ZOFRAN Suppositories (2017)
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Περιεχόμενα
Name of the medicinal product
Zofran Suppositories 16 mg.
Qualitative and quantitative composition
Each suppository contains 16 mg of ondansetron.
Pharmaceutical form
White torpedo shaped suppositories.
Therapeutic indications
Adults Zofran Suppositories are indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.
Posology and method of administration
Adults The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by ...
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 interactions when ondansetron ...
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 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <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
Mechanism of Action Ondansetron is a potent, highly selective 5HT<sub>3</sub> receptor-antagonist. The precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents ...
Pharmacokinetic properties
Following oral administration, ondansetron is passively and completely absorbed from the gastrointestinal tract and undergoes first pass metabolism. Peak plasma concentrations of about 30 ng/mL are attained ...
Preclinical safety data
No additional data of relevance.
List of excipients
Witepsol S58.
Incompatibilities
None reported.
Shelf life
3 years.
Special precautions for storage
Store below 30°C.
Nature and contents of container
Each suppository is in an individually sealed cavity enclosed in a perforated cardboard mount and packed into a carton.
Special precautions for disposal and other handling
Insert into the rectum. For detailed instructions see the patient information leaflet included in every pack.
Marketing authorization holder
Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Marketing authorization number(s)
PL 00101/0979
Date of first authorization / renewal of the authorization
Date of first authorisation: 16 January 1997 Date of latest renewal: 15 January 2002
Date of revision of the text
30 January 2017
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