Страна: Сингапур
Язык: английский
Источник: HSA (Health Sciences Authority)
Glucagon (as hydrochloride)
NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
H04AA01
1mg/ml
INJECTION, POWDER, FOR SOLUTION
Glucagon (as hydrochloride) 1mg/ml
INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR
Prescription Only
Novo Nordisk A/S
ACTIVE
1996-12-09
GlucaGen ® 1mg Vial site DK Professional Leaflet STF 2015 Based on 8-9401-00-010-1 1 GLUCAGEN ® 1 MG Powder and solvent for solution for injection QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Human glucagon produced in _Saccharomyces cerevisiae_ by recombinant DNA technology. One vial contains 1 mg glucagon as hydrochloride corresponding to 1 mg (1 IU) glucagon/ml after reconstitution. For the full list of excipients, see _List of excipients_ . PHARMACEUTICAL FORM Powder and solvent for solution for injection. Before reconstitution the compacted powder should be white or nearly white. The solvent should be clear and colourless without particles. CLINICAL PARTICULARS INDICATIONS THERAPEUTIC INDICATION GlucaGen ® is indicated for treatment of severe hypoglycaemic reactions, which may occur in the management of insulin treated children and adults with diabetes mellitus. DIAGNOSTIC INDICATION GlucaGen ® is indicated for motility inhibition in examinations of the gastrointestinal tract in adults. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _THERAPEUTIC INDICATION (SEVERE HYPOGLYCAEMIA)_ Dosage for adult patients: Administer 1 mg by subcutaneous or intramuscular injection. SPECIAL POPULATIONS _Paediatric population (< 18 years old):_ GlucaGen ® can be used for the treatment of severe hypoglycaemia in children and adolescents. Dosage for paediatric patients: Children below 25 kg or younger than 6-8 years: Administer 0.5 mg. Children above 25 kg or older than 6-8 years: Administer 1.0 mg. _Elderly (≥ 65 years old):_ GlucaGen ® can be used in elderly patients. _Renal and hepatic impairment:_ GlucaGen ® can be used in patients with renal and hepatic impairment. GlucaGen ® 1mg Vial site DK Professional Leaflet STF 2015 Based on 8-9401-00-010-1 2 _DIAGNOSTIC INDICATION (INHIBITION OF GASTROINTESTINAL MOTILITY)_ Dosage for adult patients: The diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum and small bowel is 0.2–0.5 mg given as intravenous injection or 1 mg g Прочитать полный документ
1 of 8 1. Name of the medicinal product GlucaGen ® 1 mg Powder and solvent for solution for injection 2. Qualitative and quantitative composition Active substance: Human glucagon produced in Saccharomyces cerevisiae by recombinant DNA technology. One vial contains 1 mg glucagon as hydrochloride corresponding to 1 mg (1 IU) glucagon/ml after reconstitution. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Powder and solvent for solution for injection. Before reconstitution the compacted powder should be white or nearly white. The solvent should be clear and colourless without particles. 4. Clinical particulars 4.1 Indications Therapeutic indication GlucaGen ® is indicated for treatment of severe hypoglycaemic reactions, which may occur in the management of insulin treated children and adults with diabetes mellitus. Diagnostic indication GlucaGen ® is indicated for motility inhibition in examinations of the gastrointestinal tract in adults. 4.2 Posology and method of administration Posology • Therapeutic indication (Severe hypoglycaemia) Dosage for adult patients: Administer 1 mg by subcutaneous or intramuscular injection. Special populations Paediatric population (< 18 years old): GlucaGen ® can be used for the treatment of severe hypoglycaemia in children and adolescents. Dosage for paediatric patients: Administer 0.5 mg (children below 25 kg or younger than 8 years) or 1 mg (children above 25 kg or older than 8 years). Elderly (≥ 65 years old): GlucaGen ® can be used in elderly patients. Renal and hepatic impairment: GlucaGen ® can be used in patients with renal and hepatic impairment. • Diagnostic indication (Inhibition of gastrointestinal motility) Dosage for adult patients: The diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum and small bowel is 0.2–0.5 mg given as intravenous injection or 1 mg given intramuscularly; the dose to relax the colon is 0.5–0.75 mg intravenously or 1–2 mg intramuscularly. 2 of 8 Special populations Paediatric population Прочитать полный документ