Acuvail (Ketorolac Tromethamine Ophthalmic Solution) 0.45%

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

KETOROLAC TROMETHAMINE; KETOROLAC TROMETHAMINE

Disponibil de la:

Allergan Malaysia Sdn Bhd

INN (nume internaţional):

KETOROLAC TROMETHAMINE; KETOROLAC TROMETHAMINE

Unități în pachet:

30 single-use vials x 0.4mL ml

Produs de:

Allergan Sales, LLC

Caracteristicilor produsului

* ARTWORK IS ACTUAL SIZE
* DROP NOTES AND TEMPLATE BEFORE PROCESSING
* IF REQUIRED, BARCODE AND CONTROL BAR(S) WILL BE ADDED BY SUPPLIER
* PERFORATION REQUIRED: NO
PART NUMBER:
96557MY_INT_01
DRAWING NUMBER:
0120001
V-CODE 128C:
FPO
PAGE:
1 OF 2
™
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ACUVAIL
®
safely and effectively. See
full prescribing information for ACUVAIL
®
.
ACUVAIL
®
(ketorolac tromethamine ophthalmic solution) 0.45%
————————————— INDICATIONS AND USAGE
——————————————
ACUVAIL
®
ophthalmic solution is a nonsteroidal, anti-inflammatory indicated for
the treatment of pain and
inflammation following cataract surgery. (1)
———————————— DOSAGE AND ADMINISTRATION
—————————————
One drop of ACUVAIL
®
should be applied by the patient to the affected eye twice daily
beginning 1 day prior to
cataract surgery, and continued through the first 2 weeks of the
postoperative period. (2.1)
——————————— DOSAGE FORMS AND STRENGTHS
—————————————
•
4.5 mg/mL ketorolac tromethamine solution in a single-use vial. (3)
———————————— WARNINGS AND PRECAUTIONS
—————————————
•
Cross-sensitivity (5.1)
•
Increased bleeding time due to interference with thrombocyte
aggregation (5.2)
•
Delayed healing (5.3)
•
Corneal effects including keratitis (5.4)
•
Contact lens wear (5.5)
•
Eye Injury and Contamination (5.6)
—————————————— ADVERSE REACTIONS
———————————————
Most common adverse reactions occurring in 1-6% of patients were
increased intraocular pressure, conjunctival
hemorrhage, and vision blurred. (7.1)
See 16 for PATIENT COUNSELING INFORMATION.
Revised: Apr 2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1
INDICATIONS AND USAGE
2
DOSAGE AND ADMINISTRATION
2.1
Recommended Dosing
3
DOSAGE FORMS AND STREN