VIGAMOX

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

MOXIFLOXACIN AS HYDROCHLORIDE

MAH:

NOVARTIS ISRAEL LTD

ATC_code:

J01MA14

pharmaceutical_form:

OPHTHALMIC SOLUTION

composition:

MOXIFLOXACIN AS HYDROCHLORIDE 0.5 %

administration_route:

OCULAR

prescription_type:

Required

manufactured_by:

ALCON PHARMACEUTICALS LTD, SWITZERLAND

therapeutic_group:

MOXIFLOXACIN

therapeutic_area:

MOXIFLOXACIN

therapeutic_indication:

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

authorization_date:

2020-06-30

PIL

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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
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SPC

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