Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Adrenaline 1 mg/mL
Link Pharmaceuticals Ltd
Adrenaline 1 mg/mL
300 mcg/0.3mL
Solution for injection
Active: Adrenaline 1 mg/mL Excipient: Hydrochloric acid Sodium chloride Sodium metabisulfite Water for injection
Syringe, Pre-filled autoinjector, 0.3 mL
Restricted
Restricted
Boehringer Ingelheim Pharma GmbH & Co KG
For the emergency treatment of serious allergic reactions or anaphylaxis caused by peanuts or other foods, drugs, insect bites or stings and other allergens. Anapen® 500, is intended for use in patients with a mean weight of 60 kg, or more or patients at high risk of severe anaphylaxis where the 300 micrograms dose may not be sufficient. Anapen® 500 and Anapen® 300 should not be used in children with bodyweight below 30 kg.
Package - Contents - Shelf Life: Syringe, Pre-filled autoinjector - 0.3 mL - 24 months from date of manufacture stored at or below 25°C protect from light. Do not refrigerate or freeze.
2008-11-25
Version: 5.0 page 1 of 7 DATA SHEET ANAPEN ® 500, ANAPEN ® 300 AND ANAPEN ® 150 _ADRENALINE 500 ΜG/0.3 ML, ADRENALINE 300 ΜG/0.3 ML AND ADRENALINE 150 ΜG/0.3 ML_ ANAPEN ® 500 ΜG ADRENALINE AUTO-INJECTOR, ANAPEN ® 300 ΜG ADRENALINE AUTO-INJECTOR AND ANAPEN ® 150 ΜG ADRENALINE AUTO-INJECTOR Auto-Injector for Intramuscular Injection of Adrenaline for the Emergency Treatment of Anaphylactic Reactions. Anapen ® 500 µg/0.3 mL delivers a single 500 microgram (µg) intramuscular dose of adrenaline from Adrenaline Injection 1:600 USP (0.3 mL). Anapen ® 300 µg/0.3 mL delivers a single 300 microgram (µg) intramuscular dose of adrenaline from Adrenaline Injection 1:1000 USP (0.3 mL). Anapen ® 150 delivers a single 150 microgram (µg) intramuscular dose of adrenaline from Adrenaline Injection 1:2000 USP (0.3 mL). DESCRIPTION Adrenaline is (_R_)-1-(3,4-dihydroxyphenyl)-2-methylaminoethanol. EMPIRICAL FORMULA: C 9 H 13 NO 3 . CAS NO: 51-43-4. Adrenaline chemical structure is: It is a white odourless crystalline powder, soluble in solutions of mineral acids and alkalis. The Anapen ® 500, Anapen ® 300 and Anapen ® 150 are auto-injector devices that provide adrenaline for intramuscular auto-injection in a sterile solution prepared from adrenaline with the aid of hydrochloric acid in Pyrogen Free Water. Anapen ® 500, Anapen ® 300and Anapen ® 150 contain 1 mL Adrenaline Injection 1:600 USP, 1:1000 USP and 1:2000 USP, respectively, and are designed to deliver a single 0.3 mL dose of 500 µg, 300 µg or 150 µg. Version: 5.0 page 2 of 7 Each 0.3 mL of solution in Anapen ® 500 contains: _Active_; 500 µg adrenaline, _Inactive_; 1.8 mg sodium chloride, 510 µg sodium metabisulfite and hydrochloric acid to adju Baca dokumen lengkap