Basic Information
ROCEPHIN FOR INJECTION 1 g/vial (INTRAMUSCULAR)
INJECTION, POWDER, FOR SOLUTION
Regulatory Information
SIN00388P
April 27, 1988
Prescription Only
Therapeutic
INTRAMUSCULAR
August 10, 2023
June 4, 2025
XJ01DD04
Company Information
ROCHE SINGAPORE PTE. LTD.
ROCHE SINGAPORE PTE. LTD.
Active Ingredients
Strength: 1 g/vial
Detailed Information
Contraindications
**2.3. CONTRAINDICATIONS** _Hypersensitivity_ Rocephin is contraindicated in patients with known hypersensitivity to ceftriaxone, any of its excipients or to any other cephalosporin. Patients with previous hypersensitivity reactions to penicillin and other beta lactam agents may be at a greater risk of hypersensitivity to ceftriaxone ( _see section 2.4.1 Warnings and Precautions General – Hypersensitivity_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Lidocaine_ Contraindications to lidocaine must be excluded before intramuscular injection of ceftriaxone when lidocaine solution is used as a solvent ( _see section 2.2 Dosage and Administration_). See contraindications section in the prescribing information of lidocaine. Ceftriaxone solutions containing lidocaine should never be administered intravenously. _Premature Neonates_ Rocephin is contraindicated in premature neonates up to postmenstrual age of 41 weeks (gestational age + chronological age). _Hyperbilirubinemic newborns_ Hyperbilirubinaemic newborns should not be treated with ceftriaxone. _In vitro_ studies have shown that ceftriaxone can displace bilirubin from its binding to serum albumin leading to a possible risk of bilirubin encephalopathy can possibly develop in these patients. _Neonates and Calcium Containing IV Solutions_ Rocephin is contraindicated in neonates (≤28 days) if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see 2.2 Dosage and Administration and 2.8 Interactions with other Medicinal Products and other Forms of Interaction – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving Rocephin and calcium-containing fluids. In some of these cases, the same intravenous infusion line was used for both Rocephin and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. At least one fatality has been reported in a neonate in whom Rocephin and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. There have been no similar reports in patients other than neonates (see 2.6.2 Post marketing Experience – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Indication Information
**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.