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Βιβλιογραφική αναφορά

Προτάσεις

SPC, Ireland: DOXORUBICIN Teva Sol. (2011)

Εκδότης

Εκδότης Teva Pharma B.V.
Διεύθυνση Computerweg 10, 3542DR, Utrecht, Netherlands
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Περιεχόμενα

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 ...

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 ...

Posology and method of administration

Doxorubicin hydrochloride should be administered only under the supervision of a qualified physician ...

Contraindications

Hypersensitivity to doxorubicin, other anthracyclines or anthracenediones or one of the excipients: ...

Special warnings and precautions for use

General warnings Doxorubicin should be administered only under the supervision of a qualified physician ...

Interaction with other medicinal products and other forms of interaction

Doxorubicin cardiotoxicity is enhanced by previous or concurrent use of other anthracyclines, or other ...

Pregnancy and lactation

Pregnancy Doxorubicin should not be given during pregnancy. In general cytostatics should only be administered ...

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 ...

Undesirable effects

Treatment with doxorubicin often causes undesirable effects, and some of these effects are serious enough ...

Overdose

No specific antidote for doxorubicin is known. An acute intoxication can become manifest within 24 hours ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anthracyclines and related substances ATC code: L01D B01 Doxorubicin belongs ...

Pharmacokinetic properties

After intravenous administration, doxorubicin elimination is characterized by a tri-phasic elimination ...

Preclinical safety data

Animal studies from literature show that doxorubicin affects the fertility, is embryo- and fetotoxic ...

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 ...

Shelf life

Vial before opening: 24 months. After first opening: Use immediately after first opening. After dilution: ...

Special precautions for storage

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

Nature and contents of container

Doxorubicin Teva 2 mg/ml concentrate for solution for infusion is supplied in vials of 5 ml (10 mg), ...

Special precautions for disposal and other handling

Doxorubicin can also be administered as intravenous infusion diluted in the concentration range of 0.05 ...

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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.