ZOMIG Nasal spray (2018)
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Περιεχόμενα
Name of the medicinal product
Zomig 5 mg Nasal Spray.
Qualitative and quantitative composition
Zomig Nasal Spray is an aqueous solution containing 50 mg/ml zolmitriptan, buffered to pH 5.0. The device delivers a unit dose of 5 mg and is intended for a single use only. For the full list of excipients, ...
Pharmaceutical form
Nasal Spray.
Therapeutic indications
Zomig Nasal Spray is indicated for the acute treatment of migraine with or without aura.
Posology and method of administration
Posology The recommended dose of Zomig Nasal Spray to treat a migraine attack is 5 mg. Zomig Nasal Spray is administered as a single dose into one nostril. Zomig Nasal Spray provides particularly rapid ...
Contraindications
Zomig Nasal Spray is contraindicated in patients with: Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 Uncontrolled hypertension Ischaemic heart disease Coronary ...
Special warnings and precautions for use
Zomig Nasal Spray should only be used where a clear diagnosis of migraine has been established. Care should be taken to exclude other potentially serious neurological conditions. There are no data on the ...
Interaction with other medicinal products and other forms of interaction
From studies using oral zolmitriptan tablets, there is no evidence that concomitant use of migraine prophylactic medications has any effect on the efficacy or unwanted effects of Zomig Nasal Spray (for ...
Fertility, pregnancy and lactation
Pregnancy Zomig Nasal Spray should be used in pregnancy only if the benefits to the mother justify potential risk to the foetus. There are no studies in pregnant women, but there is no evidence of teratogenicity ...
Effects on ability to drive and use machines
There was no significant impairment of performance of psychomotor tests with doses up to 20 mg oral Zomig. Zomig Nasal Spray has no or negligible influence on the ability to drive and use machines. However ...
Undesirable effects
Summary of the safety profile Zomig is well tolerated. Adverse reactions are typically mild/moderate, transient, not serious and resolve spontaneously without additional treatment. Possible adverse reactions ...
Overdose
Symptoms There has been no experience of overdose with zolmitriptan nasal spray. Volunteers receiving single oral doses of 50 mg commonly experienced sedation. Management The elimination half-life of zolmitriptan ...
Pharmacodynamic properties
Pharmacotherapeutic group: Selective serotonin (5HT<sub>1</sub>) agonists ATC code: N02CC03 Mechanism of action In pre-clinical studies, zolmitriptan has been demonstrated to be a selective agonist for ...
Pharmacokinetic properties
Zolmitriptan, following intranasal administration, is rapidly absorbed with detectable levels in the plasma within 5 minutes of dosing. A proportion of the dose seems to be directly absorbed in the naso-pharynx. ...
Preclinical safety data
An oral teratology study of Zomig has been conducted. At the maximum tolerated doses of Zomig, 1200 mg/kg/day (AUC 605 μg/ml.h: approx. 3700 x AUC of the human maximum recommended daily intake of 15 mg) ...
List of excipients
Each Zomig Nasal Spray vial contains the following excipients: Citric acid Disodium phosphate Purified Water
Incompatibilities
Not applicable.
Shelf life
Shelf life: 30 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Ph Eur Type I glass vials which are closed with chlorobutyl rubber stoppers. The vials are assembled into a unit dose nasal spray device, comprising of a vial holder, an actuation device and a protection ...
Special precautions for disposal and other handling
The protection cover must not be removed until immediately before use. For instructions for use see the patient information leaflet. Any unused medicinal product or waste material should be disposed of ...
Marketing authorization holder
Grünenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex, UB11 1BD, UK
Marketing authorization number(s)
PL 21727/0085
Date of first authorization / renewal of the authorization
Date of first authorisation: 19th September 2002 Date of latest renewal: 18th June 2008
Date of revision of the text
18<sup>th</sup> September 2018
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