Table of Contents

1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
11. Legal category

1. Name of the medicinal product
 Puregon 50 IU/0.5 ml solution for injection

Puregon 100 IU/0.5 ml solution for injection

2. Qualitative and quantitative composition
 Puregon 50 IU/0.5ml solution for injection

One vial contains 50 IU recombinant follicle-stimulating hormone (FSH) in 0.5 ml aqueous solution. This corresponds to a strength of 100 IU/ml. One vial contains 5 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein). The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.

Puregon 100 IU/0.5ml solution for injection

One vial contains 100 IU recombinant follicle-stimulating hormone (FSH) in 0.5ml aqueous solution. This corresponds to a strength of 200 IU/ml. One vial contains 10 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein). The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form
 Solution for injection (injection).

Clear and colourless solution.

4. Clinical particulars
  
4.1 Therapeutic indications
 In adult females:

Puregon is indicated for the treatment of female infertility in the following clinical situations:

• Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate.

• Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].

In adult males:

• Deficient spermatogenesis due to hypogonadotrophic hypogonadism.

4.2 Posology and method of administration
 Treatment with Puregon should be initiated under the supervision of a physician experienced in the treatment of fertility problems.

The first injection with Puregon should be performed under direct medical supervision.

Posology

Dosage in th