MOVENTIG Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Moventig 12.5 mg film-coated tablets. Moventig 25 mg film-coated tablets.
Qualitative and quantitative composition
Moventig 12.5 mg film-coated tablets: Each film-coated tablet contains naloxegol oxalate equivalent to 12.5 mg naloxegol. Moventig 25 mg film-coated tablets: Each film-coated tablet contains naloxegol ...
Pharmaceutical form
Moventig 12.5 mg film-coated tablet (tablet): Oval, 10.5x5.5 mm, mauve tablet. Moventig 25 mg film-coated tablet (tablet): Oval, 13x7 mm, mauve tablet. Tablets are engraved with nGL on one side and the ...
Therapeutic indications
Moventig is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s). For definition of inadequate response to laxative(s), ...
Posology and method of administration
Posology The recommended dose of Moventig is 25 mg once daily. When naloxegol therapy is initiated, it is recommended that all currently used maintenance laxative therapy should be halted, until clinical ...
Contraindications
Hypersensitivity Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or any other opioid antagonist. Gastrointestinal obstruction Patients with known or suspected ...
Special warnings and precautions for use
Conditions with increased potential for gastrointestinal perforation Cases of gastrointestinal perforation have been reported in the post-marketing setting, including fatal cases when naloxegol was used ...
Interaction with other medicinal products and other forms of interaction
Interaction with CYP3A4 inhibitors and inducers Interaction with strong CYP3A4 inhibitors In an open-label, non-randomized, fixed-sequence, 3-period, 3-treatment, crossover study to evaluate the effect ...
Fertility, pregnancy and lactation
Pregnancy There are limited data from the use of naloxegol in pregnant women. Studies in animals have shown reproductive toxicity where systemic exposures were several times above the therapeutic exposure ...
Effects on ability to drive and use machines
Moventig has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile In the pooled data from clinical trials the most commonly reported adverse reactions with naloxegol (≥5%) are: abdominal pain, diarrhoea, nausea, headache and flatulence. ...
Overdose
Doses of naloxegol up to 1,000 mg were administered in healthy volunteers in clinical studies. A potential CNS effect (reversal of opioid-induced miosis, as measured by pupillometry) was observed in 1 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for constipation, peripheral opioid receptor antagonists ATC code: A06AH03 Mechanism of action and pharmacodynamic effects Naloxegol is a PEGylated derivative of the mu-opioid ...
Pharmacokinetic properties
Absorption Following oral administration, naloxegol is absorbed rapidly, with peak concentrations (C<sub>max</sub>) achieved at less than 2 hours. In a majority of subjects, a secondary plasma concentration ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and fertility. Embryo-foetal development studies were conducted ...
List of excipients
Tablet core: Mannitol (E421) Cellulose microcrystalline (E460) Croscarmellose sodium (E468) Magnesium stearate (E470b) Propyl gallate (E310) Tablet coat: Hypromellose (E464) Titanium dioxide (E171) Macrogol ...
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
Alu/alu blister. 12.5 mg film-coated tablets: Pack sizes of 30 and 90 film-coated tablets in non-perforated blisters. Pack sizes of 30 1 and 90 1 film-coated tablets in perforated unit dose blisters. ...
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. The mixture can also be administered via a nasogastric ...
Marketing authorization holder
Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP, Hoofddorp, The Netherlands
Marketing authorization number(s)
EU/1/14/962/001 EU/1/14/962/002 EU/1/14/962/003 EU/1/14/962/004 EU/1/14/962/005 EU/1/14/962/006 EU/1/14/962/007 EU/1/14/962/008 EU/1/14/962/009 EU/1/14/962/010 EU/1/14/962/011
Date of first authorization / renewal of the authorization
Date of first authorisation: 8 December 2014 Date of latest renewal: 23 September 2019
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