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 300 IU/0.36 ml solution for injection

Puregon 600 IU/0.72 ml solution for injection

Puregon 900 IU/1.08 ml solution for injection

2. Qualitative and quantitative composition
 One cartridge contains a net total dose of 300 IU recombinant follicle-stimulating hormone (FSH) in 0.36 ml aqueous solution, 600IU recombinant follicle-stimulating hormone (FSH) in 0.72 ml aqueous solution or 900IU recombinant follicle-stimulating hormone (FSH) in 1.08 ml aqueous solution. The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of 833 IU/ml aqueous solution. This strength corresponds to 83.3 microgram of protein / ml (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein).

For the full list of excipients, see section 6.1.

3. Pharmaceutical form
 Solution for injection (injection).

Clear and colourless solution.

In cartridges, designed to be used in conjunction with a pen injector.

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.

Go to top of the page4.2 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 the female

There are great inter- and intra-individual variations in the response of the ovaries to exogenous gonadotrophins. This makes it impo