ACUVAIL

Χώρα: Ινδονησία

Γλώσσα: Ινδονησιακά

Πηγή: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Δραστική ουσία:

KETOROLAC TROMETAMOL

Διαθέσιμο από:

MENARINI INDRIA LABORATORIES - Indonesia

INN (Διεθνής Όνομα):

KETOROLAC TROMETAMOL

Δοσολογία:

0.45 W/V %

Φαρμακοτεχνική μορφή:

TETES MATA

Μονάδες σε πακέτο:

DUS, 1 VIAL PLASTIK @ 0.4 ML

Κατασκευάζεται από:

ALLERGAN SALES LLC - United States of America

Ημερομηνία της άδειας:

2020-03-26

Αρχείο Π.Χ.Π.

ACUVAIL™
(KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION) 0.45%
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 after cataract
surgery until the pain disappears or maximum 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)
Excipient List:

Carboxymethylcellulose Sodium, 7M8SFPH (Medium Viscosity)

Carboxymethylcellulose Sodium, 7H3SXF (High Viscosity)

Sodium Chloride

Sodium Citrate Dihydrate

Sodium Hydroxide (1N)

Hydrochloric Acid (1N)

Purified Water ----------------------------------------------------- WARNINGS AND
PRECAUTIONS ------------------------------------------

Delayed healing (5.1)

Cross-sensitivity or Hypersensitivity (5.2)

Increased bleeding time due to interference with thrombocyte
aggregation (5.3)

Corneal effects including keratitis (5.4)

Contact lens wear (5.5)

Eye injury and contamination (5.6)
DISETUJUI OLEH BPOM: 05/03/2020
EREG10043711800009 ------------------------------------------------------------ ADVERSE
REACTIONS -------------------------------------------------
Most common adverse reactions occurring in 1-6% of patients were
increased intraocular pressure,
conjunctival hemorrhage, and vision blurred. (6.1)
SEE 16 FOR PA