Šalis: Singapūras
kalba: anglų
Šaltinis: HSA (Health Sciences Authority)
CEFTRIAXONE DISODIUM EQV CEFTRIAXONE
ROCHE SINGAPORE PTE. LTD.
J01DD04
1 g/vial
INJECTION, POWDER, FOR SOLUTION
CEFTRIAXONE DISODIUM EQV CEFTRIAXONE 1 g/vial
INTRAMUSCULAR
Prescription Only
F HOFFMANN-LA ROCHE LTD
ACTIVE
1988-04-27
ROCEPHIN® Ceftriaxone BROAD-SPECTRUM CEPHALOSPORIN ANTIBIOTIC 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Rocephin is a long acting, broad spectrum cephalosporin antibiotic for parenteral use. 1.2 TYPE OF DOSAGE FORM Powder for solution for injection Powder for solution for infusion 1.3 ROUTE OF ADMINISTRATION • intramuscular injection • intravenous injection • 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. _Solvent for parenteral use:_ 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. Rocephin contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) 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); 1 − 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 pneumonia, and ear, nose and throat infections; − genital infections, including gonorrhea. And perioperative prophylaxis of infections. 2.2 DOSAGE AND ADMINISTRATION _STANDARD DOSAGE _ Adults and children over 12 years The usual dosage is 1-2 g of Rocephin once daily (every 24 hours). In severe cases or in i Perskaitykite visą dokumentą
1 Please visit www.roche.com.sg/pharma/rocephin for a printable version of this leaflet. INF/INJ-ROC-2022 08-0 ROCEPHIN ® Ceftriaxone 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). 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 pneumonia, and ear, nose and throat infections; Genital infections, including gonorrhea. And perioperative prophylaxis of infections. 2.2. DOS Perskaitykite visą dokumentą