| Customization: | Available |
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| Application: | Internal Medicine |
| Usage Mode: | for Injection |
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| PRODUCT NAME: | Cefotaxime Sodium for Injection |
| STRENGTH: | 0.25g, 0.5g, 1.0g, 2.0g |
| PACKING DETAILS: | 10 vials/box; 50 vials/box |
| STORAGE: | Store in a cool and dry place below 25ºC, protected from light. |
| SHELF LIFE: | 36 months |
| REGISTRATION DOSSIERS ARE AVAILABLE. | |
| CONSIGNMENT MANUFACTURING, BRAND OEM/ODM SERVICE IS AVAILABLE. | |
1. Cefotaxime is indicated in the treatment of serious infections, either before the infecting organism has been identified or when caused by bacteria of established sensitivity, including
osteomyelitis,
septicaemia,
bacterial endocarditis,
meningitis, and
peritonitis.
and other serious bacterial infections suitable for parenteral antibiotic therapy.
2. Cefotaxime may be used for pre-operative prophylaxis in patients undergoing surgical procedures, that may be classified as contaminated or potentially so.
2. Posology and method of administration
Cefotaxime may be administered intravenously, by bolus injection or by infusion, or by intramuscular injection. The dosage, route and frequency of administration should be determined by the severity of infection, the sensitivity of causative organisms and condition of the patient. Therapy may be initiated before the results of sensitivity tests are known.
Adults:
The recommended dosage for mild to moderate infections is 1g 12 hourly. However, dosage may be varied according to the severity of the infection, sensitivity of causative organisms and condition of the patient. Therapy may be initiated before the results of sensitivity tests are known.
In severe infections dosage may be increased up to 12g daily given in three or four divided doses. For infections caused by sensitive Pseudomonas species daily doses of greater than 6g will usually be required.
Children:
The usual dosage range is 100-150mg/kg/day in two to four divided doses. However, in very severe infection doses of up to 200mg/kg/day may be required.
Neonates: The recommended dosage is 50mg/kg/day in two to four divided doses. In severe infections 150-200mg/kg/day, in divided doses, have been given.
Dosage in renal impairment: Because of extra-renal elimination, it is only necessary to reduce the dosage of cefotaxime in severe renal failure (GFR <5ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1g, daily dose should be halved without change in the frequency of dosing, i.e. 1g twelve hourly becomes 0.5g twelve hourly, 1g eight hourly becomes 0.5g eight hourly, 2g eight hourly becomes 1g eight hourly etc. As in all other patients, dosage may require further adjustment according to the course of the infection and the general condition of the patient.
Dosage in hepatic impairment: No dosage adjustment is required.
Intravenous and Intramuscular Administration: Reconstitute cefotaxime with Water for Injections PhEur as directed in Section 6.6 (Instructions for use/handling). Shake well until dissolved and then withdraw the entire contents of the vial into the syringe.
Intravenous administration (Injection or Infusion): Cefotaxime may be administered by intravenous infusion using the fluids stated in Section 6.6 (Instructions for use/handling). The prepared infusion may be administered over 20-60 minutes.
For intermittent I.V. injections, the solution must be injected over a period of 3 to 5 minutes. During post-marketing surveillance, potentially life-threatening arrhythmia has been reported in a very few patients who received rapid intravenous administration of cefotaxime through a central venous catheter.
Cefotaxime and aminoglycosides should not be mixed in the same syringe or perfusion fluid.
3. Contraindications
Hypersensitivity to cephalosporins.
In patients with a history of hypersensitivity to Cefotaxime and/or to any component of Cefotaxime 2g Powder for solution for injection or infusion, a penicillin or to any other type of beta-lactam drug.
Allergic cross reactions can exist between penicillins and cephalosporins (see section 44.).
For pharmaceutical forms containing lidocaine:
• known history of hypersensitivity to lidocaine or other local anaesthetics of the amide type
• non-paced heart block
• severe heart failure
• administration by the intravenous route
• infants aged less than 30 months of age.
4.Undesirable effects
Jarisch-Herxheimer reaction
For the treatment of borreliosis, a Jarisch-Herxheimer reaction may develop during the first days of treatment.
The occurrence of one or more of the following symptoms has been reported after several week's treatment of borreliosis: skin rash, itching, fever, leucopenia, increase in liver enzymes, difficulty of breathing, joint discomfort.
Hepatobiliary disorders
Increase in liver enzymes (ALAT, ASAT, LDH, gamma-GT and/or alkaline phosphatase) and/or bilirubin have been observed. These laboratory abnormalities may rarely exceed twice the upper limit of the normal range and elicit a pattern of liver injury, usually cholestatic and most often asymptomatic.
5.Overdose
Symptoms of overdose may largely correspond to the profile of side effects.
There is a risk of reversible encephalopathy in cases of administration of high doses of β-lactam antibiotics including cefotaxime.
In case of overdose, cefotaxime must be discontinued, and supportive treatment initiated, which includes measures to accelerate elimination, and symptomatic treatment of adverse reactions (e.g. convulsions).
No specific antidote exists. Serum levels of cefotaxime may be reduced by peritoneal dialysis or haemodialysis.
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Brief Introduction to Our Company:
Shandong Sino Pharmaceutical Technology Co., Ltd. (S.S.P.T.) is a different kind of pharmaceuticals (both finished medicine products and raw materials), health products, cosmetics and medical supplies company for human needs, focusing on global markets, especially the developing world. Working with the highest levels of government and local distributors alike, we aim to not only expand our business scale and scope but also have a special interest in serving the needs of the end consumer that requires our products the most. To this end, we have a presence in 5 continents with an expanding product range to meet the demand of our main markets.
Moreover, our manufacturing facilities follow strict GMP rules and regulations. We have intergraded all GMP guidelines into internal procedures improving the degree to which results are consistently exceeding expectations. As one of the best pharmaceutical companies in China, we take our ethical obligation to improving access to high quality and affordable WHO essential drugs seriously. This is the ethical basis our company was founded on.
Consignment Manufacturing, Brand OEM/ODM Service are available.
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