Follitropin beta, a hormone known as follicle-stimulating hormone (FSH), at a strength of 833 IU/mL  aqueous solution per cartridge.

One cartridge of Puregon contains the following amounts of Puregon solution:

* 0.480 mL equal to a net dose of 300 IU

* 0.840 mL equal to a net dose of 600 IU

* 1.230 mL equal to a net dose of 900 IU

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).

The primary amino acid sequence is identical to that of natural human FSH. Small differences in the carbohydrate chain structure are known to exist.

* sucrose

* sodium citrate

* methionine

* polysorbate 20

* benzyl alcohol

* water for injections

The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid anhydrous. Puregon 300 IU, 600 IU and 900 IU is available in packs containing one cartridge.

After subcutaneous administration of Puregon, maximum concentration of FSH is reached within about 12 hours. Due to the sustained release from the injection site and the elimination half-life of about 40 hours (ranging from 12 to 70 hours), FSH levels remain increased for 24-48 hours. Due to the relatively long elimination half-life, repeated administration of the same dose will lead to plasma concentrations of FSH that are approximately 1.5-2.5 times higher than after single dose administration. This increase enables therapeutic FSH concentrations to be reached.

The absolute bioavailability of subcutaneously administered Puregon is approximately 77%. Recombinant FSH is biochemically very similar to urinary human FSH and is distributed, metabolised, and excreted in the same way.

Puregon solution for injection is a clear, colourless solution.

Contraindication to use Puregon

• If you have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus
• If you are allergic (hypersensitive) to follitropin beta or any of the other ingredients of Puregon
• If you have heavy or irregular vaginal bleeding where the cause is not known
• If you suffer from primary ovarian failure
• If you have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD)
• If you have malformations of the sexual organs which make a normal pregnancy impossible
• If you have fibroids in the uterus which make a normal pregnancy impossible

Please inform your doctor if you have experienced an allergic reaction to neomycin and/or streptomycin (antibiotics) in the past.

Please discuss this with your doctor, before starting treatment, especially if:

You already know you have an increased risk of thrombosis

You, or anyone in your immediate family, have ever had a thrombosis

There is neither clinical experience nor evidence from studies in animals that use of Puregon during pregnancy might lead to congenital abnormalities. You should not use Puregon if you are already pregnant, or suspect that you might be pregnant.

After treatment with gonadotrophin preparations, there is an increased risk of having multiple pregnancies. Multiple pregnancies carry an increased health risk for both the mother and her babies around the time of birth. Furthermore, multiple pregnancies and characteristics of the patients undergoing fertility treatment (e.g. age of the female, sperm characteristics) may be associated with an increased risk of congenital abnormalities. There is a slightly increased risk of extra-uterine pregnancy in women with damaged fallopian tubes.

In women undergoing fertility treatment there may be a slightly higher risk of miscarriage.

You should not use Puregon if you are breast-feeding.

Always use Puregon exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will decide on the dose of Puregon to be given. This dose may be adjusted as your treatment progresses. There are large differences between women in the response of the ovaries to FSH, which makes it impossible to set a dosage schedule which is suitable for all patients. To find the right dosage, follicle growth is checked by means of ultrasound scanning, and measurement of the amount of estradiol (female sex hormone) in blood or urine.

Puregon only works if it is injected in a muscle or under the skin.

Injections into a muscle (intramuscular) should only be given by a doctor or a nurse.

Injections under the skin (subcutaneous) may, in some cases, be given by you or your partner.

Inform your doctor.

Too high a dose may cause overstimulation of the ovaries.

Do not take a double dose to make up for a forgotten dose.

Do tell your doctor that you missed a dose.

Like all medicines, Puregon can cause side effects, although not everybody gets them.

Minor side effects include:

Bruising

Pain

Redness

Swelling and itching at the site of injection

Overstimulation of the ovaries

Rarely, blood clots may occur without unwanted overstimulation of the ovaries

Keep out of the reach and sight of children.

Do not use Puregon after the expiry date which is stated on the label after 'EXP:'.

Store Puregon in the refrigerator (2 °C – 8 °C), do not freeze.

Puregon can also be stored at room temperature (at or below 25 degrees C) for a short period of time of no more than 3 months

Do not use Puregon if you notice that the solution contains particles or is not clear.

Puregon 300IU/0.36 ml of solution in 1.5 ml cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.

Pack of 1 cartridge and 6 needles to be used with the Puregon Pen.

Cartridges contain a minimum of 400 IU FSH activity in 0.480 ml aqueous solution, which is sufficient for a net total dose of 300 IU.

Puregon 600IU/0.72 ml of solution in 1.5ml cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.

Pack of 1 cartridge and 6 needles to be used with the Puregon Pen.

Cartridges contain a minimum of 700 IU FSH activity in 0.840 ml aqueous solution, which is sufficient for a net total dose of 600 IU.

Puregon 900IU/1.08 ml of solution in 1.5ml cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.

Pack of 1 cartridge and 9 needles to be used with the Puregon Pen.

Cartridges contain a minimum of 1025 IU FSH activity in 1.230 ml aqueous solution, which is sufficient for a net total dose of 900 IU.