Country: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
LACTULOSE
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
A06AD11
SYRUP
LACTULOSE 66.7 G / 100 ML
PER OS
Not required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
LACTULOSE
LACTULOSE
Constipation. Acute and chronic hepatic encephalopathy.
2023-03-31
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 Aqra d-dokument sħiħ
- 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 Aqra d-dokument sħiħ