This information is intended for use by health professionals

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 25°C; 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

Date of first authorisation: 13 November 1998.

Date of latest renewal: 28 March 2010

10. Date of revision of the text

17 November 2017.