Summary of Product Characteristics (SmPC) - Saline Steri-neb 0.9% w/v
1 NAME OF THE MEDICINAL PRODUCT
Saline Steri-Neb 0.9% w/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 0.9% w/v solution of sodium chloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for nebulisation
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For dilution of solutions for nebulisation.
4.2 Posology and method of administration
Posology
Adults, children and elderly: use as directed by the physician.
Method of administration
By inhalation from a suitable nebuliser.
For instructions on dilution of the medicinal product before administration, see section 6.6.
4.3 Contraindications
Not applicable.
4.4 Special warnings and precautions for use
Not applicable.
4.5 Interaction with other medicinal products and other forms of interaction
Not applicable.
4.6 Fertility, pregnancy and lactation
Not applicable.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Not applicable.
4.9. Overdose
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Isotonic (0.9% w/v) sodium chloride solution is widely used for dilution purposes.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for injections
6.2. Incompatibilities
Not applicable
6.3 Shelf life
2 years
6.4 Special precautions for storage
Do not store above 25°C.
Do not refrigerate or freeze.
6.5 Nature and contents of container
A unit dose blow moulded hermetically sealed 3ml ampoule containing 2.5 ml of a clear, colourless to light yellow aqueous solution. Strips of 5 Steri-Nebs are packed into foil laminate pouches, which in turn are packed into boxes containing 20 and 100 (Steri-Nebs).
6.6 Special precautions for disposal and other handling
Saline Steri-Neb is for the dilution of solutions for nebulisation.
Only use Saline Steri-Neb in a nebuliser. Do not swallow the solution or use it in injections.
- Prepare the nebuliser for use according to the manufacturer’s instructions
- Empty the solution that needs diluting into the nebuliser following the manufacturer’s instructions
- Remove a Steri-Neb from the labelled strip by twisting and pulling
- Hold the Steri-Neb upright and twist off the cap
- Squeeze the contents into the reservoir of the nebuliser.
- Following the manufacturer’s instructions, use the nebuliser
- After using the nebuliser, throw away any solution that is left in the reservoir
- Clean the nebuliser thoroughly
- Discard any unused portion of Saline Steri-Neb.
7 MARKETING AUTHORISATION HOLDER
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK Ridings Point
Whistler Drive
Castleford
West Yorkshire
WF10 5HX
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00530/0691
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1 January 2004
10 DATE OF REVISION OF THE TEXT
08/06/2021