Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
MOXIFLOXACIN AS HYDROCHLORIDE
NOVARTIS ISRAEL LTD
J01MA14
OPHTHALMIC SOLUTION
MOXIFLOXACIN AS HYDROCHLORIDE 0.5 %
OCULAR
Required
ALCON PHARMACEUTICALS LTD, SWITZERLAND
MOXIFLOXACIN
MOXIFLOXACIN
For the treatment of bacterial conjunctivitis caused by susceptible strains or organisms.
2020-06-30
.ﺔﻴﻧﺎﺛ ﻝﻭﺎﺣ ـ ﻦﻴﻌﻟﺍ ﻞﺧﺍﺪﻟ ﻂﻴﻘﻨﺘﻟﺍ ﻲﻓ ﺢﺠﻨﺗ ﻢﻟ ﺍﺫﺇ ∙ _ ﻦﻳﺪﻴﻟﺍ ﻞﺴﻏ ﺐﺠﻳ_ ،ﺔﻴﻧﺎﺜﻟﺍ ﻦﻴﻌﻟﺍ ﻲﻓ ﺓﺮﻄﻗ ﻂﻴﻘﻨﺗ ﻚﻴﻠﻋ ﺐﺟﻮﺗ ﺍﺫﺇ ∙ ﻚﻟﺫ ﺪﻌﺑﻭ _ﻯﺮﺧﻷﺍ ﻰﻟﺇ ﺓﺪﺣﺍﻭ ﻦﻴﻋ ﻦﻣ ﺕﺎﺛﻮﻠﺘﻟﺍ ﻝﺎﻘﺘﻧﺇ ﺐﻨﺠﺘﻟ_ ﺔﻴﻧﺎﺜﻟﺍ ﻦﻴﻌﻟﺍ ﻲﻓ ﻩﻼﻋﺃ ﺕﺮﻛ ﹸ ﺫ ﻲﺘﻟﺍ ﺕﺎﻤﻴﻠﻌﺘﻟﺍ ﺓﺩﻭﺎﻌﻣ ﺐﺠﻳ . ﹰ ﺎﻀﻳﺃ .ﻝﺎﻤﻌﺘﺳﻹﺍ ﺪﻌﺑ ﻝﺎﺤﻟﺍ ﻲﻓ ﹰ ﺍﺪﻴﺟ ﺔﻨﻴﻨﻘﻟﺍ ﻖﻠﻏﺃ ∙ ،ﻦﻴﻨﻴﻌﻟﺍ ﺕﺍﺮﻄﻗ ﻦﻣ ﺪﺣﺍﻭ ﻉﻮﻧ ﻦﻣ ﺮﺜﻛﺃ ﻞﻤﻌﺘﺴﺗ ﺖﻨﻛ ﺍﺫﺇ ∙ ﻝﺎﻤﻌﺘﺳﺇ ﻦﻴﺑ ﻖﺋﺎﻗﺩ 5-10 ﻞﻗﻷﺍ ﻰﻠﻋ ﺭﺎﻈﺘﻧﻹﺍ ﺐﺠﻴﻓ ﻢﻫﺍﺮﻤﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ ﺐﺠﻳ .ﻯﺮﺧﻷﺍ ﻦﻴﻨﻴﻌﻟﺍ ﺕﺍﺮﻄﻗﻭ ﺲﻛﻮﻣﺎﭽﯿﭬ .ﻦﻴﻨﻴﻌﻟﺍ ﺕﺍﺮﻄﻗ ﻝﺎﻤﻌﺘﺳﺇ ﻦﻣ ﺀﺎﻬﺘﻧﻹﺍ ﺪﻌﺑ ﻂﻘﻓ ﺔﻴﻨﻴﻌﻟﺍ ﻦﻴﻌﻟﺍ ﻞﺴﻏ ﻚﻴﻠﻋ _،ﺮﺒﻛﺃ _ _ﹰ_ _ﺎﻴﺋﺍﻭﺩ _ _ﹰ_ _ﺍﺭﺍﺪﻘﻣ ﺄﻄﺨﻟﺎﺑ ﺖﻠﻤﻌﺘﺳﺇ ﺍﺫﺇ_ ﻊﻠﺑ ﺍﺫﺇ ﻭﺃ ﹰ ﺎﻃﺮﻔﻣ ﹰ ﺎﻴﺋﺍﻭﺩ ﹰ ﺍﺭﺍﺪﻘﻣ ﺖﻠﻤﻌﺘﺳﺇ ﺍﺫﺇ .ﺮﺗﺎﻔﻟﺍ ﺀﺎﻤﻟﺎﺑ ﻲﻓ ﺉﺭﺍﻮﻄﻟﺍ ﺔﻓﺮﻏ ﻰﻟﺇ ﹰ ﻻﺎﺣ ﻪﺟﻮﺗ ،ﺀﺍﻭﺪﻟﺍ ﻦﻣ ﺄﻄﺨﻟﺎﺑ ﻞﻔﻃ .ﺀﺍﻭﺪﻟﺍ ﺔﺒﻠﻋ ﻚﻌﻣ ﺮﻀﺣﺃﻭ ،ﻰﻔﺸﺘﺴﻤﻟﺍ ﺯﻮﺠﻳ ﻻ ،ﺏﻮﻠﻄﻤﻟﺍ ﺖﻗﻮﻟﺍ ﻲﻓ _ﺀﺍﻭﺪﻟﺍ ﺍﺬﻫ ﻝﺎﻤﻌﺘﺳﺇ ﺖﻴﺴﻧ ﺍﺫﺇ_ ﻲﺋﺍﻭﺩ ﺭﺍﺪﻘﻣ ﻝﺎﻤﻌﺘﺳﺇ ﺐﺠﻳ .ﻒﻋﺎﻀﻣ ﻲﺋﺍﻭﺩ ﺭﺍﺪﻘﻣ ﻝﺎﻤﻌﺘﺳﺇ Soma hati kamili
VIG API JUL22 V3 1. NAME OF THE MEDICINAL PRODUCT VIGAMOX 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of VIGAMOX solution contains 5.45 mg moxifloxacin hydrochloride equivalent to 5 mg moxifloxacin (0.5% w/v). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops (ophthalmic solution). Clear, greenish yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VIGAMOX is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains or organisms. For a full list of susceptible strains and organisms, see sections 5.1 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For ocular use only. Not for injection. VIGAMOX 5 mg/ml eye drops, solution should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye. DOSAGE AND ADMINISTRATION: Instill one drop in the affected eye 3 times a day for 4 days. Pediatric Use: VIGAMOX Solution has been shown to be safe and effective in pediatric patients including neonates. There is no evidence that the ophthalmic administration of VIGAMOX Solution has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals. No dosage adjustment is necessary. Geriatric Use: No overall differences in safety and effectiveness have been observed between elderly and other adult patients. Special Populations: Patients with renal impairment: The pharmacokinetic parameters of oral moxifloxacin are not significantly altered by mild, moderate or severe renal impairment. No dosage adjustment of VIGAMOX Solution is necessary in patients with renal impairment. Patients with hepatic impairment: Pharmacokinetic parameters of oral moxifloxacin were not significantly altered in patients with mild to moderate hepatic insufficiency (Child Pugh Classes A and B). VIG API JUL22 V3 Studies were not preformed in patients with severe hepatic impairment (Child Pugh Class C). Because of the low systemic exposure by the topical route of administr Soma hati kamili