Tavanic solution for infusion

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

levofloxacin (levofloxacin hemihydrate)

Доступна с:

Sanofi-Aventis Deutschland GmbH

код АТС:

J01MA12

ИНН (Международная Имя):

levofloxacin (levofloxacin hemihydrate)

дозировка:

5mg/ml

Фармацевтическая форма:

solution for infusion

Штук в упаковке:

100ml glass bottle

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2017-08-08

тонкая брошюра

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TAVANIC
® 5 MG/ML SOLUTION FOR INFUSION
levofloxacin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse.
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 use Tavanic solution for infusion
3.
How to use Tavanic solution for infusion
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 patients with pneumonia

Urinary tract, including your kidneys and 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 USE TAVANIC SOLUTION FOR INFUSION
DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR 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).

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.TRADE NAME OF THE MEDICINAL PRODUCT
Tavanic® 5 mg/ml solution for infusion
NONPROPRIETARY NAME: Levofloxacin
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
50 ml solution for infusion contains 250 mg levofloxacin as
levofloxacin hemihydrate.
100 ml solution for infusion contains 500 mg levofloxacin as
levofloxacin hemihydrate.
Excipients with known effect:
50 ml solution for infusion contains 7.9 mmol (181 mg) sodium.
100 ml solution for infusion contains 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 a pH value of 4.3 –
5.3 and an osmolarity of 282 – 322 mOsm/l.
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,
chronic bacterial prostatitis,
inhalation anthrax: for post-exposure prophylaxis and as 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 the official guidance on the
appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tavanic solution for infusion is slowly infused once or twice daily
via the intravenous route. The dosage
depends on the type and severity of the infection and the
susceptibility of the presumed causative pathogen.
_Table 1: Dosage in patients with normal renal function (creatinine
clearance >50 ml/min)_
INDICATION_ _
DAILY DOSAGE
(according to severity)
DURATION OF TREATMENT
1
(according to severity)
Community-acquired
pneumonia
500 mg once or twice daily
7 – 14 days
Pyelonephritis
500 mg once daily
7 – 10 days
Complic