EPIRUBICIN HYDROCHLORIDE Solution for injection or infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Epirubicin Hydrochloride 2 mg/ml solution for injection or infusion.
Qualitative and quantitative composition
Each ml contains 2 mg epirubicin hydrochloride. Each 5/10/25/50/100 ml vial contains 10/20/50/100/200 mg epirubicin hydrochloride. Excipient: Contains sodium 3.54 mg/ml (0.154 mmol). For a full list of ...
Pharmaceutical form
Solution for injection or infusion. A clear red solution.
Therapeutic indications
Epirubicin is used in the treatment of a range of neoplastic conditions including; Carcinoma of the breast Gastric cancer When administered intravesically, epirubicin has been shown to be beneficial in ...
Posology and method of administration
Epirubicin is for intravenous or intravesical use only. The safety and efficacy of epirubicin in children has not been established Intravenous administration It is advisable to administer epirubicin via ...
Contraindications
Epirubicin is contraindicated in: Patients who have demonstrated hypersensitivity to the active substance or to any of the excipients, other anthracyclines or anthracenediones Lactation Intravenous use: ...
Special warnings and precautions for use
General Epirubicin hydrochloride should be administered only under the supervision of a qualified physician who is experienced in the use of cytotoxic therapy. Patients should recover from acute toxicities ...
Interaction with other medicinal products and other forms of interaction
Epirubicin hydrochlorideis mainly used in combination with other cytotoxic drugs. Additive toxicity may occur especially with regard to bone marrow/haematologic and gastrointestinal effects (see section ...
Fertility, pregnancy and lactation
Fertility Epirubicin hydrochloride could induce chromosomal damage in human spermatozoa. Men undergoing treatment with epirubicin hydrochloride should use effective contraceptive methods and if appropriate ...
Effects on ability to drive and use machines
There have been no reports of particular adverse events relating to effects on ability to drive and to use machines.
Undesirable effects
Τhe following undesirable effects have been observed and reported during treatment with epirubicin with the following frequencies: Very Common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1,000 to <1/100, ...
Overdose
Acute overdosage with epirubicin hydrochloride will result in severe myelosuppression (mainly leucopoenia and thrombocytopenia), gastrointestinal toxic effects (mainlymucosal inflammation) and acute cardiac ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anthracyclines and related substances ATC code: L01DB03 The mechanism of action of epirubicin hydrochloride is related to its ability to bind to DNA. Cell culture studies have ...
Pharmacokinetic properties
In patients with normal hepatic and renal function, plasma levels after I.V. injection of 60-150 mg/m² of the drug follow a tri-exponential decreasing pattern with a very fast first phase and a slow terminal ...
Preclinical safety data
The main target organs in rat, rabbit and dog following repeated dosing were the haemolymphopoietic system, GI tract, kidney, liver and reproductive organs. Epirubicin hydrochloride was also cardiotoxic ...
List of excipients
Sodium Chloride Hydrochloric acid (For pH adjustment) Water for Injections
Incompatibilities
Epirubicin hydrochloride contact with any solution of an alkaline pH should be avoided as it will result in hydrolysis of the drug. Epirubicin hydrochloride should not be mixed with heparin due to chemical ...
Shelf life
<u>Shelf life of the product as package for sale:</u> 2 year. <u>Shelf life after first opening the container:</u> The vials are for single use only and any unused portion must be discarded after use. ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage after dilution, see section 6.3.
Nature and contents of container
<u>5 and 10 ml vials:</u> Type I tubular glass vial with 20 mm chlorobutyl RTS rubber stopper and aluminium flip-off white seal. <u>25 ml vial:</u> Type I tubular glass vial with 20 mm chlorobutyl RTS ...
Special precautions for disposal and other handling
Epirubicin Hydrochloride 2 mg/ml Injection may be further diluted in Glucose 5% or Sodium Chloride 0.9% and administered as an intravenous infusion. For information on the stability of the infusion solutions, ...
Marketing authorization holder
Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Marketing authorization number(s)
PL 20075/0024
Date of first authorization / renewal of the authorization
19.02.2009
Date of revision of the text
26/03/2019
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