- Approval Id
- 4da23dbe6c7f4499
- Drug Approval Emc Name
- GHRH Ferring, Powder and solvent for solution for injection 50µg
- Drug Name
- GHRH Ferring, Powder and solvent for solution for injection 50µg
- Company Address
- Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
- Company Website
- http://www.ferring.co.uk
- Company Telephone
- +44 (0)844 931 0050
- Company Medical Info Email
- medical.uk@ferring.com
- Company Customer Care Direct Line
- 0800 111 4125
- Atc Code
- V04CD05
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Ferring Pharmaceuticals LtdDrayton HallChurch RoadWest DraytonUB7 7PS
- Authorisation Number
- | | |
| --- | --- |
| GHRH Ferring | PL 03194/0050 |
| Diluent for GHRH Ferring | PL 03194/0051 |
- Authorisation Date
- 24th October 2008
- Instruction Authorisation Holder
- Ferring Pharmaceuticals LtdDrayton HallChurch RoadWest DraytonUB7 7PS
- Instruction Authorisation Number
- | | |
| --- | --- |
| GHRH Ferring | PL 03194/0050 |
| Diluent for GHRH Ferring | PL 03194/0051 |
- Instruction Authorisation Date
- 24th October 2008
- Instruction Composition
- \*Active Ingredient\*
Somatorelin as acetate, 50 micrograms per ampoule.
- Instruction Dosage Form
- Lyophilised powder for injection.Sterile solution for reconstitution of an injectable preparation.
- Instruction 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 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 somatostatin4.5 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)\*\* | \*\*Uncommon ( ≥ 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 pressure\\*, Minor fluctuation in heart rate\\* | | | |
| Gastrointestinal disorders | | | Nausea, vomiting | | |
| General disorders and administration site conditions | | Transient flushing | Injection site pain, Chest tightness | | |
\\*In combination with flushingAs with all intravenous injections of peptides, anaphylactic reactions cannot be excluded.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.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Tests for pituitary functionATC-code: V04CD05Somatorelin 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 Preclinical safety data
Not applicable.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
\*Powder:\*
No excipients
\*Each diluent ampoule contains:\*
| | |
| --- | --- |
| Sodium chloride Ph.Eur | 9mg |
| Water for injection to, Ph.Eur | 1.0ml |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.).The diluent is supplied in clear glass ampoules of high hydrolytic resistance (hydrolytic Class 1 according to Ph. Eur.).6.6 Special precautions for disposal and other handling
Reconstitute GHRH Ferring with the solvent supplied, immediately prior to use.
- Instruction Content
- ## Composition
\*Active Ingredient\*
Somatorelin as acetate, 50 micrograms per ampoule.
## Pharmaceutical Form
Lyophilised powder for injection.Sterile solution for reconstitution of an injectable preparation.
## 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 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 somatostatin4.5 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)\*\* | \*\*Uncommon ( ≥ 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 pressure\\*, Minor fluctuation in heart rate\\* | | | |
| Gastrointestinal disorders | | | Nausea, vomiting | | |
| General disorders and administration site conditions | | Transient flushing | Injection site pain, Chest tightness | | |
\\*In combination with flushingAs with all intravenous injections of peptides, anaphylactic reactions cannot be excluded.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.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Tests for pituitary functionATC-code: V04CD05Somatorelin 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 Preclinical safety data
Not applicable.
## Pharmaceutical Particulars
6.1 List of excipients
\*Powder:\*
No excipients
\*Each diluent ampoule contains:\*
| | |
| --- | --- |
| Sodium chloride Ph.Eur | 9mg |
| Water for injection to, Ph.Eur | 1.0ml |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.).The diluent is supplied in clear glass ampoules of high hydrolytic resistance (hydrolytic Class 1 according to Ph. Eur.).6.6 Special precautions for disposal and other handling
Reconstitute GHRH Ferring with the solvent supplied, immediately prior to use.
- Company Detail Path
- /organization/ferring-pharmaceuticals-inc
