Eyreida 0.3 mg/ml eye drops, solution

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Bimatoprost

Tersedia dari:

Aspire Pharma Limited

Kode ATC:

S01EE03

INN (Nama Internasional):

Bimatoprost

Dosis:

0.3 milligram(s)/millilitre

Bentuk farmasi:

Eye drops, solution

Area terapi:

bimatoprost

Status otorisasi:

Not marketed

Tanggal Otorisasi:

2019-11-08

Selebaran informasi

PACKAGE LEAFLET:
INFORMATION FOR THE USER
0.3MG/ML EYE DROPS, SOLUTION
Bimatoprost
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-Keepthisleaflet.Youmayneedto
readitagain.
-Ifyouhaveanyfurtherquestions,
askyourdoctororpharmacist.
-Thismedicinehasbeenprescribed
foryouonly.Donotpassitonto
others.Itmayharmthem,evenif
theirsignsofillnessarethesame
asyours.
-Ifyougetanysideeffects,talkto
yourdoctororpharmacist.
Thisincludesanypossibleside
effectsnotlistedinthisleaflet.
Seesection4.
IMPORTANT INFORMATION ABOUT THE
ADMINISTRATION OF THIS PRODUCT
EyreidaEyeDropsarecontained
withinanovelmultidoseeyedrop
bottle,whichallowsforthesolution
nottocontainanypreservatives.Due
tothedesignofthecontainer,
administrationwiththeseeyedrops
isnotthesameasstandardeye
dropbottles.
•
Priortofirstuse,practiceusingthe
dropsawayfromtheeye.Slowly
squeezethebottletodeliverone
dropintheairtogetusedtothe
pressureandtimerequiredtodeliver
onedrop.
•
Pleasenotethattheremightbea
fewsecondsdelaybetween
squeezingandthedropcomingout.
Donotsqueezetoohard,ormore
thanonedropmaycomeout.
•
Afteruseandpriortorecapping,the
bottleshouldbeshakenonceina
downwardsdirection,without
touchingthedroppertip,inorderto
removeanyresidualliquidonthetip.
Thisisnecessaryinordertoensure
deliveryofsubsequentdrops.
•
Ifmorethanonetypeofeyedropis
used,leaveatleast5minutes
betweenadministrationofeacheye
dropsolution.
Pleasereadthefullinstructionson
thecorrectuseofthisproductin
SECTION 3oftheleaflet(‘‘Howto
useEyreida’’),beforeusingthese
eyedrops.
WHAT IS IN THIS LEAFLET
1.WhatEyreidaisandwhatitis
usedfor
2. Whatyouneedtoknowbeforeyou
useEyreida
3. HowtouseEyreida
4. Possiblesideeffects
5. Ho

Karakteristik produk

Health Products Regulatory Authority
21 November 2019
CRN0094YS
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eyreida 0.3 mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 0.3 mg of bimatoprost.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless, eye drops. Osmolality: 261-319 mOsm/Kg
pH: 6.8 – 7.8
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.
Eyreida eye drops solution is a sterile solution that does not contain
a preservative.
_Paediatricpopulation:_
The safety and efficacy of Eyreida in children aged 0 to 18 years has
not yet been established. No data are currently available.
_Hepatic or renal impairment_
_ _
Eyreida 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 (preserved 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.
_Before instillation of the eye drops_
- Users should be instructed to wash their hands before opening the
bottle.
- Users should also be instructed to not use this medicine if they
notice that the tamper-proof seal on the bottle neck is broken
before they firs