0.25 mg / 0.5 ml solution for injection, Pre-filled Syringe
Fyremadel vs Ganirelix.
What Ganirelix Is And What It Is Used For
Fyremadel contains the active substance ganirelix and belongs to a group of medicines called “anti-gonadotropin-releasing hormones” which counteract the effect of natural gonadotropin-releasing hormone ( GnRH ).
GnRH controls the release of one of the gonadotropins (luteinizing hormone ( LH ) and follicle-stimulating hormone ( FSH )). Gonadotropins play an important role in human fertility and reproduction. In women, FSH is needed for the growth and maturation of follicles in the ovaries. Follicles are small round blisters that contain egg cells.
LH is needed for the mature egg cells to detach from the follicles and ovaries (ie ovulation). Ganirelix counteracts the effect of GnRH, which results in a reduction in the release of, above all, LH.
What is Fyremadel Used For In Ivf?
This is a common question about Fyremadel. What does it do? The benefits of Firemadel are mainly for pregnant women. Premature ovulation can occasionally occur for women undergoing assisted reproduction, including in vitro fertilization (IVF) and other methods, leading to a significantly reduced chance of becoming pregnant. Lighthouse is used to prevent premature LH increases that can cause premature ovulation.
What Is Fyremadel Used For?
In clinical trials, ganirelix was combined with recombinant follicle-stimulating hormone ( FSH ) or corifollitropin alfa, a long-acting follicle stimulator.
Fyremadel also approved for treating other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
How To Give Fyremadel Injection
- If you are allergic to ganirelix or any of the other ingredients of this medicine.
- If you are hypersensitive to gonadotropin-releasing hormone ( GnRH ) or GnRH- like substances.
- If you have moderate or severe renal or hepatic impairment.
- If you are pregnant or breastfeeding.
Warnings And Cautions About Using Fyremadel
Talk to your doctor, pharmacist, or nurse and read use directions before using ganirelix:
- If you have an active allergic condition, talk to your doctor. Depending on the severity, your doctor will decide if additional checks are needed during treatment. Cases of allergic reactions have been reported as early as after the first dose.
- An overstimulation condition may develop during and after hormonal stimulation of the ovaries. This condition is related to the stimulation procedure with gonadotropins. See the package leaflet for the gonadotropin preparation you have been prescribed.
- Congenital malformations may be slightly higher after assisted reproduction than after spontaneous conception. This slightly increased risk is related to the characteristics of patients undergoing fertility treatment (e.g. the woman’s age and sperm characteristics) and because multiple pregnancies are more common after assisted reproduction.
- The incidence of congenital malformations after assisted reproduction when using ganirelix does not differ from the use of other GnRH- like substances in assisted reproduction.
- There is a slightly increased risk of ectopic pregnancy in women with damaged fallopian tubes.
- The efficacy and safety of ganirelix have not been established in women weighing less than 50 kg or more than 90 kg. Ask your doctor for more information.
Children And Young People
There is no relevant use of Fyremadel for children or young people.
Other Medicines And Fyremadel
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Fyremadel And Pregnancy, Breastfeeding and Fertility
Lighthouse should be used in controlled ovarian stimulation for assisted reproduction (ART). Do not use during pregnancy and breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving And Using Machines With Fyremadel Injection
The effects of ganirelix on driving ability and the use of machines have not been studied.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring increased vigilance.
One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. A description of fyremadel side effects and effects can be found in other sections of the package leaflet. Read all the information in this leaflet for guidance.
If you are not sure, talk to your doctor or pharmacist.
This medicine contains less than 1 mmol (23 mg) sodium per injection, ie essentially ‘sodium-free’.
How To Give Fyremadel IVF Injection
Lighthouse is used as part of the treatment in assisted reproduction (ART), including in vitro fertilization (IVF).
You will give yourself the injections, so your doctor will explain what you need to do. Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Fyremadel When To Take?
Following are the details about when to take the ganirelix injections
Stage 1
Stimulation of the ovaries with follicle-stimulating hormone ( FSH ) or chorifollitropin can start on day 2 or 3 of your period.
Stage 2
Tablets (0.25 mg) should be injected directly under the skin once daily starting on day 5 or day 6 of the stimulation. Depending on how your ovaries react, your doctor may decide that you should start on another day.
Teal should not be mixed with FSH, but both preparations should be given at approximately the same time but not at the same injection site.
Daily treatment with ganirelix should continue until you have a sufficient number of follicles of sufficient size.
Stage 3
The final maturation of the egg cells in the follicles can be initiated by injecting human chorionic gonadotropin ( hCG ). The time between two four-food injections and between the last four-food injection one and hCG – injection one should not exceed 30 hours, as premature ovulation (ie, release of egg cells) can otherwise occur.
Therefore, when injecting ganirelix in the morning, the treatment with ganirelix should continue throughout the treatment period with gonadotropin, including the day of ovulation induction.
When injecting Ganirelix in the afternoon the last ganirelix injection should be given in the afternoon the day before ovulation induction.
Fyremadel Injection Instructions
The Injection Site For Ganirelix
it’s available as pre-filled syringes that contain a dose; follow the Fyremadel injection instructions for IVF. The contents should be injected slowly, directly under the skin, preferably in the thigh. Check the solution before using it.
Do not use the solution if it is not free of particles or ready. If you give the injections yourself or your partner does, follow the instructions carefully. Do not mix ganirelix with other medicines.
How To Inject Ganirelix Injection
Preparation Of The Injection Site For Ganirelix
Follow the ganirelix injection instructions before giving IVF. Wash your hands thoroughly with soap and water. Wash the injection site with a disinfectant (eg alcohol) to remove bacteria from the skin. Clean about 5 cm around the place where the needle is to be inserted and let the disinfectant dry for at least one minute before continuing.
Insertion Of The Injection Needle
Remove the cover from the needle. Pinch between the thumb and forefinger a large area of the skin. Insert the needle at the base of the pinched skin at a 45° angle to the surface of the skin. Vary the injection site with each injection.
Checking The Position Of The Fyremadel Injection Needle
Carefully pull back on the plunger to check that the needle is in the correct position. If blood is drawn into the syringe, it means that the tip of the needle has entered a blood vessel. If this happens, do not inject ganirelix.
Remove the syringe, cover the injection site with a swab soaked in disinfectant, and press against it; it should stop bleeding within a minute or two.
Do not use this syringe but dispose of it properly. Start over with a new syringe.
Fyremadel Injection Of The Solution
When the needle is positioned correctly, push the plunger in slowly and steadily so that the solution is injected correctly and the skin is not damaged.
Removal Of The Injection Needle
Quickly pull the needle and press it against the injection site with a disinfectant swab.
Use the pre-filled syringe only once.
Side Effects Of An Overdose Of Fyremadel Injection
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
Missed Fyremadel Injection
This is a common question what happens if you miss ganirelix injection IVF? If you have missed a dose of ganirelix injection, take it as soon as possible.
Do not take a double dose to make up for a forgotten dose.
If you are more than 6 hours late (so that the time between two injections is more than 30 hours) take a dose as soon as possible and contact your doctor for further advice.
If You Stop Using Fyremadel injection
Do not stop taking it unless your doctor has instructed you to, as it may affect the outcome of your treatment.
Ask your doctor, pharmacist, or nurse if you have any further questions about using this product.
Side Effects Of Fyremadel Ivf Injection:
This medicine can cause side effects like all medicines, although not everybody gets them.
Common Ganirelix Side Effects (May affect less than 1 user in 10)
- Local skin reactions at the injection site (especially redness with or without swelling). The local reaction usually disappears within 4 hours after injection.
Uncommon Ganirelix Injection Side Effects (may affect less than 1 user in 100)
- Headache
- Nausea
- The general feeling of illness (general feeling of being sick, feeling bad).
Rare Fyremadel Injection side effects(may affect less than 1 in 10,000 users)
- More extensive allergic reactions have been observed as early as after the first dose.
In addition, Fyremadel side effects have been reported that are known in connection with controlled ovarian hyperstimulation therapy, such as:
- Abdominal pain is also reported as ganirelix injection side effects.
- Ovarian hyperstimulation syndrome (OHSS). (OHSS occurs when your ovaries overreact to drugs you take during fertility treatment.)
- Ectopic pregnancy (when an embryo develops outside the uterus).
- Miscarriage (see package leaflet of the FSH product you are being treated with).
In addition to fyremadel injection side effects, the deterioration of the previous eczema has been reported in a patient after the first ganirelix- dose one.
Fyremadel injection Storage
This is important to know about the ganirelix storage. Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after “EXP.” The expiration date is the last day of the specified month.
This medicine does not require any special instructions for ganirelix injection storage.
Check the syringe before use. Only use syringes with a clear, particle-free solution and from undamaged packaging.
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 Packaging And Other Information
Content Declaration
- The active substance is ganirelix. Each pre-filled syringe contains 0.25 mg of ganirelix (as acetate) in 0.5 ml of an aqueous solution.
- The other ingredients are acetic acid (E260), mannitol (E421), and injection water. The pH (acidity) may have been adjusted with sodium hydroxide and acetic acid.
What The Medicine Ganirelix Looks Like And Contents Of The Pack
Ganirelix is a clear and colorless aqueous solution of ganirelix for injection. The solution is ready to use and intended for subcutaneous administration.
Lighthouse material is available in packs of 1 or 5 pre-filled syringes with injection needles (27 G).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer of Ganirelix
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Information is provided by
Ferring Läkemedel AB
Södergaten 26, FLOOR 4
Box 4041
SE-203 11 Malmö