Pajjiż: Singapor
Lingwa: Ingliż
Sors: HSA (Health Sciences Authority)
Ceftriaxone sodium 2386.6mg eqv Ceftriaxone (sterile)
NOVARTIS (SINGAPORE) PTE LTD
J01DD04
2000mg
INJECTION, POWDER, FOR SOLUTION
Ceftriaxone sodium 2386.6mg eqv Ceftriaxone (sterile) 2000mg
INTRAVENOUS, INTRAMUSCULAR
Prescription Only
Sandoz GmbH
ACTIVE
2014-09-25
MEGION ® POWDER FOR SOLUTION FOR INJECTION/INFUSION 1. NAME OF THE MEDICINAL PRODUCT Megion Powder for Solution for Injection/Infusion 1 g Megion Powder for Solution for Injection/Infusion 2 g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Megion Powder for Solution for Injection/Infusion 1 g 1 vial contains Ceftriaxone (as disodium) 1 g Megion Powder for Solution for Injection/Infusion 2 g 1 vial contains Ceftriaxone (as disodium) 2 g For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection/infusion. Vials containing white to light-yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Megion is indicated for infections caused by pathogens sensitive to ceftriaxone, 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 • Perioperative prophylaxis of infections Consideration should be given to official local guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _STANDARD DOSE _ ADULTS AND ADOLESCENTS AGED OVER 12 YEARS The usual dose is 1 - 2 g of ceftriaxone once daily (every 24 hours). In severe cases or in infections caused by moderately sensitive organisms, the dose may be raised to 4 g once daily. PEDIATRIC USE Neonates, infants and children up to 12 years The following dose schedules are recommended for once daily administration: Neonates (up to 14 days): 20 - 50 mg/kg bodyweight once daily. The daily dose should not exceed 50 mg/kg. Ceftriaxone is contraindicated in premature neonates up to a postmenstrual age of 41weeks (gestational age + chronological Aqra d-dokument sħiħ