ROCEPHIN VIAL 500MG IM

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

CEFTRIAXONE SODIUM; LIGNOCAINE/LIDOCAINE

Available from:

ROCHE (MALAYSIA) SDN. BHD.

INN (International Name):

CEFTRIAXONE SODIUM; LIGNOCAINE/LIDOCAINE

Units in package:

1Units Units

Manufactured by:

F.HOFFMANN-LA ROCHE LTD

Patient Information leaflet

NOT APPLICABLE

Summary of Product characteristics

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