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SPC: SAVENE Powder and solvent for solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Savene 20 mg/ml powder and solvent for concentrate for solution for infusion.

Qualitative and quantitative composition

Each vial contains 500 mg dexrazoxane (589 mg dexrazoxane hydrochloride). Each ml contains 20 mg of dexrazoxane after reconstitution with 25 ml of Savene solvent. Excipients with known effects: Solvent ...

Pharmaceutical form

Powder and solvent for concentrate for solution for infusion. Powder vial: White to off-white lyophilisate. Solvent bottle: Clear isotonic solution (295 mOsml/l, pH approx. 7.4).

Therapeutic indications

Savene is indicated in adults for the treatment of anthracycline extravasation.

Posology and method of administration

Savene must be administered under the supervision of a physician experienced in the use of anti-cancer medicinal products. Posology Treatment should be given once daily for 3 consecutive days. The recommended ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Women of childbearing potential not using contraceptive measures (see section 4.6). Breast-feeding (see section ...

Special warnings and precautions for use

Continuous monitoring Local examination should be performed on a regular basis after treatment until resolution. If there is suspicion of extravasation by vesicant compounds other than anthracyclines through ...

Interaction with other medicinal products and other forms of interaction

Concomitant use contraindicated: Yellow fever vaccine: Risk of fatal generalised vaccinial disease (see section 4.3). Concomitant use not recommended: Other live attenuated vaccines: risk of systemic, ...

Pregnancy and lactation

Women of childbearing potential/Contraception in males and females Since dexrazoxane possesses mutagenic activity and is used with anthracyclines known to have cytotoxic, mutagenic and embryotoxic properties, ...

Effects on ability to drive and use machines

Dizziness, somnolence and syncope have been reported in a few patients included in Savene studies TT01 and TT02 (see section 4.8). Dexrazoxane has minor influence on the ability to drive and use machines. ...

Undesirable effects

A number of published reports comprising more than 1000 patients have demonstrated a uniform pattern of dose dependent adverse reactions. Most common adverse reactions are nausea/vomiting, bone marrow ...

Overdose

Signs and symptoms of overdosage are likely to consist of leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea, skin reactions and alopecia. Treatment should be symptomatic.

Pharmacodynamic properties

Pharmacotherapeutic group: Detoxifying agents for antineoplastic agents ATC code: V03AF02 Two pharmacodynamic properties of dexrazoxane are described in the literature: Prevention of anthracycline cardiotoxicity, ...

Pharmacokinetic properties

Savene must only be administered intravenously. Distribution Bibliographical data demonstrate that serum kinetics of dexrazoxane after intravenous administration follow an open two-compartment model independent ...

Preclinical safety data

Repeat-dose toxicity studies with dexrazoxane have shown that primary target organs were tissues that undergo rapid cell division: bone marrow, lymphoid tissue, testes and digestive tract. Myelosuppression ...

List of excipients

Powder vial: none Solvent bottle: Sodium chloride Potassium chloride Magnesium chloride hexahydrate Sodium acetate trihydrate Sodium gluconate Sodium hydroxide Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life Powder and solvent: 3 years. After reconstitution and dilution: Chemical and physical in-use stability has been demonstrated for 4 hours when stored at 2 to 8°C. From a microbiological point ...

Special precautions for storage

Store below 25°C. Keep the vials and bottles in the outer carton in order to protect from light. For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

Nature and contents of container

Savene powder: Amber-coloured, 36-ml, glass type I vial with stopper made of chlorobutyl rubber and a flip-off cap. Savene solvent: 500 ml solution in bottles made of Type-I (Ph.Eur.) glass. Pack sizes: ...

Special precautions for disposal and other handling

Before infusion, Savene powder must be reconstituted with 25 ml Savene solvent to give a concentration of 20 mg dexrazoxane per ml. The concentrate is slightly yellow. The concentrate should then be diluted ...

Marketing authorization holder

Clinigen Healthcare B.V., Schiphol Boulevard 359, WTC Schiphol Airport, D Tower 11th floor, 1118BJ, Schiphol, The Netherlands

Marketing authorization number(s)

EU/1/06/350/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 28 July 2006 Date of latest renewal: 18 July 2011

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