Tavanic 5mg/ml solution for infusion

국가: 몰타

언어: 영어

출처: Malta Medicines Authority

유효 성분:

LEVOFLOXACIN

제공처:

Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta

ATC 코드:

J01MA12

INN (국제 이름):

LEVOFLOXACIN 5 mg/ml

약제 형태:

SOLUTION FOR INFUSION

구성:

LEVOFLOXACIN 5 mg/ml

처방전 유형:

POM

치료 영역:

ANTIBACTERIALS FOR SYSTEMIC USE

승인 상태:

Withdrawn

승인 날짜:

2008-01-04

환자 정보 전단

PACKAGE LEAFLET 
2

PACKAGE LEAFLET: INFORMATION FOR THE USER 

TAVANIC 5 MG/ML SOLUTION FOR INFUSION 
levofloxacin 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN
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,
nurse or pharmacist. 

 If you get any side effects, talk to your doctor,
nurse or pharmacist. This includes any possible 
side effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET  
1.  What Tavanic solution for infusion is and what it is used
for 
2.  What you need to know before you are given Tavanic
solution for infusion 
3.  How Tavanic solution for infusion is given 
4.  Possible side effects 
5.  How to store Tavanic solution for infusion 
6.  Contents of the pack and other information 

1. 
WHAT TAVANIC SOLUTION FOR
INFUSION IS AND WHAT IT IS USED FOR 

The name of your medicine is Tavanic
solution for infusion. Tavanic solution for infusion contains a 
medicine called levofloxacin. This belongs to a
group of medicines called antibiotics. Levofloxacin is 
a ‘quinolone’ antibiotic. It works by killing the bacteria
that cause infections in your body. 

TAVANIC SOLUTION FOR INFUSION CAN BE USED TO TREAT INFECTIONS
OF THE: 


Lungs, in people with pneumonia 


Urinary tract, including your kidneys or bladder  


Prostate gland, where you have a long lasting infection  


Skin and underneath the skin, including muscles. This is
sometimes called ‘soft tissue’.  

In some special situations, Tavanic solution for infusion may be
used to lessen the chances of getting a 
pulmonary disease named anthrax
or worsening of the disease af

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Tavanic 5 mg/ml solution for infusion 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

100ml of solution for infusion contains 500 mg of levofloxacin as
levofloxacin 
hemihydrate.   

Excipients with known effect: 
100ml of solution for infusion contain 15.8 mmol (363 mg)
sodium. 

For the full list of excipients, see section 6.1 

3 
PHARMACEUTICAL FORM 

Solution for infusion. 

Clear greenish-yellow isotonic solution with pH of 4.3 to 5.3 and
osmolarity of 282 – 
322 mOsm/litre. 

4 
CLINICAL PARTICULARS 
4.1 
THERAPEUTIC INDICATIONS 

Tavanic solution for infusion is indicated in adults for the
treatment of the following 
infections (see sections 4.4 and 5.1): 



Community-acquired pneumonia 


Complicated skin and soft tissue infections 

For the above-mentioned infections Tavanic should
be used only when it is 
considered inappropriate to use antibacterial agents that
are commonly recommended 
for the initial treatment of these infections. 



Pyelonephritis and complicated urinary tract infections
(see section 4.4) 


Chronic bacterial prostatitis 


Inhalation Anthrax: postexposure prophylaxis and curative treatment
(see section 
4.4) 

Consideration should be given to official guidance on the
appropriate use of 
antibacterial agents. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Tavanic solution for infusion is administered by slow intravenous
infusion once or 
twice daily.   The dosage depends on the type and severity of
the infection and the 
susceptibility of the presumed causative pathogen. Treatment with
Tavanic after 
initial use of the intravenous preparation may be completed with an
appropriate oral 
presentation according to the SPC for the film-coated tablets and
as considered 
appropriate for the individual patient.  Given
the bioequ