TOBREX STERILE OPHTHALMIC SOLUTION 0.3%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

TOBRAMYCIN

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

S01AA12

Dosage:

3 mg/ml

Pharmaceutical form:

SOLUTION

Composition:

TOBRAMYCIN 3 mg/ml

Administration route:

OPHTHALMIC

Prescription type:

Prescription Only

Manufactured by:

ALCON-COUVREUR NV

Authorization status:

ACTIVE

Authorization date:

1990-05-22

Summary of Product characteristics

Tobrex
®
Ophthalmic Solution May 2021.SIN Page 1 of 10 1. NAME OF THE MEDICINAL PRODUCT TOBREX
®
3 mg/mL Tobramycin sterile eye drops, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of solution contains 3 mg tobramycin.
Preservative: 1 mL of solution contains 0.1 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Sterile ophthalmic solution.
Clear, colourless to pale yellow or brown solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tobrex
®
Ophthalmic Solution contains tobramycin, a water-soluble
aminoglycoside
antibiotic
active
against a wide variety of gram- negative and gram-positive ophthalmic
pathogens.
Tobrex
®
Ophthalmic Solution is a topical antibiotic indicated in the treatment
of external infections of the
eye and
its adnexa caused by susceptible
bacteria. Appropriate monitoring of bacterial response
to
topical antibiotic therapy should accompany the use of Tobrex
®
Ophthalmic Solution. Clinical studies
have
shown tobramycin to be safe and effective for use in children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
As indicated by physician:
In mild to moderate disease, instill 1 to 2 drops into the affected
eye(s) every 4 hours. In severe
infections, instill 2 drops into the eye(s) hourly until improvement,
following which treatment should
be reduced prior to discontinuation.
Tobrex
®
ophthalmic ointment may be used in conjunction with Tobrex
®
ophthalmic solution.
Tobrex
®
Ophthalmic Solution May 2021.SIN Page 2 of 10
Use in children
The safety and efficacy of Tobrex
®
ophthalmic solution in children younger than 1 year of age have
not
been established.
Use in patients with hepatic or renal impairment
The safety and efficacy of Tobrex
®
ophthalmic solution in patients with hepatic or renal impairment
have
not been established.
Use in elderly population
No overall clinical differences in safety or efficacy have been
observed between the elderly and other
adult populations.
Method of administration
For ocular use.
Keep