SIALANAR Oral solution (2024)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Sialanar 320 micrograms/ml oral solution.
2. Qualitative and quantitative composition
Each ml contains 400 micrograms of glycopyrronium bromide equivalent to 320 micrograms of glycopyrronium. <u>Excipient(s) with known effect:</u> Each ml contains 2.3 mg sodium benzoate (E211). For the ...
3. Pharmaceutical form
Oral solution. Clear, colourless solution.
4.1. Therapeutic indications
Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.
4.2. Posology and method of administration
Sialanar should be prescribed by physicians experienced in the treatment of paediatric patients with neurological disorders. Posology Due to the lack of long term safety data, Sialanar is recommended for ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy and breast-feeding. Glaucoma. Urinary retention. Severe renal impairment (eGFR <30 ml/min/1.73m²), ...
4.4. Special warnings and precautions for use
Anticholinergic effects Anticholinergic effects such as urinary retention, constipation and overheating due to inhibition of sweating may be dose dependent and difficult to assess in a disabled child. ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Paediatric population There are limited data available relating to interactions with other medicinal products in the paediatric age group. The following medicinal ...
4.6. Fertility, pregnancy and lactation
Women of child-bearing potential Effective contraception should be considered prior to treating women of childbearing age, where appropriate. Pregnancy There are no data on the use of Sialanar in pregnant ...
4.7. Effects on ability to drive and use machines
Sialanar has moderate influence on the ability to drive and use machines. The anticholinergic effects of glycopyrronium may cause blurred vision, dizziness and other effects that may impair a patients ...
4.8. Undesirable effects
Summary of the safety profile Adverse reactions are common with glycopyrronium due to its known pharmacodynamic anticholinergic effects. The most common adverse reactions are dry mouth (11%), constipation ...
4.9. Overdose
Symptoms Overdose of glycopyrronium can result in anticholinergic syndrome, produced by the inhibition of cholinergic neurotransmission at muscarinic receptor sites. Clinical manifestations are caused ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Medicinal products for functional gastrointestinal disorders, synthetic anticholinergics, quaternary ammonium compounds <b>ATC Code:</b> A03AB02 Mechanism of action Glycopyrronium ...
5.2. Pharmacokinetic properties
Absorption Mean absolute oral bioavailability of glycopyrronium comparing a single 50 μg/kg oral dose and a single 5 μg/kg intravenous dose was low at approximately 3% (range 1.3–13.3%) in children aged ...
5.3. Preclinical safety data
Non-clinical data, including genotoxicity or carcinogenicity studies have not been performed for Sialanar. Limited non-clinical data reveal no special hazard for humans based on conventional studies of ...
6.1. List of excipients
Sodium benzoate (E211) Raspberry flavouring (containing propylene glycol E1520) Sucralose (E955) Citric acid (E330) Purified water
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
3 years. 2 months after first opening.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Amber coloured glass bottle with a high density polyethylene tamper evident child resistant closure with expanded low density polyethylene liner. The bottle contains 60 ml or 250 ml of oral solution. ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Proveca Pharma Limited, 2 Dublin Landings, North Wall Quay, Dublin 1, Ireland
8. Marketing authorization number(s)
EU/1/16/1135/001 (250 ml bottle) EU/1/16/1135/002 (60 ml bottle)
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 15 September 2016 Date of latest renewal: 17 June 2021
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