Natriumthiosulfaat Hope 250 mg/ml, oplossing voor injectie

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

NATRIUMTHIOSULFAAT 5-WATER 250 mg/ml SAMENSTELLING overeenkomend met ; NATRIUMTHIOSULFAAT 0-WATER 159,2 mg/ml

Beschikbaar vanaf:

Hope Pharmaceuticals, Ltd. 9 Cherrywood TALLANSTOWN (IERLAND)

ATC-code:

V03AB06

INN (Algemene Internationale Benaming):

NATRIUMTHIOSULFAAT 5-WATER 250 mg/ml SAMENSTELLING overeenkomend met ; NATRIUMTHIOSULFAAT 0-WATER 159,2 mg/ml

farmaceutische vorm:

Oplossing voor injectie

Samenstelling:

BOORZUUR (E 284) ; KALIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Thiosulfate

Autorisatie datum:

2018-07-10

Bijsluiter

1
NATRIUMTHIOSULFAAT HOPE 250 MG/ML, OPLOSSING VOOR INJECTIE
natriumthiosulfaat
READ ALL OF THIS LEAFLET CAREFULLY
This leaflet contains information about sodium thiosulfate, which will
have already been
given to you by injection into one of your veins.
•
Although you will not be taking this medicine yourself, this leaflet
contains
important information to help you understand how Sodium Thiosulfate is
used.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
1.
What is sodium thiosulfate and what it is used for
2.
Before you are given sodium thiosulfate
3.
How sodium thiosulfate is given
4.
Possible side effects
5.
How to store sodium thiosulfate
6.
Contents of the pack and other information
1.
WHAT SODIUM THIOSULFATE IS AND WHAT IT IS USED FOR
Sodium Thiosulfate 250 mg/mL Solution for Injection is used as an
antidote for cyanide
poisoning. Cyanide poisoning is a condition that develops when you
inhale, touch, or
swallow cyanide. Cyanide is a poisonous chemical that prevents your
body from absorbing
oxygen. The lack of oxygen can damage your organs and be
life-threatening.
2.
BEFORE YOU ARE GIVEN SODIUM THIOSULFATE
Your doctor will take special care if you:
•
have had an allergic reaction to sulfites.
You will be monitored during use with sodium thiosulfate, and the dose
of the medication will
be adjusted if necessary.
This medicine contains approximately 3.6 g of sodium per
vial,equivalent to 180% of the
WHO recommended maximum daily intake of 2g sodium for an adult.
This medicine contains 115 mg of potassium per 50ml vial.
This medicine also contains 140 mg of boric acid per 50ml vial.If you
are pregnant, talk to
your doctor as it contains boron, which may be harmful to your baby.
2
USING OTHER MEDICINES
The following medicines have side effects that are similar to the side
effects

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Natriumthiosulfaat Hope 250 mg/ml, oplossing voor injectie
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 mL vial contains 12.5 g of sodium thiosulfate (250 mg/mL).
Excipient of known effect:
3.6 g of sodium in 50 ml of solution for injection.
115 mg of potassium in 50 ml of solution for injection.
140 mg of boric acid in 50 mL of solution for injection.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for Injection
The solution for injection is a clear and colourless solution.
4
CLINICAL PARTICULARS
_4.1_
_ _
_THERAPEUTIC INDICATIONS_
Sodium thiosulfate is indicated for sequential use with
hydroxocobalamin or
sodium nitrite for the treatment of acute cyanide poisoning that is
judged to be
life-threatening.
When the diagnosis of cyanide poisoning is uncertain, the potentially
life-
threatening risks associated with sodium thiosulfate should be
carefully weighed
against the potential benefits, especially if the patient is not in
extremis.
Sodium thiosulfate is to be administered together with appropriate
decontamination and supportive measures (see section 4.4).
_4.2_
_ _
_POSOLOGY AND METHOD OF ADMINISTRATION_
Posology
For intravenous use. For single use only.
_Adults_
Initial dose: 10 mL (300 mg) of sodium nitrite (rate of 2.5 to 5
mL/minute) should
be administered intravenously, immediately followed by 50 mL (12.5 g)
of sodium
thiosulfate (rate of 5 mL/minute).
Alternatively, an initial dose of 5 g hydroxocobalamin administered as
an
intravenous infusion over 15 minutes followed by 50 mL (12.5 g) of
sodium
thiosulfate (rate of 5 mL/minute).
_Special populations_
_ _
_Older people_
_ _
No specific dose adjustment is required in elderly patients (aged > 65
years).
_Paediatric population_
In infants to adolescents (0 to 18 years old), 0.2 mL/kg (6 mg/kg or
6-8 mL/m
2
BSA) of sodium nitrite (rate of 2.5 to 5 mL/minute) not to exceed 10
mL should
be administered intravenously, immediately followed by 1 mL/kg of bod