Summary of Product Characteristics Updated 22-Nov-2017 | Galen Limited
Saline Steripoules 2.5ml.
Sodium Chloride 0.9%.
For a full list of excipients, see Section 6.1.
Nebuliser Solution (2.5ml).
Saline Steripoules 2.5ml is indicated for the dilution of solutions for nebulisation in adults, the elderly, and children.
As directed by the physician.
Method of Administration:
By inhalation from a suitable nebuliser.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Hypersensitivity to the active substance or to the excipient listed in section 6.1.
The solution should not be injected or administered orally.
Do not use unless the product is clear and the pack intact. Discard any surplus after use.
Saline Steripoules 2.5ml should be used with a nebuliser, only under the direction of a physician. Patients using nebuliser solutions at home should be warned that if the usual relief is diminished or the usual duration of action reduced, they should consult their doctor.
As with all medication, particular caution must be exercised during the first trimester of pregnancy.
Saline Steripoules has no or negligible influence on the ability to drive and use machines.
Saline Steripoules are not expected to cause any undesirable effects in normal use.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Substantial oral ingestion may require the use of a diuretic to remove excess sodium.
Pharmcotherapeutic group: electrolyte solution, ATC code: B05XA03.
Water for Injections.
Do not store above 25°C; Store in the original packaging in order to protect from light. Discard any remaining solution immediately after use.
Strips of 10 LDPE plastic ampoules (Steripoules) wrapped in an aluminium foil bag, each Steripoule containing 2.5ml of a clear, colourless solution. Cartons containing 20 Steripoules.
Use Saline Steripoules 2.5ml for dilution of solutions for nebulisation. The contents should be used immediately after opening.
1. Prepare the nebuliser for filling as recommended by the manufacturer.
2. Empty the solution to be diluted into the nebuliser following the manufacturer's instructions.
3. Remove a Steripoule from the plastic strip, hold upright and open by twisting off the cap.
4. Squeeze the prescribed amount of solution from the opened Steripoule into the reservoir of the nebuliser.
5. Assemble the nebuliser and use it as directed by the manufacturer.
6. After use discard any solution left in the reservoir and clean the nebuliser following the manufacturer's instructions.
Use only as directed by the physician.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Seagoe Industrial Estate
Date of first authorisation: 13 November 1998.
Date of latest renewal: 28 March 2010
17 November 2017.