Cardioxane 500mg powder for solution for infusion (2012)

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης	Novartis Pharmaceuticals UK Ltd
Διεύθυνση	Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

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Name of the medicinal product

CARDIOXANE 500mg, powder for solution for infusion.

Qualitative and quantitative composition

Dexrazoxane 500.00mg as its hydrochloride salt. For a vial of powder. For a full list of excipients, see section 6.1.

Pharmaceutical form

Powder for solution for infusion. Sterile, pyrogen free, white to off-white, lyophilised powder.

Therapeutic indications

Prevention of chronic cumulative cardiotoxicity caused by doxorubicin or epirubicin use in advanced and/or metastatic adult breast cancer patients who have received a prior cumulative dose of 300 mg/m² ...

Posology and method of administration

Posology CARDIOXANE is administered by a short intravenous infusion (15 minutes), approximately 30 minutes prior to anthracycline administration at a dose equal to 10 times the doxorubicin-equivalent dose ...

Contraindications

Children and adolescents up to 18 years of age (see sections 4.4 and 4.8) Patients who are hypersensitive to dexrazoxane Breast-feeding (see section 4.6)

Special warnings and precautions for use

Myelosuppressive effects that may be additive to those of chemotherapy were reported with CARDIOXANE (see section 4.8). Cell counts at nadir may be lower in patients treated with dexrazoxane. Haematological ...

Interaction with other medicinal products and other forms of interaction

CARDIOXANE may increase haematological toxicity induced by chemotherapy or radiation, requiring careful monitoring of haematological parameters during the first two treatment cycles (see section 4.4). ...

Fertility, pregnancy and lactation

Women of childbearing potential/contraception in males and females Both sexually active men and women should use effective methods of contraception during treatment. For men the contraception should be ...

Effects on ability to drive and use machines

Patients should be advised to be cautious when driving or using machines if they experience fatigue during treatment with CARDIOXANE.

Undesirable effects

CARDIOXANE is administered together with anthracycline chemotherapy and, consequently, the relative contributions of anthracycline and CARDIOXANE to the adverse reaction profile may be unclear. The most ...

Overdose

The signs and symptoms of overdose are likely to consist of leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea, skin reactions and alopecia. There is no specific antidote and symptomatic treatment ...

Pharmacodynamic properties

Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment ATC code: V03AF02 The exact mechanism by which dexrazoxane exerts its cardioprotective effect has not been fully elucidated, however ...

Pharmacokinetic properties

After intravenous administration to cancer patients, serum kinetics of dexrazoxane generally follow an open two-compartment model with first-order elimination. The maximum plasma concentration observed ...

Preclinical safety data

Preclinical studies indicate that, with repeated dexrazoxane administration, the primary target organs are those of rapid cell division: bone marrow, lymphoid tissue, testes and gastrointestinal mucosa. ...

List of excipients

Not applicable.

Incompatibilities

Incompatibilities with other medicinal products or materials are not known. However CARDIOXANE should not be mixed with other medicinal products during infusion, other than the diluents mentioned in section ...

Shelf life

Before opening: 3 years. After reconstitution and dilution: Chemical and physical in-use stability of reconstituted and subsequently diluted CARDIOXANE is 4 hours at 25°C. From a microbiological point ...

Special precautions for storage

Before opening: Do not store above 25°C. In order to protect from light store in the original package.

Special precautions for storage

Recommendations for safe handling Prescribers should refer to national or recognised guidelines on handling cytotoxic agents when using CARDIOXANE. Reconstitution should only be carried out by trained ...

Nature and contents of container

Vials (Type I brown glass), containing 500 mg of powder, closed with a chlorobutyl rubber stopper and an aluminium cap with pre-cut strip. The product is further enclosed in an outer carton. It is supplied ...

Marketing authorization holder

Novartis Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR

Marketing authorization number(s)

PL 00101/0937

Date of first authorization / renewal of the authorization

1 September 2006 / 16 February 2012

Date of revision of the text

16 February 2012