TOBRADEX, eye ointment

Quốc gia: Malta

Ngôn ngữ: Tiếng Anh

Nguồn: Medicines Authority

Thành phần hoạt chất:

DEXAMETHASONE; TOBRAMYCIN

Sẵn có từ:

Novartis Pharmaceuticals UK Limited

Mã ATC:

S01CA01

INN (Tên quốc tế):

DEXAMETHASONE; TOBRAMYCIN

Dạng dược phẩm:

EYE OINTMENT

Thành phần:

DEXAMETHASONE 1 mg/g; TOBRAMYCIN 3 mg/g

Loại thuốc theo toa:

POM

Khu trị liệu:

OPHTHALMOLOGICALS

Tình trạng ủy quyền:

Authorised

Tờ rơi thông tin

BASIC PATIENT LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
_Keep this leaflet. You may need to read it again._
_If you have further questions, please ask your doctor or your
pharmacist._
_This medicine has been prescribed for you personally and you should
not pass it on to _
_others. It may harm them, even if their symptoms are the same as
yours._
CONTENT OF THIS LEAFLET:
1.
What TOBRADEX is and what it is used for
2.
Before you use TOBRADEX
3.
How to use TOBRADEX
4.
Possible undesirable effects
5
Storing TOBRADEX
6.
Further information
NAME OF THE MEDICINAL PRODUCT
TOBRADEX, eye drops, suspension
-
The active substances are tobramycin 3 mg/ml and dexamethasone 1
mg/ml.
-
The other ingredients are benzalkonium chloride, tyloxapol, disodium
edetate, sodium
chloride, hydroxyethylcellulose, anhydrous sodium sulfate, sulphuric
acid and/or sodium
hydroxide and purified water to 1ml.
TOBRADEX, eye ointment
-
The active substances are tobramycin 3 mg/g and dexamethasone 1 mg/g.
-
The other ingredients are anhydrous chlorobutanol, liquid paraffin and
vaseline to 1 g.
MARKETING AUTHORISATION HOLDER
Novartis
Pharmaceuticals UK
Limited
Frimley Business Park
Frimley, Camberley
Surrey, GU 16 7SR,
United Kingdom
MANUFACTURER
SA Alcon-Couvreur NV
Rijksweg 14
2870 Puurs
Belgium
MARKETING AUTHORISATION NUMBER
Eye Drops : MA088/05801
1
Eye Ointment : MA088/05802
1.
WHAT TOBRADEX IS AND WHAT IT IS USED FOR
Tobradex, eye drops, suspension, is packed in droptainers of 5 ml, 10
ml and 15 ml.
Tobradex, eye ointment is packed in a tube of 3.5 g.
Tobradex is a combination of a corticosteroid for the treatment of eye
inflammations and an
antibiotic for the treatment of eye infections.
Tobradex is indicated for the treatment of steroid-responsive
inflammations of the eye
surface (cornea and conjunctiva) and front portion of the eye
(uveitis) where there is a
bacterial infection or the risk of a bacterial infection exists in
adults and children aged 2
years and older.
2.
BEFORE YOU USE
TOBRAMYCIN/DEXAMETH

Đặc tính sản phẩm

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TOBRADEX, eye drops, suspension
TOBRADEX, eye ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Eye drops:
tobramycin 3 mg/ml - dexamethasone 1 mg/ml
Eye ointment:
tobramycin 3 mg/g - dexamethasone 1 mg/g
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
-
Eye drops, suspension
-
Eye ointment
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For ocular steroid-responsive inflammatory conditions for which a
corticosteroid is indicated and where
bacterial ocular infection, or a risk of bacterial ocular infection,
exists, due to tobramycin-responsive
microorganisms resistant to most of the other antibiotics, especially
Pseudomonas aeruginosa in adults
and children aged 2 years and older.
Ocular steroids are indicated in inflammatory conditions of the
palpebral and bulbar conjunctiva,
cornea and anterior segment of the globe where the inherent risk of
steroid use in certain infective
conjunctivitis accepted to obtain a diminution in edema and
inflammation. They are also indicated in
chronic anterior uveitis and corneal injury from chemical agents,
radiation, thermal burns, or
penetration of foreign bodies (considering the contraindications).
Corticoids in eye drops or ophthalmic ointment should be prescribed
only after ocular examination.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For ocular use only.
Eye Drops:
One to two drops instilled into the conjunctival sac every 4 hours.
During the initial 24 to 48 hours the
dosage may be increased to 1 or 2 drops every 2 hours. In severe
disease, instill 1 or 2 drops every hour
until inflammation is controlled, and gradually decrease frequency to
1 or 2 drops every 2 hours during
3 days, and thereafter 1 to 2 drops every 4 hours during 5 to 8 days,
and finally 1 to 2 drops every day
during the 5 to 8 last days, if necessary.
Care should be taken not to discontinue therapy prematurely.
After cap is removed, if tamper evident snap collar is loose, remove
before using product.
Page 2 of 9
Ointment