg twice a day should be given for two days before increasing to 2.5 mg and 5 mg twice a day. If the dose cannot be increased to 2.5 mg twice a day the treatment should be withdrawn.

See also posology on diuretic treated patients above.

Titration and maintenance dose

The daily dose is subsequently increased by doubling the dose at intervals of one to three days up to the target maintenance dose of 5 mg twice daily.

The maintenance dose is divided in 2 administrations per day where possible.

If the dose cannot be increased to 2.5 mg twice a day treatment should be withdrawn. Sufficient experience is still lacking in the treatment of patients with severe (NYHA IV) heart failure immediately after myocardial infarction. Should the decision be taken to treat these patients, it is recommended that therapy be started at 1.25 mg once daily and that particular caution be exercised in any dose increase.

Special populations

Patients with renal impairment

Daily dose in patients with renal impairment should be based on creatinine clearance (see section 5.2):

- if creatinine clearance is

- if creatinine clearance is between 30-60 ml/min, it is not necessary to adjust the initial dose (2.5 mg/day); the maximal daily dose is 5 mg;

- if creatinine clearance is between 10-30 ml/min, the initial dose is 1.25 mg/day and the maximal daily dose is 5 mg;

- in haemodialysed hypertensive patients: ramipril is slightly dialysable; the initial dose is 1.25 mg/day and the maximal daily dose is 5 mg; the medicinal product should be administered few hours after haemodialysis is performed.

Patients with hepatic impairment (see section 5.2)

In patients with hepatic impairment, treatment with Ramipril must be initiated only under close medical supervision and the maximum daily dose is 2.5 mg Ramipril.

Elderly

Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable effects especially in very old and frail patients. A reduced initial dose of 1.25 mg ramipril should be considered.

Paediatric population

Ramipril is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.

4.3 Contraindications

• Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin Converting Enzyme) inhibitors (see section 6.1)

• History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or AIIRAs)

• Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5)

• Significant bilateral renal artery stenosis or renal artery stenosis in a single functioningkidney

• 2^nd and 3^rd trimester of pregnancy (see sections 4.4 and 4.6)

• Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.

4.4 Special Warnings And Precautions For Use

Special populations

Pregnancy: ACE inhibitors such as ramipril, or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued ACE inhibitor/ AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors/ AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).

      • Patients at particular risk of hypotension

- Patients with strongly activated renin-angiotensin-aldosterone system

Patients with strongly activated renin-angiotensin-aldosterone system are at risk of an acute pronounced fall in blood pressure and deterioration of renal function due to ACE inhibition, especially when an ACE inhibitor or a concomitant diuretic is given for the first time or at first dose increase.

Significant activation of renin-angiotensin-aldosterone system is to be anticipated and medical supervision including blood pressure monitoring is necessary, for example in:

- patients with severe hypertension

- patients with decompensated congestive heart failure

- patients with haemodynamically relevant left ventricular inflow or outflow impediment (e.g. stenosis of the aortic or mitral valve)

- patients with unilateral renal artery stenosis with a second functional kidney

- patients in whom fluid or salt depletion exists or may develop (including patients with diuretics)

- patients with liver cirrhosis and/or ascites

- patients undergoing major surgery or during anaesthesia with agents that produce hypotension.

Generally, it is recommended to correct dehydration, hypovolaemia or salt depletion before initiating treatment (in patients with heart failure, however, such corrective action must be carefully weighed out against the risk of volume overload).

- Transient or persistent heart failure post MI

- Patients at risk of cardiac or cerebral ischemia in case of acute hypotension

The initial phase of treatment requires special medical supervision.

      • Elderly patients

See section 4.2.

Surgery

It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery.

Monitoring of renal function

Renal function should be assessed before and during treatment and dosage adjusted especially in the initial weeks of treatment. Particularly careful monitoring is required in patients with renal impairment (see section 4.2). There is a risk of impairment of renal function, particularly in patients with congestive heart failure or after a renal transplant.

Angioedema

Angioedema has been reported in patients treated with ACE inhibitors including ramipril (see section 4.8).

In case of angioedema, Ramipril must be discontinued.

Emergency therapy should be instituted promptly. Patient should be kept under observation for at least 12 to 24 hours and discharged after complete resolution of the symptoms.

Intestinal angioedema has been reported in patients treated with ACE inhibitors including Ramipril (see section 4.8). These patients presented with abdominal pain (with or without nausea or vomiting).

Anaphylactic reactions during desensitization

The likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens are increased under ACE inhibition. A temporary discontinuation of Ramipril should be considered prior to desensitization.

Hyperkalaemia

Hyperkalaemia has been observed in some patients treated with ACE inhibitors including Ramipril. Patients at risk for development of hyperkalaemia include those with renal insufficiency, age (> 70 years), uncontrolled diabetes mellitus, or those using potassium salts, potassium retaining diuretics and other plasma potassium increasing active substances, or conditions such as dehydration, acute cardiac decompensation, metabolic acidosis. If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended (see section 4.5).

Neutropenia/agranulocytosis

Neutropenia/agranulocytosis, as well as thrombocytopenia and anaemia, have been rarely seen and bone marrow depression has also been reported. It is recommended to monitor the white blood cell count to permit detection of a possible leucopoenia. More frequent monitoring is advised in the initial phase of treatment and in patients with impaired renal function, those with concomitant collagen disease (e.g. lupus erythematosus or scleroderma), and all those treated with other medicinal products that can cause changes in the blood picture (see sections 4.5 and 4.8).

Ethnic differences

ACE inhibitors cause higher rate of angioedema in black patients than in non black patients.

As with other ACE inhibitors, ramipril may be less effective in lowering blood pressure in black people than in non black patients, possibly because of a higher prevalence of hypertension with low renin level in the black hypertensive population.

Cough

Cough has been reported with the use of ACE inhibitors. Characteristically, the cough is non-productive, persistent and resolves after discontinuation of therapy. ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Contra-indicated combinations

Extracorporeal treatments leading to contact of blood with negatively charged surfaces such as dialysis or haemofiltration with certain high-flux membranes (e.g. polyacrylonitril membranes) and low density lipoprotein apheresis with dextran sulphate due to increased risk of severe anaphylactoid reactions (see section 4.3). If such treatment is required, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.

Precautions for use

Potassium salts, heparin, potassium-retaining diuretics and other plasma potassium increasing active substances (including Angiotensin II antagonists, trimethoprim, tacrolimus, ciclosporin): Hyperkalaemia may occur, therefore close monitoring of serum potassium is required.

Antihypertensive agents (e.g. diuretics) and other substances that may decrease blood pressure (e.g. nitrates, tricyclic antidepressants, anaesthetics, acute alcohol intake, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin): Potentiation of the risk of hypotension is to be anticipated (see section 4.2 for diuretics)

Vasopressor sympathomimetics and other substances (e.g. isoproterenol, dobutamine, dopamine, epinephrine) that may reduce the antihypertensive effect of Ramipril: Blood pressure monitoring is recommended.

Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count: Increased likelihood of haematological reactions (see section 4.4).

Lithium salts: Excretion of lithium may be reduced by ACE inhibitors and therefore lithium toxicity may be increased. Lithium level must be monitored.

Antidiabetic agents including insulin: Hypoglycaemic reactions may occur. Blood glucose monitoring is recommended.

Non-steroidal anti-inflammatory drugs and acetylsalicylic acid: Reduction of the antihypertensive effect of Ramipril is to be anticipated. Furthermore, concomitant treatment of ACE inhibitors and NSAIDs may lead to an increased risk of worsening of renal function and to an increase in kalaemia.

4.6 Pregnancy And Lactation

Ramipril is not recommended during the first trimester of pregnancy (see section 4.4) and contraindicated during the second and third trimesters of pregnancy (see section 4.3).

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.

ACE inhibitor/ Angiotensin II Receptor Antagonist (AIIRA) therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). (See also 5.3 'Preclinical safety data'). Should exposure to ACE inhibitor have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Newborns whose mothers have taken ACE inhibitors should be closely observed for hypotension, oliguria and hyperkalaemia (see also sections 4.3 and 4.4).

Because insufficient information is available regarding the use of ramipril during breastfeeding (see section 5.2), ramipril is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

4.7 Effects On Ability To Drive And Use Machines

Some adverse effects (e.g. symptoms of a reduction in blood pressure such as dizziness) may impair the patient's ability to concentrate and react and, therefore, constitute a risk in situations where these abilities are of particular importance (e.g. operating a vehicle or machinery).

This can happen especially at the start of treatment, or when changing over from other preparations. After the first dose or subsequent increases in dose it is not advisable to drive or operate machinery for several hours.

4.8 Undesirable Effects

The safety profile of ramipril includes persistent dry cough and reactions due to hypotension. Serious adverse reactions include angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/agranulocytosis.

Adverse reactions frequency is defined using the following convention:

Very common (

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System Organ Class	Common	Uncommon	Rare	Very rare	Not known
Cardiac disorders		Myocardial ischaemia including angina pectoris or myocardial infarction, tachycardia, arrhythmia, palpitations, oedema peripheral
Blood and the lymphatic system disorders		Eosinophilia	White blood cell count decreased (including neutropenia or agranulocytosis), red blood cell count decreased, haemoglobin decreased, platelet count decreased		Bone marrow failure, pancytopenia, haemolytic anaemia
Nervous system disorders	Headache, dizziness	Vertigo, paraesthesia, ageusia, dysgeusia,	Tremor, balance disorder		Cerebral ischaemia including ischaemic stroke and transient ischaemic attack, psychomotor skills impaired, burning sensation, parosmia
Eye disorders		Visual disturbance including blurred vision	Conjunctivitis
Ear and labyrinth disorders			Hearing impaired, tinnitus
Respiratory, thoracic and mediastinal disorders	Non-productive tickling cough, bronchitis, sinusitis, dyspnoea	Bronchospasm including asthma aggravated, nasal congestion
Gastrointestinal disorders	Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting	Pancreatitis (cases of fatal outcome have been very exceptionally reported with ACE inhibitors), pancreatic enzymes increased, small bowel angioedema, abdominal pain upper including gastritis, constipation, dry mouth	Glossitis		Aphtous stomatitis
Renal and urinary disorders		Renal impairment including renal failure acute, urine output increased, worsening of a pre-existing proteinuria, blood urea increased, blood creatinine increased
Skin and subcutaneous tissue disorders	Rash in particular maculo-papular	Angioedema; very exceptionally, the airway obstruction resulting from angioedema may have a fatal outcome; pruritus, hyperhidrosis	Exfoliative dermatitis, urticaria, onycholysis,	Photosensitivity reaction	Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, psoriasis aggravated, dermatitis psoriasiform, pemphigoid or lichenoid exanthema or enanthema, alopecia
Musculoskeletal, connective tissue and bone disorders	Muscle spasms, myalgia	Arthralgia
Metabolism and nutrition disorders	Blood potassium increased	Anorexia, decreased appetite,			Blood sodium decreased
Vascular disorders	Hypotension, orthostatic blood pressure decreased, syncope	Flushing	Vascular stenosis, hypoperfusion, vasculitis		Raynaud's phenomenon
General disorders and administration site conditions	Chest pain, fatigue	Pyrexia	Asthenia
Immune system disorders					Anaphylactic or anaphylactoid reactions, antinuclear antibody increased
Hepato-biliary disorders		Hepatic enzymes and/or bilirubin conjugated increased,	Jaundice cholestatic, hepatocellular damage		Acute hepatic failure, cholestatic or cytolytic hepatitis (fatal outcome has been very exceptional).
Reproductive system and breast disorders		Transient erectile impotence, libido decreased			Gynaecomastia
Psychiatric disorders		Depressed mood, anxiety, nervousness, restlessness, sleep disorder including somnolence	Confusional state		Disturbance in attention

4.9 Overdose

Symptoms associated with overdosage of ACE inhibitors may include excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure. The patient should be closely monitored and the treatment should be symptomatic and supportive. Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including, administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration. Ramiprilat, the active metabolite of ramipril is poorly removed from the general circulation by haemodialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: ACE Inhibitors, plain, ATC code C09AA05.

Mechanism of action

Ramiprilat, the active metabolite of the prodrug ramipril, inhibits the enzyme dipeptidylcarboxypeptidase I (synonyms: angiotensin-converting enzyme; kininase II). In plasma and tissue this enzyme catalyses the conversion of angiotensin I to the active vasoconstrictor substance angiotensin II, as well as the breakdown of the active vasodilator bradykinin. Reduced angiotensin II formation and inhibition of bradykinin breakdown lead to vasodilatation.

Since angiotensin II also stimulates the release of aldosterone, ramiprilat causes a reduction in aldosterone secretion. The average response to ACE inhibitor monotherapy was lower in black (Afro-Caribbean) hypertensive patients (usually a low-renin hypertensive population) than in non-black patients.

Pharmacodynamic effects

Antihypertensive properties:

Administration of ramipril causes a marked reduction in peripheral arterial resistance. Generally, there are no major changes in renal plasma flow and glomerular filtration rate. Administration of ramipril to patients with hypertension leads to a reduction in supine and standing blood pressure without a compensatory rise in heart rate.

In most patients the onset of the antihypertensive effect of a single dose becomes apparent 1 to 2 hours after oral administration. The peak effect of a single dose is usually reached 3 to 6 hours after oral administration. The antihypertensive effect of a single dose usually lasts for 24 hours.

The maximum antihypertensive effect of continued treatment with ramipril is generally apparent after 3 to 4 weeks. It has been shown that the antihypertensive effect is sustained under long term therapy lasting 2 years.

Abrupt discontinuation of ramipril does not produce a rapid and excessive rebound increase in blood pressure.

Heart failure:

In addition to conventional therapy with diuretics and optional cardiac glycosides, ramipril has been shown to be effective in patients with functional classes II-IV of the New-York Heart Association. The drug had beneficial effects on cardiac haemodynamics (decreased left and right ventricular filling pressures, reduced total peripheral vascular resistance, increased cardiac output and improved cardiac index). It also reduced neuroendocrine activation.

Clinical efficacy and safety

Cardiovascular prevention/Nephroprotection;

A preventive placebo-controlled study (the HOPE-study), was carried out in which ramipril was added to standard therapy in more than 9,200 patients. Patients with increased risk of cardiovascular disease following either atherothrombotic cardiovascular disease (history of coronary heart disease, stroke or peripheral vascular disease) or diabetes mellitus with at least one additional risk factor (documented microalbuminuria, hypertension, elevated total cholesterol level, low high-density lipoprotein cholesterol level or cigarette smoking) were included in the study.

The study showed that ramipril statistically significantly decreases the incidence of myocardial infarction, death from cardiovascular causes and stroke, alone and combined (primary combined events).

The HOPE study: Main results

	Ramipril	Placebo	relative risk (95% confidence interval)	p-value
%	%
All patients	N = 4,645	N = 4,652
Primary combined events	14.0	17.8	0.78 (0.70-0.86)	< 0.001
Myocardial infarction	9.9	12.3	0.80 (0.70-0.90)	< 0.001
Death from cardiovascular causes	6.1	8.1	0.74 (0.64-0.87)	< 0.001
Stroke	3.4	4.9	0.68 (0.56-0.84)	< 0.001
Secondary endpoints
Death from any cause	10.4	12.2	0.84 (0.75-0.95)	0.005
Need for Revascularisation	16.0	18.3	0.85 (0.77-0.94)	0.002
Hospitalisation for unstable angina	12.1	12.3	0.98 (0.87-1.10)	NS
Hospitalisation for heart failure	3.2	3.5	0.88 (0.70-1.10)	0.25
Complications related to diabetes	6.4	7.6	0.84 (0.72-0.98)	0.03

The MICRO-HOPE study, a predefined substudy from HOPE, investigated the effect of the addition of ramipril 10 mg to the current medical regimen versus placebo in 3,577 patients at least

The primary analysis showed that 117 (6.5 %) participants on ramipril and 149 (8.4 %) on placebo developed overt nephropathy, which corresponds to a RRR 24 %; 95 % CI [3-40], p = 0.027.

The REIN study, a multicenter randomized, double-blind parallel group, placebo-controlled study aimed at assessing the effect of treatment with ramipril on the rate of decline of glomerular function rate (GFR) in 352 normotensive or hypertensive patients (18-70 years old) suffering from mild (i.e. mean urinary protein excretion > 1 and < 3 g/24 h) or severe proteinuria (

The main analysis of patients with the most severe proteinuria (stratum prematurely disrupted due to benefit in ramipril group) showed that the mean rate of GFR decline per month was lower with ramipril than with placebo; -0.54 (0.66) vs. -0.88 (1.03) ml/min/month, p = 0.038. The intergroup difference was thus 0.34 [0.03-0.65] per month, and around 4 ml/min/year; 23.1 % of the patients in the ramipril group reached the combined secondary endpoint of doubling of baseline serum creatinine concentration and/or end-stage renal disease (ESRD) (need for dialysis or renal transplantation) vs. 45.5 % in the placebo group (p = 0.02).

Secondary prevention after acute