DBL™ Sodium thiosulfate

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Sodium thiosulfate pentahydrate 250 mg/mL

Dostupné s:

Pfizer New Zealand Limited

INN (Mezinárodní Name):

Sodium thiosulfate pentahydrate 250 mg/mL

Dávkování:

25% w/v

Léková forma:

Solution for injection

Složení:

Active: Sodium thiosulfate pentahydrate 250 mg/mL Excipient: Dibasic sodium phosphate dodecahydrate Sodium metabisulfite Water for injection

Jednotky v balení:

Vial, glass, 5x10mL, 50 mL

Třída:

General sale

Druh předpisu:

General sale

Výrobce:

Hospira Australia Pty Ltd

Terapeutické indikace:

DBL™ Sodium Thiosulfate Injection is indicated as an antidote in the treatment of cyanide poisoning. It is frequently used in conjunction with sodium nitrite. Sodium thiosulfate is also indicated to prevent sodium nitroprusside induced cyanide poisoning

Přehled produktů:

Package - Contents - Shelf Life: Vial, glass, 10mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light

Datum autorizace:

1984-01-26

Charakteristika produktu

Version: pfdsodti10621
Supersedes: Version 5.0
Page 1 of 6
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DBL
™
Sodium Thiosulfate Injection 25% w/v solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium thiosulfate pentahydrate 2.5 g in 10 mL (25% w/v solution).
EXCIPIENT(S) WITH KNOWN EFFECT

Sodium metabisulfite
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
DBL
™
Sodium Thiosulfate Injection is a clear, colourless, sterile solution.
The pH of the
solution is between 7.0 and 9.0.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL
™
Sodium Thiosulfate Injection is indicated as an antidote in the
treatment of cyanide
poisoning. It is frequently used in conjunction with sodium nitrite.
Sodium
thiosulfate
is
also
indicated
to
prevent
sodium
nitroprusside
induced
cyanide
poisoning.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
_CYANIDE POISONING_
Adult dose:
The usual adult dose is 12.5 g (50 mL of a 25% solution) administered
intravenously at a rate of 1.25 g/min (5 mL/min). If signs of cyanide
toxicity are still present
30 mins to 2 hours after administration, both sodium nitrite and
sodium thiosulfate may be
repeated at half the original dose.
_PREVENTION OF SODIUM NITROPRUSSIDE INDUCED CYANIDE TOXICITY_
Adult dose: Administer intravenously concurrently with sodium
nitroprusside at 5 to 10 times
the dose rate of sodium nitroprusside.
Version: pfdsodti10621
Supersedes: Version 5.0
Page 2 of 6
SPECIAL POPULATIONS
_CYANIDE POISONING_
Paediatric population
_Paediatric dose:_ The usual paediatric dose is 412.5 mg/kg (1.65
mL/kg of a 25% solution) or
7 g/m
2
(28 mL/m
2
) administered at a rate of 0.625 to 1.25 g/min (2.5 to 5 mL/min). A
maximum
dose of 12.5 g (50 mL of a 25% solution) is recommended.
Alternatively, a paediatric dose based on haemoglobin concentration
has been recommended.
HAEMOGLOBIN CONCENTRATION
DOSE OF SODIUM THIOSULFATE
80 g/L (8 g/dL)
1.10 mL/kg of 25% solution
100 g/L (10 g/dL)
1.35 mL/kg of 25% solution
120 g/L (12 g/dL)
1.