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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Bleo-Kyowa Powder for solution for injection (2012)

Εκδότης

Εκδότης ProStrakan
Διεύθυνση Galabank Business Park, Galashiels, TD1 1QH
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Περιεχόμενα

Name of the medicinal product

Bleo-Kyowa.

Qualitative and quantitative composition

Bleomycin Sulphate equivalent to 15,000 IU (15 10^3^ IU).

Pharmaceutical form

Powder for solution for injection. White to light yellowish, freeze-dried substance.

Therapeutic indications

Squamous cell carcinoma affecting the mouth, nasopharynx and paranasal sinuses, larynx, oesophagus, external ...

Posology and method of administration

Adults Routes of administration Bleomycin is usually administered intramuscularly but may be given intravenously ...

Contraindications

Bleomycin is contra-indicated in patients with acute pulmonary infection or greatly reduced lung function. ...

Special warnings and precautions for use

Patients undergoing treatment with bleomycin should have chest X-rays weekly. These should continue to ...

Interaction with other medicinal products and other forms of interaction

When bleomycin is used as one of the drugs in multiple chemotherapy regimes the toxicity of bleomycin ...

Pregnancy and lactation

Bleomycin should not normally be administered to patients who are pregnant or to mothers who are breast-feeding. ...

Effects on ability to drive and use machines

This depends on the patients condition and should be considered in co-operation with the doctor.

Undesirable effects

The most frequently observed adverse reactions in 1613 patients receiving bleomycin were pulmonary manifestations ...

Overdose

The acute reaction to an overdosage of bleomycin would probably include hypotension, fever, rapid pulse ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other cytotoxic antibiotics ATC code: L01DC01 Bleomycin is a basic, water-soluble ...

Pharmacokinetic properties

Bleomycin is administered parenterally. After intravenous (IV) administration of a bolus dose of 15 ...

Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included ...

List of excipients

None.

Incompatibilities

Bleomycin solution should not be mixed with solutions of essential amino acids, riboflavine, ascorbic ...

Shelf life

3 years.

Special precautions for storage

Protect from light. Store at 2°C-8°C.

Nature and contents of container

5 ml colourless glass vials with rubber closure and aluminium cap containing freeze dried bleomycin sulphate ...

Special precautions for disposal and other handling

Bleomycin should be handled with care. Precautions should be taken to avoid bleomycin coming into contact ...

Marketing authorization holder

ProStrakan Limited Galabank Business Park Galashiels= TD1 1QH UK

Marketing authorization number(s)

PL 16508/0046

Date of first authorization / renewal of the authorization

03/07/2006

Date of revision of the text

April 2012
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.