GEMCITABINE / HOSPIRA Concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Gemcitabine 38 mg/ml Concentrate for Solution for Infusion.
Qualitative and quantitative composition
One ml of Gemcitabine Concentrate for Solution for Infusion contains gemcitabine hydrochloride, equivalent to 38 mg gemcitabine. The quantitative composition of each presentation is provided in the table ...
Pharmaceutical form
Concentrate for solution for infusion. A clear, colourless or light straw-coloured solution, practically free from visible particles. pH: 2.0-3.0 Osmolarity: 266 mOsmol/L
Therapeutic indications
Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin. Gemcitabine is indicated for treatment of patients with locally advanced or metastatic ...
Posology and method of administration
Gemcitabine should only be prescribed by a physician qualified in the use of anti-cancer chemotherapy. Recommended posology Bladder cancer Combination use The recommended dose for gemcitabine is 1000 mg/m², ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding (see section 4.6).
Special warnings and precautions for use
Prolongation of the infusion time and increased dosing frequency have been shown to increase toxicity. Haematological toxicity Gemcitabine can suppress bone marrow function as manifested by leucopaenia, ...
Interaction with other medicinal products and other forms of interaction
No specific interaction studies have been performed (see section 5.2) Radiotherapy Concurrent (given together or ≤7 days apart): Toxicity associated with this multimodality therapy is dependent on many ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of gemcitabine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Based on results from animal studies and the mechanism ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, gemcitabine has been reported to cause mild to moderate somnolence, especially in combination with alcohol ...
Undesirable effects
The most commonly reported adverse drug reactions associated with Gemcitabine treatment include: nausea with or without vomiting, raised liver transaminases (AST/ALT) and alkaline phosphatase, reported ...
Overdose
There is no known antidote for overdose of gemcitabine. Doses as high as 5700 mg/m² have been administered by intravenous infusion over 30-minutes every 2 weeks with clinically acceptable toxicity. In ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents/pyrimidine analogues. ATC code: L01BC05 Mechanism of action Cellular metabolism and mechanism of action Gemcitabine (dFdC), which is a pyrimidine antimetabolite, ...
Pharmacokinetic properties
The pharmacokinetics of gemcitabine have been examined in 353 patients in seven studies. The 121women and 232 men ranged in age from 29 to 79 years. Of these patients, approximately 45% had non-small cell ...
Preclinical safety data
In repeat-dose studies of up to 6 months in duration in mice and dogs, the principal finding was schedule and dose-dependent haematopoietic suppression which was reversible. Gemcitabine is mutagenic in ...
List of excipients
Water for injections Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (E524) (for pH adjustment)
Incompatibilities
This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vial: 18 months. In-Use: Further dilution: After dilution, chemical and physical in-use stability has been demonstrated for: Diluent Target Concentration Storage Conditions Time period ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
200 mg/5.3 ml presentation: A 10ml, Type I clear glass vial, stoppered with a chlorobutyl closure and sealed with an aluminium seal and flip-off top. Each vial of the 200mg presentation contains 5.3ml ...
Special precautions for disposal and other handling
Handling The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution. Handling of the concentrate should be done in a safety box and protective ...
Marketing authorization holder
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK
Marketing authorization number(s)
PL 04515/0224
Date of first authorization / renewal of the authorization
First Authorisation: 23<sup>rd</sup> December 2010 Date of latest renewal: 14<sup>th</sup> December 2015
Date of revision of the text
07/2019
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