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VINCRISTINE HOSPIRA Solution for injection (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Vincristine Sulfate 1 mg/ml solution for injection.

Qualitative and quantitative composition

Each 1 ml contains 1 mg of vincristine sulfate. Each 2 ml contains 2 mg of vincristine sulfate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Solution for injection. A sterile, colourless solution.

Therapeutic indications

Vincristine sulfate is used either alone or in conjunction with other oncolytic drugs for the treatment of: Leukaemias, including acute lymphocytic leukaemia, chronic lymphocytic leukaemia, acute myelogenous ...

Posology and method of administration

Posology The following dosage regimens have been used: Adults The drug is administered intravenously at weekly intervals. The recommended dose is 1.4 to 1.5 mg/m² up to a maximum weekly dose of 2 mg. ...

Contraindications

Intrathecal administration of vincristine sulfate is usually fatal. Hypersensitivity to vincristine sulfate or to any of the excipients listed in section 6.1. Patients with the demyelinating form of Charcot-Marie-Tooth ...

Special warnings and precautions for use

Warnings This preparation is for intravenous use only. It should be administered by physicians experienced in the administration of vincristine sulfate. Vincristine sulfate should not be given by intrathecal, ...

Interaction with other medicinal products and other forms of interaction

The neurotoxicity of vincristine sulfate may be additive with that of isoniazid and other drugs acting on the nervous system. Acute shortness of breath and severe bronchospasm have been reported following ...

Pregnancy and lactation

Pregnancy Caution is necessary with the use of all oncolytic drugs during pregnancy. Both men and women receiving vincristine should be informed of the potential risk of adverse effects. Reliable methods ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects

In general, adverse reactions are reversible and are related to dosage size and cumulative dosage. The use of small amounts of vincristine daily for long periods is not advised. The most common adverse ...

Overdose

Side effects following the use of vincristine are dose related. In children under 13 years of age, death has occurred following doses of vincristine that were 10 times those recommended for therapy. Severe ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agent vinca alkaloid ATC Code: L01 A02 Mechanism of action Vincristine is an antineoplastic drug with broad-spectrum anti-tumor activity in man. The drug may ...

Pharmacokinetic properties

Vincristine is poorly absorbed orally. The clearance of the drug after rapid intravenous injection follows a triphasic decay pattern: a very rapid steep descent (alpha phase); a narrow-middle region (beta-phase) ...

Preclinical safety data

Both in vivo and in vitro laboratory tests have failed to demonstrate conclusively that this product is mutagenic. No evidence of carcinogenicity was found following intraperitoneal administration in rats ...

List of excipients

Mannitol Water for injections

Incompatibilities

It is not recommended that vincristine sulfate should be mixed with any other drug and should not be diluted in solutions that raise or lower the pH outside the range 3.5 to 5.5. Furosemide both in syringe ...

Shelf life

2 years.

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.

Nature and contents of container

2 ml Type I clear glass vials, with rubber closures and aluminium caps in packs of 5 vials. 2 ml Type I clear Onco-Tain vials, with rubber closures and aluminium caps in packs of 5 vials. 2.25 ml Type ...

Special precautions for disposal and other handling

Cytotoxic Handling Guidelines Administration: Should be administered only by or under the direct supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic agents. Preparation ...

Marketing authorization holder

Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK

Marketing authorization number(s)

PL 04515/0008

Date of first authorization / renewal of the authorization

9<sup>th</sup> November 2007

Date of revision of the text

10/2018

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