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New Puregon 300 IU/ 0.36 ML Solution For injection 1 Crdridge ingredient follitropine beta View larger

Puregon 300 IU/ 0.36 ML Solution For injection 1 Crdridge ingredient follitropine beta

PR5233

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Puregon 300 IU/ 0.36 ML Solution For injection 1 Crdridge ingredient follitropine beta

PUREGON 600 IU / 0.72 mlcontaining solution for injection is

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Ovarian emerged after treatment with gonadotropins including PUREGON torsion. Over torsion is the rotation of an ovary. As a result of ovarian rotation, blood flow to the ovary can be stopped.

Before using this medicine, tell your doctor if you have:

- If you have had ovarian ovulation syndrome (OHSS)

- If you are pregnant or if you think you may be pregnant - If you have had a

stomach (abdominal) operation in the past

- If you have had an ovarian rotation before - If you have

cysts in your ovaries or if there have been cysts in the past.

Ovarian tumors and other tumors of the

reproductive system Reports of ovarian and other reproductive system tumors were obtained in women treated with infertility. It is not known whether treatment with fertility drugs increases the risk of these tumors in infertile women.

Other medical conditions

Also tell your doctor if the following is true for you before using this medicine: if a doctor has told

you that your pregnancy will be dangerous to you.

If you are a man: Men with

too many FSH in their

blood The rise of FSH levels in the blood indicates testicular damage. PUREGON is generally not effective in such cases. To monitor the effects of your treatment, your doctor may ask you to have a semen analysis 4 to 6 months after starting treatment.

Please consult with your doctor if these warnings are valid for you, even at any time in the past.

MazON Using PUREGON with food and drink The

use of food and drinks in combination with food does not have any negative effect.

Pregnancy

Consult your doctor or pharmacist before using any medication.

If you are pregnant or think you may be pregnant, you should not use PUREGON.

If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Ask your doctor or pharmacist before using any medication.

PUREGON may affect milk production. PUREGON is not likely to enter breast milk. If you are breastfeeding, consult your doctor before using PUREGON.

Vehicle and machine use

PUREGON is unlikely to affect your ability to drive and operate machines.

Important information on certain excipients in the content of PUREGON

This medicinal product contains less than 1 mmol (23 mg) of sodium per injection; that is, it is essentially umsuz non-liberal ody.

Children

PUREGON has no use in children.

Ifcombination with other drugs, the

PUREGON is used ineffect of PUREGON may increase.

Higher doses of PUREGON may be required if a patient is given a GnRH agonist (a drug used to prevent early ovulation).

If you are currently using any prescription or non-prescription medication, or if you have recently used it, please inform your doctor or pharmacist.

3. How is PUREGON used?

Instructions for proper use and dose / frequency of administrationinstructed

Always use PUREGON exactly asby your doctor. If in doubt, check with your doctor or pharmacist.

Dosage in women:

Your doctor will decide the initial dose. This dose can be adjusted during your treatment period. In terms of the response of the ovaries to FSH in women; there are large differences that make it impossible to determine a dosage scheme applicable to all patients. Follicle growth to find the correct dose; ultrasound scans and blood estradiol (female sex hormone) levels are measured by measuring.

• Women who do not ovulate (ovulation):

Your doctor first determines an initial dose and is used for at least 7 days. If no response can be obtained from your ovaries, the dose is gradually increased until follicle growth and / or plasma estradiol levels indicate adequate response. The same daily dose is then continued until a follicle has grown sufficiently. 7 .14 day treatment is usually sufficient. When this period is completed, PUREGON treatment is stopped and human chorionic gonadotropin (hCG) can be administered and ovulation can be achieved.

• Reproductive programs with medical assistance; For example, in vitro fertilization:

Your doctor first determines an initial dose, and this dose is used for at least the first 4 days. Your dose can then be adjusted according to the response of your ovary. When a sufficient number of follicles reach sufficient size; The last period of follicle maturation is initiated by giving hCG. Eggs are collected after 34-35 hours.

Dosage in men:

PUREGON istogether with another hormone (hCG450for a period of at least 3 boyunca4 months

prescribed) at a dose ofIU (150 IU 3 times). The period of treatment is equal to the duration of sperm development and the time to recovery. If your sperm production has not started at the end of this period, treatment can be continued for 18 months.

Method and method of

administration How are injections done?

The PUREGON solution for injection in the cartridges has been developed for use in the PUREGON Pen. Separate instructions for pen use should be followed carefully. If the solution contains particles or is not clear, do not use the cartridge. Injections can be made just under the skin (eg on the lower abdomen) by you or your partner. Your doctor will tell you when and how this will be done. If you are injecting PUREGON into yourself, follow the instructions carefully to give PUREGON the least discomfort and correctness. First injection of PUREGON should only be performed in the presence of a doctor or nurse.

Different age groups:

There is no indication for the use of PUREGON in children and the elderly.

Special use cases: No

special handling.

If you have an impression that PUREGON's effect is too strong or too weak, talk to your doctor or pharmacist.

Tellused more PUREGON than you should use

your doctor immediately if you have.

A very high PUREGON dose may cause ovarian stimulation (OHSS) of your ovaries. If you suffer from abdominal pain, tell your doctor immediately. see. Section 4, Possible Side Effects.

If you have used more than you should use from PUREGON, talk to a doctor or pharmacist.

If you forget to use

PUREGON, contact your doctor if you forget to use PUREGON.

Do not take a double dose to compensate for forgotten doses.

Effects on treatment with PUREGON No

data is available on this subject.

Ask your doctor if you have any other questions regarding the use of this medicine.

4. What are the possible side effects?

Like all medicines, PUREGON can cause side effects, but not everyone.

Serious side effects in women

A complication of FSH treatment is the overexcitation of the ovaries. Overexcitation of the ovaries can progress to a serious medical condition called Over Hyperstimulation Syndrome (OHSS), which may be a serious medical problem. This risk can be reduced by careful monitoring of follicle development during the treatment period. Your doctor will perform ultrasound imaging of your ovaries to carefully monitor the number of maturing follicles. Your doctorblood hormone

can also control yourlevels. The first signs of overexcitation of the ovaries are pain in the stomach, nausea or diarrhea. In more severe cases, symptoms may result in the growth of the ovaries, fluid accumulation in the abdomen and / or the chest (this may cause sudden weight gain due to fluid accumulation) or may result in circulating blood clots (see Section 2 Warnings and Precautions).

If any of the other symptoms related to abdominal pain or overexcitation of the ovaries develop, even if they occur within a few days after injection, talk to your doctor immediately.

If you are a woman:

Common side effects (approximately 1 in 10 people):

- Headache

- Injection site reactions (such as bruising, pain, redness, swelling and itching)

- Ovarian stimulation syndrome of ovaries (Ovarian hyperstimulation syndrome - OHSS)

- Pelvis pain

- abdominal pain and / or bloating

Uncommon side effects (approximately 1 in every 100 people):

- Breast complaints (including sensitivity)

- Diarrhea, constipation or discomfort in the abdomen

- Uterine enlargement

- To be as embarrassed

- Hypersensitivity reactions (Rash, redness, urticaria and pruritus)

- Ovarian cysts or ovaries growth

- Ovarian torsion (rotation of the ovaries)

- Vaginal bleeding

Infrequent side effects (approximately 1 in every 10,000 people):

- Blood clots in some way without excessive stimulation See also Chapter 2 Warnings and Precautions

Pregnancy outside the uterus (ectopic pregnancy), low and multiple pregnancies have also been reported. These side effects are considered to be related to Assisted Reproductive Technology (ART) or subsequent pregnancy rather than PUREGON use.

Men if you are:

Common side effects (seen in approximately 1 in every 10 people):

- Acne

- Injection site reactions (eg., Hardening and pain)

- Headache

- Rash

- Breast little growth

- Testicular cyst

reporting of side effects

in the Operating InstructionsTalk to your doctor, pharmacist or nurse if there are any side effects that may or may not occur. Also located on the site where you experience side effects www.titck.gov.t "Drug Side Impact Statement" by clicking on the icon or 0800314 00 08 number one side effect reporting line by calling Turkey Pharmacovigilance Center (TÜFAM) Notifications. By informing you of any side effects, you will contribute to further information on the safety of the drug you are using.

If you encounter any side effects not mentioned in these instructions, please inform your doctor or pharmacist.

5. Storage of

PUREGON Keep PUREGON out of the reach of children and in its packaging.

Store by pharmacist Store between

2 ° C - 8 ° C (refrigerated). Do not freeze.

Patient storage

There are two options:

1. Store between 2 ° C - 8 ° C (refrigerated). Do not freeze.

2. Store at 25 ° C or lower (room temperature), provided it does not last longer than 3 months at a time.

Note the date you removed the product from the refrigerator. Store the cartridge in its cardboard box.

The product can be stored for a maximum of 28 days after the cartridge has been punctured by rubber filling. Please note on the first day you use the cartridge as shown in the PUREGON Pen Instruction Manual.

Discard the needles immediately after injection.

Do not mix any other drugs into the cartridges.

Empty cartridges should not be refilled.

Use in accordance with expiration dates.

Do not use PUREGON after the expiration date on the packaging / use before the expiry date. The expiry date refers to the last day of that month.

Do not dispose of medicines in domestic waste or sewage. Ask your pharmacist how to take the medications you no longer use. These measures will help protect the environment.

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