ALOXI Solution for injection (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Aloxi 250 micrograms solution for injection.
Qualitative and quantitative composition
Each ml of solution contains 50 micrograms palonosetron (as hydrochloride). Each vial of 5 ml of solution contains 250 micrograms palonosetron (as hydrochloride). For the full list of excipients, see section ...
Pharmaceutical form
Solution for injection. Clear, colourless solution.
Therapeutic indications
Aloxi is indicated in adults for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, the prevention of nausea and vomiting associated with moderately emetogenic ...
Posology and method of administration
Aloxi should be used only before chemotherapy administration. This medicinal product should be administered by a healthcare professional under appropriate medical supervision. Posology Adults 250 micrograms ...
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 in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to Aloxi, were headache (9%) and constipation (5%). ...
Overdose
No case of overdose has been reported. Doses of up to 6 mg have been used in adult clinical studies. The highest dose group showed a similar incidence of adverse reactions compared to the other dose groups ...
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 intravenous administration, an initial decline in plasma concentrations is followed by slow elimination from the body with a mean terminal elimination half-life of approximately 40 ...
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
Mannitol Disodium edetate Sodium citrate Citric acid monohydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products.
Shelf life
5 years. Upon opening of the vial, use immediately and discard any unused solution.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Type I glass vial with chlorobutyl siliconised rubber stopper and aluminium cap. Available in packs of 1 vial containing 5 ml of solution.
Special precautions for disposal and other handling
Single use only, any unused solution should be discarded. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, Ireland
Marketing authorization number(s)
EU/1/04/306/001
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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