0.25 mg / 0.5 ml solution for injection , pre-filled syringe
1. What Fyremadel 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. Folliclesare small round blisters that contain egg cells. LH is needed for the mature egg cells to detach from the follicles and ovaries (ie ovulation). Fyremadel counteracts the effect of GnRH , which results in a reduction in the release of, above all, LH .
What Fyremadel is used for
For women undergoing assisted reproduction, including in vitro fertilization (IVF) and other methods, premature ovulation can occasionally occur, leading to a significantly reduced chance of becoming pregnant. Lighthouse is used to prevent premature LH increases that can cause premature ovulation.
In clinical trials , ganirelix was used in combination with recombinant follicle-stimulating hormone ( FSH ) or korifollitropin alfa, a long-acting follicle stimulator.
Ganirelix contained in Fyremadel may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before using Fyremadel
Do not use Fyremadel
- if you are allergic to ganirelix or any of the other ingredients of this medicine (listed in section 6).
- 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
Talk to your doctor, pharmacist or nurse before using Fyremadel:
- If you have an active allergic condition, talk to your doctor. Your doctor will decide, depending on the severity, if additional checks are needed during treatment. Cases of allergic reactions have been reported, as early as after the first dose .
- during and after hormonal stimulation of the ovaries, an overstimulation condition may develop. This condition is related to the stimulation procedure with gonadotropins . See the package leaflet for the gonadotropin preparation you have been prescribed.
- The incidence of congenital malformations after assisted reproduction may be slightly higher than after spontaneous conception. This slightly increased risk is thought to be related to the characteristics of patients undergoing fertility treatment (eg the woman’s age, sperm characteristics) and due to the fact that multiple pregnancies are more common after assisted reproduction.
- The incidence of congenital malformations after assisted reproduction when using Fyremadel 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 Fyremadel 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.
Pregnancy, breastfeeding and fertility
Lighthouse should be used in controlled ovarian stimulation for assisted reproduction (ART). Do not use Fyremadel during pregnancy and breastfeeding.
If you are pregnant or breast-feeding, 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
The effects of Fyremadel on driving ability and use of machines have not been studied.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . A description of these effects and side 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.
Lighthouse food contains excipients
This medicine contains less than 1 mmol (23 mg) sodium per injection , ie essentially ‘sodium-free’.
3. How to use Fyremadel
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.
Stimulation of the ovaries with follicle-stimulating hormone ( FSH ) or chorifollitropin can start on day 2 or 3 of your period.
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 Fyremadel should continue until you have a sufficient number of follicles of a sufficient size.
The final maturation of the egg cells in the follicles can be initiated by injection of 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 Fyremadel in the morning , the treatment with Fyremadel should continue throughout the treatment period with gonadotropin, including the day of ovulation induction. When injecting Fyremadel in the afternoonthe last Fyremadel injection should be given in the afternoon the day before ovulation induction.
Fyremadel is available as pre-filled syringes that contain a dose . 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 is not ready. If you give the injections yourself or if your partner does, follow the instructions carefully. Do not mix Fyremadel with other medicines.
Preparation of the injection site
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 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 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 Fyremadel. Remove the syringe, cover the injection site with a swab soaked in disinfectant and press against, 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 .
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 needle
Quickly pull out the needle and press against the injection site with a swab of disinfectant.
Use the pre-filled syringe only once.
If you use too much of Fyremadel
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.
If you have forgotten to use Fyremadel
If you find that you have missed a dose, 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
Do not stop taking Fyremadel unless your doctor has instructed you to do so, as it may affect the outcome of your treatment.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Common (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 (may affect less than 1 user in 100)
- general feeling of illness (general feeling of being sick, feeling bad).
Very rare (may affect less than 1 in 10,000 users)
- more extensive allergic reactions have been observed, as early as after the first dose one.
In addition, side effects have been reported that are known in connection with controlled ovarian hyperstimulation therapy such as:
- abdominal pain
- ovarian hyperstimulation syndrome (OHSS). (OHSS occurs when your ovaries overreact to drugs you take during your fertility treatment.)
- ectopic pregnancy (when an embryo develops outside the uterus)
- miscarriage (see package leaflet of the FSH product you are being treated with).
Deterioration of the previous eczema has been reported in a patient after the first ganirelix- dose one.
5. How to store Fyremadel
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
Check the syringe before use. Only use syringes with 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.
6. Contents of the packaging and other information
- The active substance is ganirelix. Each pre-filled syringe contains 0.25 mg of ganirelix (as acetate) in 0.5 ml of aqueous solution .
- The other ingredients are acetic acid (E260), mannitol (E421), water for injections. The pH (a measure of the acidity) may have been adjusted with sodium hydroxide and acetic acid.
What the medicine looks like and contents of the pack
Fyremadel is a clear and colorless aqueous solution 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
Sun Pharmaceutical Industries Europe BV
2132 JH Hoofddorp
Information is provided by
Ferring Läkemedel AB
Södergaten 26, FLOOR 4
SE-203 11 Malmö