LAEVOLAC

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

LACTULOSE

Διαθέσιμο από:

MEGAPHARM LTD

Φαρμακολογική κατηγορία (ATC):

A06AD11

Φαρμακοτεχνική μορφή:

SOLUTION (ORAL)

Σύνθεση:

LACTULOSE 670 MG/ML

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Not required

Κατασκευάζεται από:

FRESENIUS KABI AUSTRIA GmbH

Θεραπευτική ομάδα:

LACTULOSE

Θεραπευτική περιοχή:

LACTULOSE

Θεραπευτικές ενδείξεις:

Constipation. Acute and chronic hepatic encephalopathy.

Ημερομηνία της άδειας:

2014-09-30

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Laevolac 3.3g/5ml Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml contain 3.3 g lactulose
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral Solution
Clear colourless to pale brownish yellow, viscous solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Constipation.
Acute and chronic hepatic encephalopathy
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The lactulose solution may be administered diluted or undiluted. The
dose should be titrated
according to the clinical response. Lactulose may be given as a single
daily dose or up to three
divided daily doses, using the measuring cup.
A single dose of lactulose should be swallowed in one and should not
be kept in the mouth for
an extended period of time.
The posology should be adjusted according to the individual needs of
the patient. The starting
dose can be adjusted after adequate treatment effect individually
(maintenance dose). Several
days (2-3 days) of treatment may be needed in some patients before
adequate treatment effect
occurs. In case of single daily dose, this should be taken at the same
time of the day, e.g.
during breakfast. During the therapy with laxatives it is recommended
to drink sufficient
amounts of fluids (1.5-2 l/day, equal to 6-8 glasses).
_Constipation_
After a few days the starting dosage may be adjusted to the
maintenance dose based upon
treatment response. Several days (2-3 days) of treatment may be needed
before treatment
effect occurs.
Starting dose
Maintenance dose
Adults and
adolescents
15 - 30 ml
15 - 30 ml
Children
(7 - 14 years)
15 ml
10 - 15 ml
Children
(1 - 6 years)
5 - 10 ml
5 - 10 ml
infants under 1 year
Up to 5 ml
Up to 5 ml
If diarrhoea occurs, the dosing regimen should be reduced.
1
_Treatment of portal systemic encephalopathy - for adults only: _
_ _
Beginning with 30 - 50 ml 3 times daily (corresponding to 60 - 100 g
Lactulose).
The dosage has to be adopted to get 2-3 soft stools daily, pH of the
stools should