FrancophonIA/ELRC3.0 huggingface dataset:
English: decrease in thyroid gland activity (which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms), feeling depressed or irritable, feeling sick to stomach, feeling unwell, mood swings, tired feeling, trouble falling asleep or staying asleep, virus infection, weakness, diarrhoea, dizziness, fever, flu-like symptoms, headache, loss of or increase in appetite, loss of weight, decrease in the rate of growth (height and weight), pain on right side of ribs, pharyngitis (sore throat), shaking chills, stomach pain, vomiting, dry skin, hair loss, irritation, itching, muscle pain, muscle aches, pain in joints and muscles, rash.
Croatian: depresivnost ili razdražljivost, osjećaj mučnine u želucu, opće loše osjećanje, promjene raspoloženja, umor, poteškoće s uspavljivanjem ili održavanjem sna, virusna infekcija, slabost, proljev, omaglica, vrućica, simptomi nalik gripi, glavobolja, gubitak ili povećanje teka, gubitak tjelesne težine, smanjenje brzine rasta (visina i težina), bol pod desnim rebrenim lukom, faringitis (upala grla), zimica i drhtavica, bol u trbuhu, povraćanje, suha koža, gubitak kose, iritacija, svrbež, bol u mišićima, bol u zglobovima i mišićima, osip.
English: Respiratory, thoracic and mediastinal disorders Very common:
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja vrlo često:
English: Contact your doctor immediately if you notice any of the following side effects occurring during combination treatment with other medicines: chest pain or persistent cough, changes in the way your heart beats, fainting, confusion, feeling depressed, suicidal thoughts or aggressive behaviour, attempt suicide, thoughts about threatening the life of others, feelings of numbness or tingling, trouble sleeping, thinking or concentrating, severe stomach pain; black or tar-like stools, blood in stool or urine, lower back or side pain, painful or difficult urination, severe bleeding from your nose, fever or chills beginning after a few weeks of treatment, problems with your eyesight or hearing, severe skin rash or redness.
Croatian: smetenost, depresivnost; razmišljanje o samoubojstvu ili agresivno ponašanje, pokušaj samoubojstva, razmišljanje o ugrožavanju života drugih ljudi, osjećaj utrnulosti ili trnci, poteškoće sa spavanjem, razmišljanjem ili koncentriranjem, jaki bolovi u trbuhu; crna ili katranasta stolica, krv u stolici ili mokraći, bol u leđima ili slabinama, bolno ili otežano mokrenje, jako krvarenja iz nosa, vrućica ili zimica koje se pojave nakon nekoliko tjedana liječenja, problemi s vidom ili sluhom, teški osip ili crvenilo kože.
English: Rebetol in combination with peginterferon alfa-2b Multiple-dose pharmacokinetic properties for Rebetol and peginterferon alfa-2b in children and adolescent patients with chronic hepatitis C have been evaluated during a clinical study.
Croatian: U kliničkom ispitivanju u djece i adolescenata s kroničnim hepatitisom C procijenjena su farmakokinetička svojstva lijeka Rebetol i peginterferona alfa-2b nakon višestrukih doza.
English: Commonly reported side effects(may affect up to1 in 10people): decrease in certainwhite blood cells called leukocytes that help fight infection, excess of sugar in the blood, low calcium level in the blood, amnesia, crying, bleeding gums, feeling faint, anger, memory impaired, mental disorder, cardiac murmur (abnormal heart beat sounds), difficult breathing, low or high blood pressure, blurred vision, changes in yourhearing, ringing in ears, earache, bloating, burning sensation on tongue, change in taste, taste loss, dry mouth, migraine,nonproductive cough, thirst, abnormal urine, passing more urine than usual, irritated colon, irritation of prostate gland, intestinal gas (flatus), jaundice (yellow skin), disorder of ovary, breast pain, lack of interest in sex or inability to perform, erectile problem, abnormal hair texture, arthritis, psoriasis, muscle spasm, puffy or swollen hands and ankles, swollen face, unsteady when walking,water impairment.
Croatian: Često prijavljene nuspojave (mogu se javiti u do 1 na 10 osoba): smanjenje broja određenih bijelih krvnih stanica koje se zovu limfociti, koje pomažu u borbi protiv infekcije, povišena razina šećera u krvi, niska razina kalcija u krvi, gubitak pamćenja, plačljivost, krvarenje iz desni, osjećaj nesvjestice, ljutnja, poremećaj pamćenja, mentalni poremećaj, šum na srcu (neuobičajeni zvuk kucanja srca), otežano disanje, nizak ili visok krvni tlak, zamagljen vid, promjene sluha, zvonjenje u ušima, bol u uhu, nadutost, osjećaj pečenja na jeziku, promjene osjeta okusa, gubitak osjeta okusa, suha usta, migrena, neproduktivan kašalj, žeđ, promjena mokraće, obilnije mokrenje, iritacija debelog crijeva, iritacija prostate, crijevni plinovi (vjetrovi), žutica (žuta koža), poremećaj jajnika, bol u dojkama, gubitakspolnog nagona ili impotencija, tegobe s erekcijom, promijenjena kvaliteta kose, artritis, psorijaza, grčevi mišića, otečene ili nabrekle šake i gležnjevi, otečeno lice, nesigurnost prihodanju, narušena ravnoteža vode u organizmu.
English: Vascular disorders Common:
Croatian: vaskulitis vrlo rijetko:
English: UAB Merck Sharp & Dohme Tel. +370 5 278 02 47 msd_lietuva@merck.com
Croatian: +370 5 278 02 47 msd_lietuva@merck.com
English: peginterferon alfa-2b (1.5 µg/kg/ week)
Croatian: % (broj) bolesnika peginterferon alfa-2b 1,5 µg/kg
English: Glycerol
Croatian: Hemoliza
English: Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord), bronchoconstriction and anaphylaxis (a severe, whole-body allergic reaction), constant cough, eye problems including damage to the retina, obstruction of the retinal artery, inflammation of the optic nerve, swelling of the eye and cotton wool spots (white deposits on the retina), enlarged abdominal area, heartburn, trouble having bowel movement or painful bowel movement, acute hypersensitivity reactions including urticaria (hives), bruises, intense pain in a limb, leg or thigh pain, loss of range of motion, stiffness, sarcoidosis (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands).
Croatian: Kada se ovaj lijek uzimao u kombinaciji s alfa interferonom, prijavljene su i sljedeće ostale nuspojave: neuobičajene misli, opažanje zvukova i slika koji nisu stvarni, promjena psihičkog stanja, dezorijentiranost, angioedem (oticanje šaka, stopala, gležnjeva, lica, usana, usta ili grla, što može uzrokovati poteškoće pri gutanju ili disanju), sindrom Vogt-Koyanagi-Harada (autoimuni upalni poremećaj koji zahvaća oči, kožu te ušne, moždane i ovojnice kralježnične moždine), bronhokonstrikcija i anafilaksija (teška alergijska reakcija cijelog organizma), uporan kašalj, tegobe s očima koje uključuju oštećenje mrežnice, opstrukciju mrežnične arterije, upalu očnog živca, oticanje oka i pamučasta krvarenja u mrežnici (bijele nakupine na mrežnici), povećan trbuh, žgaravica, poteškoće kod pražnjenja crijeva ili bolno pražnjenje crijeva, akutne reakcije preosjetljivosti uključujući urtikariju (koprivnjaču), modrice, jaka bol u udovima, bol u nozi ili bedru, smanjen opseg pokreta, ukočenost, sarkoidoza (bolest koju prati stalna vrućica, gubitak tjelesne težine, bol i oticanje zglobova, oštećenja kože i oticanje limfnih čvorova).
English: Rhabdomyolysis*, myositis*
Croatian: kardiomiopatija, aritmija*
English: HVL (>600,000 IU/mL)
Croatian: Početno virusno opterećenje Visoko (>600 000 IU/ml)
English: Common:
Croatian: često:
English: Blood thyroid stimulating hormone increased, thyroglobulin increased
Croatian: povišene vrijednosti TSH-a u krvi, povišene vrijednosti tiroglobulina manje često:
English: Plasma HCV-RNA is measured with a research-based quantitative polymerase chain reaction assay by a central laboratory *Intent to treat population includes 7 patients for whom at least 12 weeks of prior therapy could not be confirmed.
Croatian: * U skupinu s namjerom liječenja uključeno je i 7 bolesnika za koje se nije moglo potvrditi prethodno liječenje u trajanju od najmanje 12 tjedana.
English: Cutaneous sarcoidosis
Croatian: Oralna otopina
English: Genotype 1, 4 17 % (21/125) 6 % (8/129) 0.006 38 % (12/32) 7 % (2/27) 0.007 Genotype 2, 3 44 % (35/80) 43 % (33/76) 0.88 53 % (10/19) 47 % (7/15) 0.730
Croatian: Odmjerena doza (ujutro / navečer) 2 ml / 2 ml 3 ml / 2 ml 3 ml / 3 ml 4 ml / 3 ml 4 ml / 4 ml 5 ml / 4 ml 5 ml / 5 ml 6 ml / 5 ml 6 ml / 6 ml 7 ml / 6 ml 7 ml / 7 ml 8 ml / 7 ml 8 ml / 8 ml 9 ml / 8 ml
English: Respiratory, thoracic and mediastinal disorders Common:
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja često:
English: SVR in patients with undetectable HCV-RNA at treatment week 12 *HCV-RNA PCR assay, with a lower limit of quantitation of 27 IU/mL
Croatian: Nemjerljiva razina HCV-RNK u 12. tjednu liječenja Odgovor na kraju liječenja* 53 (542/1019) Relaps* SVR* SVR u bolesnika s nemjerljivom HCV-RNK u 12. tjednu liječenja
English: For complete information be sure to read the “How to use” section of the Package Leaflet for the other medicines used in combination with Rebetol.
Croatian: "Kako uzimati" u Uputama o lijeku za druge lijekove koji se primjenjuju u kombinaciji s lijekom Rebetol.
English: 80 mg/mL Concentrate for solution for infusion
Croatian: 80 mg/mL Koncentracija otopine za infuziju
English: Aloxi should be injected over 30 seconds.
Croatian: Aloxi treba ubrizgati tijekom 30 sekundi.
English: Significance level at α=0.05.
Croatian: Razina značajnosti pri α = 0,05.
English: The overall safety was maintained during all cycles.
Croatian: Sveukupna sigurnost održavana je tijekom svih ciklusa.
English: It is unlikely that you will forget to take this medicine.
Croatian: Malo je vjerojatno da ćete zaboraviti uzeti ovaj lijek.
English: • ringing in the ear
Croatian: • zvonjava u uhu
English: • trouble sleeping
Croatian: • poteškoće sa spavanjem
English: Date of latest renewal: 23 March 2010
Croatian: Datum posljednje obnove odobrenja: 23. ožujka 2010.
English: p-value c
Croatian: p-vrijednost c
English: If you are allergic to peanut or soya, do not take this medicine.
Croatian: Ako ste alergični na kikiriki ili soju, nemojte uzimati ovaj lijek.
English: Currently available data are described in section 5.1 and section 5.2, but no recommendation on posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 5.1 i 5.2, međutim, nije moguće dati preporuku o doziranju.
English: Complete Response was not formally evaluated for the repeat cycle application.
Croatian: Potpuni odgovor formalno nije bio procijenjen za ponovljeni ciklus primjene.
English: Aloxi is normally given by a doctor or nurse.
Croatian: Aloxi obično daje liječnik ili medicinska sestra.
English: Two paediatric trials were performed.
Croatian: Provedena su dva pedijatrijska ispitivanja.
English: • high levels of certain liver enzymes
Croatian: • visoke razine određenih jetrenih enzima
English: This medicinal product should be administered by a healthcare professional under appropriate medical supervision.
Croatian: Ovaj lijek treba davati zdravstveni radnik pod odgovarajućim liječničkim nadzorom.
English: • This medicine can be taken with or without food.
Croatian: • Ovaj se lijek može uzimati s hranom ili bez nje.
English: Approximately 62 % of palonosetron is bound to plasma proteins.
Croatian: Približno 62% palonozetrona vezano je za proteine plazme.
English: Pharmacokinetic information is provided in section 5.2.
Croatian: Farmakokinetičke informacije navedene su u dijelu 5.2.
English: Do not stop taking this medicine without talking to your doctor.
Croatian: Nemojte prestati uzimati ovaj lijek bez prethodnog razgovora s liječnikom.
English: • feeling happier than usual or feeling anxious
Croatian: • raspoloženje bolje nego obično ili osjećaj tjeskobe
English: 12 to <17 y µg/kg
Croatian: 12 do <17 god µg/kg
English: Each vial contains one dose.
Croatian: Jedna bočica sadrži jednu dozu.
English: In particular, tell them if you are taking the following medicines:
Croatian: Svakako im recite ako uzimate sljedeće lijekove:
English: Other medicines and Aloxi
Croatian: Drugi lijekovi i Aloxi
English: However, if you think you have forgotten to take your dose, tell your doctor straight away.
Croatian: Ipak, ako mislite da ste zaboravili uzeti svoju dozu, odmah obavijestite liječnika.
English: • The doctor will work out the right dose based on bodyweight.
Croatian: • Liječnik će odrediti pravilnu dozu ovisno o tjelesnoj težini.
English: Children and Adolescents (aged 1 month to 17 years):
Croatian: Djeca i adolescenti (u dobi od 1 mjeseca do 17 godina):
English: • you have an imbalance of certain minerals in your blood which has not been treated - such as potassium and magnesium.
Croatian: • ako imate neravnotežu nekih minerala u krvi koja nije bila liječena - kao npr. kalija i magnezija.
English: However, in general the antiemetic effect for the 0-24 hour interval was similar throughout the consecutively repeated cycles and the overall safety was maintained during all cycles.
Croatian: Međutim, antiemetički je učinak bio uglavnom sličan za interval 0-24 sata tijekom uzastopno ponavljanih ciklusa, a sveukupna sigurnost održavana je tijekom svih ciklusa.
English: ATC code: A04AA05
Croatian: ATK oznaka: A04AA05.
English: Atrioventricular block first degree, atrioventricular block second degree
Croatian: Atrioventrikularni blok prvog stupnja, atrioventrikularni blok drugog stupnja
English: Please see section 4.2 for information on paediatric use.
Croatian: Vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni.
English: The total body clearance (L/h/kg) in patients 12 to 17 years old was similar to that in healthy adults.
Croatian: Ukupni tjelesni klirens (l/h/kg) u bolesnika u dobi od 12 do 17 godina bio je sličan onome u zdravih odraslih osoba.
English: The study was designed to show non-inferiority.
Croatian: Ispitivanje je osmišljeno da pokaže neinferiornost.
English: Medicines that can affect your heart beat
Croatian: Lijekovi koji mogu utjecati na otkucaje srca
English: There are no apparent differences in volume of distribution when expressed as L/kg.
Croatian: Nije bilo prividnih razlika u volumenu distribucije kada je izražen u l/kg.
English: This is because we do not know if Aloxi may harm the baby.
Croatian: Tako je zbog toga što još nije poznato može li Aloxi naškoditi djetetu.
English: No Nausea (Likert Scale)
Croatian: Bez mučnine (Likertova ljestvica)
English: In adults, different dose levels are indicated in column title.
Croatian: Za odrasle bolesnike različite razine doza naznačene su u naslovima stupaca.
English: Ten percent of patients have a mean terminal elimination half-life greater than 100 hours.
Croatian: Deset posto bolesnika ima terminalni poluvijek eliminacije dulji od 100 sati.
English: Children Do not give this medicine to children
Croatian: Djeca Ovaj lijek nije za primjenu u djece.
English: Significance levels at alpha 0.0167 (adjusted for multiple comparisons).
Croatian: Razina značajnosti pri α = 0,0167 (prilagođena za višestruke usporedbe).
English: This includes:
Croatian: Oni uključuju:
English: Aloxi is indicated in paediatric patients 1 month of age and older for:
Croatian: Aloxi je indiciran u pedijatrijskih bolesnika u dobi od 1 mjeseca i starijih za:
English: Complete Response (No Emesis and No Rescue Medication)
Croatian: Potpuni odgovor (bez emeze i bez simptomatskog lijeka)
English: Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Croatian: Bolesnici s nasljednim nepodnošenjem fruktoze ne bi smjeli uzimati ovaj lijek.
English: Clearance c, L/h/kg Volume of distribution c, d, L/kg 6.08
Croatian: Klirensc, l/h/kg Volumen distribucijec, d, l/kg a
English: Chi-square test.
Croatian: Hi-kvadrat test.
English: What Aloxi looks like and contents of the pack
Croatian: Kako Aloxi izgleda i sadržaj pakiranja
English: Following oral administration, palonosetron is well absorbed with its absolute bioavailability reaching 97 %.
Croatian: Nakon oralne primjene palonozetron se dobro apsorbira uz svoju apsolutnu bioraspoloživost koja doseže 97%.
English: The safety and efficacy of Aloxi in children aged less than 1 month have not been established.
Croatian: Sigurnost primjene i djelotvornost Aloxija u djece mlađe od 1 mjeseca nisu ustanovljene.
English: • you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na palonozetron ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • The maximum dose is 1500 micrograms.
Croatian: • Najveća doza iznosi 1500 mikrograma.
English: Children and young people (aged 1 month to 17 years)
Croatian: Djeca i mlađe osobe (u dobi od 1 mjeseca do 17 godina)
English: As there are no data concerning palonosetron excretion in breast milk, breast-feeding should be discontinued during therapy.
Croatian: S obzirom da ne postoje podaci o izlučivanju palonozetrona u majčino mlijeko, za vrijeme terapije treba prekinuti dojenje.
English: Therefore, patients with known hypersensitivity to peanut or soya, should be monitored closely for signs of an allergic reaction.
Croatian: Stoga bi bolesnike za koje se zna da su preosjetljivi na kikiriki ili soju, trebalo pomno nadzirati zbog znakova alergijske reakcije.
English: Very rare ARs°
Croatian: Vrlo rijetke nuspojave°
English: What Aloxi is and what it is used for
Croatian: Što je Aloxi i za što se koristi
English: Purified water
Croatian: Voda, pročišćena
English: Palonosetron is not mutagenic.
Croatian: Palonozetron nije mutagen.
English: 97.5 % CI
Croatian: 97,5%-tni CI
English: Therefore, Aloxi capsules may be taken without regard to meals.
Croatian: Stoga se Aloxi kapsule mogu uzimati bez obzira na obroke.
English: Hypokalemia and hypomagnesemia should be corrected prior to 5-HT3-antagonist administration.
Croatian: Hipokalijemiju i hipomagnezijemiju treba ukloniti prije primjene antagonista 5-HT3.
English: Prevention of Chemotherapy Induced Nausea and Vomiting (CINV):
Croatian: Sprječavanje kemoterapijom izazvane mučnine i povraćanja (CINV):
English: PK parameters expressed as Geometric Mean (CV) except for T½ which is median.
Croatian: Farmakokinetički parametri izraženi kao geometrijska sredina (CV) osim za t½ koji je medijan vrijednosti.
English: Sodium citrate
Croatian: Natrijev citrat
English: Very rare (<1/10,000) adverse reactions were reported post-marketing.
Croatian: Vrlo rijetke nuspojave (<1/10 000) bile su zabilježene nakon stavljanja lijeka u promet.
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included> 18.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD <Sadrži 2D barkod s jedinstvenim identifikatorom.>
English: However, as for other 5-HT3 antagonists, caution should be exercised in the use of palonosetron in patients who have or are likely to develop prolongation of the QT interval.
Croatian: Međutim, kao i za druge antagoniste 5-HT3, potreban je oprez pri primjeni palonozetrona u bolesnika koji imaju produljenje QT intervala ili je vjerojatno da će se ono u njih pojaviti.
English: The low total body clearance and large volume of distribution resulted in a terminal elimination half-life in plasma of approximately 40 hours.
Croatian: Nizak ukupni tjelesni klirens i veliki volumen distribucije rezultirao je terminalnim poluvijekom eliminacije u plazmi od približno 40 sati.
English: • The recommended dose of Aloxi is 250 micrograms.
Croatian: • Preporučena doza Aloxija je 250 mikrograma.
English: Anxiety, euphoric mood
Croatian: Anksioznost, euforično raspoloženje
English: CYP2D6 inducers and inhibitors
Croatian: Induktori i inhibitori CYP2D6
English: Palonosetron at the recommended dose is widely distributed in the body with a volume of distribution of approximately 6.9 to 7.9 l/kg.
Croatian: Palonozetron se u preporučenoj dozi naširoko raspodjeljuje u tijelu, uz volumen distribucije od približno 6,9 do 7,9 l/kg.
English: A total of 670 paediatric surgical patients participated, age 30 days to 16.9 years.
Croatian: Sudjelovalo je ukupno 670 pedijatrijskih kirurških bolesnika u dobi od 30 dana do 16,9 godina.
English: * Includes the following: burning, induration, discomfort and pain
Croatian: *Uključuje sljedeće: žarenje, induracija, nelagoda i bol
English: There are limited data on the use of Aloxi in the prevention of nausea and vomiting in children under 2 years of age.
Croatian: Postoje ograničeni podaci o primjeni Aloxija za sprječavanje mučnine i povraćanja u djece mlađe od 2 godine.
English: 97.5 % CI b
Croatian: 97,5%-tni CI b
English: Palonosetron is a selective high-affinity receptor antagonist of the 5HT3 receptor.
Croatian: Palonozetron je selektivni antagonist visokog afiniteta za 5HT3 receptor.
English: The proportion of patients without emesis during 0-72 hours post-operatively was similar after palonosetron 1 µg/kg or 3 µg/kg (88% vs 84%).
Croatian: Udio bolesnika bez emeze u trajanju od 0-72 sata poslije operacije bio je sličan nakon primjene palonozetrona 1 µg/kg ili 3 µg/kg (88% naspram 84%).
English: The majority of patients in the study were women (73 %), white (69 %), and naïve to previous chemotherapy (59 %).
Croatian: Većina bolesnika u ispitivanju bile su žene (73%), bjelkinje (69%) i do tada nisu primale kemoterapiju (59%).
English: Aloxi should be used only before chemotherapy administration.
Croatian: Aloxi treba primjenjivati samo prije kemoterapije.
English: Each capsule contains 7 mg sorbitol.
Croatian: Jedna kapsula sadrži 7 mg sorbitola.
English: While this study demonstrated that paediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults (see section 4.8).
Croatian: Iako je ovo ispitivanje pokazalo da je za sprječavanje mučnine i povraćanja izazvanih kemoterapijom pedijatrijskim bolesnicima potrebna veća doza palonozetrona nego odraslim bolesnicima, profil sigurnosti podudara se s profilom ustanovljenim u odraslih (vidjeti dio 4.8).
English: • abnormal heart rate or lack of blood flow to the heart
Croatian: • abnormalna brzina srčanih otkucaja ili nedostatan dotok krvi u srce
English: What Aloxi contains
Croatian: Što Aloxi sadrži
English: • high levels of sugar in the blood or sugar in the urine
Croatian: • visoke razine šećera u krvi ili u mokraći
English: D. CONDITIONS OR RESTRICTIONSWITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: 0 - 24 hours 24 - 120 hours 0 - 120 hours Complete Control (Complete Response and No More Than Mild Nausea)
Croatian: 0 - 24 sata 24 - 120 sati 0 - 120 sati Potpuna kontrola (potpuni odgovor i ne više od blage mučnine)
English: A specific thorough QT/QTc study was conducted in healthy volunteers for definitive data demonstrating the effect of palonosetron on QT/QTc (see section 5.1).
Croatian: Temeljito ispitivanje upravo QT/QTc intervala, provedeno je u zdravih dobrovoljaca kako bi se dobili definitivni podaci o učinku palonozetrona na QT/QTc (vidjeti dio 5.1).
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Croatian: Ispitivanja na životinjama ne pokazuju izravne ili neizravne štetne učinke na trudnoću, razvoj embrija/fetusa, porođaj ili razvoj nakon rođenja.
English: 6.4 Special precautions for storage This medicinal product does not require any special storage conditions.
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Lijek ne zahtijeva posebne uvjete čuvanja.
English: Injection site reaction*
Croatian: Reakcija na mjestu uboda*
English: If you decide not to take Aloxi (or other similar medicines), it is likely your chemotherapy will cause you to feel sick or be sick (nausea and vomiting).
Croatian: Ako odlučite da nećete uzimati Aloxi (ili drugi sličan lijek), vjerojatno će Vam kemoterapija uzrokovati osjećaj mučnine ili povraćanje.
English: Available in packs of 1 vial containing 5 ml of solution.
Croatian: Dostupan je u pakiranju od 1 bočice koja sadrži 5 ml otopine.