Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Hypersensitivity reaction
Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions, (both generalised and local), have been reported with Orgalutran, as early as with the first dose, during post-marketing surveillance. These events have included anaphylaxis (including anaphylactic shock), angioedema and urticaria. (see section 4.8). If a hypersensitivity reaction is suspected, Orgalutran should be discontinued and appropriate treatment administered. In the absence of clinical experience, Orgalutran treatment is not advised in women with severe allergic conditions.
Latex allergy
The needle cover contains dry natural/ rubber latex which comes into contact with the needle and may cause allergic reactions (see section 6.5).
Ovarian hyperstimulation syndrome (OHSS)
Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation. OHSS must be considered an intrinsic risk of gonadotrophin stimulation.
OHSS should be treated symptomatically, e.g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin.

Ectopic pregnancy

Since infertile women undergoing assisted reproduction, and particularly in vitro fertilisation (IVF), often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.


Congenital malformations
The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be higher than after spontaneous conceptions. This is thought to be due to differences in parental characteristics (e.g., maternal age, sperm characteristics) and an increased incidence of multiple gestations. In clinical studies investigating more than 1,000 newborns it has been demonstrated that the incidence of congenital malformations in children born after COH treatment using Orgalutran is comparable with that reported after COH treatment using a GnRH agonist.


Women weighing less than 50 kg or more than 90 kg
The safety and efficacy of Orgalutran have not been established in women weighing less than 50 kg or more than 90 kg (see sections 5.1 and 5.2).
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially ‘sodium-free’.

Effects on Driving

4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.