LUBION Solution for injection Ref.[28021] Active ingredients: Progesterone

Posology

Adults

Once daily injection of 25 mg from day of oocyte retrieval, usually until 12 weeks of confirmed pregnancy.

As the indications for Lubionare restricted to women of child-bearing age, dosage recommendations for children and the elderly are not appropriate.

Lubion is given by subcutaneous (25 mg) or intramuscular (25 mg) injection. Special populations

Elderly

No clinical data have been collected in patients over age 65.

Renal and Hepatic impairment

There is no experience with use of Lubionin patients with impaired liver or renal function.

Paediatric population

The safety and efficacy of Lubion in children (0 to 18 years) has not been established.

There is no relevant use of Lubionin the paediatric population or elderly in the indicationfor luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women.

Method of administration

Treatment with Lubionshould be initiated under the supervision of a physician experienced in the treatment of fertility problems.

Lubion is intended for intramuscular or subcutaneous administration.

Intramuscular administration

Choose an appropriate area (femoral quadriceps of the right or left thigh). Swab proposed area, insert a deep injection (needle at an angle of 90°).The product should be injected slowly to minimise local tissue damage.

Subcutaneous administration

Choose an appropriate area (front of thigh, lower abdomen), swab proposed area, pinch the skin together firmly and insert the needle at an angle of 45° to 90°. The product should be injected slowly to minimise local tissue damage.

High doses of progesterone may cause drowsiness.

Treatment of overdose consists of discontinuation of Lubiontogether with initiation of appropriate symptomatic and supportive care.

2 years.

The medicinal product must be used immediately after first opening: any remaining solution must be discarded.

Store below 25°C. Do not refrigerate or freeze.

Store in the original package in order to protect from light.

Colourless Type I glass vial fitted with a bromobutyl rubber stopper, and an aluminium seal and ‘flip off’ cap. Each pack contains 1, 7 or 14 vials. Not all pack sizes may be marketed.

The solution is for single use only.

A medical specialist must perform all i.m. injections.

The solutionshould not be administered if it contains particles or is discoloured.

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