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PARVOLEX Solution for infusion (2014)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης UCB Pharma Limited
Διεύθυνση 208 Bath Road, Slough, Berkshire, SL1 3WE
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Περιεχόμενα

Name of the medicinal product

Parvolex 200 mg/ml Concentrate for Solution for Infusion.

Qualitative and quantitative composition

Each ml contains Acetylcysteine 200mg. Each 10 ml contains 322.6 mg of sodium. For a full list of excipients, see section 6.1.

Pharmaceutical form

Solution for infusion. Clear colourless solution contained in a 10 ml clear colourless Type I glass ampoule.

Therapeutic indications

N-acetylcysteine is indicated for the treatment of paracetamol overdose in patients: who have taken a staggered overdose irrespective of plasma paracetamol level. Staggered is defined as an overdose where ...

Posology and method of administration

Acetylcysteine should be administered by intravenous infusion preferably using Glucose 5% as the infusion fluid. Sodium Chloride 0.9% solution may be used if Glucose 5% is not suitable. Adults The full ...

Contraindications

There are no contraindications to the treatment of paracetamol overdose with acetylcysteine.

Special warnings and precautions for use

Intravenous acetylcysteine, given within 24 hours of ingestion of a potentially hepatotoxic overdose of paracetamol, is indicated to prevent or reduce the severity of liver damage. It is most effective ...

Interaction with other medicinal products and other forms of interaction

There are no known interactions.

Pregnancy and lactation

The safety of acetylcysteine in pregnancy has not been investigated in formal prospective clinical trials. However, clinical experience indicates that use of acetylcysteine in pregnancy for the treatment ...

Effects on ability to drive and use machines

There are no known effects on ability to drive and use machines.

Undesirable effects

The most common adverse reactions reported with acetylcysteine are nausea, vomiting, flushing and skin rash. Less commonly, more serious anaphylactoid reactions have been reported that include angioedema, ...

Overdose

There is a theoretical risk of hepatic encephalopathy. Overdosage of acetylcysteine has been reported to be associated with effects similar to the anaphylactoid reactions noted in section 4.8 (Undesirable ...

Pharmacodynamic properties

Acetylcysteine is considered to reduce the hepatic toxicity of NAPQI (n-acetyl-p-benzo-quinoneimine), the highly reactive intermediate metabolite following ingestion of a high dose of paracetamol, by at ...

Pharmacokinetic properties

Following intravenous administration of acetylcysteine using the standard 20-hour intravenous regimen, plasma levels of 300 to 900mg/l have been reported to occur shortly after the start of the infusion, ...

Preclinical safety data

None stated.

List of excipients

Disodium edetate Sodium hydroxide Water for injections

Incompatibilities

Acetylcysteine is not compatible with rubber or metals, particularly iron, copper and nickel. Silicone rubber and plastic are satisfactory for use with Parvolex. A change in the colour of the solution ...

Shelf life

3 years.

Special precautions for storage

Store below 25°C.

Nature and contents of container

Clear, Type I glass, 10ml snap ring ampoules. 10 10ml ampoules are packed in cartons.

Special precautions for disposal and other handling

Acetylcysteine to be diluted for intravenous infusion using either 5% dextrose, 0.9% sodium chloride, 0.3% potassium chloride with 5% glucose, or 0.3% potassium chloride with 0.9% sodium chloride. The ...

Marketing authorization holder

Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, Co. Meath, Ireland

Marketing authorization number(s)

PL 35104/0011

Date of first authorization / renewal of the authorization

14/10/1992 / 14/01/2003

Date of revision of the text

21/03/2014

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