GHRH Ferring 50microgram powder and solvent for solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Somatorelin acetate

Available from:

Ferring Pharmaceuticals Ltd

ATC code:

V04CD05

INN (International Name):

Somatorelin acetate

Dosage:

50microgram

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06050100; GTIN: 5015919723129

Patient Information leaflet

GHRH
FERRING 50
MICROGRAMS
_P_
_atient Information_
SOMATORELIN
Remember
Only a doctor can prescribe this medicine. It should never be
given to anyone except the person it has been prescribed for. It
may harm them even if they have the same symptoms.
_Please read this information leaflet carefully before_
_treatment with the medicine._
_This leaflet does not contain the complete_
_information, so if you have any questions or if there_
_is anything you are unsure about, please ask your_
_doctor or pharmacist._
GHRH FERRING PL 03194/0050
Diluent PL 03194/0051
This leaflet was revised in June 2012.
GHRH PIL
5. HOW TO STORE GHRH
6. FURTHER INFORMATION
WHAT GHRH FERRING CONTAINS
• The active substance is
somatorelin acetate. Each
ampoule contains 50
micrograms of somatorelin
acetate.
• The diluent contains water for
injection and sodium chloride.
MARKETING AUTHORISATION HOLDER
AND MANUFACTURER
Marketing Authorisation Holder:
Ferring Pharmaceuticals Ltd.,
Drayton Hall, Church Road
West Drayton, UB7 7PS.
Manufactured by
Ferring GmbH, Wittland 11,
D-24109 Kiel, Germany.
WHAT GHRH FERRING LOOKS LIKE
AND CONTENTS OF THE PACK
GHRH Ferring is a sterile
freeze-dried powder. It is
supplied in boxes of 1 clear glass
ampoule with 1 ampoule of
diluent 1ml. The diluent is used
to dissolve the powder before it
is injected.
THE FOLLOWING UNCOMMON SIDE
EFFECTS AFFECT BETWEEN 1 AND 10
OF EVERY 1000 PATIENTS TREATED:
• Nausea
• Vomiting
• Injection site pain
• Cheat tightness
If any of the side effects become
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor, nurse or
pharmacist.
• Keep out of the reach and sight
of children.
• Do not use GHRH after the expiry
date stated on the box and
ampoule (glass bottle). The expiry
date refers to the last day of that
month.
• Do not store GHRH above 25°C.
• Medicines should not be
disposed of via wastewater or
household waste. Ask your doctor
or pharmacist how to dispose of
medicines no longer required.
These measures will help to

Summary of Product characteristics

OBJECT 1
GHRH FERRING
Summary of Product Characteristics Updated 23-Aug-2013 | Ferring
Pharmaceuticals Ltd
1. Name of the medicinal product
GHRH Ferring, Powder and solvent for solution for injection 50µg
2. Qualitative and quantitative composition
_Active Ingredient_
Somatorelin as acetate, 50 micrograms per ampoule.
3. Pharmaceutical form
Lyophilised powder for injection.
Sterile solution for reconstitution of an injectable preparation.
4. Clinical particulars
4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
GHRH is applied to determine the somatotropic function of the anterior
pituitary gland in cases of
suspected growth hormone deficiency. The test distinguishes between
pituitary and hypothalamic
disorders but is not suitable as a screening test for growth hormone
deficiencies.
The diluent is supplied for the reconstitution of an injectable
preparation.
4.2 Posology and method of administration
The recommended dosage for adult patients of standard weight is the
content of one ampoule of GHRH
Ferring (50 micrograms somatorelin) dissolved in 1ml of the supplied
solvent. The solution is
administered intravenously as a bolus injection.
In cases of highly overweight adult patients and in children, a dosage
of 1 microgram per kg body weight
is indicated.
GHRH Test: After withdrawal of approximately 2ml of venous blood from
the fasted patient, the increase
of basal growth hormone levels in plasma or serum after a single
intravenous injection of the product is
measured. For this procedure, the content of one ampoule is dissolved
in 1ml of solvent (0.9% NaCl), or a
volume corresponding to 1 microgram per kg body weight if appropriate,
is administered intravenously to
the fasted patient as a bolus injection (within 30 seconds).
To evaluate the growth hormone increment in plasma or serum, a second
blood sample is taken 30
minutes after the injection. Peak growth hormone values may
occasionally occur sooner or later.
Therefore, additional blood samples may be taken 15, 45, 60 and 90
minutes