Valsts: Armēnija
Valoda: angļu
Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
levofloxacin (levofloxacin hemihydrate)
Sanofi-Aventis Deutschland GmbH
J01MA12
levofloxacin (levofloxacin hemihydrate)
5mg/ml
solution for infusion
100ml glass bottle
Prescription
Registered
2017-08-08
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). Izlasiet visu dokumentu
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 Izlasiet visu dokumentu