Anapen 300
देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
उत्पाद विशेषताएं
(SPC)
22-04-2013
अनुरोध भेजा।
सक्रिय संघटक:
Adrenaline 1 mg/mL
थमां उपलब्ध:
Link Pharmaceuticals Ltd
INN (इंटरनेशनल नाम):
Adrenaline 1 mg/mL
डोज़:
300 mcg/0.3mL
फार्मास्यूटिकल फॉर्म:
Solution for injection
रचना:
Active: Adrenaline 1 mg/mL Excipient: Hydrochloric acid Sodium chloride Sodium metabisulfite Water for injection
पैकेज में यूनिट:
Syringe, Pre-filled autoinjector, 0.3 mL
वर्ग:
Restricted
प्रिस्क्रिप्शन प्रकार:
Restricted
द्वारा बनाया गया:
Boehringer Ingelheim Pharma GmbH & Co KG
चिकित्सीय संकेत:
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.
उत्पाद समीक्षा:
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.
प्राधिकरण की तारीख:
2008-11-25
उत्पाद विशेषताएं
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
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