Mucodyne Paediatric Syrup 125 mg/5ml

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Carbocisteine

から入手可能:

Ipsen Pharmaceuticals Limited

ATCコード:

R05CB; R05CB03

INN（国際名）:

Carbocisteine

投薬量:

125 mg/5ml

医薬品形態:

Syrup

処方タイプ:

Product subject to prescription which may be renewed (B)

治療領域:

Mucolytics; carbocisteine

認証ステータス:

Not marketed

承認日:

1980-04-01

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mucodyne Paediatric Syrup 125 mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each of 5 ml of syrup contains 125 mg of Carbocisteine.
Excipients:
Also includes Sucrose 3.25g/5ml
Sodium Methylhydroxybenzoate (E219) 7.5mg/5ml
Red Ponceau 4R (E124) 0.25 mg/5ml
Ethanol 32mg/5ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
A red colour syrup with an odour and taste of raspberry and cherry.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carbocisteine is a mucolytic agent for the adjunctive therapy of
respiratory tract disorders characterised by excessive or
viscous mucus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is oral.
Recommended Dosage:
Children:
Children 2-5 years:
2.5 - 5ml four times daily
Children 5-12 years:
10ml - three times daily
4.3 CONTRAINDICATIONS
Use in patients with a known hypersensitivity to Carbocisteine.
Use in patients with active peptic ulceration.
Use in patients below 2 years of age.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is recommended in the elderly, in those with a history of
gastroduodenal ulcers, or those taking concomitant
medications known to cause gastrointestinal bleeding. If
gastrointestinal bleeding occurs, patients should discontinue
medication.
Because of the possible effect on the mucous glands of the stomach,
this product should be used with caution in
patients with a history of peptic ulceration.
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