Natriumnitriet Hope 30 mg/ml, oplossing voor injectie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

NATRIUMNITRIET (E 250) 30 mg/ml

Beschikbaar vanaf:

Hope Pharmaceuticals, Ltd. 9 Cherrywood TALLANSTOWN (IERLAND)

ATC-code:

V03AB08

INN (Algemene Internationale Benaming):

NATRIUMNITRIET (E 250) 30 mg/ml

farmaceutische vorm:

Oplossing voor injectie

Samenstelling:

STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Sodium Nitrite

Autorisatie datum:

1900-01-01

Bijsluiter

1
NATRIUMNITRIET HOPE 30 MG/ML, OPLOSSING VOOR INJECTIE
natriumnitriet
READ ALL OF THIS LEAFLET CAREFULLY
This leaflet contains information about sodium nitrite, 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 nitrite 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 nitrite and what it is used for
2.
Before you are given sodium nitrite
3.
How sodium nitrite is given
4.
Possible side effects
5.
How to store sodium nitrite
6.
Contents of the pack and other information
1.
WHAT SODIUM NITRITE IS AND WHAT IT IS USED FOR
Sodium Nitrite 30 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 NITRITE
Your doctor will take special care if you:
•
are pregnant or breast-feeding (See Pregnancy and breast-feeding);
•
have low blood pressure;
•
have a condition called anaemia (This is a reduction in number of red
blood cells
in the bloodstream. Anaemia can make the skin appear pale and can
cause
weakness or breathlessness);
•
suffer from Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency (This
may
result in anaemia.);
•
have a history of elevated levels of methemoglobin (This is a modified
form of
hemoglobin that reduces the amount of oxygen in the bloodstream and
can cause
weakness or breathlessness.);
2
•
have inhaled smoke from a fire;
•
have had an allergic reaction to sodium nitrite.
You will be monitor

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Natriumnitriet Hope 30 mg/ml, oplossing voor injectie
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL vial contains 300 mg of sodium nitrite (30 mg/mL). 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 nitrite is indicated for sequential use with sodium thiosulfate
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 nitrite should be carefully
weighed
against the potential benefits, especially if the patient is not in
extremis.
Sodium nitrite is to be administered together with appropriate
decontamination
and supportive measures (see section 4.4).
Consideration should be given to official guidelines for the treatment
of cyanide
intoxication.
_4.2_
_ _
_POSOLOGY AND METHOD OF ADMINISTRATION_
Posology
For intravenous use. For single use only.
_Adults_
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).
_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 body
weight (250 mg/kg or approximately 30-40 mL/m
2
of BSA) (rate of 2.5 to 5
mL/minute) not to exceed 50 mL total dose of sodium thiosulfate.
NOTE: If no treatment response is observed within 30 to 60 minutes or
if signs
of poisoning reappear, repeat treatment after 30 minutes of initial
administration
using one-half the original