GONAPEPTYL DEPOT Powder and solvent for suspension for injection prolonged release Ref.[8225] Active ingredients: Triptorelin

The product should only be used under the supervision of an appropriate specialist having requisite facilities for regular monitoring of response.

The treatment of children with triptorelin should be under the overall supervision of the paediatric endocrinologist or of a paediatrician or endocrinologist with expertise in the treatment of central precocious puberty.

It is important that the injection of the sustained release form be performed strictly in accordance with the instructions given in section 6.6.

Following reconstitution, the suspension has to be injected immediately.

Dosage and method of administration

The dosage of one syringe, equivalent to 3.75 mg triptorelin, is injected every 28 days either subcutaneously (e.g. into the skin of the abdomen, the buttock or thigh) or deep intramuscularly. The injection site should be changed each time.

Men

Once every four weeks an injection with one syringe, equivalent to 3.75 mg triptorelin. In order to continually suppress testosterone levels, it is important to comply with a 4-weekly administration.

Women

Uterine myomas and endometriosis

Once every four weeks an injection with one syringe, equivalent to 3.75 mg triptorelin. The treatment must be initiated in the first 5 days of the cycle.

Children

Dosing at the beginning of treatment should be based on body weight, one injection of triptorelin should be injected on days 0, 14, and 28. Thereafter one injection every 4 weeks. Should the effect be insufficient, the injections may be given every 3 weeks. Dosing should be based on body weight according to the table.

Note for specific patient groups:

• There is no need to adjust the dose for the elderly.
• According to current data, dose reduction or prolongation of the dosage interval in patients with impaired renal function is not necessary.

Duration of administration

Prostate carcinoma

Treatment with GONAPEPTYL Depot is usually a long-term therapy.

Uterine myomas and endometriosis

The duration of treatment depends on the initial degree of severity of endometriosis and on the evolution of its clinical manifestations (functional and anatomical) and on the evolution of the volume of the uterine myomas, determined by ultrasonography during treatment. Normally, the maximum attainable result is achieved after 3 to 4 injections.

In view of the possible effect on bone density, therapy should not exceed a duration of 6 months (see 4.4).

Central precocious puberty (CPP)

Treatment should be stopped if a bone maturation of older than 12 years in girls and older than 13 years in boys has been achieved.

There is insufficient experience of overdosing with triptorelin to draw conclusions on possible adverse effects. Considering the package form and the pharmaceutical form, overdosing is not expected.

If overdose occurs, symptomatic management is indicated.

3 years.

Reconstituted suspension: 3 minutes.

Store at 2°C-8°C (in a refrigerator). Keep the container in the outer carton.

Powder: Pre-filled syringe.

Solvent: Pre-filled syringe.

Pre-filled syringes (borosilicate glass type I, clear) with a connector (polypropylene), black chlorobutyl rubber stopper (plunger stopper, type I) and injection needle.

Pack sizes:

1 pre-filled syringe (powder) plus
1 pre-filled syringe (solvent)
3 pre-filled syringes (powder) plus
3 pre-filled syringes (solvent)

GONAPEPTYL Depot is for single use only and any unused suspension should be discarded.

1. Preparation

Instructions for the physician how to prepare the suspension.

Since successful treatment depends upon correct preparation of the suspension, the following instructions must be strictly followed.

- Take the package of GONAPEPTYL Depot from the refrigerator.

- Remove the cap from the disposable syringe containing the powder.

Keep upright to prevent spilling.

- Open the package with the connector without removing the connector.

- Screw the syringe containing the sustained release microparticles on the connector in the package, then remove it.

Screw the syringe containing the suspension agent tightly on the free end of the connector and ensure that it fits tightly,

2. Reconstitution of a suspension

Empty the liquid into the syringe with the powder, then shoot it back and forth into the first syringe – the first two or three times without pushing the injection rod all the way in. Repeat this about 10 times or until you have a homogeneous milky white to faintly yellow suspension. While preparing the suspension, you might possibly create some foam. It is important that the foam be dissolved or removed from the syringe before giving the injection.

3. Injection

- Remove the connector together with the empty syringe.

- Mount the injection needle on the syringe with the ready-to-use suspension.

- Inject subcutaneously or deep into the muscle immediately.