BENDAMUSTINE HYDROCHLORIDE ACCORD Powder for concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Bendamustine hydrochloride Accord 2.5 mg/ml Powder for concentrate for solution for infusion.
Qualitative and quantitative composition
One vial contains 25 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate). One vial contains 100 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate). 1 ml of ...
Pharmaceutical form
Powder for concentrate for solution for infusion. White, microcrystalline powder.
Therapeutic indications
First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate. Indolent non-Hodgkins lymphomas as monotherapy in ...
Posology and method of administration
Posology Monotherapy for chronic lymphocytic leukaemia 100 mg/m² body surface area bendamustine hydrochloride on days 1 and 2; every 4 weeks up to 6 times. Monotherapy for indolent non-Hodgkins lymphomas ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. During breast-feeding. Severe hepatic impairment (serum bilirubin >3.0 mg/dl). Jaundice. Severe bone marrow suppression ...
Special warnings and precautions for use
Myelosuppression Patients treated with bendamustine hydrochloride may experience myelosuppression. In the event of treatment-related myelosuppression, leukocytes, platelets, haemoglobin, and neutrophils ...
Interaction with other medicinal products and other forms of interaction
No in-vivo interaction studies have been performed. When Bendamustine is combined with myelosuppressive agents, the effect of Bendamustine and/or the co-administered medicinal products on the bone marrow ...
Fertility, pregnancy and lactation
Pregnancy There are insufficient data from the use of Bendamustine in pregnant women. In nonclinical studies bendamustine hydrochloride was embryo-/fetolethal, teratogenic and genotoxic (see section 5.3). ...
Effects on ability to drive and use machines
Bendamustine hydrochloride has major influence on the ability to drive and use machines. Ataxia, peripheral neuropathy and somnolence have been reported during treatment with Bendamustine hydrochloride ...
Undesirable effects
The most common adverse reactions with bendamustine hydrochloride are hematological adverse reactions (leukopenia, thrombopenia), dermatologic toxicities (allergic reactions), constitutional symptoms (fever), ...
Overdose
After application of a 30 min infusion of Bendamustine once every 3 weeks the maximum tolerated dose (MTD) was 280 mg/m². Cardiac events of CTC grade 2 which were compatible with ischaemic ECG changes ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, alkylating agents ATC code: L01AA09 Bendamustine hydrochloride is an alkylating antitumour agent with unique activity. The antineoplastic and cytocidal ...
Pharmacokinetic properties
Distribution The elimination half-life t1/2ß after 30 min i.v. infusion of 120 mg/m² area to 12 subjects was 28.2 minutes. Following 30 min i.v. infusion the central volume of distribution was 19.3 l. ...
Preclinical safety data
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: Histological ...
List of excipients
Mannitol
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life: 3 years. The powder should be reconstituted immediately after opening of the vial. The reconstituted concentrate should be diluted immediately with 0.9% sodium chloride solution. Solution for ...
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Keep the vial in the outer carton in order to protect from light. For storage conditions of the reconstituted or diluted ...
Nature and contents of container
Type I amber glass vials of 10 ml or 50 ml with bromobutyl rubber stopper and an aluminium flip-off cap. 10 ml-vials contain 25 mg bendamustine hydrochloride and are supplied in packs of 5, 10 and 20 vials. ...
Special precautions for disposal and other handling
When handling Bendamustine, inhalation, skin contact or contact with mucous membranes should be avoided (wear gloves and protective clothes!). Contaminated body parts should be carefully rinsed with water ...
Marketing authorization holder
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom
Marketing authorization number(s)
PL 20075/0459
Date of first authorization / renewal of the authorization
Date of first authorisation: 20<sup>th</sup> November 2015
Date of revision of the text
18/07/2019
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