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SPC, Ireland: DOXORUBICIN Teva Sol. (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Teva Pharma B.V.
Διεύθυνση :
Computerweg 10, 3542DR, Utrecht, Netherlands
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Δωρεάν εγγραφή

Name of the medicinal product

Doxorubicin Teva 2 mg/ml Concentrate for Solution for Infusion.

Qualitative and quantitative composition

1 ml of Doxorubicin Teva 2 mg/ml contains 2 mg doxorubicin hydrochloride 5 ml of Doxorubicin Teva 2 mg/ml contains 10 mg doxorubicin hydrochloride 10 ml of Doxorubicin Teva 2 mg/ml contains 20 mg doxorubicin ...

Pharmaceutical form

Concentrate for solution for infusion Clear, red solution. pH = 2.7-3.3

Therapeutic indications

Breast cancer Neoadjuvant and adjuvant therapy of osteosarcoma Advanced soft-tissue sarcoma in adults Small-cell lung cancer (SCLC) Hodgkins lymphoma Highly malignant non-Hodgkins lymphoma Induction and ...

Posology and method of administration

Doxorubicin hydrochloride should be administered only under the supervision of a qualified physician experienced in cytotoxic therapy. Also, patients must be carefully and frequently monitored during the ...

Contraindications

Hypersensitivity to doxorubicin, other anthracyclines or anthracenediones or one of the excipients: Contraindications for intravenous administration marked persisting myelosuppression and/or severe stomatitis ...

Special warnings and precautions for use

General warnings Doxorubicin should be administered only under the supervision of a qualified physician experienced in cytotoxic therapy. Also, patients must be carefully and frequently monitored during ...

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-fluorouracil, cyclophosphamide or paclitaxel) or with products ...

Pregnancy and lactation

Pregnancy Doxorubicin should not be given during pregnancy. In general cytostatics should only be administered during pregnancy on strict indication, and the benefit to the mother weighed against possible ...

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, as nausea and vomiting are frequent, patients should be warned against driving and using machines.

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

No specific antidote for doxorubicin is known. An acute intoxication can become manifest within 24 hours as, e.g., heart failure with chest pain, angina pectoris and myocardial infarction. A cardiologist ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anthracyclines and related substances ATC code: L01D B01 Doxorubicin belongs to the group of anthracyclines and is a cytostatic antibiotic that has been isolated from cultures ...

Pharmacokinetic properties

After intravenous administration, doxorubicin elimination is characterized by a tri-phasic elimination from plasma with a terminal half life of approximately 30 hours. The distribution volume is approximately ...

Preclinical safety data

Animal studies from literature show that doxorubicin affects the fertility, is embryo- and fetotoxic and teratogenic. Other data shows that doxorubicin is mutagenic.

List of excipients

Sodium chloride Hydrochloric acid (E507) Sodium hydroxide (E524) Water for injections

Incompatibilities

Doxorubicin must not be mixed with heparin, as this will result in precipitation. Until detailed compatibility information about miscibility is available, Doxorubicin should not be mixed with other medicinal ...

Shelf life

Vial before opening: 24 months. After first opening: Use immediately after first opening. After dilution: Chemical and physical in-use stability after dilution to a concentration of 0.5 mg/ml in 9 mg/ml ...

Special precautions for storage

Store in a refrigerator (2-8°C). Do not freeze. For storage conditions of the diluted medicinal product, see section 6.3.

Nature and contents of container

Doxorubicin Teva 2 mg/ml concentrate for solution for infusion is supplied in vials of 5 ml (10 mg), 10 ml (20 mg), 25 ml (50 mg) or 100 ml (200 mg) containing a red-orange, clear, sterile solution. Primary ...

Special precautions for disposal and other handling

Doxorubicin can also be administered as intravenous infusion diluted in the concentration range of 0.05 mg/ml to 0.5 mg/ml in 9 mg/ml (0.9%) sodium chloride solution for infusion or in 50 mg/ml (5%) glucose ...

Marketing authorization holder

Teva Pharma B.V. Computerweg 10 3542 DR Utrecht Netherlands

Marketing authorization number(s)

PA 749/83/1

Date of first authorization / renewal of the authorization

Date of first authorisation: 20th November 2009

Date of revision of the text

March 2011