SAVENE Powder and solvent for solution for infusion Ref.[9514] Active ingredients: Dexrazoxane

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 dose is:

Day 1: 1000 mg/m²
Day 2: 1000 mg/m²
Day 3: 500 mg/m²

The first infusion should be initiated as soon as possible, within the first six hours after the accident. Treatment Day 2 and Day 3 should start at the same hour (+/- 3 hours) as Day 1.

For patients with a body surface area of more than 2 m² the single dose should not exceed 2000 mg.

Renal impairment

In patients with moderate to severe renal impairment (creatinine clearance <40 mL/min) the Savene dose should be reduced by 50% (see section 4.4 and 5.2).

Hepatic impairment

Dexrazoxane has not been studied in patients with impaired hepatic function and its use in such patients is not recommended (see section 4.4).

Elderly

Safety and efficacy have not been evaluated in the elderly and the use of dexrazoxane in such patients is not recommended.

Paediatric population

The safety and efficacy of Savene in children below the age of 18 years have not been established and no data are available.

Method of administration

For intravenous use after reconstitution and dilution.

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.

The indicated dose should be administered as an intravenous infusion over 1-2 hours into a large vein of an extremity or area other than the one affected by the extravasation. Cooling procedures such as ice packs should have been removed from the area at least 15 minutes before the Savene administration in order to allow sufficient blood flow.

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

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 of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 4 hours at 2 to 8°C.

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.

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: Savene is available as an emergency kit consisting of 10 vials of Savene powder and 3 bottles of Savene solvent supplied with 3 bottle hangers.

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 further in the remaining Savene solvent.

Caution must be exercised during reconstitution and dilution and the normal procedures for proper handling of cytotoxic medicinal products should be adopted. The preparation should not be handled by pregnant staff. Use of gloves and other protective clothing to prevent skin contact is recommended. Skin reactions have been reported following contact with dexrazoxane. If the powder or solution contacts the skin or mucous membranes, wash immediately and thoroughly with water.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.