Cardioxane 500mg powder for solution for infusion (2012)
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1. Name of the medicinal product
CARDIOXANE 500mg, powder for solution for infusion.
2. 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.
3. Pharmaceutical form
Powder for solution for infusion. Sterile, pyrogen free, white to off-white, lyophilised powder.
4.1. 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 ...
4.2. 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 ...
4.3. 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)
4.4. 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 ...
4.5. 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). ...
4.6. 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 ...
4.7. 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.
4.8. 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 ...
4.9. 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 ...
5.1. 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 ...
5.2. 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 ...
5.3. 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. ...
6.1. List of excipients
Not applicable.
6.2. 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 ...
6.3. 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 ...
6.4. Special precautions for storage
Before opening: Do not store above 25°C. In order to protect from light store in the original package.
6.5. 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 ...
6.6. Special precautions for disposal and other handling
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 ...
7. Marketing authorization holder
Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
8. Marketing authorization number(s)
PL 00101/0937
9. Date of first authorization / renewal of the authorization
1 September 2006 / 16 February 2012
10. Date of revision of the text
16 February 2012