SYRISAL Oral solution Ref.[49958] Active ingredients: Sodium chloride

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Syri Limited, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK Trading as: Thame Laboratories, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK OR Trading as: SyriMed, Unit 4, Bradfield Road, ...

Product name and form

Syrisal 1 mmol/ml Oral Solution.

Pharmaceutical Form

Oral solution.

A clear, colourless solution.

Qualitative and quantitative composition

Each ml of oral solution contains 1 mmol (58.44 mg) of sodium chloride.

Excipients with known effect: Each ml of oral solution contains 0.8 mg of methyl parahydroxybenzoate (E218), 0.05 mg of propyl parahydroxybenzoate (E216), 0.05 ml (63 mg/ml) of glycerol (E422) and 23mg of sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Sodium chloride

Sodium chloride is the principle salt involved in maintaining the osmotic tension of blood and tissues. Changes in osmotic tension influence the movement of fluids and diffusion of salts in cellular tissue.

List of Excipients

Glycerol (E422)
Sodium citrate
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Purified water

Pack sizes and marketing

Bottle: Amber or clear glass.

Closure: Child resistant plastic screw cap.

Pack size: 100ml and 300ml.

Not all pack size may be marketed.

Dosing Device: 20 ml dosage syringe with 1 ml graduation mark and a syringe adaptor.

Marketing authorization holder

Syri Limited, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

Trading as:

Thame Laboratories, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

OR

Trading as: SyriMed, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

Marketing authorization dates and numbers

PL 39307/0001

Date of first Authorisation: 05 September 2016
Date of last renewal: 13 August 2021

Drugs

Drug Countries
SYRISAL Ireland, United Kingdom

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