10% Sodium Chloride Kobayashi

Components:
Sodium Chloride
Sodium Chloride
Method of action:
Anesthetic, Detoxifying, Moisturizing Nasal Mucosa, Osmotherapy Agent, Rinsing, Sodium Supplement
Anesthetic, Detoxifying, Moisturizing Nasal Mucosa, Osmotherapy Agent, Rinsing, Sodium Supplement
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Name of the medicinal product

10% Sodium Chloride Kobayashi

Qualitative and quantitative composition

Sodium Chloride

Therapeutic indications

The information provided in Therapeutic indications of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
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For dilution of solutions for nebulisation.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
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Adults, children and elderly: use as directed by the physician.

10% Sodium Chloride Kobayashi is only to be used as a diluent for diluting products for nebulisation and should not be used 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 nebulised product to be diluted that your physician has prescribed you for detailed instructions on use of this solution as a diluent. To ensure accurate dosing it is recommended that a dosing syringe is used if necessary.

Method of Administration: By inhalation from a suitable nebuliser or an intermittent positive pressure ventilator after the single dose ampoule has been opened and its contents transferred to the nebuliser chamber. Administration should be in accordance with the manufacturer's instructions for the device.

1. Prepare the nebuliser by following the manufacturer's instructions and the advice of your doctor.

2. The nebulised product to be diluted should be introduced into the nebuliser chamber as instructed in the appropriate patient information leaflet.

3. Carefully separate a new saline ampoule from the strip. Never use 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 use a dosing syringe as required into the nebuliser chamber and swirl gently to mix.

5. Assemble the nebuliser and use it as directed by your doctor.

6. After nebulisation, clean the nebuliser according to the manufacturer's instructions. It is important that the nebuliser is kept clean.

As the single dose units contain no preservatives it is important that the contents are used immediately after opening and a fresh ampoule is used for each administration to avoid microbial contamination. Partly used, opened or damaged single dose units should be discarded.

Any solution remaining in the nebuliser chamber should be discarded.

Contraindications

The information provided in Contraindications of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
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The solution should not be administered orally or parenterally.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
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Do not use unless the product is clear and the pack intact. Discard any surplus after use. 10% Sodium Chloride Kobayashi 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.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
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Not known.

Undesirable effects

The information provided in Undesirable effects of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
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10% Sodium Chloride Kobayashi is 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

Overdose

The information provided in Overdose of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
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Substantial oral ingestion may require the use of a diuretic to remove excess sodium.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
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Isotonic (0.9% w/v) sodium chloride solution is widely used for dilution purposes.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
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Not applicable

Preclinical safety data

The information provided in Preclinical safety data of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
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There are no findings of relevance to the prescriber other than those already mentioned elsewhere in the SPC. Please refer to the product to be reconstituted.

Incompatibilities

The information provided in Incompatibilities of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
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Not applicable

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
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No special requirements.

Name of the medicinal product
10% Sodium Chloride Kobayashi
Qualitative and quantitative composition
Sodium Chloride
Therapeutic indications
The information provided in Therapeutic indications of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
more... close

For dilution of solutions for nebulisation.

Dosage (Posology) and method of administration
The information provided in Dosage (Posology) and method of administration of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
more... close

Adults, children and elderly: use as directed by the physician.

10% Sodium Chloride Kobayashi is only to be used as a diluent for diluting products for nebulisation and should not be used 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 nebulised product to be diluted that your physician has prescribed you for detailed instructions on use of this solution as a diluent. To ensure accurate dosing it is recommended that a dosing syringe is used if necessary.

Method of Administration: By inhalation from a suitable nebuliser or an intermittent positive pressure ventilator after the single dose ampoule has been opened and its contents transferred to the nebuliser chamber. Administration should be in accordance with the manufacturer's instructions for the device.

1. Prepare the nebuliser by following the manufacturer's instructions and the advice of your doctor.

2. The nebulised product to be diluted should be introduced into the nebuliser chamber as instructed in the appropriate patient information leaflet.

3. Carefully separate a new saline ampoule from the strip. Never use 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 use a dosing syringe as required into the nebuliser chamber and swirl gently to mix.

5. Assemble the nebuliser and use it as directed by your doctor.

6. After nebulisation, clean the nebuliser according to the manufacturer's instructions. It is important that the nebuliser is kept clean.

As the single dose units contain no preservatives it is important that the contents are used immediately after opening and a fresh ampoule is used for each administration to avoid microbial contamination. Partly used, opened or damaged single dose units should be discarded.

Any solution remaining in the nebuliser chamber should be discarded.

Contraindications
The information provided in Contraindications of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
more... close

The solution should not be administered orally or parenterally.

Special warnings and precautions for use
The information provided in Special warnings and precautions for use of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
more... close

Do not use unless the product is clear and the pack intact. Discard any surplus after use. 10% Sodium Chloride Kobayashi 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.

Effects on ability to drive and use machines
The information provided in Effects on ability to drive and use machines of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
more... close

Not known.

Undesirable effects
The information provided in Undesirable effects of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
more... close

10% Sodium Chloride Kobayashi is 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

Overdose
The information provided in Overdose of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
more... close

Substantial oral ingestion may require the use of a diuretic to remove excess sodium.

Pharmacodynamic properties
The information provided in Pharmacodynamic properties of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
more... close

Isotonic (0.9% w/v) sodium chloride solution is widely used for dilution purposes.

Pharmacokinetic properties
The information provided in Pharmacokinetic properties of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
more... close

Not applicable

Preclinical safety data
The information provided in Preclinical safety data of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
more... close

There are no findings of relevance to the prescriber other than those already mentioned elsewhere in the SPC. Please refer to the product to be reconstituted.

Incompatibilities
The information provided in Incompatibilities of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
more... close

Not applicable

Special precautions for disposal and other handling
The information provided in Special precautions for disposal and other handling of 10% Sodium Chloride Kobayashi is based on data of another medicine with exactly the same composition as the 10% Sodium Chloride Kobayashi of the medicine (Sodium Chloride). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug 10% Sodium Chloride Kobayashi directly from the package or from the pharmacist at the pharmacy.
more... close

No special requirements.

Available in countries
See all
close