Duphalac syrup

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Lataa Valmisteyhteenveto (SPC)
31-03-2021

Aktiivinen ainesosa:

lactulose

Saatavilla:

ABBOTT Biologicals B.V.

ATC-koodi:

A06AD11

INN (Kansainvälinen yleisnimi):

lactulose

Annos:

667mg/ml

Lääkemuoto:

syrup

Kpl paketissa:

plastic bottle 200ml, plastic bottle 500ml, plastic bottle 1000ml

Prescription tyyppi:

OTC

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2021-03-31

Valmisteyhteenveto

                                Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTIC
NAME OF THE MEDICINAL PRODUCT
Duphalac, 667 g/l, syrup
QUALITATIVE AND QUANTITATIVE COMPOSITION
Duphalac syrup contains 667 g lactulose per 1000 ml.
One 15 ml sachet contains 10 g lactulose.
Purified water up to 1ml.
PHARMACEUTICAL FORM
Syrup
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
- Constipation: regulation of the physiological rhythm emptying of the
colon;
- Softening stool for medical purposes (hemorrhoids, conditions after
surgery on the colon and
the anus);
- Hepatic encephalopathy: treatment and prevention of hepatic coma or
precoma.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use
Lactulose solution can be taken in diluted and undiluted. Must be
immediately adopted to
swallow a single dose, without delaying the mouth. All dosage should
be individualized. When
set single daily dose, it must be taken into one and the same time,
for example during lunch.
During therapy, laxatives are advised to take plenty of fluids (1.5-2
liters, equivalent to 6-8
glasses) a day.
For accurate dosing of the drug should be used in bottles supplied
measuring cup. Using the drug
in bags must tear Area bag and immediately take the contents.
The dosage for the treatment of constipation or for softening stools
in medical applications
The daily dose of lactulose can be taken once or dividing it into two
using a measuring cup.
Initial dose can be adjusted to a maintenance dose, depending on the
response to the drug.
Sometimes it can take a few days (2-3 days) for the development of
therapeutic effect.
Page 2 of 6
Starting dose
daily
Maintenance dose
daily
Adults and adolescents
15-45 ml (10-30 g lactulose) (1-3
sachets)
15-30 ml (10-20 g lactulose)
(1-2 sachets)
Children 7-14 years
15 ml (10 g lactulose) (1 sachets)
10-15 ml (7-10 g lactulose)
(1 sachets*)
Children 1-6 years
5-10 ml (3-7 g lactulose)
5-10 ml (3-7 g lactulose)
Children under 1 year
under 5 ml (under 3 g lactulose)
under 5 ml (under 3 g
lactulose)
* If maintenance dose is less than 15 ml, it is necessary to use the
d
                                
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