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SPC, UK: ONDANSETRON Solution for injection or infusion (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Ondansetron 2 mg/ml Solution for Injection or Infusion.

Qualitative and quantitative composition

Each ml of solution for injection or infusion contains 2mg ondansetron (as ondansetron hydrochloride dihydrate). Each ampoule with 2ml contains 4mg ondansetron (as ondansetron hydrochloride dihydrate). ...

Pharmaceutical form

Solution for Injection or Infusion. Clear colourless solution.

Therapeutic indications

Adults Management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, Prevention and treatment of post-operative nausea and vomiting (PONV). Paediatric Population Management of chemotherapy-induced ...

Posology and method of administration

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

Contraindications

Concomitant use with apomorphine (see section 4.5) Hypersensitivity to any component of the preparation.

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

In psychomotor testing ondansetron does not impair performance nor cause sedation. No detrimental effects on such activities are predicted from the pharmacology of ondansetron.

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 to <1/100), rare (≥1/10,000 and <1/1000) ...

Overdose

Symptoms and Signs 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). ...

Pharmacodynamic properties

ATC code: A04 Antiemetics and antinauseants ATC group: A04AAO1 Serotonin (5HT<sub>3</sub>) antagonist Mechanism of Action Ondansetron is a potent, highly selective 5HT<sub>3</sub> receptor-antagonist. ...

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

Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity and carcinogenic potential. Ondansetron and its metabolites ...

List of excipients

Citric acid monohydrate Sodium citrate Sodium chloride Sodium hydroxide (for pH adjustment) Hydrochloric acid, concentrated (for pH adjustment) Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

Shelf life Unopened: 3 years. Injection: After first opening the medicinal product should be used immediately. Infusion: Chemical and physical in-use stability has been demonstrated for 7 days at 25°C ...

Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Keep ampoules in the outer carton in order to protect from light. For storage conditions of the diluted medicinal product, ...

Nature and contents of container

Type I clear glass ampoules/ amber glass ampoules. 2 ml: Pack sizes: Carton containing 10 ampoules. Carton containing 5 ampoules. 4 ml: Pack sizes: Carton containing 10 ampoules. Carton containing 5 ampoules. ...

Special precautions for disposal and other handling

The solution must not be sterilised in an autoclave. Ondansetron Injection should only be admixed with those infusion solutions which are recommended: Sodium Chloride Intravenous Infusion BP 0.9%w/v Glucose ...

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization number(s)

PL 20075/0082

Date of first authorization / renewal of the authorization

11/12/2009

Date of revision of the text

26/03/2018

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