SALINE 2.5ML STERIPOULES
Active substance(s): SODIUM CHLORIDE
NAME OF THE MEDICINAL PRODUCT
Saline Steripoules 2.5ml.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Posology and method of administration
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
Hypersensitivity to the active substance or to the excipient listed in section 6.1.
The solution should not be injected or administered orally.
Special warnings and precautions for use
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
Interaction with other medicinal products and other forms of interaction
Fertility, pregnancy and lactation
As with all medication, particular caution must be exercised during the first trimester of
Effects on ability to drive and use machines
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.
Preclinical safety data
List of excipients
Water for Injections.
Special precautions for storage
Do not store above 25ºC; Store in the original packaging in order to protect from light.
Discard any remaining solution immediately after use.
Nature and contents of container
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
Special precautions for disposal and other handling
Use Saline Steripoules 2.5ml for dilution of solutions for nebulisation. The contents
should be used immediately after opening.
Prepare the nebuliser for filling as recommended by the manufacturer.
Empty the solution to be diluted into the nebuliser following the manufacturer’s
Remove a Steripoule from the plastic strip, hold upright and open by twisting off
Squeeze the prescribed amount of solution from the opened Steripoule into the
reservoir of the nebuliser.
Assemble the nebuliser and use it as directed by the manufacturer.
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
MARKETING AUTHORISATION HOLDER
Seagoe Industrial Estate
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
4th October 2004
DATE OF REVISION OF THE TEXT