FML LIQUIFILM

Страна: Израел

Език: английски

Източник: Ministry of Health

Активна съставка:

FLUOROMETHOLONE

Предлага се от:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

АТС код:

S01BA07

Лекарствена форма:

OPHTHALMIC SUSPENSION

Композиция:

FLUOROMETHOLONE 0.1 %W/V

Начин на приложение:

OCULAR

Вид предписание :

Required

Произведено от:

ALLERGAN PHARMACEUTICALS IRELAND

Терапевтична група:

FLUOROMETHOLONE

Терапевтична област:

FLUOROMETHOLONE

Терапевтични показания:

To treat eye inflammation.

Дата Оторизация:

2014-12-31

Листовка

FML APL TIK FEB 23 CL
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is dispensed with a doctor’s prescription only
FML LIQUIFILM
®
OPHTHALMIC SUSPENSION
ACTIVE INGREDIENT
fluorometholone 0.1% w/v
Inactive ingredients and allergens in the medicinal product: see
section 2 under
‘Important information about some of this medicine’s
ingredients’, and section 6
- ‘Additional information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This
leaflet contains concise information about this medicine. If you have
any further
questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness/for you. Do
not pass it
on to others. It may harm them, even if it seems to you that their
illness/medical
condition is similar to yours.
This medicine is not intended for children below the age of two years.
1. WHAT IS THIS MEDICINE INTENDED FOR?
FML is used to treat eye inflammation.
THERAPEUTIC GROUP: corticosteroids.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:

you are sensitive (allergic) to the substance fluorometholone or any
of
the other ingredients in this medicine (see section 6, ‘Additional
Information’).

you have a bacterial, viral or fungal eye infection.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
Do not use FML for more than one week unless your doctor or eye
specialist
recommends that you do so.
Prolonged use may cause the pressure inside the eye (intraocular
pressure) to
increase, which could lead to glaucoma, rarely to damage to the optic
nerve,
lack of clearness of vision, cataracts, delay in the healing of wounds
or the
development of an eye infection. The intraocular pressure will be
regularly
measured.
If you are being treated or have previously been treated for herpes
simplex, use
FML only under your doctor’s close supervision.
The use of the bottle by more than one person may lead to a spread of
an
infection.
Contact your doctor if you experience blurred vision

Данни за продукта

FML API DEC 23 CL
Page 1 of 7
1.
NAME OF THE MEDICINAL PRODUCT
FML
LIQUIFILM
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluorometholone 0.1% w/v.
Excipients with known effect:
Benzalkonium chloride 0.046 mg/mL
Disodium phosphate heptahydrate, sodium dihydrogen phosphate
monohydrate
(containing total amount of phosphate buffers 4.86 mg/mL)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ophthalmic Suspension.
A white, microfine suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FML Liquifilm is indicated to treat eye inflammation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
FML Liquifilm is for topical ophthalmic use only, applied as drops
into
the conjunctival sac.
Shake FML Liquifilm well before use.
Posology
Instil 1-2 drops into the conjunctival sac 2-4 times daily. During the
first
24 to 48 hours of treatment, the dose may be safely increased to 2
drops
at one-hour intervals.
The treatment should not be withdrawn too early.
In chronic conditions, withdrawal of treatment should be carried out
by
gradually decreasing the frequency of applications.
_Paediatric population _
The safety and efficacy in children aged 2 years or less has not been
established._ _
FML API DEC 23 CL
Page 2 of 7
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
FML Liquifilm is contraindicated in most viral diseases of the cornea
and conjunctiva, including epithelial herpes simplex keratitis
(dendritic
keratitis), vaccinia, varicella, as well as mycobacterial and
untreated
bacterial infection of the eye and fungal diseases of ocular
structures,
and any undiagnosed ‘red eye’ as this may indicate a viral
infection.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Eye drops containing corticosteroids should not be used for longer
than
a week except under an eye specialist’s careful surveillance
combined
with regular measurement of intraocular pressure.
Prolonged use of corticosteroids may result in elevated intrao