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New Puregon 600 IU/ 0.36 ML Solution For injection 1 Crdridge ingredient follitropine beta View larger

Puregon 600 IU/ 0.72 ML Solution For injection 1 Crdridge ingredient follitropine beta

PR8412

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Puregon 600 IU/ 0.72 ML Solution For injection 1 Crdridge ingredient follitropine beta

• Active substance: Follitropin beta (FSH). Each cartridge contains follitropin beta, a hormone known as follicle stimulating hormone

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USAGE INSTRUCTIONS

scotterFollitropin beta

applied under the skin of.

Each cartridge contains 600 IU / 0.72 ml injection solution.

• Excipients: Sucrose, sodium citrate, benzyl alcohol, L-methionine and polysorbate in water for injection 20. The pH of the solution may be adjusted with sodium hydroxide and / or hydrochloric acid.

Please read this INSTRUCTIONS carefully before using this medicine because it contains important information for you.

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When you go to a doctor or hospital during the use of this medicine, tell your doctor that you are taking this medicine.

• Follow the instructions in this manual. Doother than the recommended dose for the

not use high or low dosesdrug.

In these Instructions for Use:

1. What is PUREGON and what is it used for?

2. Things to consider before using PUREGONto use PUREGON

3. How?

4. What are the possible side effects?

5. Storage of PUREGON

Headings are included.

1. What is PUREGON and what is it used for?

PUREGON injection solution; follicle-stimulating hormone (FSH) is a hormone called follitropin beta.

FSH is included in the group of gonadotropins, which play an important role in the fertility and reproduction of humans. FSH is necessary for the growth and development of follicles in the ovaries (ovaries). Follicles are small, round sacs that carry egg cells.

FSH is necessary for sperm production in men.

PUREGON injection is a clear, colorless liquid. It is presented in a glass cartridge. Available in packages containing 1 cartridge.

PUREGON is used for the treatment of infertility in any of the following cases:can be used to provide

Women

• PUREGONovulation in women who do not have ovulation (ovulation), when no response to clomiphene citrate treatment is achieved.

• PUREGON can be used to provide multiple follicle development in women with assisted reproductive techniques, including in vitro fertilization (IVF) and other methods.

Men

• PUREGON can be used to provide sperm production in men who are infertile due to lack of hormones.

2.before using

CautionsPUREGON DO NOT use PUREGON in the following situations

• If you are allergic to follitropin beta or any of the excipients in PUREGON (see Auxiliary for a complete list of excipients).

• If you have aovary, breast, uterus, testes or brain (pituitary gland or hypothalamus)

tumor of the.

• If you have unexplained, severe or irregular vaginal bleeding.

• If your ovaries area condition known as primary (primary) ovarian failure

not working due to.

• If you have ovarian cysts or your ovaries have grown for a reason other than polycystic ovary syndrome (PCOS).

• Ifreproductive organs that do not allow a normal pregnancy

there are malformations in your.

• If you have fibroid tumor (s) in your uterus that does not allow for a normal pregnancy

• If you are a man andto acalled primary testicular failure

you are infertile duecondition.

Warnings and precautions

Before using PUREGON, talk to your doctor:

If you

have previously experienced an allergic reaction to certain antibiotics, such as neomycin and / or streptomycin, please inform your doctor.

If you have problems with no pituitary gland or hypothalamus under control

when trying least your thyroid gland (hypothyroidism),

your adrenal glands do not work properly (adrenocortical insufficiency)

prolactin in your blood levels are high (hyperprolactinemia)

If you have any other medical conditions (eg diabetes, heart disease or any other long-term illness ).

If you are a woman:

Ovarian hyperstimulation syndrome (OHSS) Your

doctorregularlyeffects of your treatment to select the right dose of PUREGON every day

willcheck the. Your ovaries can be examined by ultrasound regularly. Your doctor can also control your blood hormone levels. A very high dose of FSH is extremely important, as ovaries are over-stimulated, which can lead to serious complications. This serious medical condition is known as ovarian stimulation syndrome (ovarian hyperstimulation syndrome - OHSS). In rare cases, severe OHSS can be life-threatening. OHSS can cause sudden accumulation of fluid in your stomach and chest areas and may lead to the formation of blood clots. If you experience severe swelling in the abdomen, pain in the stomach (abdominal pain), vomiting (nausea), sudden weight gain due to vomiting or fluid accumulation, diarrhea, decreased urine volume, or difficulty breathing, call your doctor immediately (see also Chapter 4, Possible side effects). ).

Regular monitoring of your response to FSH treatment will help prevent your ovaries from being over-stimulated. If you have abdominal pain and these pains occur a few days after the last injection, contact your doctor immediately.

Multiple pregnancy or birth defects

Even if only one embryo has been transported into your uterus, the risk of multiple pregnancies is increased after treatment with gonadotropin preparations. Multiple pregnancies may jeopardize the health of both the mother and her infants during the delivery process. Furthermore, the characteristics of patients treated for multiple pregnancies and infertility (for example, the age of women, sperm characteristics of both men, the genetic background of both parents) may be related to an increase in the risk of birth defects.

Pregnancy complications

Except for uterus, the risk of pregnancy (ectopic pregnancy) increases slightly. Therefore, your doctor should perform an early ultrasound examination to exclude the possibility of pregnancy outside the uterus.

Women with fertility treatment have a lower likelihood of miscarriage.

Blood clot (Thrombosis)

PUREGON treatment (such as pregnancy itself) can increase the risk of developing blood clots (thrombosis). Thrombosis is the formation of a blood clot in a blood vessel.

Blood clots can cause serious medical conditions, such as:

- obstruction in your lungs (lung embolism) -

stroke -

heart attack -

blood vessel problems (thrombophlebitis) -

loss of blood flow (deep vein thrombosis); you may lose your arm or your leg.

Before starting treatment with this subject, you in particular has the following characteristics, please talk to your doctor:

If you already know that you are likely Thrombosis live

if you or close family member before thrombosis developed in any

excessively if you are overweight

Ovarian torsion

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