Tavanic 5 mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levofloxacin

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

J01MA; J01MA12

INN (International Name):

Levofloxacin

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Prescription type:

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

Therapeutic area:

Fluoroquinolones; levofloxacin

Authorization status:

Marketed

Authorization date:

1998-01-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TAVANIC® 5 MG/ML SOLUTION FOR INFUSION
_Levofloxacin _
IS THIS LEAFLET HARD TO SEE OR READ? PHONE [phone]
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 after
you are exposed to the bacteria
causing anthrax.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TAVANIC SOLUTION FOR
INFUSION
DO NOT HAVE THIS MEDICINE AND TELL YOUR DOCTOR IF:
• You are allergic to levofloxacin, any other quinolone antibiotic
such as moxifloxacin, ciprofloxacin or
ofloxacin or any o

Summary of Product characteristics

Health Products Regulatory Authority
01 February 2023
CRN00CTPM
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tavanic 5 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
50ml of solution for infusion contains 250 mg of levofloxacin as
levofloxacin hemihydrate.
100ml of solution for infusion contains 500 mg of levofloxacin as
levofloxacin hemihydrate.
Excipients with known effect:
50ml of solution for infusion contains 7.9 mmol of sodium, which is
181 mg of sodium.
100ml of solution for infusion contains 15.8 mmol of sodium, which is
363 mg of 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):
- Acute pyelonephritis and complicated urinary tract infections (see
section 4.4)
- Chronic bacterial prostatitis
- Inhalation Anthrax: postexposure prophylaxis and curative treatment
(see section 4.4).
In the below-mentioned infections Tavanic should be used only when it
is considered inappropriate to use other antibacterial
agents that are commonly recommended for the treatment of these
infections.
- Community-acquired pneumonia
- Complicated skin and soft tissue infections
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 individua