Olfovel 500mg Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

LEVOFLOXACIN HEMIHYDRATE

Boleh didapati daripada:

IMEKS PHARMA SDN. BHD.

INN (Nama Antarabangsa):

LEVOFLOXACIN HEMIHYDRATE

Unit dalam pakej:

50Tablet Tablets; 100Tablet Tablets; 500Tablet Tablets; 30Tablet Tablets

Dikeluarkan oleh:

T.O. CHEMICALS (1979) LTD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
OLFOVEL 500
® TABLET
Levofloxacin hemihydrate (512.5mg)
_ _
1
WHAT IS IN THE LEAFLET
1.
What Olfovel is used for
2.
How Olfovel works
3.
Before you use Olfovel
4.
How to use Olfovel
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Olfovel
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT OLFOVEL
IS USED FOR
Olfolvel is used to treat:
• Pneumonia (inflammation of the lung)
• Acute exacerbation of chronic bronchitis
(breathing difficulty due to airway
narrowing)
• Acute sinusitis (inflammation of sinus)
• Skin and skin structure infections
• Chronic bacterial prostatitis (recurring
infections in the prostate)
• Acute pyelonephritis (sudden and severe
kidney infection)
• Urinary tract infection
HOW OLFOVEL
WORKS
Levofloxacin is an antimicrobial agent. It
inhibits the enzymes that required for growth
of microorganisms.
It is active against many microorganisms.
BEFORE YOU USE OLFOVEL_ _
_ _
-
_When you must not use it_
Do not take Olfolvel, if you:
• Are allergic to levofloxacin, any other
quinolone antibiotic or any of the other
ingredients of this medicine
• Have ever had epilepsy
• Have ever had a problem with your tendons
such as tendonitis that was related to
treatment with a ‘quinolone antibiotic’.
• Are a child or a growing teenager
• Are pregnant, might become pregnant or
think you may be pregnant
• Are breast-feeding
-
_Before you start to use it _
Talk to your doctor or pharmacist if you
• Are 60 years old or older
• Are using corticosteroids
• Have ever had a fit (seizure)
• Have kidney problems
• Have something known as ‘glucose-6-
phosphate dehydrogenase deficiency’
• Have ever had mental health problems
• Are diabetic
• Have ever had liver problems
• Have myasthenia gravis
• Are born with or have family history of
abnormal heart rate
• Have salt imbalance in the blood (low level
of potassium or magnesium in the blood)
• Have a hist

Ciri produk

CONTENTS
Each
tablet
contains
Levofloxacin
Hemihydrate
512.5
mg
equivalent
to
Levofloxacin 500.0 mg
DESCRIPTION
Pale orange, long round biconvex film coated tablets with bisec-line
and letter B,
L on one side and figure 500 on the other side.
PHARMACODYNAMICS
Levofloxacin is a broad spectrum quinolone antimicrobial agent.
Chemically,
levofloxacin,
a
chiral
fluorinated
carboxyquinolone
with
the
pure
(-)-(S)-
enantiomer of the racemic drug substance ofloxacin. The mechanism of
action of
levofloxacin involves inhibition of DNA gyrase and bacterial
topoisomerase IV.
Both of the enzymes are grouped as type II topoisomerases that
required for
DNA replication, transcription, repair and recombination.
IN VITRO ANTIMICROBIAL ACTIVITY
Levofloxacin is often bactericidal at concentration equal to or
slightly greater
than inhibitory concentration. It has also been shown to be active
against most
strains of the following microorganisms:
Aerobic gram-positive microorganisms
Enterococcus
faecalis
(many
strains
are
only
moderately
susceptible),
_Staphylococcus _
_aureus_
(methicilin-susceptible
strains),
Staphylococcus
coagulase negative (methicilin-susceptible strains), _ Staphylococcus
epidermidis_
(methicilin-susceptible
strains),
_Staphylococcus _
_saprophyticus_,
_Streptococcus _
_pneumoniae_ (including multi-drug resistant strains [MDRSP]*),
_Streptococcus _
_pyogenes_, _Streptococcus_ _agalactiae_
.
*MDRSP (Multi-drug resistant _ Streptococcus pneumoniae_) isolates are
strains
resistant to two or more of the following antibiotics: penicillin
(MIC=2µg/ml), 2
nd
generation
cephalosporins,
e.g.,
cefuroxime,
macrolides,
tetracyclines
and
trimethoprim / sulfamethoxazole.
Aerobic gram-negative microorganisms
_Enterobacter _
_cloacae_,
_Enterobacter _
_aerogenes_,
_Enterobacter _
_agglomerans_,
_Escherichia coli_, _ Haemophilus influenza_, _ Haemophilus
parainfluenzae_, _ Klebsiella _
_pneumonia_, _ Klebsiella oxytoca_, _ Legionella pneumophila_, _
Moraxella catarrhalis_,
_Proteus _
_mirabilis_,
_Proteus _
_vulgaris_,
_Providenc