DOXORUBICIN Concentrate for solution for infusion (2016)
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Περιεχόμενα
Name of the medicinal product
Doxorubicin 2 mg/ml Concentrate for Solution for Infusion.
Qualitative and quantitative composition
1 ml contains 2 mg Doxorubicin hydrochloride. Each 5 ml vial contains 10 mg of Doxorubicin hydrochloride. Each 10 ml vial contains 20 mg of Doxorubicin hydrochloride. Each 25 ml vial contains 50 mg of ...
Pharmaceutical form
Concentrate for solution for infusion. The product is a clear, red solution, with a pH in the range of 2.5-3.5 and osmolality between 270 mOsm/kg to 320 mOsm/kg.
Therapeutic indications
Doxorubicin is indicated in the following neoplastic conditions, Examples include: Small-cell lung cancer (SCLC) Breast cancer Advanced ovarian carcinoma Intravesically for bladder cancer Neoadjuvant and ...
Posology and method of administration
Doxorubicin Injection should be administered only under the supervision of a qualified physician with extensive experience in cytotoxic treatment. Also, patients must be carefully and frequently monitored ...
Contraindications
Hypersensitivity to the active substance doxorubicin hydrochloride or to any of the excipients. Contraindications for intravenous administration: Hypersensitivity to anthracendiones or other anthracyclines ...
Special warnings and precautions for use
Doxorubicin Injection should be administered only under the supervision of a qualified physician experienced in cytotoxic therapy for i.v. or intravesical use. Doxorubicin hydrochloride may potentiate ...
Interaction with other medicinal products and other forms of interaction
Doxorubicin cardiotoxicity is enhanced by previous or concurrent use of other anthracyclines, or other potentially cardiotoxic drugs (e.g. 5-fluorouracile, cyclophosphamide or paclitaxel) or with products ...
Fertility, pregnancy and lactation
Pregnancy Doxorubicin has been found in foetal tissue (liver, kidney, lungs) at concentrations several times those in maternal plasma indicating that it does pass the placenta. In animals studies, doxorubicin ...
Effects on ability to drive and use machines
Due to the frequent occurrence of nausea and vomiting, driving cars and operation of machinery should be discouraged.
Undesirable effects
Treatment with doxorubicin often causes undesirable effects, and some of these effects are serious enough to entail careful monitoring of the patient. The frequency and kind of undesirable effects are ...
Overdose
Single doses of 250 mg and 500 mg of doxorubicin have proved fatal. Acute overdosage of doxorubicin may lead to myelosuppression (particularly leucopenia and thrombocytopenia), generally 10-15 days following ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anthracyclines and related substances ATC code: L01DB01 Doxorubicin is an anthracycline antibiotic. The mechanism of action is not completely elucidated. It is postulated that ...
Pharmacokinetic properties
Distribution Following intravenous injection, doxorubicin is rapidly cleared from the blood and widely distributed into tissues including lungs, liver, heart, spleen, lymph nodes, bone marrow and kidneys. ...
Preclinical safety data
Animal studies from literature show that Doxorubicin affects the fertility, is embryo- and foetotoxic and teratogenic. Other data shows that Doxorubicin is mutagenic.
List of excipients
Sodium chloride Hydrochloric acid (for pH adjustment) Water for injections
Incompatibilities
Doxorubicin should not be mixed with heparin, as a precipitate may form and it should not be mixed with 5-fluorouracil as degradation may occur. Prolonged contact with any solution of an alkaline pH should ...
Shelf life
Shelf life Unopened vials: 18 months. Opened vials: The product should be used immediately after opening the vial. Prepared infusion solutions: Chemical and physical in-use stability has been demonstrated ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Keep the vial in the outer carton in order to protect from light. For storage conditions of the diluted medicinal product, see section 6.3.
Nature and contents of container
For 5 ml: Concentrate for solution for infusion is filled in 5 ml Type I clear tubular glass vial closed with chlorobutyl rubber stopper and aluminium flip off pink seal. For 10 ml: Concentrate for solution ...
Special precautions for disposal and other handling
Doxorubicin is a potent cytotoxic agent which should only be prescribed, prepared and administered by professionals who have been trained in the safe use of the preparation. The following guidelines should ...
Marketing authorization holder
Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Marketing authorization number(s)
PL 20075/0109
Date of first authorization / renewal of the authorization
12/03/2010
Date of revision of the text
23/05/2016
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