PECTODRILL FOR CHESTY COUGHS 250/5 Mg/Ml Oral Solution
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
09-06-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
CARBOCISTEINE
थमां उपलब्ध:
Pierre Fabre Medicament
INN (इंटरनेशनल नाम):
CARBOCISTEINE
डोज़:
250/5 Mg/Ml
फार्मास्यूटिकल फॉर्म:
Oral Solution
प्रिस्क्रिप्शन प्रकार:
Product not subject to medical prescription
प्राधिकरण का दर्जा:
Withdrawn
प्राधिकरण की तारीख:
2010-11-25
उत्पाद विशेषताएं
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0329/009/001
Case No: 1999987
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE, F-92654 BOULOGNE, CEDEX, , FRANCE
an authorisation, subject to the provisions of the said Regulations, in respect of the product
PECTRODRILL FOR CHESTY COUGHS 250MG/5ML ORAL SOLUTION
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 24/03/2006 until 23/03/2011 .
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/03/2006_
_CRN 1999987_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PectoDrill for chesty coughs 250mg/5ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Carbocisteine 5.00g per 100ml
Each 5ml contains 250mg carbocisteine
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Oral solution
A yellow to light brown, clear syrup with a weak
odour suggesting caramel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mucolytic agent for use in lower respiratory
tract disorders characterised by excessive or viscous mucus.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Oral route
ADULTS AND CHILDREN 12 YEARS AND OVER:
The usual dose is three 5ml three times daily initially,
reducing t
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