Omidria
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
09-03-2023
Valmisteyhteenveto
(SPC)
09-03-2023
Julkisesta arviointikertomuksesta
(PAR)
01-09-2015
Aktiivinen ainesosa:
ketorolac, phenylephrine
Saatavilla:
Rayner Surgical (Ireland) Limited
ATC-koodi:
S01
INN (Kansainvälinen yleisnimi):
phenylephrine, ketorolac
Terapeuttinen ryhmä:
Ophthalmologicals
Terapeuttinen alue:
Lens Implantation, Intraocular; Pain, Postoperative
Käyttöaiheet:
Omidria is indicated in adults for maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.
Tuoteyhteenveto:
Revision: 7
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2015-07-28
Pakkausseloste
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
OMIDRIA 10 MG/ML + 3 MG/ML CONCENTRATE FOR SOLUTION FOR INTRAOCULAR
IRRIGATION
phenylephrine/ketorolac
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Omidria is and what it is used for
2.
What you need to know before you use Omidria
3.
How Omidria is used
4.
Possible side effects
5.
How Omidria is stored
6.
Contents of the pack and other information
1.
WHAT OMIDRIA IS AND WHAT IT IS USED FOR
Omidria is a medicine used during surgery on the eye. It contains the
active substances phenylephrine
and ketorolac. Phenylephrine acts to keep the pupil dilated (widened).
Ketorolac is a painkiller that
belongs to the group called non-steroidal anti-inflammatory drugs
(NSAIDS); it also helps stop the
pupil from contracting (getting smaller).
Omidria is used in adults to rinse the eye during surgery to implant a
new lens (part of the eye that
focuses light passing through the pupil to allow you to see clearly).
This is known as intraocular lens
replacement. The medicine is used to keep the pupil dilated (widened)
during surgery and to reduce
eye pain after the procedure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OMIDRIA
DO NOT USE OMIDRIA:
-
if you are allergic to phenylephrine or ketorolac or any of the other
ingredients of this medicine
(listed in section 6);
-
if you have an eye condition called narrow-angle glaucoma.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Omidria if you:
-
have heart disease;
-
have raised blood pressure;
-
have overactive thyroid gland (hyperthyroidism);
-
are allergic to acetylsalicylic acid or other painkillers called
Lue koko asiakirja
Valmisteyhteenveto
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
1.
NAME OF THE MEDICINAL PRODUCT
Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular
irrigation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4 mL of concentrate for solution in the vial contains
phenylephrine hydrochloride equivalent to
40.6 mg (10.2 mg/mL) of phenylephrine and ketorolac trometamol
equivalent to 11.5 mg
(2.88 mg/mL) of ketorolac.
After dilution in 500 mL of irrigation solution, the solution contains
0.081 mg/mL of
phenylephrine and of 0.023 mg/mL ketorolac.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for intraocular irrigation.
Clear, colourless to slightly yellow, solution with a pH: 6.3 ±0.3.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Omidria is indicated in adults for maintenance of intraoperative
mydriasis, prevention of
intraoperative miosis and reduction of acute postoperative ocular pain
in intraocular lens replacement
surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Omidria must be administered in a controlled surgical setting by a
qualified ophthalmological surgeon
experienced in intraocular lens replacement surgery.
Posology
The recommended dose is 4.0 mL of Omidria concentrate for solution
diluted in 500 mL of irrigation
solution administered by intraocular irrigation to the affected eye
during surgery.
For instructions on dilution of the medicinal product before
administration, see section 6.6.
_Special populations _
_Elderly _
The elderly population has been studied in clinical studies. No dose
adjustment is
required.
_Renal or hepatic impairment _
No formal studies have been conducted with Omidria in patients with
renal or hepatic impairment. No
dose adjustment or special considerations are anticipated for patients
with renal or hepatic impairment
(see section 5.2).
2
_Paediatric population _
The safety and efficacy of Omidria in children aged below 18 years
have not been established. No data
are available.
Method of administration
Intraocular use (after
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