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 gonadotrophin releasing hormone (GnRH) or a GnRH analogue
• if you have a moderate or severe kidney or liver disease
• if you are pregnant or breast-feeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Fyremadel

• if you have an active allergic condition, please tell your doctor. Your doctor will decide, depending on the severity, if additional monitoring is required during treatment. Cases of allergic reactions have been reported, as early as with the first dose.
• allergic reactions, both generalised and local, including hives (urticaria), swelling of the face, lips, tongue and/or throat that may cause difficulty in breathing and/or swallowing (angioedema and/or anaphylaxis) have been reported (see also section 4.) If you have an allergic reaction, stop taking Fyremadel and seek immediate medical assistance.
• latex allergy, the needle cover contains dry natural rubber/latex which comes into contact with the needle and may cause allergic reactions.
• during or following hormonal stimulation of the ovaries, ovarian hyperstimulation syndrome may develop. This syndrome is related to the stimulation procedure with gonadotrophins. Please refer to the Package Leaflet of the gonadotrophin-containing medicine prescribed for you.
• the incidence of congenital malformations after assisted reproduction techniques may be slightly higher than after spontaneous conceptions. This slightly higher incidence is thought to be related to characteristics of the patients undergoing fertility treatment (e.g. age of the woman, sperm characteristics) and to the higher incidence of multiple gestations after assisted reproduction techniques. The incidence of congenital malformations after assisted reproduction techniques using Fyremadel is not different from that after using other GnRH analogues in the course of assisted reproduction techniques.
• there is a slightly increased risk of pregnancy outside of the uterus (an ectopic pregnancy) in women with damaged fallopian tubes.
• the efficacy and safety of Fyremadel has not been established in women weighing less than 50 kg or more than 90 kg. Ask your doctor for further information.

Children and adolescents

There is no relevant use of Fyremadel in children or adolescents.

Other medicines and Fyremadel

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

Pregnancy, breast-feeding and fertility

Fyremadel should be used during controlled ovarian stimulation for assisted reproduction techniques (ART). Do not use Fyremadel during pregnancy and breast-feeding.

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 ability to drive and use machines have not been studied.

Fyremadel contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially “sodium-free”.