Meropenem-Asteria powder for solution for i/v injection/infusion

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

meropenem

Διαθέσιμο από:

Hankook Korus Pharm Co.

Φαρμακολογική κατηγορία (ATC):

J01DH02

INN (Διεθνής Όνομα):

meropenem

Δοσολογία:

500mg

Φαρμακοτεχνική μορφή:

powder for solution for i/v injection/infusion

Μονάδες σε πακέτο:

(1), (5), (10) glass vials

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2015-12-17

Αρχείο Π.Χ.Π.

Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Meropenem-Asteria Inj. 500mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical Name
Quantity/vial
Use
1
Meropenem Dried Sodium Carbonate
604mg
(500mg as Meropenem)
Active
ingredient
3. PHARMACEUTICAL FORM
Power for Injection
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Strains
Staphylococcus
aureus
,
Streptococcus
pyogenes,
Streptococcus
agalactiae,
streptococci,
Enterococcus
faecalis
(excluding
vancomycin-resistant
isolates),
Pseudomonas
aeruginosa,
Escherichia coli, Proteus mirabilis, Bacteroides fragilis,
Peptostreptococcus species
,
Klebsiella
pneumoniae, B. thetaiotaomicron,
and
Peptostreptococcus species
.
Streptococcus pneumoniae,
Haemophilus influenzae,
and
Neisseria meningitidis.
Indication
Pneumonia including community acquired pneumonia and nosocomial
pneumonia, Broncho
pulmonary infections in cystic fibrosis, Complicated urinary tract
infections, Complicated
intra-abdominal infections, Intra- and post-partum infections,
Complicated skin and soft tissue
infections, Acute bacterial meningitis (Pediatric patients ≥ 3
months only)
4.2 Posology and method of administration
Adults and Children over 50 kg body weight
The recommended dose of Meropenem for Injection is 500 mg given every
8 hours for skin and
skin structure infections. Meropenem for Injection should be
administered by intravenous
infusion over approximately 15 to 30 minutes.
Adults with Renal Impairment
Dosage should be reduced in patients with creatinine clearance less
than 51 mL/min.
Summary of Product Characteristics
Creatinine
Clearance(mL/min)
Dose
Dosing Inteval
≥ 51
Recommended dose
Every 8h
26-50
Recommended dose
Every 12h
10-25
One-half recommended dose
Every 12h
< 10
One-half recommended dose
Every 24h
Elderly Patients
No dosage adjustment is required for elderly patients with creatinine
clearance values above 50
mL/min.
Pediatric Patients
Children under 3 months of age
The safety and efficacy of Meropenem in children under 3 months