SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

GHRH Ferring, Powder and solvent for solution for injection 50pg

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient

Somatorelin as acetate, 50 micrograms per ampoule.

3.    PHARMACEUTICAL FORM

Lyophilised powder for injection.

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 GHRLI Ferring (50 micrograms somatorelin) dissolved in imi 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.

GH-RH 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 intravenous 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 after GHRH injection for better assessment of growth hormone release.

4.3 Contraindications

Hypersensitivity to somatorelin (human) acetate or to any of the excipients.

4.4 Special warnings and precautions for use

Because of the possible inhibitory influence of human growth hormone (hGH) on the somatotropic function of the pituitary gland the GHRH-test should not be carried out sooner than 1 week after discontinuation of treatment with human growth hormone.

The test results may be affected by the following conditions:

-    untreated hyper - and hypothyroidism

-    obesity, hyperglycaemia, elevated fatty acids

-    high level somatostatin

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use of substances influencing the release of growth hormone, such as growth hormone itself, as well as atropine, levodopa, dopamine, clonidine, arginine, ornithine. glycine, glucagon, insulin, oral glucose, thyreostatics and propranolol should be avoided. High levels of glucocorticoids as well as somatostatin or its analogues may inhibit the growth hormone release.

4.6 Fertility, pregnancy and lactation

In general, there is no indication for administration of somatorelin during pregnancy and lactation.

There are no adequate data from the use of GHRH Ferring in pregnant women.

Animal studies are insufficient with respect to effects on pregnancy. The potential risk for humans is unknown. Somatorelin should not be used during pregnancy unless clearly necessary.

There is insufficient information on the excretion of somatorelin in human or animal breast milk. The potential for adverse effects in the nursing infant from exposure to the drug is unknown. Somatorelin should not be used during lactation unless clearly necessary.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Due to the short duration of action of somatorelin the influence on the ability to drive and use machines is expected to be negligible.

4.8 Undesirable effects

MedDRA Organ Class	Very common ( > 1/10)	Common ( > 1/100 to < 1/10)	Uncomm on ( > 1/1000 to < 1/100)	Rare ( > 1/10000 to < 1/1000)	Very rare ( < 1/10000)
Nervous system disorders		Transient disturbances in sense of smell and taste
Cardiac disorders		Minor fluctuation in blood pressure1, Minor fluctuation in heart rate1
Gastrointestinal disorders			Nausea, vomiting
General disorders and administration site conditions *		Transient flushing	Injection site pain, Chest tightness

4.9    Overdose

No case of overdose has been reported.

In case of overdose, the reported undesirable effects may occur (see section 4.8). Since somatorelin is eliminated rapidly from the body no measures in case of overdose are necessary.

5    PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Tests for pituitary function ATC-code: V04C D05

Somatorelin is normally synthesised in the hypothalamus and stimulates the secretion of growth hormone from the pituitary gland. GHRH is the synthetic form of somatorelin and is identical in structure and function to somatorelin released by the human hypothalamus. Somatorelin physiologically increases plasma growth hormone levels.

5.2. Pharmacokinetic Properties

After intravenous application of different doses of somatorelin in man, the concentrations of somatorelin in plasma increase within 5 minutes to the maximum value, followed by a rapid decrease. The basal values are reached again after 30-40 minutes.

5.3. Pre-clinical Safety Data

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1.    List of Excipients

None.

6.2.    Incompatibilities

GHRH Ferring should not be administered together with other preparations for parenteral use (e.g. mixed injections or infusion solutions).

6.3 Shelf life

The Shelf life is 3 years.

GHRH should not be used after the expiry date printed on the package.

6.4. Special Precautions for Storage

Do not store above 25°C.

6.5. Nature and Contents of Container

GHRH Ferring is supplied in clear glass ampoules of high hydrolytic resistance (hydrolytic Class 1 according to Ph. Eur.).

6.6. Instruction for Use, Handling and Disposal

Reconstitute GHRH Ferring with the solvent supplied, immediately prior to use.

7    MARKETING AUTHORISATION HOLDER

Ferring Pharmaceuticals Ltd

Drayton Hall

Church Road

West Drayton

UB7 7PS

UK

8. MARKETING AUTHORIZATION NUMBER(S)

PL 03194/0050

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23/10/2008

DATE OF REVISION OF THE TEXT

24/10/2014

1

In combination with flushing

As with all intravenous injections of peptides, anaphylactic reactions cannot be excluded.