DBL™ Dexamethasone Sodium Phosphate

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Dexamethasone sodium phosphate 4 mg/mL

Dostępny od:

Pfizer New Zealand Limited

INN (International Nazwa):

Dexamethasone sodium phosphate 4 mg/mL

Dawkowanie:

4 mg/mL

Forma farmaceutyczna:

Solution for injection

Skład:

Active: Dexamethasone sodium phosphate 4 mg/mL Excipient: Creatinine Hydrochloric acid Sodium citrate dihydrate Sodium hydroxide Water for injection

Sztuk w opakowaniu:

Ampoule, glass, 1mL, 5 dose units

Klasa:

Prescription

Typ recepty:

Prescription

Wyprodukowano przez:

Sanofi Chimie

Podsumowanie produktu:

Package - Contents - Shelf Life: Ampoule, glass, 1mL - 5 dose units - 18 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 1mL - 50 dose units - 18 months from date of manufacture stored at or below 25°C protect from light

Data autoryzacji:

1984-09-20

Charakterystyka produktu

Version: pfddexai11122
Supersedes: pfddexai10322
Page 1 of 18
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DBL
TM
Dexamethasone Sodium Phosphate Injection 4 mg/mL Solution for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of solution contains dexamethasone sodium phosphate
equivalent to 4 mg of
dexamethasone phosphate.
The 4 mg/1 mL ampoule formulation contains sodium citrate and
creatinine. No preservatives
or antioxidants are present.
The 8 mg/2 mL vial formulation contains sodium citrate, disodium
edetate and sodium sulfite
(as an antioxidant).
EXCIPIENT(S) WITH KNOWN EFFECT
Vial (8 mg/2 mL)
Sodium sulfite
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Dexamethasone phosphate (as sodium) is a white or slightly yellow,
very hygroscopic,
crystalline powder. It is odourless or has a slight odour of alcohol.
Dexamethasone phosphate
(as sodium) is soluble 1 in 2 of water, slightly soluble in alcohol,
practically insoluble in
chloroform and ether, and very slightly soluble in dioxane.
DBL Dexamethasone Sodium Phosphate Injection is a clear colourless
solution, free from
visible particulate matter.
The pH of the solutions is adjusted using sodium hydroxide and/or
hydrochloric acid.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
REPLACEMENT THERAPY - ADRENOCORTICAL INSUFFICIENCY
Dexamethasone has predominantly glucocorticoid activity and therefore
is not a complete
replacement therapy in cases of adrenocortical insufficiency.
Dexamethasone should be
supplemented with salt and/or a mineralocorticoid, such as
deoxycorticosterone. When so
supplemented, dexamethasone is indicated in:
•
Acute adrenocortical insufficiency - Addison’s disease, bilateral
adrenalectomy;
Version: pfddexai11122
Supersedes: pfddexai10322
Page 2 of 18
•
Relative adrenocortical insufficiency - Prolonged administration of
adrenocortical steroids
can produce dormancy of the adrenal cortex. The reduced secretory
capacity gives rise to
a state of relative adrenocortical insu