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CYCLOPHOSPHAMIDE Powder for solution for injection/infusion (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Cyclophosphamide 1000 mg Powder for Solution for Injection or Infusion.

Qualitative and quantitative composition

Each vial of Cyclophosphamide 1000 mg Powder for Solution for Injection or Infusion contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1000 mg cyclophosphamide. Strength after reconstitution: ...

Pharmaceutical form

Powder for solution for injection/infusion. White crystalline powder.

Therapeutic indications

Cyclophosphamide may be used alone or in combination with other chemotherapeutic agents, depending on the indication. Cyclophosphamide is indicated in the treatment of: Chronic Lymphocytic Leukemia (CLL). ...

Posology and method of administration

Cyclophosphamide should only be used by clinicians experienced in the use of cancer chemotherapy. Cyclophosphamide should only be administered where there are facilities for regular monitoring of clinical, ...

Contraindications

Cyclophosphamide is contra-indicated in patients with: Hypersensitivity to cyclophosphamide, any of its metabolites. Cute infections. Bone marrow aplasia or bone marrow depression prior to treatment. ...

Special warnings and precautions for use

Warnings Anaphylactic Reactions, Cross-sensitivity with Other Alkylating Agents Anaphylactic reactions including those with fatal outcomes have been reported in association with cyclophosphamide. Possible ...

Interaction with other medicinal products and other forms of interaction

Cyclophosphamide is inactive, but is metabolised in the liver, mainly by CYP2A6, 2B6, 2C9, 2C19 and 3A4, into two active metabolites. Planned co-administration or sequential administration of other substances ...

Fertility, pregnancy and lactation

Women of childbearing potential Girls treated with cyclophosphamide during pre-pubescence generally develop secondary sexual characteristics normally and have regular menses. Girls treated with cyclophosphamide ...

Effects on ability to drive and use machines

Patients undergoing treatment with cyclophosphamide may experience undesirable effects (including nausea, vomiting, dizziness, blurred vision, visual impairment) which could affect the ability to drive ...

Undesirable effects

The frequency of adverse reactions reported in the table below are derived from clinical trials and from post marketing experience and are defined using the following convention: very common (≥1/10), common ...

Overdose

Serious consequences of overdosage include manifestations of dose dependent toxicities such as myelosuppression, urotoxicity, cardiotoxicity (including cardiac failure), veno occlusive hepatic disease, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic and Immunomodulating Agents; Antineoplastic agents. Alkylating agents. Nitrogen mustard analogues ATC code: L01AA01 Cyclophosphamide has been demonstrated to have ...

Pharmacokinetic properties

Cyclophosphamide is administered as an inactive prodrug that is activated in the liver. Absorption Cyclophosphamide is quickly and almost completely absorbed from parenteral sites. Distribution Less than ...

Preclinical safety data

Acute toxicity The acute toxicity of cyclophosphamide is relatively low. This was demonstrated in studies on mice, guinea pigs, rabbits and dogs. Chronic toxicity Chronic administration of toxic doses ...

List of excipients

None.

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years. Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C for the reconstituted solution. From a microbiological point of view, the reconstituted solution ...

Special precautions for storage

Do not store above 25°C. For storage conditions after reconstitution of the medicinal product, see section 6.3.

Nature and contents of container

Cyclophosphamide, Powder for Solution for Injection or Infusion, is available in the following pack sizes: 1, 5 or 10 clear colourless 100 ml Type I-glass vials containing 1000 mg cyclophosphamide sealed ...

Special precautions for disposal and other handling

For each 100 mg of cyclophosphamide, 5 ml of solvent must be added for reconstitution. The choice of diluent for reconstituting Cyclophosphamide containing cyclophosphamide depends on the route of administration ...

Marketing authorization holder

Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization number(s)

PL 04416/1394

Date of first authorization / renewal of the authorization

Date of first authorisation: 18 August 2014

Date of revision of the text

07/06/2017

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