MAXITROL OPHTHALMIC SUSPENSION

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

DEXAMETHASONE; NEOMYCIN AS SULFATE; POLYMYXIN B SULFATE

Disponibbli minn:

NOVARTIS ISRAEL LTD

Kodiċi ATC:

S01AA18

Għamla farmaċewtika:

OPHTHALMIC SUSPENSION

Kompożizzjoni:

DEXAMETHASONE 1.0 MG/ML; NEOMYCIN AS SULFATE 3,500 IU/ML; POLYMYXIN B SULFATE 6000 IU/ML

Rotta amministrattiva:

OCULAR

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

ALCON COUVREUR, BELGIUM

Grupp terapewtiku:

POLYMYXIN B

Żona terapewtika:

POLYMYXIN B

Indikazzjonijiet terapewtiċi:

Maxitrol is indicated in ocular inflammation when concurrent use of antimicrobial in judged necessary.

Data ta 'l-awtorizzazzjoni:

2014-09-30

Fuljett ta 'informazzjoni

_؟ءاودلا لامعتسإ ةيفيك)3_
حاضيتسلإا كيلع .بيبطلا تاميلعت بسح
ً
امئاد رضحتسملا لامعتسإ بجي
جلاعلا ةقيرطو يئاودلا رادقملا نأشب
ً
اقثاو نكت مل اذإ يلديصلا نم وأ بيبطلا
نم
رادقملا .طقف بيبطلا لبق نم ناددحي
جلاعلا ةقيرطو يئاودلا رادقملا
.رضحتسملاب
رتميتنس ىتح رتميتنس هردق »طيرش«( ةليلق
ةيمك :ةداع وه يدايتعلإا يئاودلا
لامعتسإ لاح يف مونلا لبق ةدحاو ةرم وأ
مويلا يف تارم 4 ىتح 3 )فصنو
.راهنلا للاخ نينيعلل ىرخأ تارطق
_.هب ىصوملا يئاودلا رادقملا زواجت زوجي
لا_
.طقف يجراخلا لامعتسلإل صصخم ءاودلا اذه
!علبلا زوجي لا
.جلاعملا بيبطلا ددح امك ةددحم تاقوأب
ءاودلا اذه لامعتسإ بجي
_:لامعتسلإا ةقيرط_
يف امب( حطس يأ ةسملامب ةبوبنلأا فرطل
حمست لا ،مهرملا ثولت بنجتل ∙
ةطساوب مهرملا ةبوبنأ فرط حسم بجي
،لامعتسلإا دعب .)اهتاذ نيعلا كلذ
.ماكحإب ةبوبنلأا قلغأ مث نمو فيظن يقرو
ليدنم
.ةبوبنلأا نع ءاطغلا عزنإ .
ً
اديج كيدي لسغإ ،
ً
لاوأ :مهرملا لامعتسإ ةيفيك ∙
»ب
ْ
ي
َ
ج« ليكشتل يلفسلا نفجلا بحسإو فلخلا ىلإ
كسأر ةلامإب مق
»طيرش«( ةليلق ةيمك .فطلب مهرملا ةبوبنأ
رصع بجي .)1 مسرلا(
اذإ لإا ،ةيفاك نوكت ةداع مهرملا نم
)فصنو رتميتنس ىتح رتميتنس هردق
ةوجفلا لخاد مهرملا لخدأ .يلديصلا وأ
بيبطلا نم ىرخأ تاميلعت تيقلت
ضمغأ .تارم ةدع كينيع فرب مقو يلفسلا
نفجلا ررح .)2 م

Karatteristiċi tal-prodott

UK SmPC (JAN 2021)
MAX DRO API MAY21 V5
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Maxitrol ophthalmic suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml suspension contains 1 mg dexamethasone, 3,500 I.U. neomycin
sulphate and 6,000 I.U.
polymyxin B sulphate.
Excipient(s) with known effect:
1 ml suspension contains 0.04 mg benzalkonium chloride.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Ophthalmic suspension
Opaque suspension, white to pale yellow, no agglomerates for topical
ocular administration.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Maxitrol ophthalmic suspension is indicated in ocular inflammation
when concurrent use of
antimicrobial in judged necessary.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
1 to 2 drops topically in the conjunctival sac
In cases of acute disorder, drops may be instilled hourly, being
tapered to discontinuation as
the inflammation subsides. In mild disorders, instill 4 to 6 times
daily.
tic and renal impairment
Hepa
Maxitrol ophthalmic suspension has not been studied in these subject
populations.
However, due to low systemic absorption of the active substances after
topical
administration of this product, dose adjustment is not necessary.
METHOD OF ADMINISTRATION
For ocular use only. Not for injection or ingestion.
Shake the bottle well before use.
After cap is removed, if tamper evident snap collar is loose, remove
before using product.
In order to prevent contamination of the dropper tip and the
suspension, caution should be
exercised to ensure that the dropper tip does not touch the eyelids,
the surroundings of the
eye, or any other surfaces.
Nasolacrimal occlusion or gently closing the eyelid after
administration is recommended.
This may reduce the systemic absorption of medicinal products
administered via the ocular
route and result in a decrease in systemic adverse reactions.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
•