VIGAMOX

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

MOXIFLOXACIN AS HYDROCHLORIDE

可用日期:

NOVARTIS ISRAEL LTD

ATC代码:

J01MA14

药物剂型:

OPHTHALMIC SOLUTION

组成:

MOXIFLOXACIN AS HYDROCHLORIDE 0.5 %

给药途径:

OCULAR

处方类型:

Required

厂商:

ALCON PHARMACEUTICALS LTD, SWITZERLAND

治疗组:

MOXIFLOXACIN

治疗领域:

MOXIFLOXACIN

疗效迹象:

For the treatment of bacterial conjunctivitis caused by susceptible strains or organisms.

授权日期:

2020-06-30

资料单张

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_ ﻦﻳﺪﻴﻟﺍ ﻞﺴﻏ ﺐﺠﻳ_ ،ﺔﻴﻧﺎﺜﻟﺍ
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ﺐﺟﻮﺗ ﺍﺫﺇ
∙
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.ﻝﺎﻤﻌﺘﺳﻹﺍ ﺪﻌﺑ ﻝﺎﺤﻟﺍ ﻲﻓ
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،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
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_ﹰ_
_ﺎﻴﺋﺍﻭﺩ _
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ﺍﺫﺇ_
ﻊﻠﺑ ﺍﺫﺇ ﻭﺃ
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ﺍﺭﺍﺪﻘﻣ ﺖﻠﻤﻌﺘﺳﺇ ﺍﺫﺇ .ﺮﺗﺎﻔﻟﺍ
ﺀﺎﻤﻟﺎﺑ
ﻲﻓ ﺉﺭﺍﻮﻄﻟﺍ ﺔﻓﺮﻏ ﻰﻟﺇ
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ﻻﺎﺣ ﻪﺟﻮﺗ ،ﺀﺍﻭﺪﻟﺍ ﻦﻣ ﺄﻄﺨﻟﺎﺑ
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ﺯﻮﺠﻳ ﻻ ،ﺏﻮﻠﻄﻤﻟﺍ ﺖﻗﻮﻟﺍ ﻲﻓ
_ﺀﺍﻭﺪﻟﺍ ﺍﺬﻫ ﻝﺎﻤﻌﺘﺳﺇ ﺖﻴﺴﻧ
ﺍﺫﺇ_
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.ﻒﻋﺎﻀﻣ ﻲﺋﺍﻭﺩ ﺭﺍﺪﻘﻣ ﻝﺎﻤﻌﺘﺳﺇ
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产品特点

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