Summary of Product Characteristics (SmPC) - Saline 2.5 ml Steripoules
1. NAME OF THE MEDICINAL PRODUCT
Saline Steripoules 2.5ml.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride 0.9%.
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Nebuliser Solution (2.5ml).
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Saline Steripoules 2.5ml is indicated for the dilution of solutions for nebulisation in adults, the elderly, and children.
4.2 Posology and method of administration
Posology
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.
4.3 Contraindications
Hypersensitivity to the active substance or to the excipient listed in section 6.1.
The solution should not be injected or administered orally.
4.4 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 doctor.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
Pregnancy
As with all medication, particular caution must be exercised during the first trimester of pregnancy.
4.7 Effects on ability to drive and use machines
Saline Steripoules has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
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.
4.9 Overdose
Substantial oral ingestion may require the use of a diuretic to remove excess sodium.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmcotherapeutic group: electrolyte solution, ATC code: B05XA03.
Not applicable.
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
24 months.
6.4 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.
6.5 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 Steripoules.
6.6 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.
- 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.
7 MARKETING AUTHORISATION HOLDER
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 27827/0020
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
04/10/2004
10 DATE OF REVISION OF THE TEXT
17/11/2017