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SPC, UK: ONDANSETRON Syrup (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Ondansetron 4mg/5ml Syrup.

Qualitative and quantitative composition

Each 5ml contains 4mg of ondansetron as the hydrochloride dihydrate. Excipients with known effects: Ethanol (less than 3mg/dose) and sodium (less than 1mmol of per dose). For the full list of excipients, ...

Pharmaceutical form

Syrup. Clear strawberry flavoured liquid.

Therapeutic indications

Adults The management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention of post-operative nausea and vomiting in adults. Paediatric Population Ondansetron ...

Posology and method of administration

Posology Chemotherapy and radiotherapy induced nausea and vomiting (CINV) Adults The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant use with apomorphine (see section 4.5).

Special warnings and precautions for use

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5HT<sub>3</sub> receptor antagonists. Respiratory events should be treated symptomatically ...

Interaction with other medicinal products and other forms of interaction

There is no evidence that ondansetron either induces or inhibits the metabolism of other drugs commonly co-administered with it. Specific studies have shown that there are no pharmacokinetic interactions ...

Fertility, pregnancy and lactation

Pregnancy The safety of ondansetron for use in human pregnancy has not been established. Evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the ...

Effects on ability to drive and use machines

Ondansetron has no or negligible influence on the ability to drive and use machines. In psychomotor testing ondansetron does not impair performance nor cause sedation. No detrimental effects on such activities ...

Undesirable effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) ...

Overdose

Symptoms There is limited experience of ondansetron overdose. In the majority of cases, symptoms were similar to those already reported in patients receiving recommended doses (see section 4.8). Manifestations ...

Pharmacodynamic properties

Pharmacotherapeutic group: Serotonin (5HT<sub>3</sub>) antagonists ATC code: A04AA Mechanism of action Ondansetron is a potent, highly selective 5HT<sub>3</sub> receptor-antagonist. Its precise mode of ...

Pharmacokinetic properties

Absorption Following oral administration, ondansetron is passively and completely absorbed from the gastrointestinal tract and undergoes first pass metabolism. Peak plasma concentrations of about 30ng/ml ...

Preclinical safety data

No additional data of relevance.

List of excipients

Citric acid anhydrous Sodium citrate dihydrate Sodium benzoate (E211) Xylitol (E967) Strawberry flavour (contains propylene glycol and ethanol) Purified water

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years unopened. Once opened, use within 28 days.

Special precautions for storage

No special requirements.

Nature and contents of container

A type III amber glass bottle with a tamper evident aluminium cap with an EPE liner, or a child resistant polypropylene cap with an EPE liner, containing 50ml.

Special precautions for disposal and other handling

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Focus Pharmaceuticals Ltd, Capital House, 1<sup>st</sup> Floor, 85 King William Street, London EC4N 7BL, United Kingdom

Marketing authorization number(s)

PL 20046/0036

Date of first authorization / renewal of the authorization

13/09/2011

Date of revision of the text

09/04/2019

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