ROCEPHIN FOR INJECTION 500 mg/vial (INTRAVENOUS)

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

CEFTRIAXONE DISODIUM EQV CEFTRIAXONE

Dostępny od:

ROCHE SINGAPORE PTE. LTD.

Kod ATC:

J01DD04

Dawkowanie:

500 mg/vial

Forma farmaceutyczna:

INJECTION, POWDER, FOR SOLUTION

Droga podania:

INTRAVENOUS

Typ recepty:

Prescription Only

Wyprodukowano przez:

F HOFFMANN-LA ROCHE LTD

Data autoryzacji:

1988-04-29

Ulotka dla pacjenta

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