HOPE PHARMACEUTICALS SODIUM NITRITE INJECTION sodium nitrite 300 mg/10 mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium nitrite, Quantity: 300 mg

Available from:

Hope Pharmaceuticals Pty Ltd

INN (International Name):

Sodium nitrite

Pharmaceutical form:

Solution

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous

Units in package:

1 glass vial

Prescription type:

(S2) Pharmacy Medicine

Therapeutic indications:

Sodium Nitrite injection is indicated as an antidote in the treatment of cyanide poisoning, in conjunction with sodium thiosulfate.

Product summary:

Visual Identification: Clear and colourless, sterile solution practically free from visible particles; Container Type: Vial; Container Material: Glass; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-05-16

Patient Information leaflet

Page 1
HOPE PHARMACEUTICALS
TM
SODIUM NITRITE INJECTION
Sodium nitrite
CONSUMER MEDICINE INFORMATION
_Date of Dispensing_
_Consumer Name _
_Pharmacist Name_
_Consumer Address _
_Pharmacist Address_
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Hope Pharmaceuticals
TM
Sodium
Nitrite Injection.
It does not contain all the
available information.
It does not take the place of
talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given Hope Pharmaceuticals
TM
Sodium Nitrite Injection against
the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT HOPE
PHARMACEUTICALS
TM SODIUM
NITRITE INJECTION IS USED FOR
Hope Pharmaceuticals
TM
Sodium
Nitrite
Injection
is
used
in
the
emergency treatment of cyanide
poisoning.
Hope Pharmaceuticals
TM
Sodium
Nitrite Injection works by helping
to prevent cyanide from binding
to important enzymes in the cells
of your body.
Your doctor may have prescribed
Hope Pharmaceuticals
TM
Sodium
Nitrite
Injection
for
another
reason. Ask your doctor
if you have any questions about
why Hope Pharmaceuticals
TM
Sodium Nitrite
Injection has
been prescribed for you.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
HOPE PHARMACEUTICALS
TM
SODIUM NITRITE INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT_
HOPE PHARMACEUTICALS
TM
SODIUM NITRITE INJECTION
SHOULD NOT BE GIVEN TO YOU IF:
•
YOU ARE SUFFERING FROM
SMOKE INHALATION AND
COMBINED CARBON MONOXIDE
AND CYANIDE POISONING
•
YOU HAVE AN ALLERGY TO
SODIUM NITRITE OR ANY OF THE
INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Symptoms of an allergic
reaction to sodium nitrite may
include skin rash, itching,
difficulty breathing and
swelling, especially of the face
and throat.
•
THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING
•
THE EXPIRY DATE ON THE PACK
HAS PASSED.

Summary of Product characteristics

Page 1
HOPE PHARMACEUTICALS
TM
SODIUM NITRITE INJECTION
(SODIUM NITRITE)
1. NAME OF THE MEDICINE
Sodium nitrite
(Sodium Nitrite)
2. QUALITATIVE AND QUANTATIVE COMPOSITION
Each 10 mL glass vial contains 300 mg of sodium nitrite in 10 mL water
for
injections (30 mg/mL). Sodium nitrite injection is a clear solution
with a pH between
7.0 and 9.0.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
HOPE PHARMACEUTICALS
TM
Sodium Nitrite Injection is a clear and colourless
sterile solution practically free from visible particles and is
intended for intravenous
injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HOPE PHARMACEUTICALS
TM
Sodium Nitrite Injection is indicated as an antidote
in the treatment of cyanide poisoning, in conjunction with sodium
thiosulfate.
4.2 DOSE AND METHOD OF ADMINISTRATION
Therapy should be instituted immediately based upon reasonable
suspicion of cyanide
toxicity. The characteristic smell of bitter almonds may not be
obvious, and is not
detectable by all individuals. Sodium nitrite should only be
administered in severe
cases.
HOPE PHARMACEUTICALS
TM
Sodium Nitrite Injection is administered by
intravenous injection. Sodium thiosulfate should be administered
immediately
Page 2
following the sodium nitrite dosage. Methaemoglobin concentration
should be
monitored and must not exceed 40%.
ADULT DOSE:
The usual adult dose is 300 mg (10 mL of a 3% solution)
administered intravenously at a rate of 75 to150 mg/min (2.5 to 5
mL/min).
PAEDIATRIC DOSE:
The usual paediatric dose is 4 mg/kg body weight (0.13 mL of a
3% solution/kg body weight) [range 4.0 to 10 mg/kg body weight, 0.13
to 0.33
mL/kg body weight] or 180 to 240 mg/m
2
(6 to 8 mL of a 3% solution/m
2
)
administered at a rate of 75 to 150 mg/min (2.5 to 5 mL of a 3%
solution/min). It is
advisable to begin with doses at the lower end of the recommended
range and
increase to the desired effect. A maximum dose of 300 mg (10 mL of a
3%
solution) is recommended.
For children under 25 kg, where ana