Zaditen

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Ketotifen fumarate 345 µg/mL equivalent to ketotifen 250 µg/mL;  

から入手可能:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN（国際名）:

Ketotifen fumarate 345 µg/mL (equivalent to ketotifen 250 µg/mL)

投薬量:

0.25 mg/mL

医薬品形態:

Eye drops, solution

構図:

Active: Ketotifen fumarate 345 µg/mL equivalent to ketotifen 250 µg/mL   Excipient: Benzalkonium chloride Glycerol Sodium hydroxide Water for injection

パッケージ内のユニット:

Bottle, dropper, LDPE, 2.5 mL

クラス:

Pharmacy only

処方タイプ:

Pharmacy only

製:

Novartis Pharma AG

適応症:

Treatment and prevention of signs and symptoms of seasonal allergic conjunctivitis.

製品概要:

Package - Contents - Shelf Life: Bottle, dropper, LDPE (5mL bottle with 2.5mL fill) - 2.5 mL - 18 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C - Bottle, dropper, LDPE - 5 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

承認日:

2002-12-03

情報リーフレット

Internal document code
1
Zad280820cNZ
ZADITEN
® EYE DROPS 0.25 MG/ML_ _
_Ketotifen_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
YOU START TO USE ZADITEN EYE
DROPS.
This leaflet answers some common
questions about Zaditen Eye Drops.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on
the final page. More recent
information on the medicine may
be available.
YOU SHOULD ENSURE THAT YOU
SPEAK TO YOUR PHARMACIST OR
DOCTOR TO OBTAIN THE MOST UP TO
DATE INFORMATION ON THE
MEDICINE.
YOU CAN ALSO DOWNLOAD THE MOST
UP TO DATE LEAFLET FROM
www.medsafe.govt.nz.
The updates may contain important
information about the medicine and
its use of which you should be
aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Zaditen
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ZADITEN IS USED FOR
Zaditen contains ketotifen which is
a histamine H 1- receptor
antagonist. This class of medicines
block histamine and other agents in
the body that cause allergic
reactions.
Zaditen is used to treat the short-
term
symptoms of seasonal
allergic
conjunctivitis (itchy, watery
or
swollen eyes and/or eyelids).
Before prescribing Zaditen Eye
Drops your doctor or pharmacist
will have examined your eye(s) and
decided that Zaditen Eye Drops is
the right medicine for you.
Your doctor or pharmacist may
have
given it to you for another
reason.
Ask your pharmacist or doctor if
you have any questions about why
this medicine has been given to
you.
This medicine is not addictive.
This medicine is available from a
pharmacy.
_USE IN CHILDREN _
Zaditen is not for use in children
under 3 years of age. The safety
and effectiveness of Zaditen in this
age group has not been establi

製品の特徴

NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ZADITEN
®
Eye Drops 0.25 mg/mL, multi-dose bottle.
ZADITEN
®
Eye Drops 0.25 mg/mL, single dose unit.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zaditen contains the active ingredient ketotifen fumarate 0.345 mg in
1 mL equivalent to
ketotifen 0.25 mg in 1 mL.
Excipient with known effect
Benzalkonium chloride 0.1 mg/mL as a preservative in the multi-dose
bottle.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to faintly yellow solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment and prevention of signs and symptoms of seasonal allergic
conjunctivitis.
4.1
DOSE AND METHOD OF ADMINISTRATION
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 paediatric 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.
Multi-dose bottles
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.
Unpreserved single dose units
The contents remain sterile until the original closure is broken. To
avoid contamination
do not touch any surface with the tip of the container. The tip of the
container 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.
4.3
CONTRAINDICATIONS
Known hypersensitivity to ketotifen or any of the excipient