Megion Powder for Solution for InjectionInfusion 2g

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Ceftriaxone sodium 2386.6mg eqv Ceftriaxone (sterile)

Saatavilla:

NOVARTIS (SINGAPORE) PTE LTD

ATC-koodi:

J01DD04

Annos:

2000mg

Lääkemuoto:

INJECTION, POWDER, FOR SOLUTION

Koostumus:

Ceftriaxone sodium 2386.6mg eqv Ceftriaxone (sterile) 2000mg

Antoreitti:

INTRAVENOUS, INTRAMUSCULAR

Prescription tyyppi:

Prescription Only

Valmistaja:

Sandoz GmbH

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2014-09-25

Valmisteyhteenveto

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