国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
SERMORELIN ACETATE
Serono Limited
SERMORELIN ACETATE
50 Microgram
Pdr+Solv for Soln for Inj
Withdrawn
2007-07-06
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT GEREF® 50 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule of powder contains sermorelin acetate equivalent to 50 micrograms of sermorelin. Each ampoule of Geref is accompanied by a solvent ampoule containing 0.9 % Sodium Chloride Injection BP. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection A white, sterile, pyrogen-free, crystalline powder for solution for injection in a clear, Type I glass ampoule accompanied by a clear, Type 1 glass ampoule containing a clear colourless, sterile solution for reconstitution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the evaluation of the functional capacity and response of the somatotrophs of the anterior pituitary. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Recommended procedure: A single intravenous injection of 1.0 microgram/kg body weight in the morning following an overnight fast. Geref should be reconstituted immediately before use with a minimum of 0.5ml of the accompanying sterile solvent. Venous blood samples should be drawn 15 minutes before and immediately prior to Geref administration. Venous blood samples are then drawn at 15, 30, 45 and 60 minutes following Geref injection. Samples at 90 and 120 minutes are optional, since in the majority of patients they do not give additional information. 4.3 CONTRAINDICATIONS Use in patients known to be hypersensitive to sermorelin acetate or any of the excipients of Geref. Use during pregnancy or lactation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The test should only be carried out and interpreted under specialist supervision. Patients already on growth hormone therapy should have therapy discontinued one to two weeks pre-test. The test should be carried out with parti 完全なドキュメントを読む