MEDORPHAN Syrup Ref.[27493] Active ingredients: Demorphan

Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

MEDORPHAN 1.5mg/ml syrup.

Pharmaceutical Form
Syrup. The solution is a slightly yellowish, clear, peach flavored syrup.

Qualitative and quantitative composition

Each ml contains 1.5 mg dextromethorphan hydrobromide.

Excipients with known effect: sucrose, sorbitol, liquid glucose, ethanol and sodium. Each ml contains 325 mg sucrose, 65 mg sorbitol, 395 mg glucose, 50.28 mg ethanol and 0.208 mg sodium.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Demorphan	Dextromethorphan is a non-opioid antitussive drug. The major metabolite of dextromethorphan, dextrorphan, binds with high affinity to σ-receptors to produce its antitussive activity without exhibiting the classic opiate effects that occur from binding into μ- and δ-receptors. In larger than therapeutic doses, dextrorphan is also an antagonist of N-methyl-D-aspartate (NMDA) receptors.

List of Excipients
Saccharin Sodium E954 Sodium Benzoate E211 Sucrose Glucose liquid spray dried Sorbitol liquid E420 (non-crystallising) Glycerol Ethanol Levomenthol Citric acid Caramel flavour (contains propylene glycol, benzyl alcohol) Peach flavour (contains propylene glycol, sodium citrate, benzyl alcohol, limonene) Purified Water

Pack sizes and marketing

150 ml or 200 ml Type III (Ph.Eur) brown glass bottles closed with one of the following caps:

Aluminium cap. A plastic measuring spoon with graduations of 2.5ml and 5ml is provided as part of the pack.
Plastic tamper evident cap. A plastic measuring cup with graduation of 5ml, 10ml, 15ml and 20ml is provided as part of the pack.
Plastic child proof cap. A plastic measuring cup with graduation of 2ml, 2.5ml, 3ml, 4ml, 5ml, 6ml, 7ml, 7.5ml, 8ml, 9ml, 10ml, 11ml, 12ml, 12.5ml and 15ml is provided as part of the pack.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

M.L.: 022945

16/05/2019

Drugs

Drug	Countries
MEDORPHAN	Cyprus

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