DBL™ Adrenaline Injection BP

Country: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

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

Доступно од:

Pfizer New Zealand Limited

INN (Међународно име):

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

Дозирање:

1:1000

Фармацеутски облик:

Solution for injection

Састав:

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

Јединице у пакету:

Ampoule, glass, 5 x 1mL, 5 mL

Класа:

Restricted

Тип рецептора:

Restricted

Произведен од:

Boehringer Ingelheim Pharma GmbH & Co KG

Терапеутске индикације:

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.

Резиме производа:

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

Датум одобрења:

1984-03-08

Карактеристике производа

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