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Sodium Nitrite 30 Mg/Ml Solution For Injection

Document: leaflet MAH GENERIC_PL 42589-0001 change

Patient Information Leaflet


SODIUM NITRITE 30 mg/mL

Solution for Injection

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 Sodium Nitrite is 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.    Further 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

Take special care with Sodium Nitrite 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.);

•    have inhaled smoke from a fire.

You will be monitored during use with Sodium Nitrite, and the dose of the medication will be adjusted if necessary.

Using other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The following medicines have side effects that are similar to the side effects that may occur with Sodium Nitrite.

•    Medicines used to treat high blood pressure such as beta blockers, diuretics, and nitrates;

•    Medicines that can increase methemoglobin levels such as procaine (used as a local anesthetic) and nitroprusside (used to reduce blood pressure).

It may be necessary for your doctor to adjust the dose of Sodium Nitrite or one of your other medications.

Do not take sodium nitrite concurrently with hydroxocobalamin.

Pregnancy and breast-feeding

Sodium Nitrite should not be used during pregnancy or while breast-feeding. Tell your doctor right away if you are pregnant or breast feeding.

3.    How Sodium Nitrite will be given

Sodium Nitrite will be given by injection into a vein by a doctor or nurse. Your doctor will choose the dose that is right for you.

If signs of cyanide poisoning reappear, your doctor will decide if you should receive more sodium nitrite.

If you have any further questions on the use of Sodium Nitrite, ask your doctor or nurse.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects of sodium nitrite include:

•    Cardiovascular: reduced blood pressure, rapid heart rate, irregular pulse, transient loss of consciousness, palpitations

•    Hematological: blood disorder resulting in oxygen deprivation in tissues

(methemogl ob inemia)

•    Central nervous system: headache, dizziness, blurred vision, seizures, confusion, coma

•    Psychiatric: anxiety

•    Gastrointestinal: nausea, vomiting, abdominal pain

•    Respiratory: rapid breathing, shortness of breath

•    Skin: urticaria (skin rash notable for pale, red, raised, itchy bumps)

•    Body as a whole: sweating, light headedness, injection site tingling, fatigue, weakness, generalized numbness and tingling, blue or purple coloured skin

The frequencies at which the above reactions occur are not known yet.

Death was reported after administration of a dose of sodium nitrite that was higher than the recommended therapeutic dose, but less than twice the recommended therapeutic dose.

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can help make sure that medicines remain as safe as possible by reporting any unwanted side effects directly via www.mhra.gov.uk/ vellowcard.

5. How to store Sodium Nitrite

Keep this medicine out of the sight and reach of children.

Do not use Sodium Nitrite Solution for Injection after the expiry date which is stated on the vial label and carton. The expiry date refers to the last day of that month.

Store below 25°C.

Sodium Nitrite 30 mg/mL Solution for Injection must be clear and colourless. If particulate matter or discolouration is present, the solution must not be used and should be discarded.

For single use only. Use immediately after opening. Discard any unused portions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further information

What Sodium Nitrite contains

Each 10 mL vial of Sodium Nitrite 30 mg/ mL Solution for Injection contains 300 mg of the active ingredient sodium nitrite (30 mg/mL). The other ingredient is water for injections.

What Sodium Nitrite looks like and contents of the pack

Each carton of Sodium Nitrite 30 mg/mL Solution for Injection contains one 10 mL glass vial.

Marketing Authorisation Holder

Hope Pharmaceuticals, Ltd.

120 Baker Street London W1U 6TU United Kingdom

Manufacturer

Cangene bioPharma, Inc. Baltimore MD 21230 USA

This leaflet was last revised on August 2015.