ALOXI Soft capsule (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Aloxi 500 micrograms soft capsules.
Qualitative and quantitative composition
Each capsule contains 500 micrograms palonosetron (as hydrochloride). Excipient(s): Each capsule contains 7 mg sorbitol. For the full list of excipients, see section 6.1.
Pharmaceutical form
Soft capsule. Plain, light beige, opaque, round to oval, soft gelatine capsules, filled with a clear yellowish solution.
Therapeutic indications
Aloxi is indicated in adults for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Posology and method of administration
Aloxi should be used only before chemotherapy administration. Posology Adults 500 micrograms palonosetron administered orally approximately one hour before the start of chemotherapy. Elderly population ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
As palonosetron may increase large bowel transit time, patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration. Two cases of constipation ...
Interaction with other medicinal products and other forms of interaction
Palonosetron is mainly metabolised by CYP2D6, with minor contribution by CYP3A4 and CYP1A2 isoenzymes. Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically ...
Fertility, pregnancy and lactation
Pregnancy For palonosetron, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Since palonosetron may induce dizziness, somnolence or fatigue, patients should be cautioned when driving or operating ...
Undesirable effects
In clinical studies at a dose of 500 micrograms (total 161 patients) the most frequently observed adverse reaction, at least possibly related to Aloxi, was headache (3.7%). In the clinical studies the ...
Overdose
No case of overdose has been reported. Doses of up to 6 mg have been used in clinical trials. The highest dose group showed a similar incidence of adverse reactions compared to the other dose groups and ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiemetics and antinauseants, Serotonin (5HT<sub>3</sub>) antagonists ATC code: A04AA05 Palonosetron is a selective high-affinity receptor antagonist of the 5HT<sub>3</sub> ...
Pharmacokinetic properties
Absorption Following oral administration, palonosetron is well absorbed with its absolute bioavailability reaching 97%. After single oral doses using buffered solution mean maximum palonosetron concentrations ...
Preclinical safety data
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. Non-clinical studies indicate ...
List of excipients
<u>Capsule content:</u> Glycerol monocaprylocaproate (type I) Polyglycerol oleate Glycerol Purified water Butylhydroxyanisole <u>Capsule shell:</u> Gelatin Sorbitol Glycerol Titanium dioxide
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Polyamide/aluminium/PVC blister containing one or five soft capsules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Helsinn Birex Pharmaceuticals Limited, Damastown, Mulhuddart, Dublin 15, Ireland
Marketing authorization number(s)
EU/1/04/306/003 EU/1/04/306/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 22 March 2005 Date of latest renewal: 23 March 2010
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