MERONEM 1 G.

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

MEROPENEM AS TRIHYDRATE

Dostupné z:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC kód:

J01DH02

Forma lieku:

POWDER FOR SOLUTION FOR INJECTION

Zloženie:

MEROPENEM AS TRIHYDRATE 1000 MG/VIAL

Spôsob podávania:

I.V

Typ predpisu:

Required

Výrobca:

ASTRA ZENECA UK LIMITED

Terapeutické skupiny:

MEROPENEM

Terapeutické oblasti:

MEROPENEM

Terapeutické indikácie:

Meronem is indicated for treatment in adults and children of the following severe infections caused by single or multiple susceptible bacteria sensitive to meropenem: - Pneumonias and nosocomial pneumonias. - Pulmonary infections in patients with cystic fibrosis. - Urinary tract infections. - Intra-abdominal infections. - Gynecological infections such as endometritis and pelvic inflammatory disease. - Skin and skin structure infections. - Meningitis. - Septicemia. Meronem has proved efficacious alone or in combination with other antimicrobial agents in the treatment of polymicrobial infections. There is no experience in pediatric patients with neutropenia or primary or secondary immunodeficiency.

Dátum Autorizácia:

2012-01-31

Príbalový leták

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור :ךיראת
29.12.2013
םש
רישכת
:תילגנאב
MERONEM 500MG
MERONEM 1G
רפסמ
םושיר
1041128624
1040828622
םש
לעב
םושירה
:
הקינזהרטסא
מ"עב )לארשי(
אפורל ןולע
םיטרפ
לע
םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
CONTRAIN
DICATION
Hypersensitivity to any other carbapenem antibacterial
agent
.
Severe hypersensitivity
(e.g.
anaphylactic
reaction,
severe skin reaction) to any other type of betalactam
antibacterial agent (e.g. penicillins or cephalosporins
Special
warnings
and
special
precautio
ns for
use
Seizures have infrequently been reported during treatment
with carbapenems, including meropenem (see section 4.8)
.
Hepatic function should be closely monitored during
treatment with meropenem due to the risk of hepatic toxicity
(hepatic dysfunction with cholestasis and cytolysis)
lactation
Meropenem has been reported to be excreted in human milk
Undesir
able
Effects
Frequency adverse reaction
Renal and urinary disorders Uncommon Blood creatinine
increased, blood urea increased
Reporting Rate of Adverse Reactions (data derived from a
combination of post-marketing clinical trial and spontaneous
sources)
General disorders and administration site conditions Not known
Pain at the injection site
Incomp
atibilitie
s
Meronem
should not be
mixed with or
added to other
drugs
Meronem is
compatible with
the following
infusion fluids:
0.9% Sodium
Chloride
solution
5% or 10%
Glucose
solution
5% Glucose
solution with
0.02% Sodium
Bicarbonate
5% Glucose and
0.9% Sodium
Chloride
solution
5% Glucose
with 0.225%
Sodium
Chloride
solution
5% Glucose
with 0.15%
Potassium
Chloride
solution
Mannitol 2.5%
or 10%
solution.
Meronem should not be mixed with or added to other drugs
Meronem is compatible with the following infusion fluids:
0.9% Sodium Chloride solution
5% or 10% Glucose solution

Súhrn charakteristických

Meronem LPD CC 12032020
Page 1 of 16
2017-0028183, 2017-0028195, 2017-0028196, 2017-0034326,
2017-0034646,2018-0036353
MERONEM 500MG
MERONEM 1G
1.
NAME OF THE MEDICINAL PRODUCT
Meronem 500mg
Meronem 1g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Meronem 500mg
Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous
meropenem.
Excipients with known effect:
Each 500 mg vial contains 104 mg sodium carbonate which equates to
approximately 2 mEq
of sodium (approximately 45 mg).
Meronem 1 g
Each vial contains meropenem trihydrate equivalent to 1 g anhydrous
meropenem.
Excipients with known effect:
Each 1 g vial contains 208 mg sodium carbonate which equates to
approximately 4 mEq of
sodium (approximately 90 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
A white to light yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Meronem IV is indicated for treatment, in adults and children, of the
following infections
caused by single or multiple bacteria sensitive to meropenem.
Meronem LPD CC 12032020
Page 2 of 16
2017-0028183, 2017-0028195, 2017-0028196, 2017-0034326,
2017-0034646,2018-0036353
•
Pneumonias and Nosocomial Pneumonias
•
Pulmonary infections in patients with cystic fibrosis
•
Urinary Tract Infections
•
Intra abdominal Infections
•
Gynaecological Infections, such as endometritis and pelvic
inflammatory disease
•
Skin and Skin Structure Infections
•
Meningitis
•
Septicaemia
Meronem has proved efficacious alone or in combination with other
antimicrobial agents in
the treatment of polymicrobial infections.
There is no experience in paediatric patients with neutropenia or
primary or secondary
immunodeficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
The dosage and duration of therapy shall be established depending on
type and severity of
infection and the condition of the patient.
The recommended daily dosage is as follows:
500 mg IV every 8 hours in the treatment of pneumonia, UTI,
gyna