BIMAGAN 0,3 mg/ml oogdruppels, oplossing

देश: नीदरलैंड

भाषा: डच

स्रोत: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

सक्रिय संघटक:

BIMATOPROST 0,3 mg/ml

थमां उपलब्ध:

S.C. Rompharm Company S.R.L. Eroilor Street, no. 1A 075100 OTOPENI (ROEMENIË)

ए.टी.सी कोड:

S01EE03

INN (इंटरनेशनल नाम):

BIMATOPROST 0,3 mg/ml

फार्मास्यूटिकल फॉर्म:

Oogdruppels, oplossing

रचना:

BENZALKONIUMCHLORIDE ; CITROENZUUR 1-WATER (E 330) ; DINATRIUMWATERSTOFFOSFAAT 7-WATER (E 339) ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; WATER, GEZUIVERD ; ZOUTZUUR (E 507),

प्रशासन का मार्ग:

Oculair gebruik

चिकित्सीय क्षेत्र:

Bimatoprost

उत्पाद समीक्षा:

Hulpstoffen: BENZALKONIUMCHLORIDE; CITROENZUUR 1-WATER (E 330); DINATRIUMWATERSTOFFOSFAAT 7-WATER (E 339); NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); WATER, GEZUIVERD; ZOUTZUUR (E 507);

प्राधिकरण की तारीख:

1900-01-01

सूचना पत्रक

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BIMAGAN 0,3 MG/ML OOGDRUPPELS, OPLOSSING
Bimatoprost
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What BIMAGAN 0.3 mg/ml is and what it is used for
2.
What you need to know before you use BIMAGAN 0.3 mg/ml
3.
How to use BIMAGAN 0.3 mg/ml
4.
Possible side effects
5.
How to store BIMAGAN 0.3 mg/ml
6.
Contents of the pack and other information
1.
WHAT BIMAGAN 0.3 MG/ML IS AND WHAT IT IS USED FOR
BIMAGAN is an antiglaucoma preparation. It belongs to a group of
medicines called prostamides.
BIMAGAN is used to reduce high pressure in the eye. This medicine may
be used on its own or with
other drops called beta-blockers which also reduce pressure.
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 liquid is made to replace this. If the
liquid cannot drain out quickly
enough, the pressure inside the eye builds up. This medicine works by
increasing the amount of liquid
that is drained. This reduces the pressure inside the eye. If the high
pressure is not reduced, it could
lead to a disease called glaucoma and eventually damage your sight.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BIMAGAN 0.3 MG/ML
DO NOT USE BIMAGAN 0.3 MG/ML:
-
if you are allergic (hypersensitive) to bimatoprost or any of the
other ingredients of this
medicine (listed in section 6).
-
if you have had to stop using eye drops in the past because of a side
effect of the preservative
benzalkonium chloride.
WARNINGS AND PRECAU

उत्पाद विशेषताएं

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BIMAGAN 0,3 mg/ml oogdruppels, oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 0.3 mg bimatoprost.
One drop contains approximately 7.5 micrograms bimatoprost.
Excipient(s) with known effect:
One ml of solution contains 0.05 mg benzalkonium chloride.
One ml of solution contains 0.95 mg phosphates.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution, practically free from particles.
pH 6.8 – 7.8; osmolality 260 – 330 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bimatoprost is indicated in 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 in children aged 0 to 18 years
has not yet been established.
SPECIAL POPULATIONS
_Use in 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, solution had no adverse
effect on liver function over 24
months.
Method of administration
2
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.
BIMAGAN 0.3 mg/ml eye drops, solution is contraindicated i