BABYLAX 1.8 G RECTAL SOLUTION 1.8 Grams Rectal Solution

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

GLYCEROL 85%

Saatavilla:

Bausch & Lomb UK Limited

INN (Kansainvälinen yleisnimi):

GLYCEROL 85%

Annos:

1.8 Grams

Lääkemuoto:

Rectal Solution

Prescription tyyppi:

Product not subject to medical prescription

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

0000-00-00

Valmisteyhteenveto

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