Gonapeptyl Depot 3.75mg powder and solvent for suspension for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Triptorelin acetate

Available from:

Ferring Pharmaceuticals Ltd

ATC code:

L02AE04

INN (International Name):

Triptorelin acetate

Dosage:

3.75mg

Pharmaceutical form:

Powder and solvent for suspension for injection

Administration route:

Intramuscular; Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030402; GTIN: 5015919883861

Patient Information leaflet

2009054567
TEAR HERE
"
THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS
ONLY:
INSTRUCTIONS FOR USE
_1._
_PREPARATION_
Instructions for the physician how to prepare the suspension. Since
successful treatment depends upon correct preparation
of the suspension, the following instructions must be strictly
followed.
•
Take the package of GONAPEPTYL Depot from the refrigerator.
•
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 syringe containing the sustained release microparticles on
the connector in the package, then remove it.
•
Screw the syringe containing the suspension agent tightly on the free
end of the connector and ensure that it fits tightly.
Preparation
Since su cess ul treatme t depends upon
rrect p epa ation of
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SUSTAINED-RELEASE
M I C R O C A P S U L E S
SUSPENSION AGENT
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_TURN OVER _
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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 i

Summary of Product characteristics

OBJECT 1
GONAPEPTYL DEPOT 3.75 MG
Summary of Product Characteristics Updated 29-Sep-2015 | Ferring
Pharmaceuticals Ltd
1. Name of the medicinal product
GONAPEPTYL DEPOT
3.75 mg
Powder and solvent for suspension for injection
2. Qualitative and quantitative composition
One pre-filled syringe contains 3.75 mg triptorelin (as acetate) to be
suspended in one ml sodium
containing suspension agent.
The product contains 3.69 mg/ml equivalent to 0.160 mmol/ml sodium
after reconstitution.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Powder and solvent for suspension for injection prolonged release in
pre-filled syringes.
Visual description:
Before mixing: White to faintly yellow powder and a clear colourless
aqueous liquid.
After mixing: Homogeneous milky white to faintly yellow suspension.
4. Clinical particulars
4.1 Therapeutic indications
_Men:_
Treatment of hormone dependent locally advanced or metastatic prostate
cancer.
_Women:_
Preoperative reduction of myoma size to reduce the symptoms of
bleeding and pain in women with
symptomatic uterine myomas.
Symptomatic endometriosis confirmed by laparoscopy when suppression of
the ovarian hormonogenesis
is indicated to the extent that surgical therapy is not primarily
indicated.
_Children:_
Treatment of confirmed central precocious puberty (girls under 9
years, boys under 10 years).
4.2 Posology and method of administration
The product should only be used under the supervision of an
appropriate specialist having requisite
facilities for regular monitoring of response.
The treatment of children with triptorelin should be under the overall
supervision of the paediatric
endocrinologist or of a paediatrician or endocrinologist with
expertise in the treatment of central
precocious puberty.
It is important that the injection of the sustained release form be
performed strictly in accordance with the
instructions given in section 6.6.
Following reconstitution, the suspension has to be injected
immediately.
Dosage and method of administration
The dosage of o