DBL™ Adrenaline Injection BP

Country: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Adrenaline acid tartrate 1.8mg equivalent to 1:1000 or 1 mg/mL Adrenaline

Disponibbli minn:

Pfizer New Zealand Limited

INN (Isem Internazzjonali):

Adrenaline acid tartrate 1.8 mg (Equiv to 1:1000 or 1 mg/mL Adrenaline)

Dożaġġ:

1:1000

Għamla farmaċewtika:

Solution for injection

Kompożizzjoni:

Active: Adrenaline acid tartrate 1.8mg equivalent to 1:1000 or 1 mg/mL Adrenaline Excipient: Sodium chloride Sodium metabisulfite Water for injection

Unitajiet fil-pakkett:

Ampoule, glass, 5 x 1mL, 5 mL

Klassi:

Restricted

Tip ta 'preskrizzjoni:

Restricted

Manifatturat minn:

Boehringer Ingelheim Pharma GmbH & Co KG

Indikazzjonijiet terapewtiċi:

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.

Sommarju tal-prodott:

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

Data ta 'l-awtorizzazzjoni:

1984-03-08

Karatteristiċi tal-prodott

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