Anapen 500

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Adrenaline 1.66 mg/mL (plus 7% overage)

Available from:

Link Pharmaceuticals Ltd

INN (International Name):

Adrenaline 1.66 mg/mL (plus 7% overage)

Dosage:

500 mcg/0.3mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Adrenaline 1.66 mg/mL (plus 7% overage) Excipient: Hydrochloric acid Nitrogen Sodium chloride Sodium metabisulfite Water for injection

Units in package:

Applicator, pre-filled, single dose, Anapen auto-injector with glass pre-filled syringe, rubber stopper and needle., 1 dose unit

Class:

Restricted

Prescription type:

Restricted

Manufactured by:

Boehringer Ingelheim Pharma GmbH & Co KG

Therapeutic indications:

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.

Product summary:

Package - Contents - Shelf Life: Syringe, Anapen auto-injector with glass pre-filled syringe, rubber stopper and needle. - 0.3 mL - 24 months from date of manufacture stored 15°C-25°C. Do not refrigerate or freeze. protect from light

Authorization date:

2010-03-30

Summary of Product characteristics

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