Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
mupirocin, Quantity: 20 mg/g
Southern Cross Pharma Pty Ltd
Mupirocin
Ointment
Excipient Ingredients: macrogol 3350; macrogol 400
Topical
15 gram tube
(S4) Prescription Only Medicine
APO-MUPIROCIN is indicated for the topical treatment of mild impetigo.
Visual Identification: white, semi-transparent homogenous preparation; Container Type: Tube; Container Material: Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-04-12
APO-Mupirocin 1 APO-MUPIROCIN _Contains the active ingredient mupirocin _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about mupirocin ointment. 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 last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Mupirocin. It contains the active ingredient mupirocin. It is used to treat mild impetigo (school sores). Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS _ APO-Mupirocin is for use on your skin only. APO-Mupirocin belongs to a group of medicines called antibiotics. Antibiotics work by killing bacteria which can cause infection. There is no evidence that this medicine is addictive. _USE IN CHILDREN _ This medicine should not be used in children under two years of age. BEFORE YOU USE THIS MEDICINE _WHEN YOU MUST NOT USE IT _ DO NOT USE THIS MEDICINE IF: • YOU ARE HYPERSENSITIVE TO, OR HAVE HAD AN ALLERGIC REACTION TO, MUPIROCIN OR AN Pročitajte cijeli dokument
AUSTRALIAN PRODUCT INFORMATION APO-MUPIROCIN, 20 MG/G (2% W/W) OINTMENT _ _ 1. NAME OF THE MEDICINE Mupirocin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of mupirocin ointment contains 20 mg of mupirocin (2% w/w) as the active ingredient. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM APO-Mupirocin ointment is a white, semi-transparent, homogeneous ointment. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS APO-Mupirocin is indicated for the topical treatment of mild impetigo. 4.2. DOSE AND METHOD OF ADMINISTRATION APO-Mupirocin is intended for topical application only. A small amount of mupirocin ointment should be applied to the affected area three times daily. The area treated may be covered with gauze dressing if desired. Usually treatment should not continue for more than 10 days. Any product remaining at the end of treatment should be discarded. 4.3. CONTRAINDICATIONS APO-Mupirocin is contraindicated in patients who have demonstrated hypersensitivity to mupirocin, mupirocin calcium, or any components of the formulation. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE If a reaction suggesting sensitivity or chemical irritation should occur with the use of APO-Mupirocin, treatment should be discontinued, the product should be wiped off and appropriate alternative therapy for the infection instituted. APO-Mupirocin is not suitable for ophthalmic use, intranasal use or application to other mucosal surfaces. Avoid contact with eyes. If contaminated, the eyes should be thoroughly irrigated with water until the residues have been removed. APO-Mupirocin is not suitable for application to the site of cannulation or for use in conjunction with cannulae. APO-Mupirocin – AUSTRALIAN PRODUCT INFORMATION 2 As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs. Pseudomembranous colitis has been reported with the use of antibiotics and may range in Pročitajte cijeli dokument