CHLORSIG 1% chloramphenicol 10 mg/g eye ointment tube

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

chloramphenicol, Quantity: 10 mg/g

Saatavilla:

Aspen Pharma Pty Ltd

INN (Kansainvälinen yleisnimi):

Chloramphenicol

Lääkemuoto:

Eye Ointment

Koostumus:

Excipient Ingredients: Wool fat; liquid paraffin; white soft paraffin

Antoreitti:

Ophthalmic

Kpl paketissa:

4g

luokka:

Medicine Registered

Prescription tyyppi:

(S3) Pharmacist Only Medicine

Käyttöaiheet:

INDICATIONS AS AT 29 January 2001: For the treatment of bacterial conjunctivitis and other superficial ocular infections caused by chloramphenicol-sensitive organisms.

Tuoteyhteenveto:

Visual Identification: White opaque ointment; Container Type: Tube; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

1991-10-14

Pakkausseloste

Chlorsig® eye drops and ointment
1
CHLORSIG®
EYE DROPS AND EYE OINTMENT
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CHLORSIG?
Chlorsig contains the active ingredient chloramphenicol. Chlorsig is
used to treat an eye infection called bacterial conjunctivitis,
which is a bacterial infection involving the mucous membrane of the
surface of the eye.
For more information, see Section 1. Why am I using Chlorsig?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CHLORSIG?
Do not use if you have ever had an allergic reaction to Chlorsig or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Chlorsig?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Chlorsig and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE CHLORSIG?
•
The dose of Chlorsig may be different for each person and their
medical condition. Your doctor, optometrist or pharmacist
will recommend the right dose for you.
•
Usual recommended doses for adults and children (2 years and over):
_Chlorsig eye drops:_ Instil 1 or 2 eye drops in the affected eye(s)
every two to six hours for up to 5 days or as directed by
your doctor, optometrist or pharmacist.
_Chlorsig eye ointment: _Apply 1.5 cm of eye ointment every three
hours for up to 5 days or as directed by your doctor,
optometrist or pharmacist.
More instructions can be found in Section 4. How do I use Chlorsig? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CHLORSIG?
THINGS YOU
SHOULD DO
•
Use Chlorsig exactly as directed.
•
Remind any doctor, dentist, optometrist or pharmacist you visit that
you are using

Valmisteyhteenveto

1
AUSTRALIAN PRODUCT INFORMATION
– CHLORSIG (CHLORAMPHENICOL) EYE DROPS AND EYE OINTMENT
1
NAME OF THE MEDICINE
Chloramphenicol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CHLORSIG EYE DROPS contains 0.5% w/v chloramphenicol.
CHLORSIG EYE OINTMENT contains 1.0% w/w chloramphenicol.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CHLORSIG EYE DROPS is a clear to slightly hazy colourless, slightly
viscous liquid and odourless. It
contains chloramphenicol 0.5% w/v in aqueous base thickened with
hypromellose. Phenylmercuric
acetate (0.002% w/v) is used as a preservative.
CHLORSIG EYE OINTMENT is a yellowish-white, slightly translucent
suspension ointment, free of visible
contamination, with an odour faintly of paraffin and wool fat. It
contains chloramphenicol 1.0% w/w
in a sterile oculentum base. Contains no preservatives.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the treatment of bacterial conjunctivitis. For use under medical
supervision only in the treatment
of other superficial ocular infections caused by
chloramphenicol-sensitive organisms.
4.2
D
OSE AND METHOD OF ADMINISTRATION
CHLORSIG EYE DROPS:
Adults and children 2 years and over: Instil 1 or 2 drops in the
affected eye(s) every two to six hours
for two to three days. The interval between applications may then be
increased. Treatment should
be continued for at least 48 hours after the eye appears normal. Do
not use for more than 5 days in
total except on medical advice.
To minimise contamination do not allow the dropper to contact the
surface of the eye.
The systemic absorption of CHLORSIG eye drops can be minimised by
applying gentle pressure on the
tear-duct for approximately one minute immediately after application.
2
Discard solution within one month of opening container.
CHLORSIG EYE OINTMENT:
Adults and children 2 years and over: Apply 1.5 cm of ointment into
the affected eye(s) every three
hours. If ointment is used together with drops for day and night
coverage, 1.5 cm should be applied
befo