ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Orgalutran 0.25 mg/0.5 ml solution for injection
2.
Each pre-filled syringe contains 0.25 mg of ganirelix in 0.5 ml aqueous solution. The active substance
ganirelix (INN) is a synthetic decapeptide with high antagonistic activity to the naturally occurring
gonadotrophin releasing hormone (GnRH). The amino acids at positions 1, 2, 3, 6, 8 and 10 of the
natural GnRH decapeptide have been substituted resulting in N-Ac-D-Nal(2)
1
, D-pClPhe
2
, D-Pal(3)
3
,
D-hArg(Et2)
6
, L-hArg(Et2)
8
, D-Ala
10
]-GnRH with a molecular weight of 1570.4.
For a full list of excipients, see section 6.1.
3.
Solution for injection.
Clear and colourless aqueous solution.
4.
The prevention of premature luteinising hormone (LH) surges in women undergoing controlled
ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).
In clinical studies Orgalutran was used with recombinant human follicle stimulating hormone (FSH)
or corifollitropin alfa, the sustained follicle stimulant.
Orgalutran should only be prescribed by a specialist experienced in the treatment of infertility.
Posology
Orgalutran is used to prevent premature LH surges in women undergoing COH. Controlled ovarian
hyperstimulation with FSH or corifollitropin alfa may start at day 2 or 3 of menses. Orgalutran
(0.25 mg) should be injected subcutaneously once daily, starting on day 5 or day 6 of FSH
administration or on day 5 or day 6 following the administration of corifollitropin alfa. The starting
day of Orgalutran is depending on the ovarian response, i.e. the number and size of growing follicles
and/or the amount of circulating oestradiol. The start of Orgalutran may be delayed in absence of
follicular growth, although clinical experience is based on starting Orgalutran on day 5 or day 6 of
stimulation.
Orgalutran and FSH should be administered approximately at the same time. However, the
preparations should not be mixed and different injection sites are to be used.
FSH dose adjustments should be based on the number and size of growing follicles, rather than on the
amount of circulating oestradiol (see section 5.1).
Daily treatment with Orgalutran should be continued up to the day that sufficient follicles of adequate
size are present. Final maturation of follicles can be induced by administering human chorionic
gonadotrophin (hCG).
Timing of last injection
Because of the half-life of ganirelix, the time between two Orgalutran injections as well as the time
between the last Orgalutran injection and the hCG injection should not exceed 30 hours, as otherwise a
2
premature LH surge may occur. Therefore, when injecting Orgalutran in the morning, treatment with
Orgalutran should be continued throughout the gonadotrophin treatment period including the day of
triggering ovulation. When injecting Orgalutran in the afternoon the last Orgalutran injection should
be given in the afternoon prior to the day of triggering ovulation.
Orgalutran has shown to be safe and effective in women undergoing multiple treatment cycles.
The need for luteal phase support in cycles using Orgalutran has not been studied. In clinical studies,
luteal phase support was given according to study centres’ practice or according to the clinical
protocol.
Paediatric population
There is no relevant use of Orgalutran in the paediatric population.
Renal and hepatic impairment
There is no experience on the use of Orgalutran in subjects with renal or hepatic impairment, as they
were excluded from clinical studies. Therefore, the use of Orgalutran is contraindicated in patients
with moderate or severe renal or hepatic impairment. (see section 4.3).
Method of administration
Orgalutran should be administered subcutaneously, preferably in the upper leg. The injection site
should be varied to prevent lipoatrophy. The patient or her partner may perform the injections of
Orgalutran themselves, provided that they are adequately instructed and have access to expert advice.
−
Hypersensitivity to the active substance or to any of the excipients.
−
Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue.
−
Moderate or severe impairment of renal or hepatic function.
−
Pregnancy or breast-feeding.
−
Special care should be taken in women with signs and symptoms of active allergic conditions.
In the absence of clinical experience, Orgalutran treatment is not advised in women with severe
allergic conditions.
−
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.
−
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.
−
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 1000 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.
−
The safety and efficacy of Orgalutran have not been established in women weighing less than
50 kg or more than 90 kg (see also section 5.1 and 5.2).
3
−
This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially
‘sodium-free’.
No interaction studies have been performed.
The possibility of interactions with commonly used medicinal products, including histamine liberating
medicinal products, cannot be excluded.
Fertility
Ganirelix is used in the treatment of women undergoing controlled ovarian hyperstimulation in
assisted reproduction programmes. Ganirelix is used to prevent premature LH surges that might
otherwise occur in these women during the ovarian stimulation.
For posology and method of administration, see section 4.2.
Pregnancy
There are no adequate data from the use of ganirelix in pregnant women.
In animals, exposure to ganirelix at the time of implantation resulted in litter resorption (see section
5.3). The relevance of these data for humans is unknown.
Breast-feeding
It is not known whether ganirelix is excreted in breast milk.
The use of Orgalutran is contraindicated during pregnancy and breast-feeding (see section 4.3).
No studies on the effects on the ability to drive and use machines have been performed.
The listing below shows all adverse reactions in women treated with Orgalutran in clinical studies
using recFSH for ovarian stimulation. The adverse reactions with Orgalutran using corifollitropin alfa
for ovarian stimulation are expected to be similar. The adverse reactions are classified according to
MedDRA system organ class and frequency; very common (≥1/10), common (≥1/100 to <1/10),
uncommon (≥1/1000 to <1/100). The frequency of hypersensitivity (very rare, <1/10,000) has been
deduced from post-marketing surveillance.
Immune system disorders
Very rare: Cases of hypersensitivity reactions including various symptoms such as rash, facial
swelling and dyspnoea have been reported among patients administered Orgalutran. Worsening of a
pre-existing eczema has been reported in one subject after the first Orgalutran dose.
Nervous system disorders
Uncommon: Headache.
Gastrointestinal disorders
Uncommon: Nausea.
General disorders and administration site conditions
Very common: Orgalutran may cause a local skin reaction at the site of injection (predominantly
redness, with or without swelling). In clinical studies, one hour after injection, the incidence of at least
once a moderate or severe local skin reaction per treatment cycle, as reported by patients, was 12 % in
4
Orgalutran treated patients and 25 % in patients treated subcutaneously with a GnRH agonist. The
local reactions generally disappear within 4 hours after administration.
Uncommon: Malaise.
Other reported adverse reactions are related to the controlled ovarian hyperstimulation treatment for
ART, notably pelvic pain, abdominal distension, OHSS (see also section 4.4), ectopic pregnancy and
spontaneous abortion.
No data on acute toxicity of Orgalutran in humans are available. Clinical studies with subcutaneous
administration of Orgalutran at single doses up to 12 mg did not show systemic adverse reactions. In
acute toxicity studies in rats and monkeys non-specific toxic symptoms such as hypotension and
bradycardia were only observed after intravenous administration of ganirelix over 1 and 3 mg/kg,
respectively.
In case of overdose, Orgalutran treatment should be (temporarily) discontinued.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, anti-gonadotrophin-
releasing hormones, ATC code: H01CC01.
Orgalutran is a GnRH antagonist, which modulates the hypothalamic-pituitary-gonadal axis by
competitive binding to the GnRH receptors in the pituitary gland. As a result a rapid, profound,
reversible suppression of endogenous gonadotrophins occurs, without initial stimulation as induced by
GnRH agonists. Following administration of multiple doses of 0.25 mg Orgalutran to female
volunteers serum LH, FSH and E
2
concentrations were maximally decreased by 74 %, 32 % and 25 %
at 4, 16 and 16 hours after injection, respectively. Serum hormone levels returned to pre-treatment
values within two days after the last injection.
In patients undergoing controlled ovarian stimulation the median duration of Orgalutran treatment was
5 days. During Orgalutran treatment the average incidence of LH rises (>10 IU/l) with concomitant
progesterone rise (>1 ng/ml) was 0.3 - 1.2 % compared to 0.8 % during GnRH agonist treatment.
There was a tendency towards an increased incidence of LH and progesterone rises in women with a
higher body weight (>80 kg), but no effect on clinical outcome was observed. However, based on the
small number of patients treated so far, an effect can not be excluded.
In case of a high ovarian response, either as a result of a high exposure to gonadotrophins in the early
follicular phase or as a result of high ovarian responsiveness, premature LH rises may occur earlier
than day 6 of stimulation. Initiation of Orgalutran treatment on day 5 can prevent these premature LH
rises without compromising the clinical outcome.
In controlled studies of Orgalutran with FSH, using a long protocol of GnRH agonist as a reference,
treatment with the Orgalutran regimen resulted in a faster follicular growth during the first days of
stimulation but the final cohort of growing follicles was slightly smaller and produced on average less
oestradiol. This different pattern of follicular growth requires that FSH dose adjustments are based on
the number and size of growing follicles, rather than on the amount of circulating oestradiol. Similar
comparative studies with corifollitropin alfa using either a GnRH antagonist or long agonist protocol
have not been performed.
5.2 Pharmacokinetic properties
After a single subcutaneous administration of 0.25 mg, serum levels of ganirelix rise rapidly and reach
peak levels (C
max
) of approximately 15 ng/ml within 1 to 2 hours (t
max
). The elimination half-life (t
½
) is
5
approximately 13 hours and clearance is approximately 2.4 l/h. Excretion occurs via faeces
(approximately 75 %) and urine (approximately 22 %). The bioavailability of Orgalutran following
subcutaneous administration is approximately 91 %.
Pharmacokinetic parameters after multiple subcutaneous dosing of Orgalutran (once daily injection)
were similar to those after a single subcutaneous dose. After repeated dosing 0.25 mg/day steady-state
levels of approximately 0.6 ng/ml were reached within 2 to 3 days.
Pharmacokinetic analysis indicates an inverse relationship between bodyweight and serum
concentrations of Orgalutran.
Metabolite profile
The major circulating component in plasma is ganirelix. Ganirelix is also the main compound found in
urine. Faeces only contain metabolites. The metabolites are small peptide fragments formed by
enzymatic hydrolysis of ganirelix at restricted sites. The metabolite profile of Orgalutran in humans
was similar to that found in animals.
5.3 Preclinical safety data
Preclinical data reveal no special hazard for humans based on safety pharmacology, repeated dose
toxicity and genotoxicity.
Reproduction studies carried out with ganirelix at doses of 0.1 to 10
µ
g/kg/day subcutaneously in the
g/kg/day subcutaneously in the rabbit showed increased litter resorption in the
highest dose groups. No teratogenic effects were observed.
µ
6.
6.1 List of excipients
Acetic acid;
Mannitol;
Water for injections.
The pH may have been adjusted with sodium hydroxide and acetic acid.
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not freeze.
Store in the original package in order to protect from light.
6.5 Nature and contents of container
Disposable pre-filled syringes (siliconised type I glass), containing 0.5 ml of sterile, ready for use,
aqueous solution closed with a rubber piston. Each pre-filled syringe is affixed with a needle closed by
a needle shield of natural rubber.
Supplied in cartons containing 1 or 5 pre-filled syringes.
6
rat and 0.1 to 50
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Inspect the syringe before use. Use only syringes with clear, particle-free solutions and from
undamaged containers.
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.
7.
N.V. Organon,
Kloosterstraat 6,
Postbus 20,
5340 BH Oss,
The Netherlands
8.
EU/1/00/130/001, 1 pre-filled syringe
EU/1/00/130/002, 5 pre-filled syringes
9.
Date of first authorisation: 17 May 2000
Date of last renewal: 17 May 2010
Detailed information on this medicinal product is available on the website of the European Medicines
Agency http://www.ema.europa.eu
7
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR
BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
8
A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturers responsible for batch release
Organon (Ireland) Ltd,
P.O. Box 2857,
Drynam Road,
Swords,
Co. Dublin,
Ireland.
N.V. Organon,
Kloosterstraat 6
Postbus 20
5340 BH Oss,
The Netherlands.
The printed package leaflet of the medicinal product must state the name and address of the
manufacturer responsible for the release of the concerned batch.
B. CONDITIONS OF THE MARKETING AUTHORISATION
•
Medicinal product subject to restricted medical prescription (See annex I: Summary of Product
Characteristics, section 4.2).
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable.
•
OTHER CONDITIONS
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the
Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Risk Management Plan
The MAH commits to performing the studies and additional pharmacovigilance activities
detailed in the Pharmacovigilance Plan, as agreed in version 1.0 of the Risk Management Plan
(RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any
subsequent updates of the RMP agreed by the CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any
updated RMP should be submitted at the same time as the following Periodic Safety Update Report
(PSUR).
In addition, an updated RMP should be submitted:
•
When new information is received that may impact on the current Safety Specification,
Pharmacovigilance Plan or risk minimisation activities
9
•
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
reached
•
At the request of the European Medicines Agency.
10
ANNEX III
LABELLING AND PACKAGE LEAFLET
11
A. LABELLING
12
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE
PACKAGING
OUTER CARTON TEXT Orgalutran 1/ 5 pre-filled syringes
1.
Orgalutran 0.25 mg/0.5 ml solution for injection
Ganirelix
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
1 pre-filled syringe contains 0.25 mg ganirelix in 0.5 ml aqueous solution.
3.
LIST OF EXCIPIENTS
Other ingredients: acetic acid, mannitol, water for injections, sodium hydroxide and/or acetic acid as
pH adjustment.
4.
Solution for injection, 1 pre-filled syringe containing 0.5 ml
Solution for injection, 5 pre-filled syringes each containing 0.5 ml
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
Subcutaneous use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
For single use only.
8.
EXPIRY DATE
EXP
9.
SPECIAL STORAGE CONDITIONS
Do not freeze
Store in the original package in order to protect from light.
13
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Any unused product or waste material should be disposed of in accordance with local requirements.
N.V. Organon,
Kloosterstraat 6,
Postbus 20,
5340 BH Oss,
The Netherlands
EU/1/00/130/001 1 pre-filled syringe
EU/1/00/130/002 5 pre-filled syringes
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Justification for not including Braille accepted.
14
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
PRE-FILLED SYRINGES TEXT Orgalutran 0.25 mg/0.5 ml
1.
Orgalutran 0.25 mg/0.5 ml solution for injection
Ganirelix
Subcutaneous use
2.
METHOD OF ADMINISTRATION
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
BN
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
6.
OTHER
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET: INFORMATION FOR THE USER
Orgalutran 0.25 mg/0.5 ml solution for injection
Ganirelix
Read all of this leaflet carefully before you start using this medicine.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
:
1.
What Orgalutran is and what it is used for
2.
Before you use Orgalutran
4.
Possible side effects
5.
How to store Orgalutran
6.
Further information
1.
WHAT ORGALUTRAN IS AND WHAT IT IS USED FOR
Orgalutran belongs to a group of medicines called “anti-gonadotrophin-releasing hormones” which act
against the actions of the natural gonadotrophin releasing hormone (GnRH). GnRH regulates the
release of gonadotrophins (luteinising hormone (LH) and follicle stimulating hormone (FSH)).
Gonadotrophins 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
the egg cells. LH is needed to release the mature egg cells from the follicles and ovaries (i.e.
ovulation). Orgalutran inhibits the action of GnRH, resulting in suppression of the release of especially
LH.
Orgalutran is used for
In women undergoing assisted reproduction techniques, including
in vitro
fertilisation (IVF) and other
methods, occasionally ovulation may occur too early causing a significant reduction in the chance of
getting pregnant. Orgalutran is used to prevent the premature LH surge that might cause such a
premature release of egg cells.
In clinical studies Orgalutran was used with recombinant follicle stimulating hormone (FSH) or
corifollitropin alfa, a follicle stimulant with a long duration of action.
2.
BEFORE YOU USE ORGALUTRAN
Do not use Orgalutran
−
if you are allergic (hypersensitive) to ganirelix or any of the other ingredients of Orgalutran;
−
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.
Take special care with Orgalutran
−
if you have an active allergic condition, please tell your doctor. He will decide, depending on
the severity, if additional monitoring is required during treatment.
17
3.
How to use Orgalutran
−
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 Orgalutran is not different from that after using other GnRH analogues in the
course of assisted reproduction techniques.
−
There is a slightly increased risk of extra-uterine pregnancy in women with damaged fallopian
tubes.
−
The efficacy and safety of Orgalutran has not been established in women weighing less than
50 kg or more than 90 kg. Ask your doctor for further information.
Use in children
There is no relevant use of Orgalutran in children.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Pregnancy and breast-feeding
Orgalutran should be used during controlled ovarian stimulation for assisted reproduction techniques
(ART). Do not use Orgalutran during pregnancy and breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
The effects of Orgalutran on ability to drive and use machines have not been studied.
Important information about some of the ingredients of Orgalutran
This medicine contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free’.
3.
HOW TO USE ORGALUTRAN
Always use Orgalutran exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Orgalutran is used as part of the treatment for assisted reproduction techniques (ART) including
in-
vitro
fertilisation (IVF).
Ovarian stimulation with follicle stimulating hormone (FSH) or corifollitropin may start at day 2 or 3
of your period. Orgalutran (0.25 mg) should be injected just under the skin once daily, starting on day
5 or day 6 of stimulation. Based on your ovarian response, your doctor may decide to start on another
day.
Orgalutran and FSH should be administered approximately at the same time. However, the
preparations should not be mixed and different injection sites are to be used.
Daily treatment with Orgalutran should be continued up to the day that sufficient follicles of adequate
size are present. Final maturation of the egg cells in the follicles can be induced by administering
human chorionic gonadotrophin (hCG). The time between two Orgalutran injections as well as the
time between the last Orgalutran injection and hCG injection should not exceed 30 hours, as otherwise
a premature ovulation (i.e. release of egg cells) may occur. Therefore, when
injecting Orgalutran in the
morning
treatment with Orgalutran should be continued throughout the gonadotrophin treatment
period including the day of triggering ovulation. When
injecting Orgalutran in the afternoon
the last
Orgalutran injection should be given in the afternoon prior to the day of triggering ovulation.
18
Instructions for use
Injection site
Orgalutran is supplied in pre-filled syringes and should be injected slowly, just under the skin,
preferably in the upper leg. Inspect the solution before use. Do not use if the solution contains particles
or is not clear. If you administer the injections yourself or have it done by your partner, follow the
instructions below carefully. Do not mix Orgalutran with any other medicines.
Preparing the injection site
Wash your hands thoroughly with soap and water. Swab the injection site with a disinfectant (for
example alcohol) to remove any surface bacteria. Clean about 5 cm (two inches) around the point
where the needle will go in and let the disinfectant dry for at least one minute before proceeding.
Inserting the needle
Remove needle cover. Pinch up a large area of skin between finger and thumb. Insert the needle at the
base of the pinched-up skin at an angle of 45° to the skin surface. Vary the injection site with each
injection.
Checking the correct needle position
Gently draw back the plunger to check if the needle is positioned correctly. Any blood drawn into the
syringe means the needle tip has penetrated a blood vessel. If this happens, do not inject Orgalutran,
but remove the syringe, cover the injection site with a swab containing disinfectant and apply pressure;
bleeding should stop in a minute or two. Do not use this syringe and dispose of it properly. Start again
with a new syringe.
Injecting the solution
Once the needle has been correctly placed, depress the plunger slowly and steadily, so the solution is
correctly injected and the skin tissues are not damaged.
Removing the syringe
Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant.
Use the pre-filled syringe only once.
If you use more Orgalutran than you should
Contact your doctor.
If you forget to use Orgalutran
If you realise that you forgot a dose, administer it as soon as possible.
Do not inject a double dose to make up for a forgotten dose.
If you are more than 6 hours late (so the time between two injections is longer than 30 hours)
administer the dose as soon as possible
and
contact your doctor for further advice.
If you stop using Orgalutran
Do not stop using Orgalutran unless advised to by your doctor, as this may affect the outcome of your
treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Orgalutran can cause side effects, although not everybody gets them.
Common side effects (affects 1 to 10 users in 100) are local skin reactions at the site of injection
(predominantly redness, with or without swelling). The local reaction normally disappears within 4
hours of administration. Very rarely, in less than 1 user in 10,000, more widespread possibly allergic
reactions have been observed.
19
Uncommon side effects (affects 1 to 10 users in1,000) are headache, nausea and malaise.
In addition, side effects are reported which are known to occur with controlled ovarian
hyperstimulation treatment (e.g. abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic
pregnancy (when the embryo develops outside the womb) and miscarriage (see the patient information
leaflet of the FSH-containing preparation you are treated with)).
Worsening of a pre-existing rash (eczema) has been reported in one subject after the first Orgalutran
dose.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5.
HOW TO STORE ORGALUTRAN
Keep out of the reach and sight of children.
Do not use Orgalutran after the expiry date which is stated on the carton and on the label after ‘EXP’.
The expiry date refers to the last day of that month.
Do not freeze.
Store in the original package, in order to protect from light.
Inspect the syringe before use. Use only syringes with clear, particle-free solutions and from
undamaged containers.
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.
FURTHER INFORMATION
What Orgalutran contains
-
The active substance is ganirelix (0.25 mg in 0.5 ml solution).
-
The other ingredients are acetic acid, mannitol, water for injections. The pH (a measurement of
the acidity) may have been adjusted with sodium hydroxide and acetic acid.
What Orgalutran looks like and contents of the pack
Orgalutran is a clear and colourless aqueous solution for injection. The solution is ready for use and
intended for subcutaneous administration.
Orgalutran is available in packs of 1 or 5 pre-filled syringes.
Not all packsizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
N.V. Organon,
Kloosterstraat 6,
Postbus 20,
5340 BH Oss,
The Netherlands.
Manufacturer
Organon (Ireland) Ltd,
P.O. Box 2857,
20
Drynam Road, Swords,
Co. Dublin,
Ireland.
N.V. Organon,
Kloosterstraat 6,
Postbus 20,
5340 BH Oss,
The Netherlands.
This leaflet was last approved in
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu
21
Source: European Medicines Agency
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