BIMATOPROST S.K.

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BIMATOPROST

متاح من:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

ATC رمز:

S01EE03

الشكل الصيدلاني:

OPHTHALMIC SOLUTION

تركيب:

BIMATOPROST 0.3 MG / 1 ML

طريقة التعاطي:

OCULAR

نوع الوصفة الطبية :

Required

المصنعة من قبل:

RAFARM S.A., GREECE

المجال العلاجي:

BIMATOPROST

الخصائص العلاجية:

Reduction of elevated intraocular pressure in chronic open angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).

تاريخ الترخيص:

2023-10-31

نشرة المعلومات

THE FORMAT OF THIS LEAFLET HAS BEEN DECIDED BY THE MINISTRY OF HEALTH,
AND ITS CONTENT HAS BEEN
CHECKED AND APPROVED BY THE MINISTRY IN NOVEMBER 2018
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(MEDICINAL PRODUCTS) - 1986
PRESCRIPTION ONLY MEDICINE
BIMATOPROST, EYE DROPS, SOLUTION
ACTIVE INGREDIENT: Bimatoprost 0.03%
Inactive ingredients and allergens in the product: see section 6,
“Further Information”
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains brief information on
the medicine. If you have further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it appears to you that they have a similar illness.
1. WHAT IS THE MEDICINE INTENDED FOR?
Bimatoprost S.K. is used to reduce intraocular pressure in patients
with chronic open-angle glaucoma, as
a single treatment or in combination with beta-blockers containing
drops.
Your eye contains a clear, watery liquid that feeds the inside of the
eye. Liquid is constantly being
drained out of the eye, and new fluid is produced to replace it. If
the liquid cannot drain out quickly
enough, the pressure inside the eye increases.
The medicine works by increasing the amount of liquid that is drained.
In this way, the pressure inside
the eye is reduced. If the high pressure is not reduced, it could lead
to a disease called glaucoma, and
can eventually damage your sight.
THERAPEUTIC GROUP: Prostaglandin analogue.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:

You are sensitive (allergic) to Bimatoprost or to any of the other
ingredients contained in the
medicine..

You have had to stop using eye drops in the past because of side
effects due to the preservative
benzalkonium chloride.
BEFORE STARTING TREATMENT WITH BIMATOPROST S.K., TELL THE DOCTOR IF:

You have breathing problems

You have liver or kidney problems

You have had a cataract surgery in the past

You have dry eye

You ha

خصائص المنتج

1/7
BIMATOPROST S.K.
Summary of Product Characteristics
1.
NAME OF THE MEDICINAL PRODUCT
2.
BIMATOPROST S.K.
eye drops, 0.3 mg/mL
One ml of solution contains 0.3 mg bimatoprost.
Excipient(s) with known effect:
Each ml of solution contains 0.05 mg of Benzalkonium chloride
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution. Clear colourless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in chronic open-angle
glaucoma and ocular hypertension in adults (as
monotherapy or as adjunctive therapy to beta-blockers).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one drop in the affected eye(s) once daily,
administered in the evening. The dose should not
exceed once daily as more frequent administration may lessen the
intraocular pressure lowering effect.
_Paediatric population_:
The safety and efficacy of
BIMATOPROST S.K
in children aged 0 to 18 years has not yet been established.
_Patients with hepatic and renal impairment: _
bimatoprost
has not been studied in patients with renal or moderate to severe
hepatic impairment and should therefore
be used with caution in such patients. In patients with a history of
mild liver disease or abnormal alanine
aminotransferase (ALT), aspartate aminotransferase (AST) and/or
bilirubin at baseline, bimatoprost 0.3 mg/mL eye
drops (multi-dose formulation), solution had no adverse effect on
liver function over 24 months.
Method of administration
If more than one topical ophthalmic medicinal product is being used,
each one should be administered at least 5 minutes
apart.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Ocular
Before treatment is initiated, patients should be informed of the
possibility of prostaglandin analogue periorbitopathy
(PAP) and increased iris pigmentation, since these have been observed
during treatment with
bimatoprost
.