Saline Nebulir Solution (Sodium Chloride 0.9% w/v) (Arrow)
Summary of Product Characteristics Updated 24-Aug-2017 | Actavis UK Ltd
1. Name of the medicinal product
Saline Nebulir Solution
(Sodium Chloride 0.9% w/v)
2. Qualitative and quantitative composition
Each 1 ml of solution contains 9 mg of Sodium Chloride
For a full list of excipients e ction 6.1
3. Pharmaceutical form
Solution for nebulisation
Clear, colourless solution in a clear, plastic single do ampoule
4. Clinical particulars
4.1 Therapeutic indications
For dilution of solutions for nebulisation.
4.2 Posology and method of administration
Adults, children and elderly: u as directed by the physician.
Saline Nebulir Solution is only to be ud as a diluent for diluting products for nebulisation and should not be ud on its own. It should not be taken orally or administered parenterally.
Each ampoule contains 2.5 ml of solution.
Refer to the patient information leaflet of the nebulid product to be diluted that your physician has prescribed you for detailed instructions on u of this solution as a diluent. T o ensure accurate dosing it is recommended that a dosing syringe is ud if necessary.
Method of Administration: By inhalation from a suitable nebulir or an intermittent positive pressure
ventilator after the single do ampoule has been opened and its contents transferred to the nebulir chamber. Administration should be in accordance with the manufacturer's instructions for the device.
儿童青少年1. Prepare the nebulir by following the manufacturer's instructions and the advice of your doctor.
2. The nebulid product to be diluted should be introduced into the nebulir chamber as instructed in the appropriate
patient information leaflet.
3. Carefully parate a new saline ampoule from the strip. Never u an ampoule that has been opened already.
3. Open the ampoule by simply twisting off the top, always taking care to hold it in an upright position.
4. Squeeze the contents of the plastic ampoule or u a dosing syringe as required into the nebulir chamber and swirl
gently to mix.
5. Asmble the nebulir and u it as directed by your doctor.
6. After nebulisation, clean the nebulir according to the manufacturer's instructions. It is important that the nebulir is
kept clean.
As the single do units contain no prervatives it is important that the contents are ud immediately after opening and a fresh ampoule is ud for each administration to avoid microbial contamination. Partly ud, opened or damaged single do units should be discarded.
Any solution remaining in the nebulir chamber should be discarded.
4.3 Contraindications
The solution should not be administered orally or parenterally.
4.4 Special warnings and precautions for u
Do not u unless the product is clear and the pack intact. Discard any surplus after u. Saline Neb
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ulir Solution should be ud with a nebulir, only under the direction of a physician. Patients using nebulir 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
Not known.
4.6 Pregnancy and lactation
As with most medicines, consult your doctor first if you are pregnant or breastfeeding.
4.7 Effects on ability to drive and u machines
Not known.
4.8 Undesirable effects
Saline Nebulir Solution is not expected to cau any undesirable effects in normal u.
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Reporting of suspected adver reactions
Reporting suspected adver 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 adver reactions via the Yellow Card Scheme; website: v.uk/yellowcard
4.9 Overdo
Substantial oral ingestion may require the u of a diuretic to remove excess sodium.
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5. Pharmacological properties
5.1 Pharmacodynamic properties
Isotonic (0.9% w/v) sodium chloride solution is widely ud for dilution purpos.
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
There are no findings of relevance to the prescriber other than tho already mentioned elwhere in the SPC. Plea refer to the product to be reconstituted.
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6. Pharmaceutical particulars
6.1 List of excipients
Water for Injections
调理月经吃什么药最好6.2 Incompatibilities
Not applicable
6.3 Shelf life
24 months
Ampoules removed from the foil overwrap should be ud within 90 days.
U immediately after first opening of the ampoule. Discard any unud contents.
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 do blow moulded hermetically aled low density polyethylene ampoule containing 2.5 ml of solution. Strips of
ten ampoules are overwrapped in an aluminium laminate foil pack. Saline Nebulir Solution is available in boxes containing 20, 60 or 100 ampoules.
6.6 Special precautions for disposal and other handling
No special requirements.
7. Marketing authorisation holder
Breath Limited
Address
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Actavis UK Ltd, a subsidiary of Accord Healthcare Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
Telephone
+44 (0)1271 385 200
Medical Information Direct Line
+44 (0)1271 385 257WWW
uk
Fax
+44 (0)1271 346 106
Medical Information e-mail
Whiddon Valley
Barnstaple
North Devon
EX32 8NS
United Kingdom
8. Marketing authorisation number(s)
PL 18023/0006
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 23rd October 2009
Date of latest renewal: 14th September 2014
10. Date of revision of the text
30th March 2015
Company Contact Details
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Actavis UK Ltd
