BABYLAX 1.8 G RECTAL SOLUTION 1.8 Grams Rectal Solution

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
GLYCEROL 85%
Available from:
Bausch & Lomb UK Limited
INN (International Name):
GLYCEROL 85%
Dosage:
1.8 Grams
Pharmaceutical form:
Rectal Solution
Prescription type:
Product not subject to medical prescription
Authorization status:
Authorised
Authorization number:
PA0555/009/001
Authorization date:
0000-00-00

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Babylax1.8gRectalSolution.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Glycerol(85%)1.8gperapplicator.

Excipients:Eachapplicatorcontains0.36mgofbenzalkoniumchloride.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Rectalsolution.

Clear,colourless,rectalsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthetreatmentofconstipation.

4.2Posologyandmethodofadministration

Forrectaluseonly.

Under3months:½to1applicator.

Over3monthsupto6years:1applicator.

Childrenover6years:1-2applicators.

Adultsandelderly:1-2applicators.

4.3Contraindications

None.

4.4Specialwarningsandprecautionsforuse

Ifconstipationpersists,consultyourdoctor.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

None.

4.6Fertility,pregnancyandlactation

None.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/11/2010 CRN 2090792 page number: 1

None.

4.8Undesirableeffects

Prolongedusemayleadtoirritationoftheanalcanal.

4.9Overdose

None.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Glycerolisatrivalentalcohol.Whenglycerolisgivenrectally,itpromotesperistalsisandevacuationofthelower

bowelbyvirtueofitsirritantaction,sothatdefecationstimulusisincreased.

5.2Pharmacokineticproperties

Thereisaslightabsorptionofglycerolfromtherectum.Theeliminationofabsorbedglycerolisviathekidneys.

5.3Preclinicalsafetydata

(RegistryoftoxicEffectsofChemicalSubstances1987)

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzalkoniumchloride

Macrogol400

Carbomer

Sodiumhydroxide

DisodiumEdetate

LD50Guineapigoral 7.75g/kg

LD50Mouse oral 4.1 g/kg

LD50Rat oral12.6 g/kg

LD50Mouse iv 6.2 g/kg

LD50Rat iv 5.6 g/kg

LD50Mouse ip 8.98g/kg

LD50Rat ip 8.3 g/kg

LD50Mouse sc 0.09g/kg

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/11/2010 CRN 2090792 page number: 2

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Unopened:3years.

Onceopened:Useimmediatelyanddiscardanyunusedsolution.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Lowdensitypolyethylenetubewithcannula.

Packagesizes:

3x3.6gapplicators

6x3.6gapplicators

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Foruseundermedicalsupervision.

Forsingleuseonly-Discardimmediatelyafteruse.

Removethecapfromtheapplicatorandinvertthecap.Withthepointinthecap,piercetheopeningofthenozzleof

theapplicator.Greasecannulaandinsertgentlyintotherectum(aswithathermometerwhentakingatemperature).

Expelcontentsbysqueezing.Themaximumeffectisobtainedifevacuationisrestrainedforaslongaspossible;inthe

caseofsmallbabieskeeplegstogetherfortwotothreeminutes.

7MARKETINGAUTHORISATIONHOLDER

Bausch&LombUKLimited

106LondonRoad

Kingston-Upon-Thames

Surrey

KT26TN

8MARKETINGAUTHORISATIONNUMBER

PA555/9/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:17December1992

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/11/2010 CRN 2090792 page number: 3

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/11/2010 CRN 2090792 page number: 4

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