LUTIGEST Vaginal tablet Ref.[7855] Active ingredients: Progesterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom

Therapeutic indications

Lutigest is indicated for luteal support as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.

Posology and method of administration

Posology

Adults

The dose of Lutigest is 100 mg administered vaginally three times daily starting at oocyte retrieval. The administration of Lutigest should be continued for 30 days, if pregnancy has been confirmed.

Paediatric population

There is no relevant use of Lutinus in the paediatric population.

Elderly

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

Use in special populations

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

Method of Administration

Lutigest is to be placed directly into the vagina by the applicator provided.

Overdose

High doses of progesterone may cause drowsiness.

Treatment of overdosage consists of discontinuation of Lutigest together with institution of appropriate symptomatic and supportive care.

Shelf life

3 years.

Special precautions for storage

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

This medicinal product does not require any special temperature storage conditions.

Nature and contents of container

Alu/Alu blisters of 3 vaginal tablets.

The blisters are available in cartons with 21 or 90 vaginal tablets with 1 vaginal applicator.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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