FrancophonIA/ELRC3.0 huggingface dataset:
English: The time to Absolute Neutrophil Count (ANC) greater than 0.5x109/l was 21 days (range 12-47 days) in allogenic patients, and 11 days (range 10-15 days) in autologous patients.
Croatian: Vrijeme do apsolutnog broja neutrofila (ABN) većeg od 0,5x109 /l bilo je 21 dan (raspon od 12-47 dana) u alogenih bolesnika i 11 dana
English: Cardiac: clotting of femoral artery, extra heart beats, decrease in heart rate, diffuse leak of fluid from the capillaries (small blood vessels).
Croatian: Srce: ugrušci u femoralnoj arteriji, dodatni otkucaji srca, smanjenje otkucaja srca, difuzan gubitak tekućine iz kapilara (krvnih žilica).
English: Either phenytoin or benzodiazepines were administered for seizure prophylaxis in patients participating to the clinical trials conducted with intravenous busulfan (see section 4.2 and 4.4).
Croatian: Za profilaksu napadaja u bolesnika koji su sudjelovali u kliničkim ispitivanjima provedenim s intravenskim busulfanom primjenjivao se ili fenitoin ili benzodiazepini (vidjeti dio 4.2 i 4.4).
English: General: fever, headache, weakness, chills, pain, allergic reaction, oedema, general pain or inflammation at injection site, chest pain, inflammation of the mucosa.
Croatian: Općenito: vrućica, glavobolja, slabost, zimica, bol, alergijska reakcija, edem, općenita bol ili upala na mjestu injiciranja, bol u prsištu, upala sluznice.
English: Respiratory: increase in breath rhythm, respiratory failure, alveolar haemorrhages, asthma, collapse of small portions of the lung, fluid around the lung.
Croatian: Disanje: ubrzanje ritma disanja, zatajenje disanja, alveolarno krvarenje, astma, kolaps manjih dijelova pluća, tekućina oko pluća.
English: Chemical and physical in-use stability after dilution in glucose 5% or sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for:
Croatian: Kemijska i fizička stabilnost u primjeni nakon razrjeđivanja u 5%-tnoj otopini glukoze ili 0,9%-tnoj (9 mg/ml) otopini natrijeva klorida za injekciju dokazana je za:
English: Transaminases increased Bilirubine increased Alkaline phosphatases increased
Croatian: Povišeni bilirubin Povišena alkalna fosfataza
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to restricted medical prescription.
Croatian: Lijek se izdaje na ograničeni recept.
English: In paediatric population
Croatian: U pedijatrijskoj populaciji
English: - 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C  5 °C (including infusion time).
Croatian: 5 °C - 12 sati nakon razrjeđivanja ako se čuva na temperaturi od 2 °C - 8 °C nakon čega je uslijedilo 3 sata čuvanja na temperaturi od 20 °C  5 °C (uključujući vrijeme infuzije).
English: The most frequent causes of reported TRM/NRMs were infection/sepsis, GVHD, pulmonary disorders and organ failure.
Croatian: Najčešći uzroci prijavljene smrtnosti povezane s liječenjem/smrtnosti koja nije povezana s relapsom bili su infekcija/sepsa, GVHD, plućni poremećaji i zatajenje organa.
English: Periodic monitoring of renal function should be considered during therapy with Busilvex (see section
Croatian: Periodični nadzor funkcije bubrega mora se razmotriti u bolesnika tijekom liječenja Busilvexom (vidjeti dio 4.8).
English: Busilvex in combination with cyclophosphamide:
Croatian: Busilvex u kombinaciji s ciklofosfamidom:
English: Veno occlusive liver disease *
Croatian: Vensko-okluzivna bolest jetre *
English: On the basis of human data, busulfan has been classified by the IARC as a human carcinogen.
Croatian: IARC) klasificirala je busulfan kao humani karcinogen.
English: Hepatomegaly Jaundice
Croatian: Hepatomegalija Žutica
English: Respiratory failure
Croatian: Respiratorno zatajenje
English: The active substance is busulfan.
Croatian: Što Busilvex sadrži - Djelatna tvar je busulfan.
English: Arrhythmia Atrial fibrillation Cardiomegaly Pericardial effusion
Croatian: Fibrilacija atrija Kardiomegalija
English: How to use Busilvex
Croatian: Kako primjenjivati Busilvex
English: followed by: - 4 cycles of 50 mg/kg body weight (BW) cyclophosphamide (BuCy4) or - one administration of 140 mg/m² melphalan (BuMel) initiated for at least 24 hours following the 16th dose of Busilvex.
Croatian: 4 ciklusa sa 50 mg/kg tjelesne težine (TT) ciklofosfamida (BuCy4) ili jedna primjena 140 mg/m² melfalana (BuMel) s početkom najmanje 24 sata nakon 16. doze lijeka Busilvex (vidjeti dio 4.5).
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Croatian: Time se omogućuje kontinuirano praćenje omjera koristi i rizika lijeka.Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: How to store Busilvex
Croatian: Kako čuvati Busilvex
English: Increase of uric acid and urea in the blood.
Croatian: Povišena mokraćna kiselina u krvi Povišena urea u krvi
English: Nutrition: low blood sodium.
Croatian: Prehrana: niska koncentracija natrija u krvi.
English: Haemorrhagic cystitis**
Croatian: Hemoragični cistitis**
English: 93% of allogeneic patients showed complete chimerism.
Croatian: Potpuni kimerizam primijećen je u 93% alogenih bolesnika.
English: Busilvex must not be put into an intravenous bag that does not contain sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Croatian: Busilvex se ne smije unositi u intravensku vrećicu koja ne sadrži otopinu natrijeva klorida 9 mg/ml (0,9%) za injekciju ili 5%-tnu otopinu glukoze za injekciju.
English: RECOMMENDATION FOR SAFE HANDLING
Croatian: PREPORUKE ZA SIGURNO RUKOVANJE
English: Busilvex following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen.
Croatian: Busilvex koji slijedi nakon fludarabina (FB) indiciran je kao terapija kondicioniranja prije presađivanja hematopoetskih progenitorskih stanica u odraslih bolesnika koji su kandidati za protokol kondicioniranja smanjenog intenziteta.
English: Invasive fungal infection
Croatian: Invazivna gljivična infekcija Plućna infekcija
English: A MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Low inter (CV=21%) and intra (CV=12%) patient variability on busulfan exposure was demonstrated through a population pharmacokinetic analysis, performed on 102 patients.
Croatian: Populacijskom farmakokinetičkom analizom provedenom na 102 bolesnika dokazana je niska inter- (CV=21%) i intravarijabilnost (CV=12%) bolesnika na izloženost busulfanu.
English: Platelet and red blood cell support, as well as the use of growth factors such as granulocyte colony stimulating agent (G-CSF), should be employed as medically indicated.
Croatian: Kada je to medicinski indicirano, potrebno je primijeniti potporna sredstva za porast broja trombocita i crvenih krvnih stanica i upotrijebiti faktore rasta kao što je sredstvo za stimulaciju rasta granulocitnih kolonija (G-CSF).
English: Cardiac: increase in heart rate, increase or decrease of blood pressure, vasodilatation (a state of increased calibre of the blood vessels), and blood clots.
Croatian: Srce: ubrzanje srčanog ritma, povećanje ili smanjenje krvnog tlaka, vazodilatacija (širenje krvnih žila) i krvni ugrušci.
English: Busilvex is administered prior to the haematopoietic progenitor cell transplantation (HPCT).
Croatian: Primjena lijeka Busilvex prethodi presađivanju hematopoetskih progenitorskih stanica (HPCT, engl. haematopoietic progenitor cell transplantation).
English: Respiratory: shortness of breath, nasal secretion (rhinitis), sore throat, cough, hiccup, nosebleeds, abnormal breath sounds.
Croatian: Disanje: nedostatak zraka, curenje nosa (rinitis), grlobolja, kašalj, štucanje, krvarenje iz nosa, neuobičajeni zvukovi disanja.
English: The effects of hepatic dysfunction on intravenous busulfan disposition have not been assessed.
Croatian: Učinci disfunkcije bubrega na djelovanje intravenskog busulfana nisu procijenjeni.
English: Myalgia Back pain Arthralgia
Croatian: Mialgija Bol u leđima Artralgija
English: One patient experienced a fatal case of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis in the Busilvex studies.
Croatian: U ispitivanjima Busilvexa jedan je bolesnik doživio smrtonosni slučaj akutnog respiratornog distres sindroma s posljedičnim zatajenjem pluća povezanog s intersticijskom fibrozom pluća.
English: Ovarian suppression and amenorrhoea with menopausal symptoms commonly occur in pre-menopausal patients.
Croatian: U bolesnica u predmenopauzi često se pojavljuje supresija jajnika i amenoreja sa simptomima menopauze.
English: After dilution: one ml of solution contains approximately 0.5 mg of busulfan.
Croatian: Nakon razrjeđivanja: Jedan ml otopine sadrži približno 0,5 mg busulfana.
English: Occurrence of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis was reported in Busilvex studies in one patient who died, although, no clear aetiology was identified.
Croatian: U ispitivanjima lijeka Busilvex kod jednog bolesnika koji je preminuo prijavljena je pojava akutnog respiratornog distres sindroma s posljedičnim zatajenjem pluća povezanog s intersticijskom fibrozom pluća, premda nije utvrđena jasna etiologija.
English: EXP: Read the leaflet for the shelf life of diluted medicine
Croatian: Rok valjanosti: Pročitajte uputu o lijeku za rok valjanosti razrijeđenog lijeka.
English: in combination with other medicine as a conditioning treatment previous HCT have been seen after reviewing the literature and the cases retrieved in the safety database of the company.
Croatian: uočeni su nakon pregleda literature te u slučajevima preuzetima iz sigurnosne baze podataka kompanije.
English: Confusion
Croatian: Smetenost
English: In that case infusion sets with minimal priming space should be used (i.e. 0.3-0.6 ml), primed with medicinal product solution prior to beginning the actual Busilvex infusion and then flushed with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Croatian: U tom je slučaju potrebno primjenjivati komplete za infuziju s minimalnim prostorom za ubrizgavanje (tj. 0,3 - 0,6 ml), u kojima je otopina lijeka infundirana prije početka stvarne infuzije Busilvexom i potom isprana otopinom natrijeva klorida 9 mg/ml (0,9%) za injekciju ili otopinom glukoze (5%) za injekciju.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 12.
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Creatinine elevated Blood lactate dehydrogenase increased
Croatian: Povišena laktat dehidrogenaza u krvi
English: STATEMENT OF ACTIVE SUBSTANCE One ml of concentrate contains 6 mg of busulfan and provides 0.5 mg/ml of busulfan after dilution
Croatian: Jedan ml koncentrata sadrži 6 mg busulfana i nakon razrjeđivanja osigurava 0,5 mg/ml busulfana
English: Nausea Vomiting Diarrhoea Stomatitis
Croatian: Mučnina Povraćanje Proljev Stomatitis
English: Hepatic: enlarged liver, jaundice, blocking of a liver vein.
Croatian: Jetra: povećana jetra, žutica, začepljenje jetrene vene.
English: = A ml of Busilvex to be diluted
Croatian: A ml Busilvexa koji je potrebno razrijediti
English: Busulfan is mutagenic and clastogenic.
Croatian: Busulfan je mutagen i klastogen.
English: All evaluable patients engrafted.
Croatian: Presađivanje je provedeno kod svih uključenih bolesnika.
English: Prior to and following each infusion, flush the indwelling catheter line with approximately 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Croatian: Prije i nakon svake infuzije isperite umetnutu katetersku liniju s približno 5 ml otopine natrijeva klorida 9 mg/ml (0,9%) za injekciju ili otopine glukoze (5%) za injekciju.
English: The recommended dose and schedule of administration is: - 0.8 mg/kg body weight (BW) of busulfan as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses, - followed by cyclophosphamide at 60 mg/kg/day over 2 days initiated for at least 24 hours following the 16th dose of Busilvex (see section 4.5).
Croatian: 0,8 mg/kg tjelesne težine (TT) busulfana u obliku dvosatne infuzije svakih 6 sati tijekom 4 uzastopna dana u ukupno 16 doza, potom slijedi ciklofosfamid u dozi od 60 mg/kg/dan tijekom 2 dana s početkom najmanje 24 sata nakon 16. doze lijeka Busilvex (vidjeti dio 4.5).
English: After dilution, 1 ml of solution for infusion contains 0.5 mg of busulfan.
Croatian: Nakon razrjeđivanja 1 ml otopine za infuziju sadrži 0,5 mg busulfana.
English: Lens disorders including clouding of the lens of the eye (cataract), and blurred vision (corneal thinning).
Croatian: Poremećaji leće uključujući zamućenost leće oka (katarakta) i zamagljeni vid (stanjivanje rožnice) Simptomi menopauze i ženska neplodnost.
English: Busilvex in combination with cyclophosphamide In adults
Croatian: Busilvex u kombinaciji s ciklofosfamidom U odraslih
English: Haematuria Moderate renal Insufficiency
Croatian: Hematurija Umjerena bubrežna insuficijencija
English: Using a non polycarbonate syringe fitted with a needle: - the calculated volume of Busilvex must be removed from the vial.
Croatian: Upotrebom nepolikarbonatnih štrcaljki opremljenih iglom: iz bočice se mora ukloniti izračunati volumen Busilvexa. sadržaj štrcaljke mora se ubrizgati u intravensku vrećicu (ili štrcaljku) koja već sadrži izračunatu količinu odabranog otapala.
English: doses in combination with other drugs in conditioning treatment previous HCT could be an important role in the development of TMA.
Croatian: Uglavnom su studije u literaturi pokazale da visoke doze intravenskog (i.v.) busulfana, u kombinaciji s drugim lijekovima tijekom terapije kondicioniranja prije transplantacije hematopoetskih matičnih stanica (HCT), mogu imati važnu ulogu u razvoju trombotičke mikroangiopatije (TMA).
English: No interaction was observed when busulfan was combined with fluconazole (antifungal agent) Published studies in adults described that ketobemidone (analgesic) might be associated with high levels of plasma busulfan.
Croatian: U objavljenim ispitivanjima na odraslima opisano je da ketobemidon (analgetik) može biti povezan s visokim razinama busulfana u plazmi.
English: Veno occlusive liver disease
Croatian: Vensko-okluzivna bolest jetre
English: When diluted Busilvex is a clear colourless solution.
Croatian: Kada je razrijeđen, Busilvex je bistra, bezbojna otopina.
English: To prepare the final solution for infusion, add (A) ml of Busilvex to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%) Preparation of the solution for infusion
Croatian: Za pripremu konačne otopine za infuziju, dodajte (A) ml Busilvexa u (B) ml otapala (otopina natrijeva klorida 9 mg/ml (0,9%) za injekciju ili 5%-tna otopina glukoze za injekciju)
English: Fertility
Croatian: Aritmija
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {10ml type I glass vial}
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE {staklena bočica tipa
English: Femoral artery thrombosis Capillary leak syndrome
Croatian: Tromboza femoralne arterije
English: Busilvex in combination with cyclophosphamide or melphalan
Croatian: Busilvex u kombinaciji s ciklofosfamidom ili melfalanom
English: 5 How to store Busilvex Contents of the pack and other information
Croatian: Kako Busilvex izgleda i sadržaj pakiranja
English: There is no common metabolism pathway between busulfan and fludarabine.
Croatian: Busulfan i fludarabin nemaju zajednički metabolički put.
English: Gastrointestinal haemorrhage
Croatian: Gastrointestinaln o krvarenje
English: Calculation of the quantity of Busilvex to be diluted and of the diluent Busilvex must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Croatian: Izračun količine Busilvexa koju je potrebno razrijediti i količine otapala Prije upotrebe, Busilvex je potrebno razrijediti s otopinom natrijeva klorida 9 mg/ml (0,9%) za injekciju ili otopinom 5%-tne glukoze za injekciju.
English: Women must stop breast-feeding before starting their treatment with Busilvex.
Croatian: Prije početka liječenja Busilvexom, žene moraju prestati s dojenjem.
English: Gastro-intestinal: nausea, inflammation of the mucosa of the mouth, vomiting, abdominal pain, diarrhoea, constipation, heart burn, anus discomfort, liquid in the abdomen.
Croatian: Probavni sustav: mučnina, upala sluznice usta, povraćanje, bol u trbuhu, proljev, zatvor, žgaravica, nelagoda u anusu, tekućina u abdomenu.
English: Chest pain Oedema
Croatian: Astenija Edem Bol
English: Immediate and complete availability of the dose is obtained after intravenous infusion of busulfan.
Croatian: Nakon intravenske infuzije busulfana doza je odmah i u potpunosti dosegnula raspoloživost.
English: Hepatic veno-occlusive disease is a major complication that can occur during treatment with Busilvex.
Croatian: Glavna komplikacija koja se može pojaviti tijekom liječenja Busilvexom je vensko-okluzivna bolest jetre.
English: Encephalopathy Cerebral haemorrhage
Croatian: Cerebralno krvarenje Encefalopatija
English: Busilvex in combination with cyclophosphamide or melphalan In adults
Croatian: Busilvex u kombinaciji s ciklofosfamidom ili melfalanom U odraslih
English: Skin desquamation Erythema Pigmentation disorder
Croatian: Deskvamacija kože Eritem
English: PREPARATION GUIDE
Croatian: UPUTE ZA PRIPREMU
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštano g sustava i vezivnog tkiva
English: 6 (mg/ml) Y: body weight of the patient in kg
Croatian: Y: tjelesna težina bolesnika u kg
English: Hyper-tension
Croatian: Hiperventilacija
English: Anxiety Depression Insomnia
Croatian: Febrilna neutropenija Anemija
English: Hypogonadism
Croatian: Hiponatrijemija
English: Stomatitis Diarrhoea Abdominal pain Nausea
Croatian: Bol u abdomenu Mučnina
English: Seizures have been reported with high dose busulfan treatment.
Croatian: Tijekom liječenja busulfanom u visokim dozama prijavljeni su napadaji.
English: Liver disorders.
Croatian: Poremećaji jetre.
English: Busilvex must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Croatian: Prije upotrebe, Busilvex se mora razrijediti s otopinom natrijeva klorida 9 mg/ml (0,9%) za injekciju ili otopinom 5%-tne glukoze za injekciju.
English: Busilvex 6 mg/ml concentrate for solution for infusion
Croatian: Busilvex 6 mg/ml koncentrat za otopinu za infuziju
English: In adult and paediatric studies, patients received either phenytoin or benzodiazepines as seizure prophylaxis treatment.
Croatian: U ispitivanjima na odraslima i djeci, bolesnici su primali fenitoin ili benzodiazepine kao profilaktičnu terapiju napadaja (vidjeti dijelove 4.4 i 4.5).
English: OTHER SPECIAL WARNING IF NECESSARY Cytotoxic: handle with caution.
Croatian: Citotoksično: rukujte s oprezom.
English: Vasodilatation
Croatian: Rok valjanosti
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING WITH BLUE BOX {Box containing 8 vials of 10ml}
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU S PLAVIM OKVIROM
English: There are no cases with oral busulfan.
Croatian: Kod peroralnog busulfana ovakvi slučajevi nisu zabilježeni.
English: Hyperventilation Respiratory failure Alveolar haemorrhages Asthma
Croatian: Respiratorno zatajenje Alveolarna krvarenja
English: Preparation of Busilvex
Croatian: Priprema Busilvexa
English: Gastro-intestinal: inflammation of the mucosa of oesophagus, paralysis of the gut, vomiting blood.
Croatian: Probavni sustav: upala sluznice jednjaka, paraliza crijeva, povraćanje krvi.
English: Tooth hypoplasia**
Croatian: Hipoplazija zuba**
English: Busilvex 6 mg/ml concentrate for solution for infusion Busulfan
Croatian: Busilvex 6 mg/ml koncentrat za otopinu za infuziju busulfan
English: Skin: Skin colour disorder, redness of the skin, skin desquamation.
Croatian: Koža: poremećaj boje kože, crvenilo kože, ljuštenje kože Bubrezi: povećanje dušičnih sastojaka u krvotoku, umjereno bubrežno zatajivanje, poremećaj bubrega.
English: Gastro-intestinal disorders
Croatian: Neutropenija Trombocitopenija
English: Atelectasis Pleural effusion
Croatian: Dispneja Epistaksa Kašalj Štucanje
English: The recommended dose of Busilvex is 0.8 mg/kg Each infusion will last 2 hours
Croatian: - Preporučena doza Busilvexa je 0,8 mg/kg - Svaka infuzija trajat će 2 sata - Busilvex će se primjenjivati svakih 6 sati tijekom 4 uzastopna dana prije presađivanja.
English: Hypoalbuminaemia Electrolyte disturbance Hyperglycaemia
Croatian: Poremećaj elektrolita Hiperglikemija
English: 7 MARKETING AUTHORISATION HOLDER
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Bun increase Decrease ejection fraction
Croatian: Povišeni dušik iz ureje u krvi (BUN) Smanjena ejekcijska frakcija
English: Dysuria Oligurea
Croatian: Stomatitis Proljev
English: Lot
Croatian: Bol
English: Marketing Authorisation Holder Pierre Fabre Médicament 45, place Abel Gance F-92654 Boulogne-Billancourt cedex France
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Pierre Fabre Médicament 45, place Abel Gance
English: Obese patients In adults
Croatian: I DOHVATA DJECE
English: Oedema general Pain
Croatian: Generalizirani edem
English: Gastro-intestinal haemorrhage Tooth hypoplasia*
Croatian: Hipoplazija zuba*
English: Tabulated summaries of adverse reactions
Croatian: Opći poremećaji i reakcije na mjestu primjene
English: In addition, the small number of patients should also be taken into consideration.
Croatian: Uz to, mali broj bolesnika također treba uzeti u obzir.
English: Most of the reported cases developed after at least one week of treatment.
Croatian: Većina prijavljenih slučajeva razvila se nakon najmanje jednog tjedna liječenja.
English: Instructions for use and handling (see also 3.
Croatian: Upute za upotrebu i rukovanje (vidjeti također 3.
English: Orange cake or powder.
Croatian: Narančasti „kolačić“ ili prašak.
English: Date of first authorisation: 24 April 2006.
Croatian: Datum prvog odobrenja: 24. travnja 2006.
English: If you receive more Tygacil than you should
Croatian: Ako primite više Tygacila nego što ste trebali
English: • If you have, or previously had liver problems.
Croatian: • Ako imate ili ste prethodno imali probleme s jetrom.
English: Your doctor will decide how long you should be treated.
Croatian: Vaš će liječnik odlučiti o tome koliko ćete se dugo liječiti.
English: Available data does not suggest that this interaction may result in significant INR changes.
Croatian: Dostupni podaci ne upućuju na to da bi ova interakcija mogla dovesti do značajnih promjena INR-a.
English: Attention should be paid to possible dehydration.
Croatian: Potrebno je pripaziti na moguću dehidraciju.
English: Note: The vial contains a 6 % overage.
Croatian: Napomena: Bočica sadrži višak od 6%.
English: Date of latest renewal: 22 February 2016.
Croatian: Datum posljednje obnove odobrenja: 22 veljače 2016.
English: The mechanism of this interaction is still not elucidated.
Croatian: Mehanizam ove interakcije još nije razjašnjen.
English: A course of treatment usually lasts for 5 to 14 days.
Croatian: Kura liječenja obično traje 5 do 14 dana.
English: Your doctor has prescribed Tygacil because you or your child at least 8 years old has one of the following types of serious infections:
Croatian: Vaš liječnik je Vama ili Vašem djetetu propisao Tygacil zato što Vi ili Vaše dijete koje ima najmanje 8 godina imate jednu od sljedećih vrsta ozbiljnih infekcija:
English: These alterations were shown to be reversible after two weeks of dosing.
Croatian: Navedene promjene su se pokazale reverzibilnima nakon dva tjedna davanja.
English: What Tygacil is and what it is used for
Croatian: Što je Tygacil i za što se koristi
English: Storage after preparation
Croatian: Čuvanje nakon pripreme
English: Results from animal studies using
Croatian: Rezultati ispitivanja na životinjama u kojima je korišten