Medica RCP |Bendamustine Accord 25mg | Indications | Side Effects | Composition | Route | all.price

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Products » Items » Bendamustine Accord 25mg

Contraindicated
Teratogenic, foetotoxic and embryotoxic

Contraindicated

Bendamustine Accord 25mg :
Type	Medicine Authorised
Originator	Ribomustin 25mg*
Agent	Mediterranean Pharmaceutical Company
Distributor	Mediterranean Pharmaceutical Company
Laboratory	Accord HealthCare
Responsible Party	Accord Healthcare Limited
Origin	UK
Manufacturer	Accord healthcare Limited
Manufacturing Type	G
Origin	UK
ATC	L01AA09

Bendamustine Accord 25mg :

Injectable

Intravenous

Bendamustine Accord 25mg :

L Antineoplastic and immunomodulating agents

L01 Antineoplastic agents

L01A Alkylating agents

L01AA Nitrogen mustard analogues

L01AA09 Bendamustine

Bendamustine Accord 25mg :

Bendamustine : 25mg/ml

Bendamustine Accord 25mg :

Chronic lymphocytic leukaemia 100mg/m² on Days 1 + 2

Lymphomas non-Hodgkin's T-cell 120mg/m² on Days 1 + 2

Multiple myeloma 120-150mg/m² on Days 1 + 2

Bendamustine Accord 25mg :

Mannitol (E421)* Digestive disorders

* Excipient with known effect

Hazard Level
◼ Major
◼ Moderate
◼ Minor
◼ Safe

Bendamustine Accord 25mg :

Revision Date : 01/06/2012

Frequency	Percentage
Very Common	≥ 1/10
Common	≥ 1/100 - < 1/10
Uncommon	≥ 1/1,000 - < 1/100
Rare	≥ 1/10,000 - < 1/1,000
Very Rare	< 1/10,000
Unknown	Cannot be Estimated

Effect	Frequency
Alopecia	Very Common
ALT increased	Common
Amenorrhoea (amenorrhea)	Common
Anaemia	Common
Anaphylactic reactions	Rare
Anaphylactic shock	Very rare
Anaphylactoid reactions	Rare
Angina pectoris	Common
Anorexia	Common
Anticholinergic syndrome	Very rare
Aphonia (Loss of voice)	Rare
Arrhythmia	Common
AST increased	Common
Ataxia	Very rare
Blood bilirubin increased	Common
Blood urea increased	Very Common
Bronchopneumopathy	Very rare
Cardiopulmonary failure	Very rare
Chills	Common
Constipation	Common
Creatinine increased	Very Common
Dehydration	Common
Dermatitis	Rare
Dermatitis allergic	Common
Diarrhoea (Diarrhea)	Common
Dysguesia (taste perversion) (Taste abnormality) (Taste disturbance)	Very rare
Encephalitis	Very rare
Erythema	Rare
Failure circulatory	Rare
Fatigue	Very Common
Fever	Very Common
Gastroduodenal haemorrhage	Very rare
Granulocytopenia	Very Common
Haemoglobin decreased	Very Common
Haemolysis	Very rare
Haemorrhage	Common
Herpes zoster disseminated	Very rare
Hyperhidrosis	Rare
Hypersensitivity reactions	Common
Hypertension	Common
Hypokalaemia	Common
Hypotension	Common
Infection	Very Common
Infertility	Very rare
Infusion site necrosis	Very rare
Insomnia	Common
Leucopenia (Leukopenia)	Very Common
Lung disorder	Common
Lyell Syndrome (Toxic epidermal necrolysis)	Very rare
Lymphocyte count decreased	Very rare
Lymphopenia	Very Common
Maculopapular rash	Rare
Mucosal inflammation	Very Common
Multi-organ failure	Very rare
Myocardial infarction	Very rare
Nausea	Very Common
Neurological disorders	Very rare
Neuropathy peripheral	Very rare
Oesophagitis	Very rare
Oesophagitis haemorrhagic	Very rare
Pain	Common
Palpitations	Common
Paraesthesia (paresthesia)	Very rare
Pericardial effusion	Uncommon
Phlebitis	Very rare
Phosphatase alkaline increased	Common
Pruritus	Rare
Pulmonary fibrosis	Very rare
Septicemia	Rare
Skin disorders	Common
Skin rash	Rare
Somnolence	Rare
Stevens-Johnson syndrome	Very rare
Stomatitis	Common
Tachycardia	Very rare
Thrombocytopenia (Thrombopenia)	Very Common
Tumour lysis syndrome	Common
Urticaria	Common
Vomiting	Very Common

Bendamustine Accord 25mg :

Belgium

Czech Republic

Denmark

Egypt

Finland

France

Germany

Greece

Italy

Lebanon

Norway

Spain

Switzerland

The Netherlands

Form	Powder for concentrate for solution for infusion
Packaging	Bottle
Package Size	5x10ml
Strength	25mg
Public Price	11186776.19 L.L.
Stratum	D
NSSF	✔
Quarantine	✘
Reg. Number	151616/1
Submission date	27/10/2016
Registration Year	2017

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