Land: Israël
Taal: Engels
Bron: Ministry of Health
MODAFINIL
ABIC MARKETING LTD, ISRAEL
N06BA07
CAPLETS
MODAFINIL 100 MG
PER OS
Required
TEVA PHARMA B.V., THE NETHERLANDS
MODAFINIL
To improve wakefulness in patients with excessive sleepiness associated with narcolepsy (with or without cataplexy), obstructive sleep apnea/hypopnea syndrome ( OSAHS ) and shift work sleep disorder (SWDS).
2019-03-18
ترشتسإ اذإ لاإ ليجيڤورپ لوانت دعوم رييغت زوجي لا ● دق مونلا دعوم نم ً ادج ً ابيرق ليجيڤورپ لوانت نإ .كبيبط .مونلا يف ةبوعص ببسي غضملا/رطشلا/قحسلا طخ دوجو مدعل )ةلوسبك لكشب ةبح( ةلوسبحلا رطش زوجي لا .ةلوسبحلا غضم /قحس صوصخب تامولعم رفوتت لا .رطشلل .اهب ىصوملا ةيئاودلا ةعرجلا زواجت زوجي لا .ةنس 18 رمع نود لافطأ ىدل جلاعلل صصخم ريغ ءاودلا اذه لفط علب اذإ وأ ربكأ ةيئاود ةعرج أطخلاب تلوانت اذإ ئراوطلا ةفرغل وأ بيبطلا ىلإ ً لااح هجوت ،ءاودلا نم أطخلاب .كعم ءاودلا ةبلع رضحأو ،ىفشتسملا يف :لمشت دق ليجيڤورپ نم ةيئاودلا ةعرجلا طرف ضارعأ .مونلا يف لكاشم ● )لملمت( ةحار ةلق ● .كابترإ ● .ناهوتب روعشلا ● .لاعفنإب روعشلا ● .)نايذه( ةيقيقح ريغ ءايشأب روعشلا وأ ،ةيؤر ،عامس ● .لاهسإو نايثغ ● .ءيطب وأ عيرس ضبن ● .ردصلا يف ملأ ● .مدلا طغض عافترإ ● زوجي لاف بولطملا تقولا يف ءاودلا اذه لوانت تيسن اذإ ةيلاتلا ةيئاودلا ةعرجلا لوانت .ةفعاضم ةيئاود ةعرج لوانت ىلع ةبظاوملا بجي .بيبطلا رشتسإو يدايتعلإا دعوملا يف .بيبطلا ةيصوت بسح جلاعلا عباط صيخشت بجي ! ةمتعلا يف ةيودلأا لوانت زوجي لا لوانتت ةرم لك يف ةيئاودلا ةعرجلا نم دكأتلاو ءاودلا . كلذ رملأا مزل اذإ ةيبطلا تاراظنلا عض . ءاود اهيف ،ءاودلا لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ .يلديصلا وأ بيبطلا ر Lees het volledige document
Provigil HS 09/2019 Certification SUMMARY OF PRODUCT CHARACTERISTICS PROVIGIL ® CAPLETS Each caplet contains: Modafinil 100 mg 1 INDICATIONS AND USAGE PROVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with narcolepsy (with or without cataplexy), obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift work sleep disorder (SWSD). Limitations of Use In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with PROVIGIL for excessive sleepiness. Provigil HS 09/2019 Certification 2 DOSAGE AND ADMINISTRATION Treatment should be initiated by or under the supervision of a physician with appropriate knowledge of indicated disorders. A diagnosis of narcolepsy should be made according to the International Classification of Sleep Disorders (ICSD2) guideline. Patient monitoring and clinical assessment of the need for treatment should be performed on a periodic basis. Posology The recommended starting daily dose is 200 mg. The total daily dose may be taken as a single dose in the morning or as two doses, one in the morning and one at noon, according to physician assessment of the patient and the patient's response. Doses of up to 400mg in one or two divided doses can be used in patients with insufficient response to the initial 200mg modafinil dose. Long-term use Physicians prescribing modafinil for an extended time should periodically re-evaluate the long-term use for the individual patients as the long-term efficacy of modafinil has not been evaluated (> 9 weeks). Patients with renal impairment There is inadequate information to determine safety and efficacy of dosing in patients with renal impairment. Patients with hepatic impairment The dose of modafinil should be reduced by half in patients with severe hepatic i Lees het volledige document