ZADITEN EYE DROPS 0.25 mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ketotifen fumarate 0.345mg eqv ketotifen

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

S01GX08

Dosage:

0.25 mg/ml

Pharmaceutical form:

SOLUTION

Composition:

Ketotifen fumarate 0.345mg eqv ketotifen 0.25 mg/ml

Administration route:

OPHTHALMIC

Prescription type:

Prescription Only

Manufactured by:

Excelvision Annonay

Authorization status:

ACTIVE

Authorization date:

2003-02-25

Patient Information leaflet

Ophthalmologicals, other antiallergics.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Zaditen: Eye drops, solution in a 5 mL bottle.
Clear, colorless to faintly yellow solution.
ACTIVE SUBSTANCE
Ketotifen hydrogen fumarate
ZADITEN: One mL contains 0.345 mg of ketotifen 
hydrogen fumarate corresponding to 0.25 mg of 
ketotifen.
Each drop contains 8.5 micrograms of ketotifen 
hydrogen fumarate corresponding to 6.15 
micrograms of ketotifen. 
Certain dosage strengths may not be available 
in all countries.
Not all presentations may be available locally.
ACTIVE MOIETY
Ketotifen.
EXCIPIENTS
ZADITEN: Benzalkonium chloride, Glycerol 
(E422), Sodium hydroxide (E524), Water for 
injections
Pharmaceutical formulations may vary between 
countries. 
INDICATIONS
Symptomatic short term treatment of seasonal 
allergic conjunctivitis in adults and children 3 
years or older.
DOSAGE AND ADMINISTRATION
DOSAGE
USE IN ADULTS 
One drop of Zaditen eye drops into the 
conjunctival sac twice a day.
USE IN CHILDREN (AGED 3 YEARS AND ABOVE)
One drop of Zaditen eye drops into the 
conjunctival sac twice a day.
Safety and effectiveness in pediatric patients 
below the age of 3 years have not been 
established.
GERIATRICS 
No dosage adjustment is required in patients 
above 65 years of age.
RENAL IMPAIRMENT 
No dosage adjustment is required in patients 
with renal impairment.
HEPATIC IMPAIRMENT 
No dosage adjustment is required in patients 
with hepatic impairment.
METHOD OF ADMINISTRATION 
ZADITEN: The contents and dispenser remain 
sterile until the original closure is broken. To 
avoid contamination do not touch any surface 
with the dropper tip. The dropper tip should also 
not come into contact with the eye as this may 
cause injury to the eye.
If Zaditen eye drops are used concomitantly 
with other eye medications there must be an 
interval of at least 5 minutes between the two 
medications.
CONTRAINDICATIONS
Known hypersensitivity to ketotifen or to any of 
t

Summary of Product characteristics

Zaditen ED May 2014.SINv3
Page 1 of 10
ZADITEN
® EYE DROP
Ophthalmologicals, other antiallergics.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Zaditen: Eye drops, solution in a 5 mL bottle. Clear, colorless to
faintly yellow solution.
ACTIVE SUBSTANCE
Ketotifen hydrogen fumarate
ZADITEN:
One mL contains 0.345 mg of ketotifen hydrogen fumarate corresponding
to 0.25
mg
of
ketotifen.
Each
drop
contains
8.5
micrograms
of
ketotifen
hydrogen
fumarate
corresponding to 6.15 micrograms of ketotifen.
Certain dosage strengths may not be available in all countries. Not
all presentations may be
available locally.
ACTIVE MOIETY
Ketotifen.
EXCIPIENTS
ZADITEN:
Benzalkonium chloride, Glycerol (E422), Sodium hydroxide (E524), Water
for
Injections.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Symptomatic short term treatment of seasonal allergic conjunctivitis
in adults and children 3
years or older.
Zaditen ED May 2014.SINv3
Page 2 of 10
DOSAGE AND ADMINISTRATION
DOSAGE
USE IN ADULTS
One drop of Zaditen eye drops into the conjunctival sac twice a day.
USE IN CHILDREN (AGED 3 YEARS AND ABOVE)
One drop of Zaditen eye drops into the conjunctival sac twice a day.
Safety and effectiveness in pediatric patients below the age of 3
years have not been
established.
GERIATRICS
No dosage adjustment is required in patients above 65 years of age.
RENAL IMPAIRMENT
No dosage adjustment is required in patients with renal impairment.
HEPATIC IMPAIRMENT
No dosage adjustment is required in patients with hepatic impairment.
METHOD OF ADMINISTRATION
ZADITEN:
The contents and dispenser remain sterile until the original closure
is broken. To
avoid contamination do not touch any surface with the dropper tip. The
dropper tip should also
not come into contact with the eye as this may cause injury to the
eye.
If Zaditen eye drops are used concomitantly with other eye medications
there must be an
interval of at least 5 minutes between the two medications.
CONTRAINDICATIONS
Known hypersensitivity to ketotifen or to any of the exc