Posology : מינונים

4.2 Posology and method of administration


Posology
Adults
Once daily injection of 25 mg from day of oocyte retrieval, usually until 12 weeks of confirmed pregnancy.
As the indications for Prolutex are restricted to women of child-bearing age, dosage recommendations for children and the elderly are not appropriate.
Prolutex is given subcutaneously (25 mg) by the patient herself after instruction or intramuscularly (25 mg) by a doctor.
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 Prolutex in patients with impaired liver or renal function.
Paediatric population
The safety and efficacy of Prolutex in children (0 to 18 years) has not been established.
There is no relevant use of Prolutex in the paediatric population or elderly in the indication for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women.


Method of administration
Treatment with Prolutex should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Prolutex 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.