Posology : מינונים

4.2 Posology and method of administration                                                                        Telavancin interferes with urine qualitative dipstick protein assays, as well as quantitative dye methods
(e.g. pyrogallol red molybdate). Microalbumin assays based on immunoassay utilizing nephelometric Posology                                                                                                         (turbidity) detection are not affected and can be used to monitor urinary protein excretion during Adults                                                                                                           telavancin treatment. For routine monitoring of renal function it is recommended to use serum creatinine The recommended dosage regimen is 10 mg/kg, once every 24 hours, for 7 to 21 days.                               concentration or estimated creatinine clearance.

Special populations                                                                                              4.6 Fertility, pregnancy and lactation Elderly patients
Elderly patients should receive a telavancin dose in accordance with their bodyweight and renal function         Pregnancy (see sections 4.3 and 5.2).                                                                                      The use of VIBATIV is contraindicated during pregnancy (see section 4.3).
Renal impairment                                                                                                 There is no human experience with telavancin. Studies in animals have shown reproductive toxicity (see VIBATIV use in patients with baseline CrCl ≤50 mL/min is contraindicated.                                        section 5.3).
Hepatic impairment                                                                                               The pregnancy status of women of childbearing potential has to be established prior to dosing with Mild to moderate degrees of hepatic impairment (Child-Pugh class B) (see section 5.2) did not result in a        telavancin. Women of childbearing potential have to use effective contraception during treatment.
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            Breastfeeding available in subjects with severe hepatic impairment (Child-Pugh class C). Therefore, caution should be          It is unknown whether telavancin is excreted in human breast milk. The excretion of telavancin in milk has exercised if telavancin is given to subjects with severe hepatic impairment.                                     not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to continue/ Obese patients                                                                                                   discontinue therapy with telavancin should be made taking into account the benefit of breastfeeding to Obese patients (defined as those with BMI > 30 kg/m2) should receive telavancin at the reduced dose of           the child and the benefit of telavancin therapy to the woman.
7.5 mg/kg once every 24 hours (see section 5.2).
Paediatric patients                                                                                              Fertility The safety and efficacy of VIBATIV in children and adolescents aged below 18 years have not yet been             Telavancin has been shown to affect sperm quantity and quality of male rats (see section 5.3) although established. No data are available.                                                                              no effect on fertility, mating, or early embryogenesis has been reported. The potential risk for humans is unknown.
Method of administration
For intravenous use.                                                                                             4.7 Effects on ability to drive and use machines 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               Dizziness, somnolence, confusion and blurred vision may occur and VIBATIV may have an influence on administered. For instructions on reconstitution and dilution, see section 6.6.                                  the ability to drive and use machines (see section 4.8).