Tavager 500 mg film-coated tablets

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Levofloxacin

から入手可能:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATCコード:

J01MA; J01MA12

INN（国際名）:

Levofloxacin

投薬量:

500 milligram(s)

医薬品形態:

Film-coated tablet

処方タイプ:

Product subject to prescription which may not be renewed (A)

治療領域:

Fluoroquinolones; levofloxacin

認証ステータス:

Marketed

承認日:

2009-03-06

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAVAGER 500 MG FILM-COATED TABLETS
levofloxacin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
▪
Keep this leaflet. You may need to read it again.
▪
If you have any further questions, ask your doctor or pharmacist.
▪
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
▪
If you get any side effect, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tavager is and what it is used for
2.
What you need to know before you take Tavager
3.
How to take Tavager
4.
Possible side effects
5.
How to store Tavager
6.
Contents of the pack and other information.
1.
WHAT TAVAGER IS AND WHAT IT IS USED FOR
Tavager belongs to a group of medicines called antibiotics. Tavager is
a ‘quinolone’ antibiotic. It
works by killing the bacteria that cause infections in your body.
Tavager can be used to treat infections of the:
▪
Sinuses
▪
Lungs, in people with long-term breathing problems or pneumonia
▪
Urinary tract, including your kidneys or bladder
▪
Prostate gland
▪
Skin and underneath the skin, including muscles. This is sometimes
called ‘soft tissue’
In some special situations, Tavager may be used to lessen the chances
of getting a pulmonary disease
named anthrax or worsening of the disease after you are exposed to the
bacteria causing anthrax.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAVAGER
DO NOT TAKE TAVAGER IF:
▪
You are allergic to levofloxacin, any other quinolone antibiotic such
as moxifloxacin,
ciprofloxacin or ofloxacin or any of the other ingredients of this
medicine (listed in section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your
lips, face, throat or tongue
▪
You have ever had epilepsy
▪
You have ever had a problem with your

製品の特徴

Health Products Regulatory Authority
05 September 2022
CRN00CM20
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tavager 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg of levofloxacin as
levofloxacin hemihydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, capsule shaped, biconvex, film-coated tablet,
debossed with “LVO” scoreline “500” on one side and “G”
scoreline “G” on the other side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tavager tablets are indicated in adults for the treatment of the
following infections
(see sections 4.4 and 5.1):
• Community-acquired pneumonia
• Acute pyelonephritis and complicated urinary tract infections (see
section 4.4)
• Bacterial prostatitis
• Inhalation Anthrax (post-exposure prophylaxis and curative
treatment) (see section 4.4).
For the below-mentioned infections Tavager tablets should be used only
when it is considered inappropriate to use other
antibacterial agents that are commonly recommended for the treatment
of these infections.
• Acute bacterial sinusitis
• Acute exacerbation of chronic obstructive pulmonary disease
including bronchitis
• Complicated skin and soft tissue infections
• Uncomplicated cystitis (see section 4.4)
Tavager tablets may also be used to complete a course of therapy in
patients who have shown improvement during initial
treatment with intravenous levofloxacin.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tavager tablets are administered once or twice daily. The dosage
depends on the type and severity of the infection and the
susceptibility of the presumed causative pathogen.
Tavager tablets may also be used to complete a course of therapy in
patients who have shown improvement during initial
treatment with intra