ROCEPHIN FOR INJECTION 1 gvial (INTRAVENOUS)

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

CEFTRIAXONE DISODIUM EQV CEFTRIAXONE

Dostupné s:

ROCHE SINGAPORE PTE. LTD.

ATC kód:

J01DD04

Dávkování:

1 g/vial

Léková forma:

INJECTION, POWDER, FOR SOLUTION

Složení:

CEFTRIAXONE DISODIUM EQV CEFTRIAXONE 1 g/vial

Podání:

INTRAVENOUS

Druh předpisu:

Prescription Only

Výrobce:

F HOFFMANN-LA ROCHE LTD

Stav Autorizace:

ACTIVE

Datum autorizace:

1988-04-29

Informace pro uživatele

November 2009 

Product Information FE/English 
Ro 13-9904 

Rocephin 

November 2009 
Production Information FE/English 
1
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); 
November 2009 

Product Information FE/English 
Ro 13-9904 

Rocephin 

November 2009 
Production Information FE/English 
2
 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; 
 gen

Charakteristika produktu

1
Please visit www.roche.com.sg/pharma/rocephin for a printable version
of this leaflet.
INF/INJ-ROC-2024 03
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.
DOSAG