Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
cefalotin sodium, Quantity: 1.058 g (Equivalent: cefalotin, Qty 1 g)
Juno Pharmaceuticals Pty Ltd
Injection, powder for
Excipient Ingredients: sodium bicarbonate
Intravenous, Intramuscular
10 x 10mL vial
(S4) Prescription Only Medicine
INDICATIONS: Cephalothin Sodium for injection is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Culture and susceptibility studies should be performed. However, therapy may be instituted before results of susceptibility studies are obtained (see PHARMACOLOGY: Microbiology). Respiratory tract: Infections caused by S. pneumoniae, Staphylococci (penicillinase and nonpenicillinase producing), group A Beta-haemolytic Streptococci, Klebsiella, and H. influenzae. Skin and soft tissue: Infections, including peritonitis, caused by Staphylococci (penicillinase and nonpenicillinase producing), group A Beta-haemolytic Streptococci, E.coli, Pr. mirabilis and Klebsiella. Genitourinary tract: Infections caused by E. coli, Pr. mirabilis and Klebsiella. Septicaemia, including endocarditis: Infections caused by S. pneumoniae, Staphylococci (penicillinase and nonpenicillinase producing), group A Beta-haemolytic Streptococci, S. viridans, E. coli, Pr. mirabilis and Klebsiella. Bone and joint: Infection caused by Staphylococci (penicillinase and non-penicillinase producing). Prophylactically in vaginal hysterectomy, head and neck surgery, insertion of prosthetic heart valves, and prosthetic arthroplasty. Cephalothin is not recommended for gastrointestinal procedures or other sites where anaerobic organisms such as Bacteriodes tend to prevail. Dosage is required pre-, intra-and postoperatively (i.e perioperatively, see DOSAGE AND ADMINISTRATION). If signs of postoperative infection develop, specimens should be cultured to identify the causative organism so that appropriate therapy can be instituted. NOTE: If the susceptibility tests show that the causative organism is resistant to cephalothin, other appropriate antibiotic therapy should be instituted.
Visual Identification: white to almost white powder or plug in a 10mL type III clear glass vial, with a rubber stopper closure and aluminium flip-off top.; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
1998-11-11
DBL™ CEPHALOTHIN FOR INJECTION 1 DBL™ CEPHALOTHIN SODIUM FOR INJECTION _Cefalotin Sodium (ke-fä-lö-thin) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL Cephalothin Sodium for Injection. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you being given DBL Cephalothin Sodium for Injection against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DBL CEPHALOTHIN SODIUM FOR INJECTION IS USED FOR DBL Cephalothin Sodium for Injection is an antibiotic used to treat infections in different parts of the body caused by bacteria. This medicine will not work against infections caused by viruses such as colds or the flu. Cefalotin sodium belongs to a group of antibiotics called cephalosporins (ke-fä-lö-spör-ins). It works by killing the bacteria causing your infection or by stopping its growth. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CEFALOTIN SODIUM HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. There is no evidence that cefalotin sodium is addictive. BEFORE YOU ARE GIVEN DBL CEPHALOTHIN SODIUM FOR INJECTION _WHEN YOU MUST NOT BE _ _GIVEN IT _ YOU SHOULD NOT BE GIVEN DBL CEPHALOTHIN SODIUM FOR INJECTION IF YOU HAVE AN ALLERGY TO: • any medicine containing cefalotin sodium • any other cephalosporins • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching, difficulty breathing, swelling of the face, lips or tongue. • you have had a serious allergic reaction to penicillins • the packaging is torn or shows signs of tampering • the expiry date on the pack has pa Прочитайте повний документ
Version: pfpcephv20619 Supersedes: pfpceph10619 Page 1 of 12 AUSTRALIAN PRODUCT INFORMATION – DBL™ CEPHALOTHIN SODIUM FOR INJECTION (CEFALOTIN SODIUM) 1. NAME OF THE MEDICINE Cefalotin sodium 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL™ Cephalothin Sodium for Injection contains the active ingredient cefalotin sodium and sodium bicarbonate. A 10% or 25% solution of cefalotin sodium in water has a pH of 4.5 to 7. However, precipitation may occur in solutions with a pH of less than 5. Therefore, sodium bicarbonate has been added to result in reconstituted solutions having a pH ranging between 6 and 8.5. 1.06 g of cefalotin sodium is approximately equivalent to 1 g of Cefalotin. Each gram of cefalotin sodium represents 2.39 mmol of sodium. The total sodium content is approximately 63 mg (sodium ion 2.8 mEq) per gram of DBL™ Cephalothin Sodium for Injection. For the full list of excipients, see Section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM DBL™ Cephalothin Sodium for injection is a powder for injection that occurs as a white to off white, almost odourless, crystalline powder. The drug is freely soluble in water, sodium chloride 0.9% solution and in glucose solutions. It is slightly soluble in dehydrated alcohol, and practically insoluble in ether and most other organic solvents. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL™ Cephalothin Sodium for Injection is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Culture and susceptibility studies should be performed. However, therapy may be instituted before results of susceptibility studies are obtained (see Section 5.1 Pharmacodynamic properties). _Respiratory tract:_ Infections caused by _S. pneumoniae, Staphylococci_ (penicillinase and nonpenicillinase producing), group A beta haemolytic _Streptococci, _ _Klebsiella_ , and _H. _ _influenzae. _ _Skin and soft tissue:_ Infections, including peritonitis, caused by _Staphylococci_ (penicillinase Прочитайте повний документ