Israel - English - Ministry of Health
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
REGULATIONS (PREPARATIONS) 1986
This medicine can be sold under doctor's prescription only
0.25 mg/0.5 ml
Solution for Injection, for Subcutaneous Use
Each pre-filled syringe contains:
0.25 mg ganirelix in 0.5 ml aqueous solution.
For a list of inactive ingredients see section 6. "FURTHER INFORMATION". See also section
“Important information about some of the ingredients of ORGALUTRAN”.
Read the entire leaflet carefully before you start using this medicine.
This leaflet contains concise information about the medicine. If you have any 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 ailment seems similar to 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.
1. WHAT THE MEDICINE IS INTENDED FOR?
ORGALUTRAN is intended for the prevention of premature luteinising hormone (LH) surges in
women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction
Therapeutic group: anti-gonadotrophin-releasing hormones.
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 USING THE MEDICINE
2.1 Do not use ORGALUTRAN if:
you are allergic (hypersensitive) to ganirelix or to any of the other ingredients of
ORGALUTRAN (for a list of all ingredients, see section 6.1);
you suffer from hypersensitivity to gonadotrophin releasing hormone (GnRH) or a GnRH
you have a moderate or severe kidney or liver disease;
you are pregnant or breast-feeding.
2.2 Special warnings concerning use of ORGALUTRAN
Before starting treatment with ORGALUTRAN, tell your doctor if:
Allergic reactions: 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
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 Orgalutran 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.
Ovarian hyperstimulation syndrome (OHSS): 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.
Multiple births or birth defects: 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.
Pregnancy complications: There is a slightly increased risk of pregnancy outside of the
uterus (an ectopic pregnancy) in women with damaged fallopian tubes.
Women weighing less than 50 kg or more than 90 kg: 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.
Children and adolescents
There is no relevant use of ORGALUTRAN in children or adolescents.
Taking other medicines
If you are taking, or have recently taken, other medicines including non-prescription
medicines and nutritional supplements, you should tell the doctor or pharmacist.
Pregnancy, breast-feeding and fertility
ORGALUTRAN should be used during controlled ovarian stimulation for assisted
reproduction techniques (ART). Do not use ORGALUTRAN during pregnancy and breast-
If you are pregnant or breast-feeding, consult the doctor or pharmacist before using any
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, that is to say
3. HOW SHOULD YOU USE THE MEDICINE?
Always use ORGALUTRAN as instructed by the doctor. You should check with the doctor or
the pharmacist if you are not sure.
ORGALUTRAN is used as part of the treatment for assisted reproduction techniques (ART)
including in vitro fertilisation (IVF).
The dosage and method of treatment will be determined by the doctor only.
The usual recommended dosage is:
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
Do not exceed the recommended dose.
Instructions for use
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
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 have accidentally taken a higher dose than you should
Contact your doctor.
If you have forgotten to use ORGALUTRAN
If you realize 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.
Do not take medicines in the dark! Check the label and the dose each time you take your
medicine. Wear glasses if you need them.
If you have any further questions on the use of the medicine, consult with a doctor or a
4. SIDE EFFECTS
As with any medicine, ORGALUTRAN may cause side effects in some users.
Do not be alarmed by reading the list of side effects, you may not suffer from any of them.
The chance of having a side effect is described by the following categories:
Very Common side effects: may affect more than 1 in 10 women
Local skin reactions at the site of injection (predominantly redness, with or without
swelling). The local reaction normally disappears within 4 hours of administration.
Uncommon side effects: may affect up to 1 in 100 women
Very rare side effects: may affect up to 1 in 10,000 women
Allergic reactions have been observed, as early as with the first dose.
Difficulty breathing (dyspnoea)
Swelling of face, lips, tongue, and/or throat that may cause difficulty in breathing and/or
swallowing (angioedema and/or anaphylaxis)
Worsening of a pre-existing rash (eczema) has been reported in one subject after the
first ORGALUTRAN dose.
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).
If a side effect appears, if any of the side effects worsens or if you suffer from a side effect
not mentioned in this leaflet, consult with the doctor.
Side effects can be reported to the Ministry of Health by using the link "Reporting side effects
due to medicinal treatment" at the home page of the Ministry of Health's web site
) which refers to the online side effects reporting form, or by using the link:
5. HOW TO STORE THE MEDICINE?
Avoid Poisoning! This medicine, as all other medicines, must be stored in a safe place out
of the reach of children and/or infants, in order to avoid poisoning. Do not induce vomiting
unless explicitly instructed to do so by a doctor.
Do not use the medicine after the expiry date (exp. date) that appears on the packaging.
The expiry date refers to the last day of the indicated month.
Storage conditions: 2-30ºC. 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
In addition to the active ingredient the medicine also contains: mannitol, acetic acid
(glacial), water for injections. The pH (a measurement of the acidity) may have been
adjusted with sodium hydroxide and/or acetic acid.
What ORGALUTRAN looks like and content of the package
ORGALUTRAN is a clear and colourless aqueous solution for injection. The solution is
ready for use and intended for subcutaneous administration. The needle cover contains
dry natural rubber/latex which comes into contact with the needle.
ORGALUTRAN is available in packs of 1 pre-filled syringe.
N.V. Organon, Oss, The Netherlands.
Marketing Authorization Holder
Merck Sharp & Dohme (Israel-1996) Company Ltd., P.O.Box 7121 Petah-Tikva, 49170.
Drug registration no. listed in the official registry of the Ministry of Health
Revised in May 2020.
NAME OF THE MEDICINAL PRODUCT
0.25 mg/0.5 mL
QUALITATIVE AND QUANTITATIVE COMPOSITION
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)
]-GnRH with a
molecular weight of 1570.4.
Excipient with known effect:
This medicinal product contains less than 1 mmol sodium (23 mg) per
injectionthat is to say
For the full list of excipients, see section 6.1.
Solution for injection.
Clear and colourless aqueous solution.
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 follicle stimulating
hormone (FSH) or corifollitropin alfa, the sustained follicle stimulant.
Posology and method of administration
Orgalutran should only be prescribed by a specialist experienced in the treatment of
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
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 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
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.
There is no experience on the use of Orgalutran in subjects with renal impairment, as
they were excluded from clinical studies. Therefore, the use of Orgalutran is
contraindicated in patients with moderate or severe renal impairment (see section
There is no experience on the use of Orgalutran in subjects with hepatic impairment,
as they were excluded from clinical studies. Therefore, the use of Orgalutran is
contraindicated in patients with moderate or severe hepatic impairment (see section
There is no relevant use of Orgalutran in the paediatric population.
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 listed in
Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other
Moderate or severe impairment of renal or hepatic function.
Pregnancy or breast-feeding.
Special warnings and precautions for use
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.
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.
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
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).
This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that
is to say essentially ‘sodium-free’.
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
The possibility of interactions with commonly used medicinal products, including
histamine liberating medicinal products, cannot be excluded.
Fertility, pregnancy and lactation
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.
It is not known whether ganirelix is excreted in breast milk.
The use of Orgalutran is contraindicated during pregnancy and breast-feeding (see
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
For posology and method of administration, see section 4.2.
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been
Summary of the safety profile
The table 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
Tabulated list of adverse reactions
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 reactions (very rare, <1/10,000) has been
deduced from post-marketing surveillance.
System organ class
Immune system disorders
Hypersensitivity reactions (including
rash, facial swelling, dyspnoea
anaphylaxis (including anaphylactic
shock), angioedema and urticaria)
Worsening of a pre-existing eczema
Nervous system disorders
General disorders and
Local skin reaction at the site of
injection (predominantly redness, with
or without swelling)
Cases have been reported, as early as with the first dose, among patients administered
Reported in one subject after the first Orgalutran dose.
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
Orgalutran treated patients and 25 % in patients treated subcutaneously with a GnRH
agonist. The local reactions generally disappear within 4 hours after administration.
Description of selected adverse reactions
Other reported adverse reactions are related to the controlled ovarian
hyperstimulation treatment for ART, notably pelvic pain, abdominal distension,
OHSS, (see section 4.4), ectopic pregnancy and spontaneous abortion.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
Any suspected adverse events should be reported to the Ministry of Health according
to the National Regulation by using an online form
Overdose in humans may result in a prolonged duration of action.
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,
In case of overdose, Orgalutran treatment should be (temporarily) discontinued.
Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues,
anti-gonadotrophinreleasing hormones, ATC code: H01CC01.
Mechanism of action
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
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 cannot 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.
Clinical efficacy and safety
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.
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 body weight and
serum concentrations of Orgalutran.
After a single subcutaneous administration of 0.25 mg, serum levels of ganirelix rise
rapidly and reach peak levels (C
) of approximately 15 ng/mL within 1 to 2 hours
). The bioavailability of Orgalutran following subcutaneous administration is
approximately 91 %.
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
The elimination half-life (t
) is approximately 13 hours and clearance is
approximately 2.4 L/h. Excretion occurs via faeces (approximately 75 %) and urine
(approximately 22 %).
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
subcutaneously in the rat and 0.1 to 50
g/kg/day subcutaneously in the rabbit
showed increased litter resorption in the highest dose groups. No teratogenic effects
List of excipients
Acetic acid, glacial,
Water for injections.
The pH may have been adjusted with sodium hydroxide and/or acetic acid.
In the absence of compatibility studies, this medicinal product must not be mixed with
other medicinal products.
Special precautions for storage
Do not freeze.
Store between 2°C and 30°C.
Store in the original package in order to protect from light.
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 that does not contain
latex. Each pre-filled syringe is affixed with a needle closed by a needle cover of
dry natural rubber/latex which comes into contact with the needle. (See section
Supplied in cartons containing 1 pre-filled syringe.
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.
N.V. Organon, Oss, the Netherlands
Merck Sharp & Dohme (Israel-1996) Company Ltd., P.O.Box 7121 Petah-Tikva,
Revised in May 2020.