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Puregon 900 IU/1.08 ml solution for injection contains a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ml.
FSH belongs to the group of gonadotrophins, which play an important role in human fertility and reproduction. FSH is needed in women for the growth and development of follicles in the ovaries. Follicles are small round sacs that contain the egg cells. In men, FSH is needed for the production of sperm.
Puregon is used to treat infertility in any of the following situations:
Please inform your doctor if you have experienced an allergic reaction to neomycin and/or streptomycin (antibiotics) in the past.
If you are a woman:
Close supervision by your doctor is very important. Usually ultrasound scans of the ovaries are regularly made, and blood or urine samples are regularly taken. The results of these tests allow your doctor to choose the correct dose of Puregon from day to day. This is very important since too high a dose of FSH may lead to rare but serious complications in which the ovaries become overstimulated. This may be noticed as pain in the abdomen. Regular monitoring of the response to FSH-treatment helps your doctor to prevent ovarian overstimulation. So contact your doctor without delay if you are experiencing significant abdominal pain, also if this occurs some days after the last injection has been given.
Treatment with Puregon (like pregnancy itself) may increase the risk of thrombosis (the formation of a blood clot in a blood vessel, most often in the veins of the legs or the lungs).
Please discuss this with your doctor, before starting treatment, especially if:
If you are a man:
Elevated FSH blood levels are indicative of testicular damage. Puregon is usually not effective in such cases. To monitor treatment, your doctor may ask you for a semen analysis to be performed 4 to 6 months after the beginning of treatment.
If Puregon is used in combination with clomifene citrate there may be an increased follicular response. If a GnRH agonist has been given, higher doses of Puregon may be needed to achieve a response. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
There is neither clinical experience nor evidence from studies in animals that use of Puregon during pregnancy might lead to congenital abnormalities. Nevertheless, 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.
Your doctor will decide on the dose of Puregon to be given. This dose may be adjusted as your treatment progresses. Further details on the treatment schedule are given below.
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.
Initially, a starting dose is set by your doctor. This dose is continued for at least seven days. If there is no ovarian response, the daily dose will then be gradually increased until follicle growth and/or plasma estradiol levels indicate an adequate response. The daily dose is then maintained until a follicle of adequate size is present. Usually, 7 to 14 days of treatment are sufficient. The administration of Puregon is then stopped and ovulation can be induced by administering human chorionic gonadotrophin (hCG).
A starting dose is set by your doctor. This dose is continued for at least the first four days. After this, the dose may be adjusted for the individual patient, based upon their ovarian response. When a sufficient number of follicles of adequate size are present, the final phase of maturation of the follicles is induced by administration of hCG. Oocyte (egg) retrieval is performed 34-35 hours later.
Puregon is usually prescribed at a dose of 450 IU/week, mostly in 3 dosages of 150 IU, in combination with another hormone (hCG), for at least 3 to 4 months. If you have not responded after this period, your treatment may carry on for at least 18 months.
Puregon solution for injection in cartridges has been developed for use in the Puregon Pen. The separate instructions for using the pen must be followed carefully. Do not use the cartridge if the solution contains particles or if the solution is not clear.
Using the pen, injections just under the skin (in the abdominal wall, for example) can be given by you or your partner. Your doctor will tell you when and how to do this. When the instructions are followed carefully, Puregon will be administered properly and with minimal discomfort.
The very first injection of Puregon should be given under medical supervision.
Inform your doctor.
Do not take a double dose to make up for a forgotten 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 the injection. Occasionally, more widespread reactions like rash have been observed.
If you are a woman:
A complication with FSH treatment is unwanted overstimulation of the ovaries. This condition can become very serious, but the risk can be reduced by careful monitoring of follicle development during treatment. The first symptoms of ovarian overstimulation may be noticed as pain in the abdomen, feeling sick or diarrhoea. In more severe cases symptoms may include enlargement of the ovaries, accumulation of fluid in the abdomen and/or chest, weight gain and the occurrence of blood clots in the circulation. Contact your doctor without delay if you are experiencing any of these symptoms, also if they develop some days after the last injection has been given.
Rarely, blood clots may occur without unwanted overstimulation of the ovaries (see also “Take special care with Puregon”).
Other side effects observed in clinical studies include headache and nausea.
If you are a man:
Some breast development or acne may occur due to treatment with hCG.
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 in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep the cartridge in the outer carton.
For your convenience, you may store Puregon at or below 25 ºC (at room temperature) for a single period of not more than 3 months. Make a note of when you start storing the product out of the refrigerator.
Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum of 28 days.
Please put the day of first use of the cartridge on the dosing record table as shown in the Instruction Manual of the Puregon Pen.
Do not use Puregon if you notice that the solution contains particles or is not clear.
Discard used needles immediately after injection.
Puregon cartridges are not designed to allow any other drug to be mixed in the cartridges.
Empty cartridges must not be refilled.
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