Tavanic Injection

/ Sanofi

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 bioequivalence of the parenteral and oral forms, the same dosage can be used.
Impaired liver function: No adjustment of dosage is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.
Elderly population: No adjustment of dosage is required in the elderly, other than that imposed by consideration of renal function.
Paediatric population: TAVANIC is contraindicated in children and growing adolescents.
Method of administration: TAVANIC solution for infusion is only intended for slow intravenous infusion; it is administered once or twice daily. The infusion time must be at least 30 minutes for 250 mg or 60 minutes for 500 mg TAVANIC solution for infusion.
See prescribing information for full details.

Community-acquired pneumonia, complicated urinary tract infections including pyelonephritis, skin and soft tissue infections.

Hypersensitivity to any of the components, epilepsy, fluoroquinolone related tendon disorders, pregnancy, lactation, children or growing adolescents under 18 years old.

In the most severe cases of pneumococal pneumonia, Tavanic may not be the optimal therapy. Nosocomial infections due to P. aeruginosa may require combination therapy. Infusion time of at least 60 minutes should be observed. If pseudomembranous colitis is suspected, Tavanic solution for infusion must be stopped immediately and patients should be treated with supportive measures. Tendinitis, patients with a history of epilepsy, patients with G-6-phosphate dehydrogenase deficiency. The dose should be adjusted in patients with renal impairment. Patients should not expose themselves unnecessarily to strong sunlight or to artificial UV rays.

Pruritus, rash, nausea, diarrhea, anorexia, vomiting, abdominal pain, dyspepsia, headache, dizziness/vertigo, drowsiness, insomnia, increased liver enzyme levels (e.g. ALT, AST), increase in bilirubin, increase in serum creatinine, pain, reddening of the infusion site and phlebitis, acute confusional states and depressive mood changes, extrapyramidal symptoms, attacks of porphyria in patients with porphyria.
See prescribing information for full details.

Quinolone antibacterial agents. iron salts, magnesium- or aluminum-containing antacids should be taken 2 hours before administration. Sucrafalt should be administered 2 hours after Tavanic. Theophylline, fenbufen or similar NSAIDs. Probenecid, cimetidine, cyclosporin, vitamin K antagonist.

Pregnancy: There are limited data on the use of levofloxacin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. However, in the absence of human data and due to that experimental data suggest a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, levofloxacin must not be used in pregnant women.
Breast-feeding: TAVANIC is contraindicated in breast-feeding women. There is insufficient information on the excretion of levofloxacin in human milk; however, other fluoroquinolones are excreted in breast milk. In the absence of human data and due to that experimental data suggest a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism,
levofloxacin must not be used in breast-feeding women.

According to toxicity studies in animals or clinical pharmacology studies performed with supra-therapeutic doses, the most important signs to be expected following acute overdosage of TAVANIC solution for infusion are central nervous system symptoms such as confusion, dizziness, impairment of consciousness, and convulsive seizures, increases in QT interval.
CNS effects including confusional state, convulsion, hallucination, and tremor have been observed in post-marketing experience.
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Haemodialysis, including peritoneal dialysis and CAPD, are not effective in removing levofloxacin from the body. No specific antidote exists.