150 IU / 0.18 ml, 300 IU 0.36 ml, 600 IU / 0.72 ml, 900 IU / 1.08 ml solution for injection follitropin beta

What Puregon is and what it is used for

Puregon 300 IU / 0.36 ml solution for injection contains follitropin beta, a hormone called follicle-stimulating hormone ( FSH ).

FSH belongs to the group of gonadotropins that play an important role in human fertility and reproduction. In women, FSH is needed for the growth and development of follicles in the ovaries. Follicles are small round sacs that contain egg cells. In men, FSH is needed for the production of sperm.

Puregon is used to treat infertility in the following situations:

Women

In women who are not ovulating and who are not responding to treatment with clomiphene citrate, Puregon can be used to induce ovulation.

In women undergoing assisted reproduction, such as in-vitro fertilization (IVF) and other methods, Puregon may cause more follicles to develop.

Men

In men who are infertile due to decreased hormone levels, Puregon can be used to produce sperm.

What you need to know before you use Puregon

Do not use Puregon

If you:

  • is allergic to follitropin beta or any of the other ingredients of Puregon (listed in section 6)
  • have a tumor in the ovaries, breasts, uterus, testicles, or brain ( pituitary gland or hypothalamus )
  • have profuse or irregular bleeding, where the cause is unknown
  • have ovaries that do not work due to a condition called primary ovarian failure
  • have ovarian cysts or enlarged ovaries that are not caused by polycystic ovary syndrome ( PCOS )
  • have genital malformations that make a normal pregnancy impossible
  • have muscle knots in the uterus that make a normal pregnancy impossible
  • is a man and is infertile due to a condition called primary testicular failure.

Warnings and cautions

Talk to your doctor before using Puregon if you

  • have had an allergic reaction to certain antibiotics ( neomycin and/or streptomycin)
  • have uncontrolled problems with the pituitary gland or the hypothalamus
  • has an underproduction in the thyroid gland ( hypothyroidism )
  • have adrenal glands that do not function properly (adrenal cortex insufficiency)
  • have high levels of prolactin in the blood ( hyperprolactinemia )
  • have any other medical conditions (eg diabetes, heart disease, or any other long-term illness).

If you are a woman:

Ovarian overstimulation syndrome (OHSS)

Your doctor will monitor the effectiveness of your treatment regularly to be able to choose the right dose of Puregon from day today. You will probably undergo regular ultrasound examinations of the ovaries. Your doctor can also check your hormone levels in the blood. This is very important because an overdose of FSH can cause serious but unusual complications, due to overstimulated ovaries and the growth of follicles. becomes larger than normal. This serious medical condition is called ovarian hyperstimulation syndrome (OHSS). In rare cases, severe OHSS can be life-threatening. OHSS causes a sudden accumulation of fluid in the abdomen and chest cavity and can cause the formation of blood clots. Contact your doctor immediately if you experience severe abdominal pain, abdominal pain, nausea, vomiting, sudden weight gain due to fluid retention, diarrhea, decreased urine output, or difficulty breathing (see also section 4, Possible side effects ).

→ Regular monitoring of the response to FSH treatment helps prevent overstimulation. Contact your doctor immediately if you get abdominal pain, even if they occur a few days after the last injection.

Multiple births or congenital anomalies

After treatment with gonadotropin preparations, there is an increased risk of multiple births even when only one embryo is inserted into the uterus. Multiple pregnancies entail an increased health risk at birth for both the mother and her children. In addition, multiple pregnancies and characteristics of the patients undergoing fertility treatment (eg woman’s age, characteristics of the sperm, genetic background of both parents) may be associated with an increased risk of congenital anomalies.

Pregnancy complications

There is a slightly increased risk of an ectopic pregnancy (ectopic pregnancy). Your doctor should therefore perform an early ultrasound examination to rule out the risk of ectopic pregnancy.

Women undergoing fertility treatment have a slightly increased risk of miscarriage.

Blood clot ( thrombosis )

Treatment with Puregon, as well as the pregnancy itself, may increase the risk of blood clots ( thrombosis ). Thrombosis is the formation of a blood clot in a blood vessel.

Blood clots can lead to serious medical conditions, such as:

  • blockage of the lungs ( pulmonary embolism )
  • stroke
  • myocardial infarction
  • blood vessel problems ( thrombophlebitis )
  • poorer blood flow (deep vein thrombosis ) which can lead to loss of an arm or a leg.

Discuss this with your doctor before starting treatment, especially:

  • If you already know that you have an increased risk of thrombosis
  • if you, or anyone else in your immediate family, has or has had a thrombosis
  • if you are severely overweight.

Ovarian torsion

Ovarian torsion has occurred after treatment with gonadotropins including Puregon. Ovarian torsion is a twisting of an ovary. Twisting of the ovaries can cause the blood flow to the ovary to stop.

Before you start taking this medicine, tell your doctor if you:

  • have ever had ovarian overstimulation syndrome OHSS
  • is pregnant or thinks you may be pregnant
  • have ever undergone abdominal surgery
  • have ever had a twist of an ovary
  • have ever had or have cysts in the ovary or ovaries.

Tumors are in the ovaries and other parts of the reproductive system

There have been reports of tumors in the ovaries and other parts of the reproductive system in women who have undergone fertility treatment. It is not known whether treatment with fertility drugs increases the risk of these tumors in infertile women.

Other medical conditions

Before you start taking this medicine, also tell your doctor if you:

  • have been told by a doctor that a pregnancy would be dangerous for you.

If you are a man:

Men with elevated levels of FSH in their blood

Elevated levels of FSH in the blood are a sign of damage to the testicles. Puregon is generally not effective in such cases. To check the effect of the treatment, your doctor may ask you for a semen sample to be analyzed 4 to 6 months after starting the treatment.

Children and young people

There is no relevant use of Puregon for children and adolescents.

Other medicines and Puregon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If Puregon is used in combination with clomiphene citrate, you can get an increased effect of Puregon. If a GnRH agonist (a medicine used to prevent premature ovulation) has been used, a higher dose of Puregon may be needed.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine. You should not use Puregon if you are already pregnant or if you think you may be pregnant.

Puregon can affect milk production. Puregon is unlikely to pass into breast milk.

If you are breastfeeding, talk to your doctor before using Puregon.

Driving and using machines

Puregon is unlikely to affect your ability to drive or use machines.

Puregon contains benzyl alcohol

This medicine contains 10 mg of benzyl alcohol per ml.

Benzyl alcohol can cause allergic reactions.

If you have liver or kidney problems, talk to your doctor or pharmacist before taking this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).

If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).

Puregon contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per injection, ie essentially ‘sodium-free’.

How to use Puregon

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dosage for women

Your doctor will determine your starting dose. This dose can be adjusted during treatment. Further details on the treatment schedule are given below.

There are significant differences between different women in the response to FSH from the ovaries, which makes it impossible to provide a dosing schedule that suits all patients. To find the right dose, your doctor will check the growth of follicles with ultrasound examination and measurement of estradiol (female sex hormone) in the blood.

  • Women who do not ovulate

Your doctor will decide on a starting dose. This dose is maintained for at least seven days. If you have no response from the ovaries, increase the daily dose gradually until the growth of follicles and/or the levels of estradiol in the blood show that you have the desired effect. The daily dose is maintained until you have a follicle of the right size. Usually, 7 to 14 days of treatment is enough. Then the treatment with Puregon is stopped and ovulation will be started by giving chorionic gonadotropin ( hCG ).

  • Medically supervised reproduction, eg IVF

A starting dose is determined by your doctor. This dose is maintained for at least the first four days. After that, your dose is adjusted based on the response from your ovaries. When you have the desired number of follicles of the right size, the last maturation phase of the follicles is started by giving hCG. Egg picking can begin 34-35 hours later.

Dosage for men

Puregon is usually given in a dose of 450 IU per week, usually in 3 doses of 150 IU, in combination with another hormone ( hCG ) for at least 3 to 4 months. The treatment period corresponds to the time it takes for sperm to form and the time during which an improvement can be expected. If your sperm production has not started within this period, your treatment may need to last for at least 18 months.

How the injections are given

Puregon solution for injection in a cartridge has been developed for use in the Puregon Pen. The separate instructions for how to use the pen must be followed carefully. Do not use a cartridge if the solution contains particles or if the solution is not clear.

When using the pen, the injections can be given just under the skin (eg in the lower abdomen) by yourself or your partner. Your doctor will tell you when and how to proceed. If you inject yourself with Puregon, follow the instructions carefully so that Puregon is given correctly and with the least possible discomfort.

The first dose of Puregondo should only be given in the presence of a doctor or nurse.

If you use more Puregon than you should 

Talk to your doctor immediately.

Too high a dose of Puregon may cause ovarian hyperstimulation (OHSS). It can be felt as abdominal pain. If you get abdominal pain, tell your doctor immediately. See also section 4, Possible side effects.

If you forget to use Puregon

If you miss a dose Do not take a double dose to make up for a missed dose.

→ Contact your doctor.

If you have any further questions on the use of this product, ask your doctor.

Possible side effects

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

Serious side effects are in women

A complication of FSH treatment is overstimulation of the ovaries. Overstimulation of the ovaries can develop into a medical condition called ovarian hyperstimulation syndrome (OHSS), which can be a serious medical problem. The risk can be reduced by careful monitoring of follicle development during treatment. Your doctor will perform ultrasound examinations of the ovaries to closely monitor the number of maturing follicles. Your doctor may also check the hormone levels in your blood. Abdominal pain, nausea, and diarrhea are the first symptoms. In more severe cases, the symptoms can also be enlargement of the ovaries, accumulation of fluid in the abdomen and/or thoracic cavity (which can cause sudden weight gain due to fluid accumulation), and the formation of blood clots in vessels. See Warnings and Precautions in Section 2.

→ Contact your doctor immediately if you experience abdominal pain or any of the other symptoms of ovarian overstimulation, even if it occurs a few days after the last injection.

If you are a woman:

Common side effects (may affect up to 1 in 10 people)

  • Headache
  • Injection site reactions (such as bruising, pain, redness, swelling, and itching )
  • Ovarian overstimulation syndrome (OHSS)
  • Pelvic pain
  • Abdominal pain and / or distended abdomen

Uncommon side effects (may affect up to 1 in 100 people)

  • Chest problems (including soreness)
  • Diarrhea, constipation, or abdominal discomfort
  • Enlarged uterus
  • Nausea
  • Hypersensitivity reactions (such as rash, redness, hives, and itching )
  • Ovarian cysts or enlargement of the ovaries
  • Ovarian torsion (twisting of the ovaries)
  • Vaginal bleeding

Rare side effects (may affect up to 1 in 1,000 people)

  • Blood clots (this can also occur without unwanted overstimulation of the ovaries, see Warnings and Precautions in section 2)

Ectopic pregnancy (ectopic pregnancy), miscarriage, and multiple births have also been reported. These side effects are not considered related to the use of Puregon, but to assisted reproduction or subsequent pregnancy.

If you are a man:

Common side effects (may affect up to 1 in 10 people)

  • Acne
  • Injection site reactions (such as hardening and pain)
  • Headache
  • Rash
  • Some breast development
  • Cyst in the testicle

How to store Puregon

Keep this medicine out of the sight and reach of children.

Storage in pharmacies

Store at 2 ° C – 8 ° C (in a refrigerator). Do not freeze.

Storage by patient

There are two options:

  1. Store at 2 ° C – 8 ° C (in a refrigerator). Do not freeze.
  2. Store at or below 25 ° C (at room temperature) for a maximum continuous period of 3 months.

Make a note of when you start storing the product outside the refrigerator.

Store cartridge one in the outer carton.

Once the needle has been pushed through the rubber insert of the cartridge, the product is stable for 28 days.

Make a note of the first day of use for the cartridge on the notecard according to the Puregon Pen’s Instruction Manual.

Do not use this medicine after the expiry date which is stated on the label after “EXP” and the carton after “EXP”. The expiration date is the last day of the specified month.

Used needles should be discarded immediately after injection.

Do not mix in any other medicines in cartridge one. Empty cartridges must not be refilled.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • Each cartridge contains the active substance follitropin beta, a hormone called follicle-stimulating hormone ( FSH ) at a strength of 833 IU / ml aqueous solution.
  • The other ingredients are sucrose, sodium citrate, L-methionine, polysorbate 20, and benzyl alcohol in water for injections. The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.

What the medicine looks like and the contents of the pack

Puregon solution for injection ( solution for injection ) is a clear, colorless liquid. It is available in glass cartridges. It is available in packs of a glass cartridge.

Marketing Authorization Holder and Manufacturer

NV Organon

Kloosterstraat 6

5349 AB Oss

Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienOrganon BelgiumPhone: 0080066550123 (+32 2 2418100)dpoc.benelux@organon.com LithuaniaOrganon Pharma BV Lithuania atstovybėTel .: +370 52041693dpoc.lithuania@organon.com
BulgariaORGANON (USA) B.V. – clone of BulgariaTel: +359 2 806 3030dpoc.bulgaria@organon.com Luxembourg / LuxemburgOrganon BelgiumPhone: 0080066550123 (+32 2 2418100)dpoc.benelux@organon.com
Czech RepublicOrganon Czech Republic sroTel: +420 233 010 300dpoc.czech@organon.com HungaryOrganon Hungary Kft.Tel .: +36 1 766 1963dpoc.hungary@organon.com
DenmarkOrganon Denmark ApSTel: +45 4484 6800info.denmark@organon.com MaltaOrganon Pharma BV, Cyprus branchTel: +356 2277 8116dpoc.cyprus@organon.com
GermanyOrganon Healthcare GmbHTel .: 0800 3384 726 (+49 (0) 89 2040022 10)dpoc.germany@organon.com The NetherlandsNV OrganonTel: 00800 66550123(+32 2 2418100)dpoc.benelux@organon.com
EestiOrganon Pharma BV Estonian ROTel: +372 66 61 300dpoc.estonia@organon.com NorwayOrganon Norway ASTel: +47 24 14 56 60info.norway@organon.com
GreeceBIANEΞ Α.Ε.:Ηλ: +30 210 80091 11Mailbox@vianex.gr AustriaOrganon Austria GmbHTel: +43 (0) 1 263 28 65medizin-austria@organon.com
SpainOrganon Salud, SLTel: +34 91 591 12 79organon_info@organon.com PolandOrganon Polska Sp. z ooTel .: +48 22 105 50 01organonpolska@organon.com
FranceOrganon FranceTel: +33 (0) 1 57 77 32 00 PortugalOrganon Portugal, Sociedade Unipessoal Lda.Tel: +351 218705500geral_pt@organon.com
CroatiaOrganon Pharma dooTel: +385 1 638 4530dpoc.croatia@organon.com RomaniaOrganon Biosciences SRLTel: +40 21 527 29 90info.romania@organon.com
IrelandOrganon Pharma (Ireland) LimitedTel: +353 15828260medinfo.ROI@organon.com SloveniaOrganon Pharma BV, Oss, Ljubljana CompanyTel: +386 1 300 10 80info.slovenia@organon.com
IcelandVistor hf.Phone: + 354 535 7000 Slovak RepublicOrganon Slovakia sroTel: +421 2 44 88 98 88dpoc.slovakia@organon.com
ItalyOrganon Italia SrlTel: +39 06 3336407dpoc.italy@organon.com Finland / FinlandOrganon Finland OyPuh / Tel: +358 (0) 29 170 3520dpoc.finland@organon.com
.ΠροςOrganon Pharma BV, Cyprus branch:Ηλ: +357 22866730dpoc.cyprus@organon.com SwedenOrganon Sweden ABTel: +46 8 502 597 00dpoc.sweden@organon.com
LatviaKomrvalsts komersanta “Organon Pharma BV” pārstāvniecībaTel: +371 66968876dpoc.latvia@organon.com United Kingdom (Northern Ireland)Organon Pharma (Ireland) LimitedTel: +353 15828260medinfo.ROI@organon.com

Muhammad Nadeem

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