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Vibativ is a brand name for Telavancin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VIBATIV is indicated for the treatment of adults with nosocomial pneumonia (NP) including ventilator associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA). VIBATIV should be used only in situations where it is known or suspected that other alternatives are not…
Verbatim from this product's EMA label. Tap a section to expand.
Posology Adults The recommended dosage regimen is 10 mg/kg, once every 24 hours, for 7 to 21 days. Medicinal product no longer authorised 3 Renal impairment Patients with renal impairment should receive an initial dose according to calculated or measured creatinine clearance as presented in the table below.
During treatment dose adjustments according to the table should be made based on calculated or measured creatinine clearance in patients with clinically relevant changes in renal function. 3). 2) did not result in a relevant change in pharmacokinetics of telavancin.
Therefore, no dose adjustment is necessary when administering telavancin to subjects with mild or moderate degrees of hepatic impairment. No data are available in subjects with severe hepatic impairment (Child-Pugh class C). Therefore, caution should be exercised if telavancin is given to subjects with severe hepatic impairment.
2). Paediatric patients The safety and efficacy of VIBATIV in children and adolescents aged below 18 years have not yet been established. No data are available. Method of administration For intravenous use. VIBATIV must be reconstituted and then further diluted prior to administration by intravenous infusion through a dedicated line or through a Y-site over a 60 minute period.
Bolus injections must not be administered. 6.
3% of patients. 0% of patients who received telavancin. The most commonly reported related adverse reactions (occurring in >1% of patients) were: fungal infection, insomnia, dysgeusia, headache, dizziness, nausea, constipation, diarrhoea, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased, pruritus, rash, renal failure acute, blood creatinine increased, urine abnormality (foamy urine), fatigue and chills.
Tabulated list of adverse reactions The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Infections and infestations Common: fungal infection Uncommon: clostridium colitis, urinary tract infection Blood and lymphatic system disorders Uncommon: anaemia, leukopenia, thrombocythaemia, thrombocytopenia, eosinophil count increased, neutrophil count increased Immune system disorders Uncommon: hypersensitivity Not known* anaphylaxis Metabolism and nutrition disorders Uncommon: decreased appetite, hyperglycaemia, hyperkalaemia, hypoglycaemia, hypokalaemia, hypomagnesaemia Psychiatric disorders Common: insomnia Uncommon: agitation, anxiety, confusional state, depression Nervous system disorders Very common: dysgeusia Common: headache, dizziness Uncommon: ageusia, migraine, paraesthesia, parosmia, somnolence, tremor Eye disorders Uncommon: eye irritation, blurred vision Ear and labyrinth disorders Uncommon: tinnitus Rare: deafness Cardiac disorders Uncommon: angina pectoris, atrial fibrillation, bradycardia, cardiac failure congestive, electrocardiogram QT corrected interval prolonged, palpitations, sinus tachycardia, supraventricular extrasystoles, ventricular extrasystolesMedicinal product no longer authorised 8 Vascular disorders Uncommon: flushing, hypertension, hypotension, phlebitis Respiratory, thoracic and mediastinal disorders Uncommon: dyspnoea, hiccups, nasal congestion, pharyngolaryngeal pain Gastrointestinal disorders Very common: nausea Common: constipation, diarrhoea, vomiting Uncommon: abdominal pain, dry mouth, dyspepsia, flatulence, hypoaesthesia oral Hepatobiliary disorders Common: alanine aminotransferase increased, aspartate aminotransferase increased Uncommon: hepatitis Skin and subcutaneous tissue disorders Common: pruritus, rash Uncommon: erythema, face oedema, hyperhidrosis, urticaria Musculoskeletal and connective tissue disorders Uncommon: arthralgia, back pain, muscle cramp, myalgia Renal and urinary disorders Common: renal failure acute, blood creatinine increased, foamy urine (lower level term) Uncommon: blood urea increased, dysuria, haematuria, microalbuminuria, oliguria, pollakiuria, renal impairment, urine odour abnormal General disorders and administration site conditions Common: fatigue, chills Uncommon: asthenia, infusion site reactions, malaise, non-cardiac chest pain, peripheral oedema, pain, pyrexia, Red Man syndrome Investigations Uncommon: international normalised ratio increased * Based on post-marketing reports.
Renal impairment In the clinical studies, patients with pre existing acute renal failure receiving telavancin had an increased risk of mortality. All-cause mortality was 32/73 (44%) in the telavancin group and 16/64 (25%) in the vancomycin group, whereas in patients without acute renal failure at baseline it was 118/678 (17%) and 124/688 (18%), respectively.
3). 8% vs. 2%, respectively). Renal function (serum creatinine and urinary output for oliguria/anuria) should be monitored daily for at least the first 3 to 5 days of therapy and every 48 to 72 hours thereafter in all patients receiving telavancin.
2. If renal function markedly decreases during treatment, the benefit of continuing telavancin should be assessed. g. diabetes mellitus, congestive heart failure, hypertension). 8). Stopping or slowing the infusion may result in cessation of these reactions.
Infusion related reactions can be limited if the daily dose is infused over a 1 hour period. Hypersensitivity Hypersensitivity reactions, including anaphylaxis, have been reported with telavancin, and may be life-threatening. If an allergic reaction to telavancin occurs, discontinue treatment and institute appropriate therapy.
Cross hypersensitivity reactions, including anaphylaxis, have been reported in patients with a history of vancomycin allergy. Caution should be exercised when prescribing telavancin to patients with a prior history of hypersensitivity reaction to vancomycin.
If an allergic reaction to telavancin occurs, discontinue treatment and institute appropriate therapy. 2 millisecond increase observed with the comparator. Caution is warranted when using telavancin to treat patients taking medicinal products known to prolong the QT interval.
In addition, caution is warranted when using telavancin to treat patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure,Medicinal product no longer authorised 5 or severe left ventricular hypertrophy.
1. e. 4). 4). Medicinal product no longer authorised 4
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Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Patients with these conditions were not included in clinical trials of telavancin. 8). 8). Patients receiving telavancin in conjunction with or sequentially with other medicinal products with known ototoxic potential should be carefully monitored and the benefit of telavancin evaluated if hearing deteriorates.
Superinfection The use of antibiotics may promote the overgrowth of non-susceptible micro-organisms. If superinfection occurs during therapy, appropriate measures should be taken. 8), and may range in severity from mild to life-threatening.
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or shortly following treatment. 1 for information on the antimicrobial spectrum). In mixed infections where Gram-negative and/or certain types of anaerobic bacteria are suspected, VIBATIV should be co-administered with appropriate antibacterial agent(s).
Specific patient groups The nosocomial pneumonia (NP) studies excluded known or suspected pulmonary disease like granulomatous diseases, lung cancer, or other malignancy metastatic to the lungs; cystic fibrosis or active tuberculosis; Legionella pneumophila pneumonia; meningitis, endocarditis, or osteomyelitis; refractory shock defined as supine systolic blood pressure <90 mm Hg for >2 hours with evidence of hypoperfusion or requirement for high-dose sympathomimetic agents.
Also patients with baseline QTc >500 msec, congenital long QT syndrome, uncompensated heart failure, or abnormal K+ or Mg2+ blood levels that could not be corrected, severely neutropenic (absolute neutrophil count <500/mm3) or anticipated to develop severe neutropenia due to prior or planned chemotherapy, or who had HIV with CD4 count <100/mm3 during the last 6 months were excluded.