DBL™ Adrenaline Injection BP
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
26-07-2021
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Active ingredient:
Adrenaline acid tartrate 1.8mg equivalent to 1:1000 or 1 mg/mL Adrenaline
Available from:
Pfizer New Zealand Limited
INN (International Name):
Adrenaline acid tartrate 1.8 mg (Equiv to 1:1000 or 1 mg/mL Adrenaline)
Dosage:
1:1000
Pharmaceutical form:
Solution for injection
Composition:
Active: Adrenaline acid tartrate 1.8mg equivalent to 1:1000 or 1 mg/mL Adrenaline Excipient: Sodium chloride Sodium metabisulfite Water for injection
Units in package:
Ampoule, glass, 5 x 1mL, 5 mL
Class:
Restricted
Prescription type:
Restricted
Manufactured by:
Boehringer Ingelheim Pharma GmbH & Co KG
Therapeutic indications:
For the treatment of acute allergic reactions, life-threatening angioneurotic oedema, and anaphylactic shock resulting from reactions to drugs, animal serums, insect stings and other allergens.
Product summary:
Package - Contents - Shelf Life: Ampoule, glass, 5 x 1mL - 5 mL - 24 months from date of manufacture stored at or below 25°C - Ampoule, glass, 50 x 1mL - 50 mL - 24 months from date of manufacture stored at or below 25°C
Authorization date:
1984-03-08
Summary of Product characteristics
Version: pfdadrni10721
Supersedes: pfdadrni10219
Page 1 of 11
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DBL™ Adrenaline 1:1000 (1 mg/mL) and 1:10,000 (1 mg/10 mL) solution
for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Adrenaline 1:1000 (1 mg/mL) and 1:10,000 (1 mg/10 mL) solution for
injection is a
sterile, clear, colourless aqueous solution.
Each ampoule of DBL Adrenaline Injection 1:1,000 contains 1.8 mg of
adrenaline acid tartrate
(equivalent to 1 mg of adrenaline)/mL of water.
Each ampoule of DBL Adrenaline Injection 1:10,000 contains 1.8 mg of
adrenaline acid
tartrate (equivalent to 1 mg of adrenaline)/10 mL of water.
EXCIPIENT(S) WITH KNOWN EFFECT
Each ampoule contains 1 mg/mL of sodium metabisulfite and 8 mg/mL of
sodium chloride.
For full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
DBL ADRENALINE 1:1,000
For the treatment of acute allergic reactions, life-threatening
angioneurotic oedema and
anaphylactic shock resulting from reactions to drugs, animal serums,
insect stings and other
allergens.
DBL ADRENALINE 1:10,000
Adjunctive use in the management of cardiac arrest and anaphylactic
shock resulting from
reactions to drugs, animal serums, insect stings and other allergens.
4.2 DOSE AND METHOD OF ADMINISTRATION
DBL Adrenaline injection does not contain any preservatives. It is for
single use in one patient
only. Discard any residue.
Do not use if the injection is brown or contains a precipitate.
Version: pfdadrni10721
Supersedes: pfdadrni10219
Page 2 of 11
Adrenaline is given by subcutaneous injection. It may also be
administered intramuscularly but
not into the buttocks.
In extreme emergencies, where a more rapid effect is required,
adrenaline may be given by
slow intravenous injection or by slow intravenous infusion but
ONLY AS A DILUTE SOLUTION (1 IN
10,000 OR 1 IN 100,000).
ACUTE ALLERGIC REACTIONS, LIFE-THREATENING ANGIONEUROTIC OEDEMA AND
ANAPHYLACTIC SHOCK
DBL ADRENALINE 1:1
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