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BLEOMYCIN Powder for solution for injection (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Bleomycin 15000 IU Powder for solution for injection/infusion.

Qualitative and quantitative composition

Each vial contains 15000 intenational units (I.U) of bleomycin (as bleomycin sulphate). Excipient with known effect: Each vial contains <1 mmol sodium. For the full list of excipients, see section 6.1. ...

Pharmaceutical form

Powder for solution for injection/infusion. White to light yellowish freeze dried substance. pH: Between 4.5 to 6.0 Osmlolarity: 260 to 340 mOsm/ltr

Therapeutic indications

Bleomycin can be used in the treatment of: Squamous cell carcinoma (SCC) of the head and neck, cervix and external genitalia. Hodgkins lymphoma. Non-Hodgkins lymphoma of intermediate and high malignancy ...

Posology and method of administration

Warning: Posology for all therapeutic indications is provided in IU and not in mg. Some hospital protocols may state use mg instead of Units (U or IU). This mg value refers to mg-activity and not to mg-dry ...

Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Ataxia telangiectasia. Pulmonary infection, severely impaired lung function or a history of lung damage caused by ...

Special warnings and precautions for use

Patients receiving Bleomycin chemotherapy must be carefully monitored by experienced oncologists. A highly rigorous risk/benefit assessment should be performed following lung or mediastinal radiotherapy. ...

Interaction with other medicinal products and other forms of interaction

Combination chemotherapy If bleomycin is used as part of combination chemotherapy, its toxicity should be taken into account for the selection and dosage of other agents with a similar toxicity spectrum. ...

Pregnancy and lactation

Pregnancy There are insufficient data on the use of bleomycin in pregnant women. Studies in animals have shown reproduction toxicity (see section 5.3). On the basis of the results of animal studies and ...

Effects on ability to drive and use machines

Possible side effects of chemotherapy with bleomycin, e.g. nausea and vomiting, may indirectly affect the patients ability to drive or use machines.

Undesirable effects

a. Summary of the safety profile Like most cytotoxic agents, bleomycin can cause immediate and delayed toxic effects. Fever on the day of injection is the earliest reaction. The most frequently observed ...

Overdose

There is no specific antidote. It is virtually impossible to eliminate bleomycin from the body by dialysis. The acute reaction following an overdose consists of hypotension, fever, tachycardia, and generalised ...

Pharmacodynamic properties

Pharmacotherapeutic group: Cytotoxic antibiotics and related substances ATC code: L01DC01 Bleomycin is a mixture of basic, water-soluble glycopeptide-antibiotics with cytotoxic activity. Bleomycin acts ...

Pharmacokinetic properties

Absorption Bleomycin is absorbed to a very limited extent orally. Following intravenous bolus injection of 15 10<sup>3</sup> IU/m² BSA, peak plasma concentrations of 1-10 IU are reached after approximately ...

Preclinical safety data

Animal experiments have demonstrated teratogenic, mutagenic and carcinogenic properties for bleomycin. Mutagenic effects in humans are expected at clinically relevant exposure levels. With respect to reproduction ...

List of excipients

Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)

Incompatibilities

Bleomycin should not be mixed with solutions of essential amino acids, riboflavin, ascorbic acid, dexamethasone, aminophylline, benzylpenicillin, carbenicillin, cefalotine, cefazoline, diazepam, furosemide, ...

Shelf life

2 years. The reconstituted/diluted product should be used immediately.

Special precautions for storage

Store in a refrigerator (2°C-8°C). For storage conditions after reconstitution/dilution of the medicinal product, see section 6.3.

Nature and contents of container

6 ml Type I tubular clear glass vial, closed with bromobutyl rubber stopper and sealed with a flip-off aluminium seal. Availbale in pack of 1vial. 10 and 100 vials. Not all pack sizes may be marketed. ...

Special precautions for disposal and other handling

Single use only, the reconstituted solution is a clear pale yellow solution. Any unused solution should be discarded. <u>Safe handling:</u> The general guidelines for safe handling of cytotoxic medicinal ...

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

Marketing authorization number(s)

PL 20075/0440

Date of first authorization / renewal of the authorization

Date of first authorisation: 08<sup>th</sup> July 2016

Date of revision of the text

06/11/2018

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