Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
ciprofloxacin, Quantity: 2 mg/mL
Aspen Pharmacare Australia Pty Ltd
Ciprofloxacin
Injection, intravenous infusion
Excipient Ingredients: lactic acid; glucose monohydrate; water for injections
Intravenous Infusion
10 x 100 mL bags
(S4) Prescription Only Medicine
Aspen Ciprofloxacin Injection for Intravenous Infusion is indicated for use in the following. Hospitalised adult patients in whom oral ciprofloxacin is indicated but cannot be administered or where the oral form is inappropriate. For the treatment of serious or life-threatening infections due to sensitive organisms involving the following organ systems. Lower respiratory tract infections (Gram-negative organisms), Skin and skin structure, Septicaemia, Bone and joint, Urinary tract. Inhalational anthrax (post exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. Note. Because Gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with Gram-positive infections, such as pneumonia due to Streptococcus pneumoniae. If anaerobic organisms are suspected of contributing to the infection, use of other suitable drugs should be considered. Strains Neisseria gonorrhoea resistant to ciprofloxacin have been reported in Australia. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with ciprofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. Ciprofloxacin is suitable to treat mixed infections caused by susceptible strains of both Gram-negative and Gram-positive aerobic bacteria. If anaerobic organisms are suspected as accompanying aetiological agents, additional therapy should be considered.
Visual Identification: Clear solution free from visible particles; Container Type: Bag; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2006-01-23
ASPEN CIPROFLOXACIN Injection for Intravenous Infusion – CMI Page 1 of 3 ASPEN CIPROFLOXACIN INJECTION FOR INTRAVENOUS INFUSION CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ASPEN CIPROFLOXACIN Injection for Intravenous Infusion. 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 being given ASPEN CIPROFLOXACIN Injection for Intravenous Infusion against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE._ _ _ _ You may need to read it again. WHAT ASPEN CIPROFLOXACIN INJECTION FOR INTRAVENOUS INFUSION IS USED FOR ASPEN CIPROFLOXACIN Injection for Intravenous Infusion contains ciprofloxacin (as ciprofloxacin lactate) as the active ingredient. It belongs to a group of antibiotics called fluoroquinolones. _ _ This medicine is used to treat many different conditions including: • lung infections • infections of skin • infections of bone and joints • kidney and bladder infections • infections in the blood • inhalation of anthrax (post- exposure). It works by killing many kinds of bacteria which cause infections in the body. Ciprofloxacin will not work against infections caused by viruses such as cold and flu. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. It is available only with a doctor’s prescription. There is no evidence that it is addictive. BEFORE YOU ARE GIVEN IT _WHEN YOU MUST NOT BE GIVEN IT _ YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • ciprofloxacin • any other quinolone antibiotics such as grepafloxacin, moxifloxacin, nalidixic acid or norfloxacin • any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may in Lesen Sie das vollständige Dokument
aspen-ciprofloxacin-iv-pi-5dec19 AUSTRALIAN PRODUCT INFORMATION ASPEN CIPROFLOXACIN INJECTION FOR INTRAVENOUS INFUSION 1 NAME OF THE MEDICINE Ciprofloxacin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Aspen Ciprofloxacin Injection for Intravenous Infusion is available as a ciprofloxacin (as lactate) 100 mg/50 mL and a 200 mg/100 mL infusion solution. It also contains the excipients lactic acid (as a solubilising agent), glucose monohydrate (55 mg/mL) and water for injections. 3 PHARMACEUTICAL FORM Aspen Ciprofloxacin Injection for Intravenous Infusion is a synthetic carboxyquinolone derivative with broad spectrum antimicrobial activity for intravenous (IV) administration. Ciprofloxacin is a faint to light yellow crystalline powder. Aspen Ciprofloxacin Injection for Intravenous Infusion is a clear, colourless to a slightly yellowish solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Aspen Ciprofloxacin Injection for Intravenous Infusion is indicated for use in the following: 1. Hospitalised adult patients in whom oral ciprofloxacin is indicated but cannot be administered or where the oral form is inappropriate. 2. For the treatment of serious or life threatening infections due to sensitive organisms involving the following organ systems: - Lower respiratory tract infections (gram-negative organisms) - Skin and skin structure - Septicaemia - Bone and joint - Urinary tract 3. Inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized _Bacillus _ _anthracis. _ Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. aspen-ciprofloxacin-iv-pi-5dec19 Note:_ _Because gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with gram-positive infections due to _ Streptococcus _ _pneumoniae_. If anaerobic organisms are suspected of contributing to the infection, use of other suitabl Lesen Sie das vollständige Dokument