Acuvail (Ketorolac Tromethamine Ophthalmic Solution) 0.45%

Country: Malasía

Tungumál: enska

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

Virkt innihaldsefni:

KETOROLAC TROMETHAMINE; KETOROLAC TROMETHAMINE

Fáanlegur frá:

Allergan Malaysia Sdn Bhd

INN (Alþjóðlegt nafn):

KETOROLAC TROMETHAMINE; KETOROLAC TROMETHAMINE

Einingar í pakka:

30 single-use vials x 0.4mL ml

Framleitt af:

Allergan Sales, LLC

Upplýsingar fylgiseðill

ACUVAIL™ OPHTHALMIC SOLUTION
Ketorolac tromethamine (0.45%)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
ACUVAIL™
is used for
2.
How
ACUVAIL™
works
3.
Before you use
ACUVAIL™
4.
How to use
ACUVAIL™
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
ACUVAIL™
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ACUVAIL™
IS USED FOR
ACUVAIL™
is used for the treatment
of
pain
and
inflammation
following
cataract surgery.
ACUVAIL™
belongs
to
a
group
of
medicines known as non-steroidal anti-
inflammatory drugs (NSAIDs).
HOW ACUVAIL™ WORKS
It works by reducing the production of
certain
substances
(such
as
prostaglandins) that cause inflammation,
and pain.
BEFORE YOU USE ACUVAIL™_ _
-
_When you must not use it _
_ _
Do not use
ACUVAIL™
if you are
allergic (hypersensitive) to ketorolac,
or
any
of
the
other
ingredients
of
ACUVAIL™
(for
a
full
list
of
ingredients, see section 8 “PRODUCT
DESCRIPTION”).
If you are hypersensitive to, or have
had an allergic reaction to aspirin or
other NSAIDs.
Symptoms of an allergic reaction may
include:
cough,
shortness
of
breath,
wheezing
or
difficulty
breathing;
swelling
of
the
face,
lips,
tongue,
throat or other parts of the body; rash,
itching or hives on the skin; fainting;
or hay fever-like symptoms.
_ _
-
_Pregnancy and lactation _
_ _
Ask
your
doctor
or
pharmacist
for
advice before using any medicine.
ACUVAIL™
should not be used if
you
are
pregnant
or
might
become
pregnant or are breast feeding, unless
your doctor recommends it.
-
_Children: _
_ _
Safety
and
effectiveness
of
ACUVAIL™
in
children
have
not
been established.
ACUVAIL™
should
not
be
administered
while
wearing
contact
lenses.
_ _
-
_Before you start use it _
Talk to your doctor if:
-
You are currently using any other
topical NSAIDs.
-
You have bleeding tendencies.
-
You
have
complicated
ocular
surgeries,
diabetes,
dry
eye
syndrome,
rheumatoid
arthritis
(systemic inflammatory disorder that

Vara einkenni

* 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 increas\�ed 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 USAGE2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosing3 DOSAGE FORMS AND STRENG