Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
ceftazidime pentahydrate, Quantity: 1165 mg (Equivalent: ceftazidime, Qty 1 g)
Southern XP IP Pty Ltd
ceftazidime pentahydrate
Injection, powder for
Excipient Ingredients: sodium carbonate; carbon dioxide
Intramuscular, Intravenous
5 vials
(S4) Prescription Only Medicine
Treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials, but not to ceftazidime; as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other antipseudomonal antibiotics cannot be used. Indications include the following. Severe infections in general. For example: septicaemia (including neonatal sepsis), bacteraemia; in patients in intensive care units with specific problems, e.g. infected burns. Respiratory tract. eg: pneumonia, bronchopneumonia, infected pleurisy, infected bronchiectasis and bronchitis. Severe ear, nose and throat infections. For example: otitis media, mastoiditis. Urinary tract. For example: acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only); infections associated with bladder and renal stones. Skin and soft tissue. For example: erysipelas, abscesses, cellulitis, infected burns and wounds, mastitis. Gastrointestinal and abdominal. For example: intra-abdominal abscesses, enterocolitis. Bone and joint. For example: osteitis, osteomyelitis, septic arthritis, infected bursitis.
Visual Identification: White to cream coloured crystalline powder; Container Type: Vial; Container Material: Glass Type III Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2008-10-14
________________________________________________________________________________ C:Products/Cefs/Ceftazidime/CMI 30oct08 30/10/08 Page 1 of 2 CEFTAZIDIME SXP _Ceftazidime _ CONSUMER MEDICINE INFORMATION What is in this leaflet Please read this leaflet carefully before you use Ceftazidime SXP. This leaflet answers some common questions about Ceftazidime SXP. 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 SXP 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 Ceftazidime SXP is used for Ceftazidime SXP belongs to a group of medicines called cephalosporins. Ceftazidime SXP 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 SXP works by killing the bacteria that cause these infections. Your doctor may have prescribed Ceftazidime SXP for another reason. There is no evidence that Ceftazidime SXP injection is addictive. Before you are given Ceftazidime SXP _When you must not be given it: _ _ _ YOU MUST NOT BE GIVEN CEFTAZIDIME SXP 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 Read the complete document
C:Products/Cefs/Ceftazidime/PI 1sep08 1/9/08 Page 1 of 12 PRODUCT INFORMATION CEFTAZIDIME SXP NAME OF THE MEDICINE PROPRIETARY NAMES: Ceftazidime SXP 1g Ceftazidime SXP 2g NON PROPRIETARY NAMES: Ceftazidime (as pentahydrate) powder for injection 1 g Ceftazidime (as pentahydrate) powder for injection 2 g CHEMICAL NAME:_ _ (6_R_,7_R_)-7-[[(Z)-2-(2-aminothiazol-4-yl)-2-[(1-carboxy-1- methylethoxy)imino]acetyl]amino]-8-oxo-3-[(1-pyridinio)methyl]-5-thia-1-azabicyclo- [4.2.0]oct-2-ene-2-carboxylate pentahydrate MOLECULAR FORMULA: C 22 H 22 N 6 O 7 S 2 .5H 2 O MOLECULAR WEIGHT: 636.6 STRUCTURE: _ _ The chemical structure of ceftazidime pentahydrate is: CAS NUMBER: 78439-06-2_ _ C:Products/Cefs/Ceftazidime/PI 1sep08 1/9/08 Page 2 of 12 DESCRIPTION Ceftazidime is a cephalosporin antibiotic for use by injection only. It is a white or almost white crystalline powder in vials containing ceftazidime as pentahydrate, with sodium carbonate anhydrous. On the addition of water for injections, Ceftazidime SXP injection dissolves with effervescence to produce a solution for injection. Ceftazidime SXP injection contains approximately 52 mg (2.3 mEq) of sodium per g of ceftazidime. Ceftazidime pentahydrate 116 mg is equivalent to ceftazidime anhydrous 100 mg. For laboratory tests associated with ceftazidime administration, ceftazidime pentahydrate should be used. PHARMACOLOGY ACTIONS: Antibiotic MICROBIOLOGY: Ceftazidime is bactericidal in action, exerting its effect on target cell wall proteins and causing inhibition of cell wall synthesis. It is stable to most beta-lactamases produced by Gram positive and Gram negative organisms and consequently is active against many ampicillin and cephalothin resistant strains (but not methicillin resistant strains). Ceftazidime has been shown to have in vitro activity against the following organisms. _ _ _GRAM NEGATIVE ORGANISMS._ _Pseudomonas aeruginosa_, Pseudomonas sp. (other), _Klebsiella _ _pneumoniae_, Klebsiella sp. (other), _Proteus mirabilis, P. vulgaris, Morganella morganii_ (formerly Read the complete document