国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
ceftazidime pentahydrate, Quantity: 2.33 g
AFT Pharmaceuticals Pty Ltd
ceftazidime pentahydrate
Injection, powder for
Excipient Ingredients: sodium carbonate
Intravenous
5 vials, 10 vials, 1 vial
(S4) Prescription Only Medicine
Ceftazidime-AFT is indicated for the treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials, but not to ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other pseudomonal antibiotics cannot be used. Indications include: ? Severe infections in general: for example septicaemia, including neonatal sepsis, bacteraemia, and in patients in intensive care units with specific problems, eg, infected burns. ? Respiratory tract infections: for example, pneumonia, broncho-pneumonia, infected pleurisy, infected bronchiectasis and bronchitis. ? Severe ear, nose and throat infections: for example, otitis media, mastoiditis. ? Urinary tract infections: for example, acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), and infections associated with bladder and renal stones. ? Skin and soft tissue infections: for example, erysipelas, abscesses, cellulitis, infected burns and wounds, mastitis. ? Gastrointestinal and abdominal infections: for example, intra-abdominal abscesses, enterocolitis. ? Bone and joint infections: for example, osteitis, osteomyelitis, septic arthritis, infected bursitis.
Visual Identification: White or almost white crystalline powder; Container Type: Vial; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-09-22
Ceftazidime-AFT _Ceftazidime Powder for Injection 1g and 2g _ _Consumer Medicine Information _ WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you use Ceftazidime-AFT. This leaflet answers some common questions about Ceftazidime-AFT. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Sometimes new risks are found even when a medicine has been used for many years. Your doctor has weighed the expected benefits of you taking Ceftazidime-AFT against the risks this medicine could 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 IS CEFTAZIDIME-AFT USED FOR? Ceftazidime-AFT belongs to a group of medicines called cephalosporins. Ceftazidime-AFT is used to treat a wide range of infections caused by bacteria. These infections may affect the chest (bronchitis or pneumonia), ears, nose, throat, bladder and urinary tract, skin and soft tissue, stomach or bones. Ceftazidime-AFT works by killing the bacteria that cause these infections. Your doctor may have prescribed Ceftazidime-AFT for another reason. There is no evidence that Ceftazidime-AFT injection is addictive. BEFORE YOU ARE GIVEN CEFTAZIDIME-AFT WHEN YOU MUST NOT BE GIVEN IT: You must not be given Ceftazidime-AFT if: • you have ever had an allergic reaction to cephalosporins, penicillins or any of the ingredients listed toward the end of this leaflet. (See "Ingredients") • the expiry date (EXP) printed on the pack has passed. • the packaging is torn or shows signs of tampering TELL YOUR DOCTOR IF: You must tell your doctor if: • you are allergic to foods, dyes, preservatives or any other medicines (in particular cephalosporins, penicillins, chloramphenicol or lignocaine) • you are taking any other medicines, including medicines you buy without a prescription • you are taking oral contraceptives (birth control p 阅读完整的文件
Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION CEFTAZIDIME-AFT (CEFTAZIMIDE PENTAHYDRATE) POWDER FOR INJECTION 1. NAME OF THE MEDICINE Ceftazidime (as pentahydrate) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ceftazidime-AFT is a cephalosporin antibiotic for use by injection only. It is supplied as a white or almost white crystalline powder in vials containing 1 g and 2 g ceftazidime (as pentahydrate) with sodium carbonate anhydrous (118 mg per gram of ceftazidime). On the addition of Water for Injections, Ceftazidime-AFT Injection dissolves with effervescence to produce a solution for injection. Ceftazidime-AFT Injection contains approximately 52 mg (2.3 mEq) of sodium per gram of ceftazidime. 1.16 g ceftazidime pentahydrate is equivalent to 1g ceftazidime free acid. For laboratory tests associated with ceftazidime administration, ceftazidime pentahydrate should be used. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM The drug product is white or almost white crystalline powder. Powder for injection 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceftazidime-AFT is indicated for the treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials, but not to ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other pseudomonal antibiotics cannot be used. Indications include: • _SEVERE INFECTIONS IN GENERAL_ : for example septicaemia, including neonatal sepsis, bacteraemia, and in patients in intensive care units with specific problems, eg, infected burns. • _RESPIRATORY TRACT INFECTIONS_ : for example, pneumonia, broncho-pneumonia, infected pleurisy, infected bronchiectasis and bronchitis. Page 2 of 14 • _SEVERE EAR, NOSE AND THROAT INFECTIONS_ : for example, otitis media, mastoiditis. • _URINARY TRACT INFECTIONS_ : for example, acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial 阅读完整的文件