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CYCLOPHOSPHAMIDE Coated Tablets (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Cyclophosphamide Tablets 50 mg.

Qualitative and quantitative composition

Each tablet contains cyclophosphamide monohydrate equivalent to 50 mg anhydrous cyclophosphamide.

Pharmaceutical form

Coated Tablet. White round biconvex sugar coated tablets with a white core.

Therapeutic indications

Cyclophosphamide is a cytotoxic drug for the treatment of malignant disease in adults and children. As a single agent, it has successfully produced an objective remission in a wide range of malignant conditions. ...

Posology and method of administration

Cyclophosphamide Tablets are for oral use. Cyclophosphamide should only be used by clinicians experienced in the use of cancer chemotherapy. Cyclophosphamide should only be administered where there are ...

Contraindications

Cyclophosphamide is contra-indicated in patients with: Hypersensitivity to cyclophosphamide or to any of its metabolites. Acute infections. Bone-marrow aplasia. Urinary tract infection. Acute urothelial ...

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

Planned coadministration or sequential administration of other substances or treatments that could increase the likelihood or severity of toxic effects (by means of pharmacodynamic or pharmacokinetic interactions) ...

Fertility, pregnancy and lactation

Pregnancy Cyclophosphamide is contraindicated in pregnancy (see section 4.3). Cyclophosphamide crosses the placental barrier. Treatment with cyclophosphamide has a genotoxic effect and may cause foetal ...

Effects on ability to drive and use machines

Patients undergoing treatment with cyclophosphamide may experience undesirable effects (including, e.g., dizziness, blurred vision, visual impairment) which could affect the ability to drive or use machines. ...

Undesirable effects

ADR frequency is based upon the following scale: Very Common (≥1/10); Common (≥1/100 - <1/10), Uncommon (≥1/1,000 - <1/100), Rare (≥1/10,000 - <1/1,000), Very Rare (<1/10,000), Unknown (adverse reactions ...

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

Cyclophosphamide has been demonstrated to have a cytostatic effect in many tumour types. The active metabolites of cyclophosphamide are alkylating agents which transfer alkyl groups to DNA during the process ...

Pharmacokinetic properties

Cyclophosphamide is well absorbed following an oral dose with a mean half-life of 4-8 hours for both oral and parenteral administration. It is an inactive pro drug with alkylating metabolites produced ...

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to the information already stated in other sections of the Summary of Product Characteristics.

List of excipients

Tablet: Maize starch Lactose monohydrate Calcium hydrogen phosphate dihydrate Talc Magnesium stearate Gelatine Glycerol (85%) Coating: Sucrose Titanium dioxide Calcium carbonate Talc Macrogol 35000 Silica ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 36 months.

Special precautions for storage

Do not store above 25°C. Store in original container.

Nature and contents of container

10 tablets in a PVC/aluminium blister strip and 10 blister strips in a box.

Special precautions for disposal and other handling

Cyclophosphamide is a cytotoxic agent. The handling of cyclophosphamide should always be in accordance with current guidelines on safe handling of cytotoxic agents. The coating of the tablets prevents ...

Marketing authorization holder

Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Marketing authorization number(s)

PL 00116/0389

Date of first authorization / renewal of the authorization

9 January 2004

Date of revision of the text

09<sup>th</sup> December 2016

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