Bimatoprost Teva 0,3 mg/ml, oogdruppels, oplossing

देश: नीदरलैंड

भाषा: डच

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

सक्रिय संघटक:

BIMATOPROST

थमां उपलब्ध:

Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM

ए.टी.सी कोड:

S01EE03

INN (इंटरनेशनल नाम):

BIMATOPROST

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:

2017-07-24

सूचना पत्रक

1
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
BIMATOPROST TEVA 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 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 Bimatoprost is and what it is used for
2.
What you need to know before you use Bimatoprost
3.
How to use Bimatoprost
4.
Possible side effects
5.
How to store Bimatoprost
6.
Contents of the pack and other information
1.
WHAT BIMATOPROST IS AND WHAT IT IS USED FOR
Bimatoprost is an antiglaucoma preparation. It belongs to a group of
medicines called prostamides.
Bimatoprost 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 BIMATOPROST
DO NOT USE BIMATOPROST:
-
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 PRECAUTIONS
Talk to your doctor or pharmacis

उत्पाद विशेषताएं

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Bimatoprost Teva 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 with known effect:
One ml of solution contains 0.05 mg benzalkonium chloride.
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.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
2
-
Bimatoprost 0.3 mg/ml is contraindicated in patients who have had a
suspected previous adverse
reaction to benzalkonium chloride that has led to discontinuation.
4.4
SPECIAL