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SPC, UK: TRILASYM Oral solution (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Trilasym 50 mg/5 ml Oral Solution.

Qualitative and quantitative composition

Each 5 ml of Oral Solution contains 50 mg of amantadine hydrochloride. Excipient(s) with known effect: Each 5 ml also contains: 3250 mg of sorbitol (E420) 10 mg of sodium benzoate (E211) 6.5 mg raspberry ...

Pharmaceutical form

Oral Solution. Clear, colourless, raspberry-flavoured liquid.

Therapeutic indications

Prophylaxis and treatment of signs and symptoms of infection caused by influenza A virus Trilasym is indicated in patients suffering from clinical influenza in which complications might be expected to ...

Posology and method of administration

Influenza A Treatment When treating influenza, the treatment should start as early as possible and to continue for 4 to 5 days. When amantadine is started within 48 hours of symptoms appearing, the duration ...

Contraindications

Known hypersensitivity to amantadine or any of the excipients listed in section 6.1 Individuals subject to convulsions A history of gastric ulceration Severe renal disease Pregnancy and breast-feeding ...

Special warnings and precautions for use

Trilasym should be used with caution in: patients with confusional or hallucinatory states or underlying psychiatric disorders patients with liver or kidney disorders patients suffering from, or who have ...

Interaction with other medicinal products and other forms of interaction

Anticholinergic agents or levodopa Concurrent administration may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects (see section 4.9 Overdose ...

Fertility, pregnancy and lactation

Pregnancy Amantadine-related complications during pregnancy have been reported. Trilasym is contraindicated during pregnancy and in women trying to become pregnant. Breastfeeding Trilasym is excreted in ...

Effects on ability to drive and use machines

Patients should be warned of the potential hazards of driving or operating machinery if they experience side effects such as dizziness or blurred vision.

Undesirable effects

Amantadines undesirable effects are often mild and transient, usually appearing within the first 2 to 4 days of treatment and promptly disappearing 24 to 48 hours after discontinuation. A direct relationship ...

Overdose

Overdose with amantadine can lead to a fatal outcome. Signs and symptoms Neuromuscular: disturbances and symptoms of acute psychosis are prominent. Central nervous system: hyperreflexia, motor restlessness, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antiparkinsonian agent and anti-influenzal virostatic ATC code: N04BB01 Mechanism of action Influenza Trilasym specifically inhibits the replication of influenza A viruses at ...

Pharmacokinetic properties

Absorption Trilasym is absorbed slowly but almost completely. Peak plasma concentrations of approximately 250 ng/ml and 500 ng/ml are seen 3 to 4 hours after single oral administration of 100 mg and 200 ...

Preclinical safety data

Reproductive toxicity studies were performed in rats and rabbits. In rat, oral doses of 50 and 100 mg/kg proved to be teratogenic. This is 33-fold the recommended dose of 100 mg for influenza. The maximum ...

List of excipients

Sodium benzoate (E211) Sorbitol (E420) Raspberry flavour containing ethanol, propylene glycol (E1520) and benzyl alcohol Citric acid monohydrate Purified Water

Incompatibilities

None known.

Shelf life

Shelf life: 24 months. After first opening the bottle: 1 month.

Special precautions for storage

Store below 25°C. Store in the original bottle, in order to protect from light.

Nature and contents of container

Type III amber glass bottle with a tamper evident polypropylene child-resistant screw cap with a polyethylene inner liner containing 150ml of solution with a polypropylene dosing cup. Pack size: 150 ml. ...

Special precautions for disposal and other handling

The box containing this medicine contains a plastic measuring cup. The cup is marked in ml (millilitres) to help measuring out the correct amount. This medicine should be taken using the measuring cup ...

Marketing authorization holder

Fontus Health Ltd, 60 Lichfield Street, Walsall, WS4 2BX, United Kingdom

Marketing authorization number(s)

PL 42924/0020

Date of first authorization / renewal of the authorization

03/05/2019

Date of revision of the text

16/09/2019

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