Bimagan 0,1 mg/ml, oogdruppels, oplossing

Country: নেদারল্যান্ডস

ভাষা: ডাচ

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

সক্রিয় উপাদান:

BIMATOPROST 0,1 mg/ml

থেকে পাওয়া:

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

এটিসি কোড:

S01EE03

INN (International Name):

BIMATOPROST 0,1 mg/ml

ফার্মাসিউটিকাল ফর্ম:

Oogdruppels, oplossing

রচনা:

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

প্রশাসন রুট:

Oculair gebruik

Therapeutic area:

Bimatoprost

পণ্য সারাংশ:

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

অনুমোদন তারিখ:

2015-04-21

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
BIMAGAN 0.1 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 any 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 0.1 mg/ml is and what it is used for
2.
What you need to know before you use Bimagan 0.1 mg/ml
3.
How to use Bimagan 0.1 mg/ml
4.
Possible side effects
5.
How to store Bimagan 0.1 mg/ml
6.
Contents of the pack and other information
1.
WHAT BIMAGAN 0.1 MG/ML IS AND WHAT IT IS USED FOR
Bimagan is an antiglaucoma preparation. It belongs to a group of
medicines called prostamides.
Bimagan eye drops are 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 0.1 MG/ML
DO NOT USE BIMAGAN 0.1 MG/ML:
-
if you are allergic 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 PRECAUTIO

পণ্য বৈশিষ্ট্য

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bimagan 0.1 mg/ml oogdruppels oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 0.1 mg bimatoprost.
One drop contains approximately 2.5 micrograms bimatoprost.
Excipient with known effect:
One ml of solution contains 0.20 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.
pH 6.8 - 7.8; osmolality 260 - 330 mOsmol/kg.
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 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, 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.
2
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Bimagan 0.1 mg/ml is contraindicated in patients who have had a
suspected previous adverse reaction
to benzalkonium chloride that has led to di