Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CEFTRIAXONE SODIUM
ROCHE (MALAYSIA) SDN. BHD.
CEFTRIAXONE SODIUM
1Units Units; 1 Ampoules; 1 Vials
F.HOFFMANN-LA ROCHE LTD
NOT APPLICABLE Läs hela dokumentet
September 2020 Product Information FE/English Ro 13-9904 Rocephin September 2020 Product Information FE/English 1 ROCEPHIN® Ceftriaxone BROAD-SPECTRUM CEPHALOSPORIN ANTIBIOTIC 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Pharmacotherapeutic group: Antibacterials for systemic use, Third-generation cephalosporins ATC code: J01DD04. 1.2 TYPE OF DOSAGE FORM Powder for solution for injection Powder for solution for infusion 1.3 ROUTE OF ADMINISTRATION Powder for solution for injection: intramuscular injection intravenous injection Powder for solution for infusion: intravenous infusion 1.4 STERILE / RADIOACTIVE STATEMENT Not applicable. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient_ : ceftriaxone in the form of the disodium salt. Vials containing dry substance equivalent to 0.25 g, 0.5 g, 1 g or 2 g ceftriaxone. _Excipients_ : As registered locally Rocephin contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone _Solvent for parenteral use (when it is supplied with Rocephin)_ : The solvent ampoule for i.v. injection contains sterile water for injections and for i.m. injection contains 1% lidocaine hydrochloride solution. 1 ml solvent for i.m. injection contains 10.66 mg lidocaine hydrochloride monohydrate equivalent to 10 mg anhydrous lidocaine hydrochloride (see section 2.3 Contraindications). September 2020 Product Information FE/English Ro 13-9904 Rocephin September 2020 Product Information FE/English 2 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) Rocephin is indicated for infections caused by pathogens sensitive to Rocephin, e.g.: sepsis; meningitis; disseminated Lyme borreliosis (early and late stages of the disease); abdominal infections (peritonitis, infections of the biliary and gastrointestinal tracts); infections of the bones, joints, soft tissue, skin and of wounds; infections in patients with impaired defense mechanisms; renal and urinary tract infections; respiratory tract infections, particularly pneum Läs hela dokumentet