BABYLAX 1.8 G RECTAL SOLUTION 1.8 Grams Rectal Solution
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
24-04-2024
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:
GLYCEROL 85%
थमां उपलब्ध:
Bausch & Lomb UK Limited
INN (इंटरनेशनल नाम):
GLYCEROL 85%
डोज़:
1.8 Grams
फार्मास्यूटिकल फॉर्म:
Rectal Solution
प्रिस्क्रिप्शन प्रकार:
Product not subject to medical prescription
प्राधिकरण का दर्जा:
Authorised
प्राधिकरण की तारीख:
0000-00-00
उत्पाद विशेषताएं
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Babylax 1.8 g Rectal Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycerol (85%) 1.8 g per applicator.
Excipients: Each applicator contains 0.36mg of benzalkonium chloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rectal solution.
Clear, colourless, rectal solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of constipation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For rectal use only.
Under 3 months: ½ to 1 applicator.
Over 3 months up to 6 years: 1 applicator.
Children over 6 years: 1 - 2 applicators.
Adults and elderly: 1 - 2 applicators.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If constipation persists, consult your doctor.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None.
4.6 FERTILITY, PREGNANCY AND LACTATION
None.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/11/2010_
_CRN 2090792_
_page number: 1_
None.
4.8 UNDESIRABLE EFFECTS
Prolonged use may lead to irritation of the anal canal.
4.9 OVERDOSE
None.
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
Glycerol is a trivalent alcohol. When glycerol is given rectally, it promotes peristalsis and evacuation of the lower
bowel by virtue of its irritant action, so that defecation stimulus is increased.
5.2 PHARMACOKINETIC PROPERTIES
There is a slight absorption of glycerol from the rectum. The elimination of absorbed glycerol is via the kidneys.
5.3 PRECLINICAL SAFETY DATA
(Registry of toxic Effects of Chemical Substances 1987)
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Benzalkonium chloride
Mac
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