Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Somatorelin acetate
Ferring Pharmaceuticals Ltd
V04CD05
Somatorelin acetate
50microgram
Powder and solvent for solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 06050100; GTIN: 5015919723129
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 Lesen Sie das vollständige Dokument
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 Lesen Sie das vollständige Dokument