AVILAC SYRUP

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

LACTULOSE

Saatavilla:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC-koodi:

A06AD11

Lääkemuoto:

SYRUP

Koostumus:

LACTULOSE 66.7 G / 100 ML

Antoreitti:

PER OS

Prescription tyyppi:

Not required

Valmistaja:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Terapeuttinen ryhmä:

LACTULOSE

Terapeuttinen alue:

LACTULOSE

Käyttöaiheet:

Constipation. Acute and chronic hepatic encephalopathy.

Valtuutus päivämäärä:

2023-03-31

Pakkausseloste

1986 - )تارضحتسم( ةلديصلا ةمظنأ بجومب
كلهتسملل ةرشن
.بيبط ةفصو نودب ءاودلا ق
ّ
وسي
بارش ك
َ
ليڤأ
.مارغ 66.7 )Lactulose( زولوتكل :ىلع للم 100 لك
يوتحي ضعب نع ةماه تامولعم' 2 ةرقفلا رظنأ
:رضحتسملا يف ةيساسحلا تاد
ّ
لومو ةلاعفلا ريغ داوملا
.ةرشنلا يف 6 ةرقفلا يفو 'ءاودلا تابكرم
ةزجوم تامولعم ىلع ةرشنلا هذه يوتحت
.ءاودلل كلامعتسإ لبق اهتياهن ىتح نعمتب
ةرشنلا أرقإ
بسحب ءاودلا لامعتسإ كيلع .يلديصلا وأ
بيبطلا عجار ،ةيفاضإ ةلئسأ كيدل ترفوت
اذإ .ءاودلا نع
.ةيفاضإ تامولعمل تجتحإ اذإ يلديصلا
رشتسإ .ةرشنلا هذه نم يئاودلا رادقملا
ةرقف يف تاميلعتلا
.مايأ ةدع دعب نسحتت مل وأ )ضارعلأا(
ضرملا ضارعأ تمقافت لاح يف بيبطلل
هجوتلا كيلع
؟ءاودلا صصخم ضرغ يلأ )1
يدبكلا يغامدلا للاتعلإا ةجلاعملو
)فاجو بلص زارب ،ءاعملأا تاكرح ماظتنإ
مدع( كاسملإا ةجلاعمل
يغامدلا للاتعلإل نكمي .)يعولا يف
ضافخنإ ،نافجر ،كابترلإ يدؤي يدبك ضرم(
نمزملاو داحلا
.يدبك تابسل يدؤي نأ يدبكلا
.ةيزومسلأا تلا
ِّ
هسملا نم :ةيجلاعلا ةليصفلا
لهسو نيل ىلإ زاربلا ل
ّ
وحت اهنأ ثيح ،زولوتكل ىمس
ُ
ت ةلهس
ُ
م ةدام ىلع يوتحي ءاود وه بارش كليڤأ
.كمسج لخاد ىلإ اهصاصتمإ متي لا ةداملا
.ءاعملأا لخاد ىلإ ءاملا بحس ةطساوب
،رورملل رثكأ
ءاودلا لامعتسإ لبق )2
:اذإ ءاودلا لامعتسإ زوجي لا
اهيوتحي يتلا ةيفاضلإا تابك�

Valmisteyhteenveto

- 1 -
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Avilac Syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Avilac aqueous oral solution contains 667 g lactulose per 1000 ml.
Lactulose oral solution contains residues from the route of production
with known effect,
see section 4.4.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
A clear, viscous liquid, colourless to brownish yellow.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. Constipation.
2. Acute and chronic hepatic encephalopathy
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The lactulose solution may be administrated diluted or undiluted. The
dose should be
titrated according to the clinical response. Lactulose may be given as
a single daily dose
or in two divided doses, using the measuring cup.
Each 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.
In case of single daily dose this should be taken at the same time,
e.g. during breakfast.
- 2 -
During the therapy with laxatives it is recommended to drink
sufficient amounts of fluids
(1.5 – 2 litres, equal to 6-8 glasses) during the day.
The measuring cup may be used.
Dosing in constipation or where a soft stool is considered of medical
benefit
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.
_Avilac oral solution _
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
adults only):
r
(fo
sing in acute and chronic hepatic encephalopathy
o
D
Starting dose: 3 times daily 30 –50 ml.
Maintenance dose: should be adjusted so that soft stools are produced
2 - 3 times per
day.
PAEDIATRIC POPULATION
The safety and efficacy in child