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GONAPEPTYL DEPOT 3.75MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Active substance(s): TRIPTORELIN ACETATE

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2009054567

PACKAGE LEAFLET: INFORMATION FOR THE USER

GONAPEPTYL® Depot 3.75mg

Powder and solvent for suspension for injection
Triptorelin

Read all of this leaflet carefully before you start treatment
with this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor
or pharmacist.
• 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 GONAPEPTYL Depot is and what it is used for
2. Before you are given GONAPEPTYL Depot
3. How to be given GONAPEPTYL Depot
4. Possible side effects
5. How to store GONAPEPYL Depot
6. Further information
1. WHAT GONAPEPTYL DEPOT IS AND WHAT IT IS USED FOR
GONAPEPTYL Depot contains triptorelin (as triptorelin
acetate).Triptorelin belongs to a group of medicines called
GnRH analogues. One of its actions is to decrease the
production of sex hormones in the body.
It is used:
In Men:
• For the treatment of hormone dependent locally
advanced or metastatic prostate cancer.
In Women:
To suppress the levels of ovarian hormones in order to • Reduce the size of uterine myomas, (commonly known as
fibroids) which are non-cancerous tumours arising from
the myometrium (smooth muscle layer) of the uterus.
• Treat endometriosis (the formation of uterine tissue
outside the uterus).
In Children:
• For the treatment of central precocious puberty (puberty
that occurs prematurely but with the physical and
hormonal changes of normal puberty).

You must not be given GONAPEPTYL Depot
• If you are allergic to triptorelin or any of the other
ingredients of GONAPEPTYL Depot.
• If you are allergic to gonadotropin-releasing hormone
(GnRH) or any other GnRH analogues.
In Women:
• If you are pregnant or are breast feeding.

side

Provides triptorelin 3.75mg in 1ml when reconstituted as
During treatment:
recommended.
Non-hormonal methods of contraception, such as a condom
or
a diaphragm,
should be
used
duringsyringe
the first
month
after
Graduations
are marked
on the
powder
label
to indicate
1
2 injection. It should also be used from 4 weeks after
the
first
/2 and /3 dose.
the last injection until the return of your periods
(menstruation).
Reconstitute the powder with the solvent, immediately prior to
use. Use within 3 minutes of reconstitution.
For single use only. Discard any unused suspension.

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.
GONAPEPTYL Depot might interfere with some medicines
used to treat heart rhythm problems (e.g. quinidine,
procainamide, amiodarone and sotalol) or might increase the
risk of heart rhythm problems when used with some other
drugs (e.g. methadone (used for pain relief and part of drug
addiction detoxification), moxifloxacin (an antibiotic)
antipsychotics used for serious mental illnesses).
Pregnancy and lactation
GONAPEPTYL Depot must not be used during pregnancy
and lactation (see also the section ‘You must not be given
GONAPEPTYL Depot’). If you are possibly pregnant,
pregnancy should be ruled out by your doctor before you
should use GONAPEPTYL Depot.
Women of childbearing potential should use effective
non-hormonal contraception, such as a condom or a
diaphragm, during treatment with GONAPEPTYL Depot until
menstruation resumes.
Driving and using machines
There are no known effects on the ability to drive or use
machinery.
However it cannot be ruled out that the ability to drive or use
machinery can be affected during treatment due to some of
the side effects (dizziness, sleep disturbances/insomnia and
disturbed eye vision. Take extra caution if you experience
these side effects.

The powder and solvent are normally mixed and injected by
a healthcare professional.
Depending on the condition you are being treated for, the
appropriate dose will be administered by intramuscular
injection (into a muscle) or subcutaneous injection (just
under the skin).
In Men:
• One injection of GONAPEPTYL Depot is normally given
every 4 weeks as a long-term therapy.
In Women:
• One injection of GONAPEPTYL Depot is normally given
every 4 weeks for up to six months.
• Treatment must be started during the first 5 days of the
menstrual cycle.
In Children:
• At the beginning of treatment one injection should be
injected on days 0, 14 and 28.
• The dose is adjusted according to body weight. Children
weighing less than 20kg are given 1.875mg (1/2 dose);
children weighing 20 - 30kg are given 2.5mg (2/3 dose);
children weighing more than 30kg are given 3.75mg.
• Thereafter, injections are given every 3 - 4 weeks,
according to effect.
The treatment duration is monitored by your doctor
If you are given more GONAPEPTYL Depot than you
should
It is not very likely that you will be given more GONAPEPTYL
Depot than you should have received. If you have been
given more GONAPEPTYL Depot than you should, talk to a
doctor or pharmacist immediately.
If you stop using GONAPEPTYL Depot
Treatment with GONAPEPTYL Depot should only be
discontinued under advice from your doctor. If you have any
further questions for the use of this product, ask your doctor
or pharmacist.

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a


Tear here "
1. Preparation
Instructions for the physician how to prepare the suspension.
Sincefollowing
successful
treatment depends
uponfor
correct
preparation
of
The
information
is intended
healthcare
professionals
only:
the suspension, the following instructions must be strictly followed.
INSTRUCTIONS FOR USE
● Take the package of GONAPEPTYL Depot from the refrigerator.
1. Preparation
● Remove the cap from the disposable syringe containing the
Instructions
for the physician how to prepare the suspension. Since successful treatment depends upon correct preparation
powder. Keep upright to prevent spilling.
of the suspension, the following instructions must be strictly followed.

Take the package of GONAPEPTYL Depot from the refrigerator.
● Open the package with the connector without removing the
• connector.
Remove the cap from the disposable syringe containing the powder. Keep upright to prevent spilling.
• Open the package with the connector without removing the connector.

Screw the
thesyringe
syringecontaining
containingthe
thepowder
sustained
release
microparticles
on the connector in the package, then remove it.
● Screw
on the
connector
in
• the
Screw
the syringe
containing
package,
then remove
it. the suspension agent tightly on the free end of the connector and ensure that it fits tightly.

oms
rine

sustained-release
microcapsules

hen
the

nder

During treatment:
In the first month of treatment girls can experience mild to
moderate episodes of vaginal bleeding.
After finalising the therapy, development of puberty
characteristics will occur. In most girls menses will start on
average one year after ending the therapy, which in most
cases is regular.
For any possible side effects please see section 4.

3. HOW YOU WILL BE GIVEN GONAPEPTYL DEPOT
Take special care with GONAPEPTYL Depot
Men and women:
• There have been reports of depression in patients taking
Gonapeptyl which may be severe. If you are taking
Gonapeptyl and develop depressed mood, inform your
doctor.
• As GONAPEPTYL Depot can lead to mood changes.
• As treatment with GONAPEPTYL Depot in rare cases can
lead to brain hemorrhage (pituitary apoplexia). Contact
your doctor immediately if you experience sudden
headache, vomiting or visual disturbances.
• As treatment with GONAPEPTYL Depot can led to
thinning of bones which increases risk of bone injury.
• If you are at additional risk of thinning of the bones
(osteoporosis) you should tell you doctor before taking
GONAPEPTYL Depot. Risk factors include:
- If any of your close family have thinning of the bones.
- If you drink excessive amounts of alcohol, have a poor
diet and/or smoke heavily.
- If you are also being treated with certain medicines
which may affect the strength of bone.

— Connector

g of
tive
-(d,l
ate.
ium
ium

In Children:
• Treatment should only be started in girls under 9 years of
age and boys under 10 years of age.

2. BEFORE YOU ARE GIVEN GONAPEPTYL DEPOT

In Men:
Tell your doctor
• If you have pains in your bones, or difficulty passing urine.
• If you have a secondary spinal or urinary tract tumour.
• If you are castrated.
• if you are diagnosed with diabetes
• If you have a high risk of heart disease, such as
diagnosed high blood pressure or heart rhythm problems
(arrhythmia).
• If you have any heart or blood vessel conditions,
including heart rhythm problems (arrhythmia), or are
being treated with medicines for these conditions. The
risk of heart
rhythm problems may be increased when
TYL® Depot
3.75mg
GONAPEPTYL.
solvent forusing
suspension
for injection
During treatment:
triptorelin
During the beginning of therapy with GONAPEPTYL Depot
LTHCARE
PROFESSIONALS
you may
experience a worsening in your disease symptoms.
Contact your doctor if any of your symptoms of the disease
get worse
Instructions for Use/Handling
the
mary
Prior
to use, GONAPEPTYL Depot should be stored at 2°C - 8°C
In
Women:
(in ayour
refrigerator).
Tell
doctor Keep container in the outer carton.
• If you are experiencing bleeding mid-cycle during
the
not use after
the expiry
date
on the packaging.
Dotreatment
(except
for the
firststated
month).
site

r of
1ml
the
ase
the

Your periods will stop during treatment. Once treatment has
finished, your periods (menstruation) will resume 7-12 weeks
after the final injection.
If your periods (menstruation) persists during treatment,
please inform your doctor.

suspension agent

Preparation
● Screw the syringe containing the suspension agent on the
free end of the connector and ensure that it fits tightly.

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a

7

4. POSSIBLE SIDE EFFECTS

In Children:
Common, between 1 and 10 patients out of every 100
patients treated: mood changes, depression.

Like all medicines, GONAPEPTYL Depot can cause side
effects, although not everybody gets them.

Uncommon, between 1 and 10 patients out of every 1000
patients treated: in girls vaginal bleeding or discharge may
occur. Nausea, vomiting and anaphylactic reaction have
been seen.

General (all patients):
If you experience swelling of the face, lips, mouth or throat
which may cause difficulty in swallowing or breathing tell
your doctor immediately or go to your nearest casualty
department.

Not known, frequency cannot be estimated from the
available data:
• allergic reactions
• pain
• nervousness
• headache
• abdominal pain
• blurred vision
• visual impairment
• abdominal discomfort
• nose bleeds
• genital haemorrhage
• hot flushes
• blood pressure increase
• rash
• weight gain
• hives
• Injection site pain,
• muscle pain
inflammation and redness
• hair loss
• general discomfort
• loosening or separation • redness
of growth zone of tubular • angioedema (swelling that
bones
occurs under the skin)
• emotional lability

Reporting of side effects
If you get any side effects, talk to your doctor. This includes
any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme,
website: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety
of this medicine.

Cases of pre-existing pituitary tumour enlargement were
reported during treatment with LH-RH agonists, however it
has not yet been observed with triptorelin therapy.
In Men:
The symptoms you are being treated for (e.g. urinary
obstruction, skeletal pain, compression of the spinal cord,
muscular discomfort and oedema of the legs, weakness and
tingling in the feet and hands) may worsen initially, due to
the increased levels of testosterone at the start of treatment.
Very common, more than 1 patient out of every 10 patients
treated: most of the side effects of GONAPEPTYL Depot in
men result from lowered testosterone levels. Impotence,
decreased libido, hot flushes, bone pain and difficulty and
pain in passing urine can be seen.
Common, between 1 and 10 patients out of every 100
patients treated: allergic reaction, depressed mood, mood
changes, depression, sleep disorder, nausea, muscle and
joint pain, tiredness, injection site reaction, injection site
pain, irritability, excessive sweating, headache and breast
enlargement in males.

5. HOW TO STORE GONAPEPTYL DEPOT
Uncommon, between 1 and 10 patients out of every 1000
patients treated: elevated values of some liver enzymes,
anaphylactic reaction, testicular wasting, high blood
pressure, decreased appetite, dry mouth, upper abdominal
pain, asthma aggravated, weight changes, embolism, hair
loss and reduced hair growth.

Keep out of the reach and sight of children.
Do not use GONAPEPTYL Depot after the expiry date which
is stated on the packaging. The expiry date refers to the last
day of that month.

— Connector

— Connector

Not known, frequency cannot be estimated from the
Store in a refrigerator (2 ºC-8 ºC)’. Keep the container in the
available data:
outer carton.
• common cold
• diabetes mellitus
• gout
• abdominal bloating
Medicines should not be disposed of via wastewater or
• vertigo
• constipation
household waste. Ask your pharmacist how to dispose of
• diarrhoea
• shortness of breath
medicines no longer required. These measures will help to
• injection site redness
• influenza like symptoms
protect the environment.
• sleepiness
• blurred vision
• sensation of tingling,
• nose bleeds
6. FURTHER INFORMATION
®
pricking or numbness

memory
impairment
GONAPEPTYL
Depot 3.75mg
• taste disturbances
• visual
impairment
Powder
and
solvent for suspension What GONAPEPTYL Depot contains
• abnormal sensation in eye • tinnitusfor injection
• increased appetite
• general discomfort
• The powder in each pre-filled syringe contains 4.12 mg of
triptorelin
• anxiety
• loss of libido
triptorelin acetate equivalent to 3.75 mg of the active
• insomnia LEAFLET FOR
• dizziness
substance, triptorelin.
HEALTHCARE PROFESSIONALS
• confusional state
• chest pain
• The other ingredients are Poly-(d,l lactide coglycolide),
• decreased activity
• chills
Propylene glycol dicaprylocaprate
Instructions for Use/Handling
flet does• not
contain complete information
onpain
the
fever
• breast
Prior to use
of the product, please read• the
Summary
• weakness
testicular
pain Prior to use, GONAPEPTYL
The solvent
contains
Depot
should be stored at 2°C - 8°C
ct Characteristics
for complete
• ejaculation
failure information.
• joint swelling (in a refrigerator). Keep container in the outer carton.

osteoarthritis
• musculoskeletal
stiffness
• Dextran 70, polysorbate 80, sodium chloride, sodium
EPTYL
Depot
should
only be used
under the
TYL® Depot
3.75mg
Do not use after the
expiry date
stated on dihydrate,
the packaging.
• shortness
of breath
• injection
site inflammation
hydrogen
phosphate
sodium hydroxide
on
of
an
appropriate
specialist
having
requisite
solvent for
suspension
when
lyingofflat
• back pain
and water for injection.
or
regular
monitoring
response.
for injection
Provides triptorelin 3.75mg in 1ml when reconstituted as
• joint stiffness
• itching
triptorelin
recommended. This medicinal product contains less than 1 mmol sodium
of skin
• pain
extremities
esented• inpurple
packs discoloration
of 1 set of the
following:
1 in
pair
of
ed
syringes,
one
with powder
and the other
with 1ml
• musculoskeletal
pain
• muscular
weakness
(3.69 mg/ml or 0.160 mmol/ml) per dose, i.e it is essentially
LTHCARE
PROFESSIONALS
Graduations are marked on the powder syringe label to indicate
t, a connector
and 2 injection needles.• Use
only the
• flatulence
hives
‘sodium free’.
1
2
/2 and /3 dose.
s provided.
The formulation contains• slow-release
• blisters
muscle spasms
apsules
and
the use of (swelling
other
needles
affect the

angioedema
that may
• difficulty
in standing
What GONAPEPTYL
Depot
looks like
andtocontents of the
Instructions
for Use/Handling
the
Reconstitute the powder
with the solvent,
immediately
prior
y of the product.
occurs
under
the
skin)

oedema
pack
mary
Prior
use, GONAPEPTYL
Depot should
at 2°C
Use- 8°C
within 3 minutes of reconstitution.
owder in•
eachto pre-filled
syringe contains
4.12mgbeofstoreduse.
• acne
(invomiting
a refrigerator).
Keep
container
theactive
outer carton.
For single use only. Discard any unused suspension.
elin acetate
equivalent to
3.75mg
of in
the
• abdominal pain
• rash
It is presented in packs of 1 set of the following: 1 or 3 pairs
the triptorelin. The other ingredients are poly-(d,l
ent,

bloodafter
pressure
changes
in ECG
Dolow
not
the expiry
date• stated
on the
packaging.
1. Preparation of pre-filled syringes (powder and solvent).
isite
coglycolide)
anduse
propyleneglycol
octanoate
decanoate.
• pain Dextran 70, Polysorbate
(QT
Instructions for the physician how to prepare the suspension.
olvent contains:
80, prolongation)
sodium
Provides
triptorelin
3.75mg
in
1ml
when
reconstituted
as
Since
successful
treatment
depends
upon correct
preparation of

euphoric
mood

increased
blood
pressure
Marketing
authorisation
holder:
e, sodium hydrogen phosphate dihydrate, sodium
recommended.
suspension,
the
following
instructions mustLtd.
be strictly followed.

body
of some

Ferring
Pharmaceuticals
ir
ideofand water
fortemperature
injection. increased • elevated valuesthe

liver and kidney enzymes
Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
1ml
● Take
Graduations
are marked on the powder syringe label
to indicate
the package of GONAPEPTYL Depot from the refrigerator.
g the
Authorisation
Holder:
1
/2 Women:
and 2/3 Limited,
dose.
In
Manufacturer:
ease
Pharmaceuticals
The Courtyard, Waterside
● Remove the cap from the disposable syringe containing the
the Berks
ngley,
6EZ, UK.
VerySL3
common,
more than 1 patient out of every 10
patients
Ferring GmbH
Reconstitute the powder with the solvent, immediately
prior Keep
to
powder.
upright to prevent spilling.
treated: decreased libido, mood changes, sleep disorder,
Wittland 11, D-24109 Kiel, Germany
use. Use within 3 minutes of reconstitution.
gurer:
of
hot flushes, abdominal pain, bone pain, excessive
● Open the package with the connector without removing the
For single
use
only. Kiel,
Discard
any unused suspension.
ctive Wittland
GmbH,
11, vaginal
D-24109
Germany
sweating,
bleeding/spotting,
vulvovaginal dryness,
This medicinal product is authorised in the Member States
connector.
-(d,l
painful
sexual
intercourse,
painful
menstruation,
enlargeof the EEA under the following names:
1. Preparation
oate.
peutic
Indications
ment
of ovaries,
pelvic
pain, how
weakness
and the
headache.
● Screw the syringe containing the powder on the connector in
Instructions
for
the
physician
to
prepare
suspension.
dium
GONAPEPTYL
UROPEPTYL Depot
Since successful treatment depends upon correct preparation
of then
the package,
remove it. Depot
dium
t of hormone-dependent
prostate
carcinoma.
Common,
between
1 and
10instructions
patients out
ofbe
every
100followed.
(Belgium, Greece, Italy,
(Germany)
the suspension,
the following
must
strictly
patients treated: allergic reaction, depressed mood
Luxembourg, the Netherlands,
● Take
package
GONAPEPTYL
Depot
the refrigerator.
depression,
nausea,
muscle
and
pain,from
tiredness,
Sweden,
Spain, Portugal,
DECAPEPTYL GYN
tive reduction
ofthe
myoma
sizeofto
reduce
thejoint
symptoms
sustained-release
m i c r o c aKingdom),
psules
injection
reaction,
site pain,
irritability.
United
(Germany)
ing
women
with injection
symptomatic
uterine
side and pain in site
● Remove the cap from the disposable syringe containing the
powder. Keep
upright1 to
prevent
spilling.out of every 1000
Uncommon,
between
10 patients
GONAPEPTYL 3.75 mg
GYNOPEPTYL (Germany)
matic endometriosis
confirmed
byand
laparoscopy
when
patients
treated:
anaphylactic
reaction,tovisual
impairment,
(France)
ion of the
ovarian
hormonogenesis
is
indicated
the
● Open the package with the connector without removing the
sensation
ofnot
tingling,
pricking
or numbness, backsuspension
pain, agent
DECAPEPTYL CR 3.75
at surgical
therapy is
primarily
indicated.
connector.
increased
blood
cholesterol,
elevated
values
of
some
liver
GONAPEPTYL Depot
(the Netherlands)
:
enzymes.
3.75
mg
(Ireland)
nt of confirmed
central
precocious
puberty
under
● Screw
the syringe
containing
the(girls
powder
on the connector in
DECAPEPTYL
boys under the
10 years).
● Screw the syringe containing the suspension agent on the
package, then remove it.
Not known, frequency cannot be estimated from the
Depot that it fitsDepot-Retardmikrokapseln
free end of the DECAPEPTYL
connector and ensure
tightly.
data:
(Czech Republic,
und Suspensionsmittel für
gy andavailable
method
of administration
• abdominal discomfort
• fever
Denmark,
Iceland, Estonia, Einmalspritzen (Austria)
2. Reconstitution
of the suspension
oms
EPTYL
Depot is injectedsustained-release
either subcutaneously

heavy,
prolonged
and/or

itching
Germany,
Latvia,
Lithuania,
m
i
c
r
o
c
a
p
s
u
l
e
s
erine
Empty the liquid into the syringe with
the powder, then pass it
the skin of the abdomen, the buttock or thigh) or

irregular
periods

dizziness
Norway,
Poland,
Slovakia)
back and forth into the first syringe - the first two DECAPEPTYL
or three times Depot
ramuscularly. The injection site should be changed

angioedema
(swelling

injection
site
inflammation
injection
without
pushing
the
injection
rod
all
the
way
in.
Repeat(Hungary)
this
e.
when
that occurs under the skin) • blood pressure about
increased
DECAPEPTYL
Depot
3.75
10 times or
until you have
a homogeneous
milky-like
the
• suspension
loss ofagent
menstrual period • breast pain
suspension. While(Finland)
preparing the suspension, youDECAPEPTYL
might create
ery four weeks
with one syringe,
equivalent
• lossanofinjection
bone mineral
• muscle
spasmssome foam. It is important that the foam beRetard
dissolved
or
injectionspräparat
mg triptorelin.
In toorder
to continually
suppress
syringe before Ngiving
the injection.
leading
increased
bone • weight
changesremoved from theDECAPEPTYL
(Germany)
i.m/s.c
(Switzerland).
nder
one levels,
it is important to comply with
a 4-weekly
weakness
• injection
site redness
● Screw the syringe containing the suspension agent on the
ation. •
Use in children:
rash
• general discomfort
free end of the connector and ensure that it fits Iftightly.
less than a full dose
is required,
use the
graduations
marked
• anxiety
• vomiting
This leaflet
was last
revised
in August
2016.
1
2
2 or /3 dose.
on
the
powder
syringe
label,
to
measure
/

diarrhoea

muscle
weakness
2. Reconstitution of the suspension
● To measure either of these doses, ensure that the suspension
usly
myomas
and
endometriosis
• vertigo

• hives
Empty
the
liquid
into
the
syringe
with
the
powder,
then
it
is in pass
the ungraduated
syringe at the end of the mixing process.
)
or
ery four weeks
an injection
equivalentof breath
• blurred
vision with one syringe,
• shortness
● three
back
andtreatment
forth intomust
the first
syringe -inthe
first
two or
timesstep of the reconstitution process is to push the
The final
nged
g triptorelin.
The
be
initiated
the
first

confusional
without
pushingstate
the injection rod all the way in. Repeat
this into the graduated syringe up to the 1/2 or 2/3 mark.
suspension
the cycle.
about 10 times or until you have a homogeneous milky-like

suspension. While preparing the suspension, you might create
:
alent
It is important
the foam
hould be some
based foam.
on bodyweight.
Childrenthat
weighing
less be dissolved or

Tear here "
ress
removed
the syringe
before
giving
the injection.
g
are injected
with from
1.875mg
(1/2 dose),
children
between
ekly
2
d 30kg receive 2.5mg ( /3 dose) and children with more
The
following
information
is intended
for healthcare professionals only:
Useare
in injected
children:
g bodyweight
with
3.75mg triptorelin
(full dose).
If less than a full dose is required, use the graduations marked
1
on
the powderthe
syringe
todose
measure
or 2/3 dose.
of a label,
suspension
eginning 2.
of Reconstitution
treatment,
appropriate
based/2 on

To
measure
either
of
these
doses,
ensure
that the then
suspension
Empty
the liquid
into on
thedays
syringe
withand
the 28.
powder,
shoot it back and forth into the first syringe – the first two or three
ght should
be injected
once
0, 14
is
in
the
ungraduated
syringe
at
the
end
of
the
mixing
times without
theinjected
injection
rodevery
all the way in.process.
Repeat this about 10 times or until you have a homogeneous milky white
alent
er, the appropriate
dosepushing
should be
once
● The
final
of the the
reconstitution
process
is suspension,
to push the you might possibly create some foam. It is important that the
first
Should
the
effect
be step
insufficient,
appropriate
dose the
to
faintly
yellow
suspension.
While preparing
1
Mixing
suspension
into the
graduatedfrom
syringe
to thebefore
/2 or 2/3giving
mark. the
given once
every
weeks.
foam
be3dissolved
or removed
the up
syringe
injection.

uctions for Use/Handling overleaf.
less
ween
specific patient groups:
more
s no need to adjust the dose for the elderly.
ose).
ing to current data, dose reduction or prolongation of
sage interval in patients with impaired renal function is
d on
cessary.
28.
very
of treatment:
dose
carcinoma (men):
Mixing
Mixing
t with GONAPEPTYL Depot is usually a long-term therapy.

Mix
approximately10
10times
times
Mix
approximately

3. Injection
myomas and
endometriosis (women):
3. syringe.
Injection
ation of •
treatment
on thetogether
initial degree
Removedepends
the connector
with theofempty
of endometriosis
on the evolution
its syringe
clinical with the ready-to-use suspension.
• Mount and
the injection
needle onofthe
● Remove the connector together with the empty syringe.
ations (functional
anatomical) and
on the
evolution
• Inject and
subcutaneously
or deep
into
the muscle immediately.
volume
of
the
uterine
myomas,
determined
by
n of
GONAPEPTYL Depot is for single use only and any unused suspension should be discarded.
● Mount the injection needle on the syringe with the
ography
during treatment. Normally, the maximum
on is
ready-to-use suspension.
e result is achieved after 3 to 4 injections.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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