BROMSITE

Страна: Израел

Език: английски

Източник: Ministry of Health

Активна съставка:

BROMFENAC AS SODIUM SESQUIHYDRATE

Предлага се от:

TARO INTERNATIONAL LTD, ISRAEL

АТС код:

S01BC11

Лекарствена форма:

OPHTHALMIC SOLUTION

Композиция:

BROMFENAC AS SODIUM SESQUIHYDRATE 0.075 %W/W

Начин на приложение:

OCULAR

Вид предписание :

Required

Произведено от:

WOODSTOCK STERILE SOLUTIONS, INC, USA

Терапевтична област:

BROMFENAC

Терапевтични показания:

For the treatment of postoperative inflammation and prevention of ocular pain in adult patients undergoing cataract surgery

Дата Оторизация:

2020-12-13

Листовка

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PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor's prescription only
BROMSITE
0.075%
Eye drops
Active ingredient and quantity: Each gram contains 0.75 mg bromfenac
(as sodium
sesquihydrate)
Inactive ingredients and allergens: see section 2 under ‘Important
information about some of
this medicine’s ingredients’, and section 6 ‘Additional
information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Bromsite is intended for the treatment of postoperative inflammation
and prevention of ocular
pain in adult patients undergoing cataract surgery.
THERAPEUTIC GROUP:
Nonsteroidal anti-inflammatory drug (NSAID)
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to bromfenac or any of the other
ingredients in this medicine (see section 6).
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
Use of topical nonsteroidal anti-inflammatory drugs more than 24 hours
prior to surgery or
use beyond 14 days postsurgery may increase patient risk for the
occurrence and severity of
corneal adverse events.
Do not use Bromsite while wearing contact lenses. See section 2 under
‘Important
information about some of this medicine’s ingredients’.
BEFORE USING BROMSITE, TELL YOUR DOCTOR IF:
•
You have a bleeding tendency
•
You suffer from:
- Diabetes,
- Ocular surface diseases (e.g., dry eye syndrome),
- Rheumatoid arthritis,
- Repeat ocular surgeries within a short period of time.
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If you suffer from one of the above conditions, you may be at
increased risk for corneal
adverse events which may become sight threatening. Use topical
nonsteroida

Данни за продукта

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SUMMARY OF PRODUCT CHARACTERISTICS
BROMSITE
1.
NAME OF THE MEDICINAL PRODUCT
Bromsite
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 0.75 mg bromfenac
(as sodium sesquihydrate)
3.
PHARMACEUTICAL FORM
Ophthalmic solution
4.
THARAPEUTIC INDICATION
Bromsite is indicated for the treatment of postoperative inflammation
and prevention of
ocular pain in adult patients undergoing cataract surgery.
5.
DOSAGE AND ADMINISTRATION
5.1 RECOMMENDED DOSING
One drop of Bromsite should be applied to the affected eye twice daily
(morning and
evening) 1 day prior to surgery, the day of surgery, and 14 days
postsurgery.
5.2 USE WITH OTHER TOPICAL OPHTHALMIC MEDICATIONS
Bromsite should be administered at least 5 minutes after instillation
of other topical
medications. Bromsite may be administered in conjunction with other
topical ophthalmic
medications such as alpha-agonists, beta-blockers, carbonic anhydrase
inhibitors,
cycloplegics, and mydriatics.
6.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the inactives
listed in section 10.
7.
WARNINGS AND PRECAUTIONS
7.1 SLOW OR DELAYED HEALING
All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including
Bromsite
(bromfenac ophthalmic solution) 0.075%, may slow or delay healing.
Topical
corticosteroids are also known to slow or delay healing. Concomitant
use of topical
NSAIDs and topical steroids may increase the potential for healing
problems.
7.2 POTENTIAL FOR CROSS-SENSITIVITY
There is the potential for cross-sensitivity to acetylsalicylic acid,
phenylacetic acid
derivatives, and other NSAIDs, including Bromsite. Therefore, caution
should be used
when treating individuals who have previously exhibited sensitivities
to these drugs.
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7.3 INCREASED BLEEDING TIME OF OCULAR TISSUE
With some NSAIDs, including Bromsite, there exists the potential for
increased bleeding
time due to interference with platelet aggregation. There have been
reports that ocularly
applied NSAIDs may cause increased bleeding of ocular tissues
(includin