Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
chloramphenicol, Quantity: 10 mg/g
Aspen Pharma Pty Ltd
Chloramphenicol
Eye Ointment
Excipient Ingredients: Wool fat; liquid paraffin; white soft paraffin
Ophthalmic
4g
Medicine Registered
(S3) Pharmacist Only Medicine
INDICATIONS AS AT 29 January 2001: For the treatment of bacterial conjunctivitis and other superficial ocular infections caused by chloramphenicol-sensitive organisms.
Visual Identification: White opaque ointment; Container Type: Tube; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-10-14
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 Soma hati kamili
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 Soma hati kamili