About Sialanar® (320mcg/ml glycopyrronium equivalent to 400mcg/ml glycopyrronium bromide) and Prescribing Information
Sialanar® received a European Paediatric Use Marketing Authorisation (PUMA) on 15th September 2016 for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.
NICE published its latest evidence summary on “Severe sialorrhoea (drooling) in children and young people with chronic neurological disorders: oral glycopyrronium bromide” in February 2017
Summary of Product Characteristics (UK)
Healthcare Educational Materials (UK)
Prescribing Information (Ireland)
Summary of Product Characteristics (Ireland)
NICE Evidence Summary
https://www.nice.org.uk/advice/es5/chapter/Key-points
Benefits of Sialanar®
The illustrations below do not represent the colour of Sialanar® or other glycopyrronium solutions
Product | Sialanar® |
---|---|
Mode of action | anticholinergic |
Composition | 320mcg/ml glycopyrronium equivalent to 400mcg/ml glycopyrronium bromide |
Pack Sizes | 250ml or 60ml amber glass bottle (includes one 8 ml low density polyethylene oral syringe and one syringe adaptor) |
Appearance | Clear and colourless |
Flavour | Raspberry |
Viscosity | Aqueous solution |
Sweetener | Sucralose (E955) |
Lactose-free | Yes |
Carbohydrate | <5mg/ml |
Gluten-free | Yes |
Storage conditions | Do not store above 25°C |
Suitable for feeding tubes | Yes – suitable for GJ, PEG and Nasogastric |
Sodium Free | Yes |
Sortbitol Free | Yes |
Fructose free | Yes |
Aspartame Free | Yes |
Tartrazine Free | Yes |
Shelf Life unopened | 3 years |
Shelf life once opened | 2 months |
Please see information below to report adverse events in the UK
Please see information below to report adverse events in the Republic of Ireland
Please refer to SMPC for dosing information.
UK-SIA-23-0039
Updated March 2023