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Parvolex (Acetylcysteline)

Parvolex 200mg

Acetylcysteline

1. What Parvolex is for

Parvolex belongs to a group of medicines called amino acids.

Parvolex is used to treat a paracetamol overdose. Parvolex protects the liver from damage caused by an overdose of paracetamol.

It is important to treat a paracetamol overdose promptly  and effectively because without treatment it can be fatal.

2. Before you are given Parvolex

Parvolex (Acetylcysteline)Do not use Parvolex if:

•  You are allergic to acetylcysteine or any of the other ingredients of Parvolex.

If this applies to you, talk to your doctor or nurse.

Check with the doctor or nurse before they give you Parvolex if:

•  You have asthma or have had any breathing difficulties in the past

•  You drink a lot of alcohol regularly

•  You are malnourished (a severe lack of food) eg. due to anorexia or AIDS

•  You weigh less than 40 kg

•  You have been told you need less fluid

Tell your doctor if you are taking any of the following medicines:

•  Anticonvulsants (medicines used to prevent epileptic fits) such as phenytoin, phenobarbital, primidone or carbamazepine

•  Rifampicin (medicine to treat serious infections such as tuberculosis (TB))

These medicines may make you more sensitive to the effects of paracetamol.

Also tell your doctor if you are taking any other medicines including medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant, or breastfeeding, ask your doctor or nurse for advice before being given Parvolex.

Important information about some of the ingredients of Parvolex

This medicinal product contains 322.6 mg of sodium in a 10 ml dose. To be taken into consideration by patients on a controlled sodium diet.

3. How you will be given Parvolex

Parvolex will be given to you by a doctor or nurse in hospital. Parvolex is given as an infusion (drip) through a needle placed in your vein. This puts Parvolex directly into your bloodstream. Before you are given Parvolex by intravenous infusion it is diluted with either 5% dextrose, 0.9% sodium chloride, 0.3% potassium chloride with 0.9% sodium chloride. The active ingredient is not compatible with some rubbers or metals. Silicone rubber and plastic are recommended for use with Parvolex.

Important:

Your doctor may test your blood to see how much paracetamol is in your blood stream before they give you Parvolex. The results of these tests will help the doctor choose the dose that is right for you and decide how long you will have the drip for. The doctor or nurse will monitor the drip to make sure it is working properly.

Adults

•  The usual starting dose is 150 mg per kilogram (kg) of body weight up to a maximum of 110 kg. This is dissolved in 200 ml of solution and given to you over a 15-minute period

•  This is usually followed by a dose of 50 mg per kg body weight up to a maximum of 110 kg. This is dissolved in 500 ml of solution and given to you over the next 4 hours

•  This is usually followed by a dose of 100 mg per kg of body weight up to a maximum of 110 kg. This is dissolved in 1 litre of solution and given to you over 16 hours.

Children

•  The doctor will decide how much Parvolex your child will be given based on their age and weight

•  Generally, children are given the same dose of Parvolex as adults but in a smaller amount of solution.

If you are given more Parvolex than you should

This is unlikely as Parvolex will be dripped into your vein slowly by a doctor who will monitor your condition. If any problem occurs, Parvolex can be stopped and any symptoms of overdosage treated urgently. Overdose with Parvolex may cause severe allergic (hypersensitivity) reactions. These are listed in Section 4 below. If you have any further questions ask your doctor or nurse.

4. Possible side effects

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

Tell your doctor immediately if you have any of the following symptoms. You may be having a severe allergic reaction:

•  Feeling or being sick

•  Flushing (red face, feeling hot)

•  A skin rash or itching

•  Difficulty in breathing or tightness your chest

•  Dizziness due to a drop in blood pressure

•  Swelling, irritation or discomfort where the needle goes into your vein

•  A rise in blood pressure and an abnormally fast heart beat (pulse).

Other side effects

•  Cessation of breathing and stopping of the heart

•  Thrombocytopenia (causing bleeding because your blood does not clot as it should)

•  Acidosis (drowsiness, feeling and being sick, breath smells of “pear drops”)

•  Electrical changes in your heart muscle (detected by an ECG monitor)

•  Raised temperature and sweating

•  Slow heart beat

•  Face pain and swelling, eye pain, blurred vision or puffy eyes

•  Fainting

•  Pain in the joints

•  Seizures (fits)

•  Feeling anxious

•  Cyanosis (bluish colour in the lips and skin)

•  Swelling or discomfort around the site of injection

•  Noisy breathing sounds or coughing

•  Changes in your blood test results, in particular a drop in plasma potassium levels

•  Changes to the time it takes for your blood to clot (may be increased or decreased)

•  Liver problems (yellowing of your eyes and skin). Although rare, deaths have occurred when Parvolex has been given.

If any of these side effects get serious, or you notice any side effects not listed in this leaflet tell your doctor or nurse.

5. How to store Parvolex

Your doctor or nurse will make sure your medicine is correctly stored and disposed of.

Keep out of the reach and sight of children.

Do not use Parvolex after the expiry date on the carton and on the ampoule label. The expiry date refers to the last day of that month. Store below 25°C.

Parvolex must be diluted in an appropriate infusion fluid  before use. Once opened use immediately. Discard after use.

Medicines should not be disposed of via wastewater or household waste.

6. Further information

  • What Parvolex contains

The active substance in Parvolex is acetylcysteine. Each millilitre (ml) of solution contains 200 mg acetylcysteine and each 10 ml ampoule contains a total of 2 g of acetylcysteine. The other ingredients are disodium edetate, sodium hydroxide (E524) and water for injection.

  • What Parvolex looks like

Parvolex is a clear colourless solution and comes in sealed 10 ml clear glass containers called ampoules. Each ampoule contains 10 ml solution. Do not use if solution becomes cloudy, changes colour or if visible particles or fibres can be seen. Each box of Parvolex contains ten 10 ml ampoules.

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