ROXIPIME POWDER FOR SOLUTION FOR INJECTION 2GVIAL

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

Cefepime hydrochloride 2.3784g eqv Cefepime

Disponible des:

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

Codi ATC:

J01DE01

formulario farmacéutico:

INJECTION, POWDER, FOR SOLUTION

Composición:

Cefepime hydrochloride 2.3784g eqv Cefepime 2g per vial

Vía de administración:

INTRAVENOUS

tipo de receta:

Prescription Only

Fabricat per:

Pharma Vision San. Ve Tic. A.Ş.

Estat d'Autorització:

ACTIVE

Data d'autorització:

2018-02-08

Fitxa tècnica

ROXIPIME 2 G
POWDER FOR SOLUTION FOR I.V. INJECTION
Summary of Product Characteristics
Page 1/24
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCTS
ROXIPIME 2 g Powder for Solution for IV Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each vial contains cefepime hydrochloride equivalent to 2 g cefepime
as powder.
EXCIPIENTS:
For excipients, see 6.1
3. PHARMACEUTICAL FORM
Sterile Powder for injection.
Light yellow -white coloured powder.
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
ROXIPIME is used in the treatment of the following infections
mentioned, if the causative
organism is susceptible.
−
Severe pneumonia;
−
Empirical treatment in febrile neutropenia; in patients at high risk
for severe infections
(for example, patients with a history of recent bone marrow
transplantation, with
hypotension at presentation, with an underlying hematologic
malignancy, or with
severe or prolonged neutropenia), antimicrobial monotherapy may not be
appropriate.
Insufficient data exist to support the efficacy of cefepime
monotherapy in such patients
−
Treatment for complicated and uncomplicated Urinary Tract Infections,
including
pyelonephritis,
−
It is used for intra-abdominal infections treatment.
Culture and susceptibility tests should be performed to determine
susceptibility of infection
factor organism against cefepime. Empirical treatment with ROXIPIME
can be started without
ROXIPIME 2 G
POWDER FOR SOLUTION FOR I.V. INJECTION
Summary of Product Characteristics
Page 2/24
waiting results of susceptibility tests and it should be regulated
according to antibiotic
treatment result when results of these tests are determined.
In patient with aerobic-anaerobic mix infection risk, if there is
especially bacteria which is
insusceptible to cefepime, in initial of treatment, anaerobic drug
addition to treatment is
recommended until determining effective microorganism. When the
results are appeared, it is
decided whether ROXIPIME may be administered as in combination with
other anti