FrancophonIA/ELRC3.0 huggingface dataset:
English: Information to be collected shall include data on renal impairment, fatal outcomes (assessed for causality), cardiac disorders, liver and hepatobiliary disorders, tinnitus and hearing loss, adherence to the SmPC and off label use.
Slovenian: Informacije, ki bodo zbrane, bodo vključevale podatke o ledvičnih okvarah, smrtnih izidih (ocenjenih glede na vzročno zvezo), srčnih boleznih, boleznih jeter, žolčnika in žolčevodov, tinitusu in izgubi sluha, upoštevanju Povzetka glavnih značilnosti zdravila ter nenamenski uporabi zdravila.
English: Telavancin is a low clearance active substance with a mean (SD) CL of 13.1 (2.0) ml/hr/kg in subjects with normal renal function, corresponding to a total CL of approximately 1 l/hr in a 75 kg subject.
Slovenian: Telavancin je zdravilna učinkovina z nizkim očistkom, s povprečnim (SD) CL 13,1 (2,0) ml/hr/kg pri osebah z normalnim delovanjem jeter, kar ustreza celokupnemu CL v vrednosti približno 1 l za osebo, ki tehta 75 kg.
English: • The need to counsel patients on important risks associated with Vibativ therapy and appropriate
Slovenian: • Bolnike je treba poučiti o pomembnih tveganjih, ki so povezana z zdravljenjem z zdravilom Vibativ, ter o ustreznih varnostnih ukrepih ob uporabi zdravila.
English: Discard any unused solution.
Slovenian: Neuporabljeno raztopino odvrzite.
English: Antibiotic-associated colitis and pseudomembranous colitis
Slovenian: Kolitis, povezan z antibiotiki, in psevdomembranski kolitis
English: The pregnancy status of women of childbearing potential must be established prior to dosing with telavancin and women of childbearing potential must use effective contraception during
Slovenian: Pred uvedbo zdravljenja s telavancinom je treba preveriti, ali je bolnica v rodni dobi noseča, in bolnice v rodni dobi morajo v času zdravljenja uporabljati učinkovito
English: If you are given more VIBATIV than you should receive, the chance of experiencing the following side effects increases: disturbed taste, nausea (feeling sick), vomiting, reactions at the site of the infusion, headache, rash, skin flushing of the upper body.
Slovenian: Če ste uporabili večji odmerek zdravila VIBATIV, kot bi smeli Če prejmete več zdravila VIBATIV, kot bi ga smeli prejeti, se poveča verjetnost za pojav naslednjih neželenih učinkov: spremembe okusa, navzeja (občutek slabosti), bruhanje, reakcije na mestu infuzije, glavobol, izpuščaj, sindrom rdečeličneža .
English: It is not known if telavancin passes into breast milk in humans.
Slovenian: Ni znano, ali se telavancin pri ljudeh izloča v materino mleko.
English: Powder for concentrate for solution for infusion
Slovenian: prašek za koncentrat za raztopino za infundiranje
English: No clinically significant differences in pharmacokinetics of telavancin were observed between healthy elderly and healthy young subjects.
Slovenian: Med zdravimi starejšimi in zdravimi mladimi osebami ni bilo opaženih nobenih klinično pomembnih razlik v farmakokinetiki telavancina.
English: Therefore, no dose adjustment is needed in elderly patients except in those with creatinine clearance of 30-50 ml/min (see sections 4.2 and 4.3).
Slovenian: Iz tega razloga prilagoditev odmerka pri starejših bolnikih ni potrebna, razen pri tistih, ki imajo očistek kreatinina od 30-50 ml/min (glejte
English: Therefore, the use of telavancin in patients with pre-existing acute renal failure and in patients with severe renal impairment is contraindicated (see
Slovenian: Zato je uporaba telavancina pri bolnikih s predhodno akutno odpovedjo ledvic ter pri bolnikih s hudo ledvično okvaro
English: After reconstitution, each ml contains 15 mg of telavancin.
Slovenian: Po rekonstituciji en ml vsebuje 15 mg telavancina.
English: Exposure to telavancin increases with increase in BMI; for each 10-unit increase in BMI, it is estimated that plasma exposure will increase by up to 25%.
Slovenian: Ocenjujejo, da povečanje za 10 enot ITM poveča plazemsko izpostavljenost za do 25 %.
English: After reconstitution, each ml of concentrated solution contains 15 mg of telavancin.
Slovenian: Po rekonstituciji vsak ml koncentrirane raztopine vsebuje 15 mg telavancina.
English: 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.
Slovenian: Najbolj pogosto so poročali o naslednjih neželenih učinkih (pojavijo se pri >1 % bolnikov): glivične okužbe, nespečnost, sprememba okusa, glavobol, omotica, slabost, zaprtost, diareja, bruhanje, povečana vrednost alanin-aminotransferaze, povečana vrednost aspartat-aminotransferaze, pruritus, izpuščaj, akutna ledvična odpoved, povišan kreatinin v krvi, nenormalen urin (penast urin), utrujenost
English: Doses less than 150 mg or greater than 800 mg should be further diluted in a volume resulting in a final solution of 0.6 to 8 mg/ml.
Slovenian: Za odmerke od 150 do 800 mg je potrebno ustrezno količino rekonstituiranega koncentrata pred infuzijo dodatno razredčiti v 100 do 250 ml. Odmerke, manjše od 150 mg ali večje od 800 mg je treba dodatno razredčiti tako, da dobimo končno raztopino, ki vsebuje od 0,6 do 8 mg/ml.
English: Discard the vial if the vacuum does not pull the diluent into the vial.
Slovenian: Če vakum ne povleče raztopine v vialo, jo zavrzite.
English: The dose for adults (18 years and older) is 10 milligrams (mg) for every kilogram (kg) of body weight, given once a day.
Slovenian: Odmerek za odrasle (18 let ali starejši) znaša 10 miligramov (mg) na vsak kilogram (kg) telesne mase, enkrat na dan. Odmerek raztopine za infundiranje se injicira neposredno v krvni obtok (kapalna infuzija v veno) v obdobju 60 minut.
English: Caution should be used when prescribing VIBATIV to patients receiving concomitant nephrotoxic medicines, those with pre existing renal disease or with co-morbidity known to predispose to kidney dysfunction (e.g. diabetes mellitus, congestive heart failure, hypertension).
Slovenian: Drugi dejavniki, ki lahko povečajo tveganje za nefrotoksičnost Previdnost je potrebna pri predpisovanju zdravila VIBATIV bolnikom, ki sočasno prejemajo nefrotoksična zdravila ter pri bolnikih s predhodno ledvično boleznijo ali s komorbidnostjo, za katero je znano, da povzroča ledvično disfunkcijo (npr. diabetes mellitus, kongestivno srčno popuščanje,
English: Degree of Renal Impairment Moderate
Slovenian: Stopnja okvare ledvične funkcije Srednje
English: Also, the pharmacokinetics of aztreonam or piperacillin tazobactam were not altered by telavancin.
Slovenian: Telavancin pa tudi ni spremenil farmakokinetike aztreonama ali piperacilin tazobaktama.
English: The test results can suggest poor blood clotting when, in fact, there is no problem.
Slovenian: Testi lahko prikažejo slabo strjevanje krvi, čeprav težav sploh ni. Povejte zdravniku, da prejemate zdravilo
English: In healthy volunteers who received a dose of 15 mg/kg, a higher incidence of adverse reactions to telavancin was seen: dysgeusia, nausea, vomiting, injection site erythema, headache, macular rash, and red man syndrome.
Slovenian: Pri zdravih prostovoljcih, ki so prejemali odmerek 15 mg/kg, so opazili višjo pojavnost neželenih učinkov telavancina: sprememba okusa, slabost, bruhanje, eritem na mestu injiciranja, glavobol,
English: Coagulation tests affected by telavancin
Slovenian: Telavancin vpliva na teste koagulacije
English: If you get any side effects, talk your doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Therefore, no dose adjustment is necessary when administering telavancin to subjects with mild or moderate degrees of hepatic impairment.
Slovenian: Zato pri dajanju telavancina bolnikom z blagimi ali zmernimi stopnjami jetrne insuficience ni potrebno prilagajati odmerka.
English: At a dose of 10 mg/kg, mean Vss averaged between 133 (SD 24) ml/kg after multiple dosing, corresponding to a value of approximately 10 l for a 75 kg person.
Slovenian: Pri odmerku 10 mg/kg je bila povprečna vrednost Vss 133 (SD 24) ml/kg po več odmerkih, kar ustreza vrednosti približno 10 l za osebo, ki tehta 75 kg. Ti podatki nakazujejo, da telavancin nima široke distribucije.
English: After addition of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection, the contents of the vial are mixed by swirling gently to facilitate reconstitution.
Slovenian: Po dodajanju raztopine dekstroze 50 mg/ml (5 %) za injiciranje ali vode za injekcije ali raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje premešajte vsebino viale z nežnim sukanjem viale, da se pospeši rekonstitucija.
English: See 4.2 for information on paediatric use.
Slovenian: Za podatke o uporabi pri pediatrični
English: 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
Slovenian: Zdravilo VIBATIV je indicirano za zdravljenje odraslih oseb z bolnišnično pljučnico, vključno z ventilatorsko pljučnico, za katero je znano oz. za katero se sumi, da jo je povzročil na meticilin odporen sev Staphylococcus aureus (MRSA).
English: Uncommon: may affect up to 1 in 100 people intestinal bacterial infection; urinary tract infection anaemia, changes in white blood cell counts; changes in blood platelet counts decreased appetite; changes in blood levels of glucose; changes in blood levels of potassium and restlessness; anxiety; confusion; depression loss of taste, migraine, abnormal touch sensation, smell disturbance, sleepiness, trembling chest pain; heart failure; abnormal heart rhythm or heart beat flushing; high or low blood pressure; inflammation of a vein breathlessness, hiccups, nasal congestion, sore throat abdominal pain; dry mouth; indigestion, bloating; numbness of the mouth skin redness; swelling of face; sweating, hives joint pain; back pain; muscle cramp; muscle pain painful urination; blood in urine; low urine output, frequent urination; abnormal urine odour lack of energy; irritation at infusion site; feeling unwell; chest discomfort; accumulation of fluid in the lower legs; pain; fever; skin flushing of upper body
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) črevesna bakterijska okužba, okužba sečil anemija, spremembe v številu belih krvničk, spremembe v številu trombocitov zmanjšan apetit, spremenjene ravni krvnega sladkorja, spremenjene ravni kalija in magnezija v vznemirjenost, anksioznost, zmedenost, depresija izguba okusa, migrena, nenormalna občutljivost dotika, motnje voha, zaspanost, tresavica bolečine v prsnem košu, odpoved srca, nenormalen srčni ritem ali srčni utrip vročinski oblivi, visok ali nizek krvni pritisk, vnetje vene zasoplost, kolcanje, nazalna kongestija, boleče grlo bolečine v predelu trebuha, suha usta, slaba prebava, napenjanje, odrevenelost ust vnetje jeter, rdečica kože, otekanje obraza, znojenje, koprivnica bolečine v sklepih, bolečine v hrbtu, mišični krči, bolečine v mišicah,
English: Appropriate infusion solutions include: dextrose 50 mg/ml (5%) solution for injection, sodium chloride 9 mg/ml (0.9%) solution for injection or lactated Ringer's solution for injection.
Slovenian: Primerne raztopine za infundiranje so med drugim: raztopina dekstroze 50 mg/ml (5 %) za injiciranje, raztopina natrijevega klorida 9 mg/ml (0,9 %) za injiciranje ali raztopina Ringerjevega laktata za injiciranje.
English: 1 vial of 30 ml with 250 mg telavancin 1 vial of 50 ml with 750 mg telavancin
Slovenian: 1 viala 30 ml z 250 mg telavancina
English: VIBATIV 750 mg powder for concentrate for solution for infusion 1 vial of 50 ml with 750 mg telavancin
Slovenian: VIBATIV 750 mg prašek za koncentrat za raztopino za infundiranje 1 viala 50 ml s 750 mg telavancina
English: Hypersensitivity reactions, including anaphylaxis, have been reported with telavancin, and may be life-threatening.
Slovenian: Pri uporabi telavancina so poročali o preobčutljivostnih reakcijah, vključno z anafilaksijo, ki so lahko življenjsko nevarne.
English: If an allergic reaction to telavancin occurs, discontinue treatment and institute
Slovenian: Če se pojavi alergijska reakcija na telavancin, je treba ukiniti zdravilo in začeti z
English: The macrophages were shown to contain telavancin and
Slovenian: Makrofagi so vsebovali telavancin in HP-β-CD.
English: Paediatric patients The pharmacokinetics of telavancin in patients below 18 years of age have not been established (see
Slovenian: Farmakokinetika telavancina pri bolnikih, mlajših od 18 let, še ni bila preučena (glejte poglavje 4.2).
English: Sodium hydroxide (for pH adjustment) (E524) Hydrochloric acid (for pH adjustment) (E507)
Slovenian: hidroksipropilbetadeks; razmerje telavancina in hidroksipropilbetadeksa je 1:10 (v/v) natrijev hidroksid (za uravnavanje pH) (E524) klorovodikova kislina (za uravnavanje pH) (E507)
English: VIBATIV 750 mg powder for concentrate for solution for infusion Each vial contains 750 mg telavancin (as hydrochloride).
Slovenian: VIBATIV 750 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 750 mg telavancina (v obliki klorida).
English: The dose given will depend on how much you weigh.
Slovenian: Odmerek je odvisen od vaše telesne mase.
English: Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT
Slovenian: Central Park, Western Avenue
English: Common: may affect up to 1 in 10 people kidney disorder, abnormal kidney function tests, foamy urine
Slovenian: zvišanje koncentracije jetrnih encimov v krvi bolezni ledvic, nenormalni testi ledvične funkcije, penast urin
English: Ask your doctor for advice before
Slovenian: Pred dojenjem se posvetujte s svojim zdravnikom.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: • Povzetek glavnih značilnosti zdravila,
English: Therefore, caution should be exercised if telavancin is given to subjects with severe hepatic impairment.
Slovenian: Zato je potrebna previdnost, kadar se telavancin daje bolnikom s
English: VIBATIV will be given to you by a doctor or a nurse.
Slovenian: Vaš zdravnik ali medicinska sestra vam bo odmeril(-a) zdravilo VIBATIV.
English: Patients with severe renal impairment, i.e. creatinine clearance (CrCl) <30 ml/min, including patients undergoing haemodialysis (see section 4.4).
Slovenian: Bolniki s hudo ledvično okvaro, npr. z očistkom kreatinina (CrCl) <30 ml/min, vključno z bolniki na
English: QUALITATIVE AND QUANTITATIVE COMPOSITION VIBATIV 250 mg powder for concentrate for solution for infusion Each vial contains 250 mg telavancin (as hydrochloride).
Slovenian: VIBATIV 250 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 250 mg telavancina (v obliki klorida).
English: Shelf life of reconstituted concentrate: The reconstituted concentrate should be diluted immediately
Slovenian: Rok uporabnosti rekonstituiranega koncentrata: Rekonstituiran koncentrat je potrebno razredčiti takoj po pripravi.
English: Severe
Slovenian: Huje
English: nausea constipation, diarrhoea, vomiting abdominal pain, dry mouth, dyspepsia, flatulence, hypoaesthesia alanine aminotransferase increased, aspartate aminotransferase erythema, face oedema, hyperhidrosis, urticaria Musculoskeletal and connective tissue disorders arthralgia, back pain, muscle cramp, myalgia renal failure acute, blood creatinine increased, foamy urine (lower blood urea increased, dysuria, haematuria, microalbuminuria, oliguria, pollakiuria, renal impairment, urine odour abnormal General disorders and administration site conditions asthenia, infusion site reactions, malaise, non-cardiac chest pain, peripheral oedema, pain, pyrexia, Red Man syndrome international normalised ratio increased * Based on post-marketing reports.
Slovenian: angina pektoris, atrijska fibrilacija, bradikardija, kongestivna srčna odpoved, podaljšanje popravljenega intervala QT na elektrokardiogramu, palpitacije, sinusna tahikardija, supraventrikularna ekstrasistola, ventrikularna ekstrasistola vročinski oblivi, hipertenzija, hipotenzija, flebitis dispneja, kolcanje, nazalna kongestija, faringolaringealne bolečine bolečina v predelu trebuha, suha usta, dispepsija, flatulenca, oralna zvečana vrednost alanin-aminotransferaze, zvečana vrednost eritem, obrazni edem, hiperhidroza, urtikarija Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija, bolečina v hrbtu, mišični krči, mialgija akutna ledvična odpoved, zvišan kreatinin v krvi, penast urin zvišana urea v krvi, disurija, hematurija, mikroalbuminurija, oligurija, polakiurija, ledvična okvara, nenormalen vonj urina
English: NAME OF THE MEDICINAL PRODUCT VIBATIV 750 mg powder for concentrate for solution for infusion
Slovenian: IME ZDRAVILA VIBATIV 750 mg prašek za koncentrat za raztopino za infundiranje
English: Reconstitution time is not more than 5 minutes for the vial containing 250 mg and not more than 10 minutes for the vial containing 750 mg.
Slovenian: Rekonstitucija traja največ 5 minut za vialo z 250 mg vsebino in največ 10 minut za vialo s 750 mg Mešanje poteka tako dolgo, dokler se vsebina viale popolnoma ne raztopi in pri pregledu s prostim
English: VIBATIV 250 mg powder for concentrate for solution for infusion VIBATIV 750 mg powder for concentrate for solution for infusion
Slovenian: VIBATIV 250 mg prašek za koncentrat za raztopino za infundiranje VIBATIV 750 mg prašek za koncentrat za raztopino za infundiranje
English: clostridium colitis, urinary tract infection anaemia, leukopenia, thrombocythaemia, thrombocytopenia, eosinophil count increased, neutrophil count increased decreased appetite, hyperglycaemia, hyperkalaemia, hypoglycaemia, hypokalaemia, hypomagnesaemia agitation, anxiety, confusional state, depression ageusia, migraine, paraesthesia, parosmia, somnolence, tremor
Slovenian: klostridijski kolitis, okužba urinarnega trakta anemija, levkopenija, trombocitemija, trombocitopenija, zvečano število evzinofilcev, zvečano število nevtrofilcev zmanjšan apetit, hiperglikemija, hiperkaliemija, hipoglikemija,
English: Vascular disorders Uncommon:
Slovenian: Ušesne bolezni, vključno z motnjami labirinta Redki:
English: Cross hypersensitivity reactions, including anaphylaxis, have been reported in patients with a history of vancomycin allergy.
Slovenian: Pri bolnikih, ki so v preteklosti imeli alergijo na vankomicin, so poročali o navzkrižnih preobčutljivostnih reakcijah, vključno z anafilaksijo.
English: The powder must be reconstituted and the resulting concentrate must then be immediately diluted further prior to use.
Slovenian: Posebni previdnostni ukrepi za odstranjevanje in drugo rokovanje Prašek je potrebno rekonstituirati, dobljeni koncentrat pa je potrebno pred nadaljnjo uporabo takoj
English: NAME OF THE MEDICINAL PRODUCT VIBATIV 250 mg powder for concentrate for solution for infusion
Slovenian: IME ZDRAVILA VIBATIV 250 mg prašek za koncentrat za raztopino za infundiranje
English: VIBATIV 750 mg powder for concentrate for solution for infusion
Slovenian: VIBATIV 750 mg prašek za koncentrat za raztopino za infundiranje
English: VIBATIV 250 mg powder for concentrate for solution for infusion
Slovenian: VIBATIV 250 mg prašek za koncentrat za raztopino za infundiranje
English: VIBATIV 250 mg powder for concentrate for solution for infusion The contents of the vial containing 250 mg telavancin must be reconstituted with 15 ml of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to obtain a concentration of approximately 15 mg/ml (total volume of approximately 17 ml).
Slovenian: VIBATIV 250 mg prašek za koncentrat za raztopino za infundiranje Vsebino viale z 250 mg telavancina morate rekonstituirati s 15 ml raztopine dekstroze 50 mg/ml (5 %) za injiciranje ali vode za injekcije ali raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje, da dobite koncentracijo približno 15 mg/ml (skupen volumen približno 17 ml).
English: The following formula can be used to calculate to volume of reconstituted VIBATIV concentrate
Slovenian: Volumen rekonstituiranega koncentrata zdravila VIBATIV, potreben za pripravo odmerka, se izračuna
English: Cardiac disorders Uncommon:
Slovenian: Srčne bolezni Občasni:
English: No evidence of increased bleeding risk has been observed in clinical trials with telavancin.
Slovenian: V kliničnih preskušanjih telavancina niso našli dokaza za povečanje tveganja krvavitve.
English: VIBATIV 750 mg powder for concentrate for solution for infusion The contents of the vial containing 750 mg telavancin must be reconstituted with 45 ml of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to obtain a concentration of approximately 15 mg/ml (total volume of
Slovenian: VIBATIV 750 mg prašek za koncentrat za raztopino za infundiranje Vsebino viale s 750 mg telavancina morate rekonstituirati s 45 ml raztopine dekstroze 50 mg/ml (5 %) za injiciranje ali vode za injekcije ali raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje, da dobite koncentracijo približno 15 mg/ml (skupen volumen približno 50 ml).
English: The solution is to be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Raztopino je treba pred uporabo pregledati s prostim očesom glede vsebnosti trdnih delcev in obarvanosti.
English: The following formula can be used to calculate the volume of reconstituted VIBATIV concentrate
Slovenian: Volumen rekonstituiranega koncentrata zdravila VIBATIV, potreben za pripravo odmerka, se izračuna z naslednjo formulo:
English: 750 mg telavancin (as hydrochloride) per vial After reconstitution each ml contains 15 mg of telavancin.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 750 mg telavancina (v obliki klorida) na vialo Po rekonstituciji en ml vsebuje 15 mg telavancina.
English: 250 mg telavancin (as hydrochloride) per vial After reconstitution each ml contains 15 mg of telavancin.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 250 mg telavancina (v obliki klorida) na vialo Po rekonstituciji en ml vsebuje 15 mg telavancina.
English: dyspnoea, hiccups, nasal congestion, pharyngolaryngeal pain
Slovenian: vznemirjenost, anksioznost, zmedenost, depresija agevzija, migrena, parestezija, parozmija, somnolenca, tresavica
English: You have to use effective contraception during
Slovenian: Med zdravljenjem z zdravilom VIBATIV morate uporabljati učinkovito
English: A dose adjustment should be made in obese patients with BMI > 30 kg/m2 (see section 4.2).
Slovenian: Pri debelih bolnikih z ITM > 30 kg/m2 je treba odmerek
English: Body mass index (BMI) at baseline was found to influence telavancin pharmacokinetics in the population pharmacokinetic analysis in healthy (without infection) adult subjects.
Slovenian: V populacijski farmakokinetični analizi zdravih odraslih preiskovancev (brez okužbe) so ugotovili, da indeks telesne mase (ITM) ob izhodišču vpliva na farmakokinetiko telavancina.
English: For instructions on reconstitution and dilution, see section 6.6.
Slovenian: Za navodila v zvezi z rekonstitucijo in raztapljanjem zdravila glejte
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje
English: The pregnancy status of women of childbearing potential has to be established prior to dosing with telavancin.
Slovenian: Pred dajanjem telavancina je treba preveriti, ali je ženska v rodni dobi noseča.
English: Manufacturer
Slovenian: Inkompatibilnosti
English: Whole blood (Lee-White) clotting time
Slovenian: Telavancin ne vpliva na teste koagulacije Čas strjevanja polne krvi (Lee-White)