SALVACYL Powder and solvent for prolonged-release suspension for injection Ref.[27669] Active ingredients: Triptorelin

Posology

The recommended dose of Salvacyl is 11.25 mg triptorelin (1 vial) administered every twelve weeks as a single intramuscular injection.

Paediatric population

The safety and efficacy of Salvacyl in children have not been established. There is no relevant use of Salvacyl in the paediatric population.

Patients with renal or hepatic impairment

No dosage adjustment is necessary for patients with renal or hepatic impairment.

Method of administration

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

Precautions to be taken before handling or administrating the medicinal product

Since Salvacyl is a suspension of microgranules, inadvertent intravascular injection must be strictly avoided.

Salvacyl must be administered under the supervision of a medically qualified person (nurse or physician).

The therapeutic benefit should be monitored regularly, for example prior to any new injection.

The injection site should be varied periodically.

The pharmaceutical form of Salvacyl and its route of administration make accidental or intentional overdose unlikely. Animal tests suggest that no effect other than the intended therapeutic effects on sex hormone concentration and on the reproductive tract will be evident with higher doses of Salvacyl. If overdose occurs, symptomatic management is indicated.

3 years.

After reconstitution, chemical and physical in- use stability has been demonstrated for 24 hours at 25°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 would normally not be longer than 24 hours at 2 to 8°C.

Do not store above 25°C.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

Powder in 6 ml Type I colourless glass vial with grey bromobutyl stopper and aluminium flip-off capsule and 2 ml of solvent in Type I colourless glass ampoule, and a kit of 1 empty injection syringe of polypropylene and 2 injection needles (one with safety device for injection and one without safety device for reconstitution).

The suspension for injection must be reconstituted using an aseptic technique and only using the ampoule of solvent for injection.

The instructions for reconstitution hereafter and in the leaflet must be strictly followed.

The solvent should be drawn into the syringe provided using the reconstitution needle (20 G, without safety system) and transferred to the vial containing the powder. The suspension should be reconstituted by swirling the vial gently from side to side for long enough until a homogeneous, milky suspension is formed. Do not invert the vial.

It is important to check there is no unsuspended powder in the vial. The suspension obtained should then be drawn back into the syringe, without inverting the vial. The reconstitution needle should then be changed and the injection needle (20 G, with safety device) used to administer the product.

As the product is a suspension, the injection should be administered immediately after reconstitution to prevent precipitation.

For single use only. After use, the safety system should be activated using a one-handed technique. Either by pushing the tab forward with the finger, or by pushing the sheath to a flat surface. In both cases, press down with a firm quick motion until a distinct audible click is heard. It should be visually confirmed that the needle is fully engaged under the lock. Used needles, any unused suspension or other waste material should be disposed of in accordance with local requirements.