国家: 新西兰
语言: 英文
来源: Medsafe (Medicines Safety Authority)
Ciprofloxacin hydrochloride 111mg equivalent to ciprofloxacin 100 mg (anhydrous); ;
Viatris Limited
Ciprofloxacin hydrochloride 111 mg (equivalent to ciprofloxacin 100 mg; anhydrous)
100 mg
Film coated tablet
Active: Ciprofloxacin hydrochloride 111mg equivalent to ciprofloxacin 100 mg (anhydrous) Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Macrogols Magnesium stearate Maize starch Microcrystalline cellulose Opadry white Y-22-7719 Polydextrose Pregelatinised maize starch Purified water Titanium dioxide Triacetin
Blister pack, PVC/PVdC/Al foil, 14 tablets
Prescription
Prescription
Neuland Laboratories Limited
For complicated urinary tract infections or pyelonephritis due to E.coli in paediatric patients aged 1-17 years. The risk-benefit assessment indicates that administration of ciprofloxacin to paediatric patients is appropriate. Treatment should only be initiated after careful benefit/risk evaluation, due to possible adverse events related to joints/surrounding tissues. The use of ciprofloxacin for other indications is not recommended in children.
Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al foil - 14 tablets - 36 months from date of manufacture stored at or below 25°C
2001-04-27
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION CIPFLOX _CIPROFLOXACIN FILM COATED TABLETS 250 MG, 500 MG AND 750 MG _ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking CIPFLOX. This leaflet answers some common questions about CIPFLOX tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking CIPFLOX against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CIPFLOX IS USED FOR CIPFLOX is used to treat infections of the: bronchial tubes and lungs, skin, bones and joints, kidneys, bladder, genital organs including prostate, abdomen blood. CIPFLOX is also used to treat inhalational anthrax (an infection caused by breathing in the spores of bacteria). CIPFLOX tablets contain the active ingredient ciprofloxacin. It belongs to a group of antibiotics called quinolones. These antibiotics work by killing the bacteria that are causing your infection. Your doctor may have prescribed it for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. CIPFLOX is available only with a doctor’s prescription. There is no evidence that CIPFLOX is addictive. BEFORE YOU TAKE CIPFLOX _WHEN YOU MUST NOT TAKE _ _IT_ DO NOT TAKE CIPFLOX IF YOU HAVE AN ALLERGY TO: ciprofloxacin or any other ingredients listed at the end of this leaflet any of the other quinolone antibiotics, including nalidixic acid, moxifloxacin and norfloxacin. Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT TAKE CIPFLOX IF YOU ARE TAKING A MEDICINE CALLED TIZANIDINE, A 阅读完整的文件
Page 1 of 25 NEW ZEALAND DATA SHEET CIPFLOX 1. PRODUCT NAME CIPFLOX 250 mg, 500 mg and 750 mg, film-coated tablets. CIPFLOX INFUSION, 2 mg/mL, solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg, 500 mg or 750 mg of ciprofloxacin. Each 100 mL bag of infusion contains 200 mg of ciprofloxacin and each 200 mL bag of infusion contains 400 mg of ciprofloxacin. For the full list of excipients, see section 6.1. THIS PRODUCT IS NOT ABLE TO DELIVER ALL APPROVED DOSE REGIMENS. 3. PHARMACEUTICAL FORM CIPFLOX 250 MG TABLETS: White bi-convex round, film-coated tablets marked “CF”, “250” on either side of a score line on one side and “G” on the other side. The score line is not intended for breaking the tablet. CIPFLOX 500 MG TABLETS IN BLISTERS: White bi-convex capsule shaped, film-coated tablets marked “CF”, “500” on either side of a score line on one side and “G” on the other side. Scored CIPFLOX 500 mg tablets can be divided into equal doses. CIPFLOX 500 MG TABLETS IN BOTTLES: White bi-convex capsule shaped, film-coated tablets debossed with “G” on one side of the tablet and “CF 500” on the other side. Unscored CIPFLOX 500 mg tablets must not be halved. CIPFLOX 750 MG TABLETS: White bi-convex capsule shaped, film-coated tablets marked “CF”, “750” on either side of a score line on one side and “G” on the other side. The score line is not intended for breaking the tablet. CIPFLOX INFUSION, 2 MG/ML INFUSION: Clear, odourless, sterile solution in a plastic bag. The pH- value of the solution for infusion ranges from 3.5 to 4.6. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ ADULTS _UNCOMPLICATED AND COMPLICATED INFECTIONS CAUSED BY CIPROFLOXACIN SENSITIVE PATHOGENS:_ Infections of the lower respiratory tract. Page 2 of 25 In the treatment of outpatients with pneumonia due to _Pneumococcus, _ciprofloxacin should not be used as a medicine of first choice. Ciprofloxacin can be regarded as a suitable treatment for pneumonias 阅读完整的文件