FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of grade ≥3 anaemia, increased AST, ALT, and bilirubin based on laboratory abnormalities were 10.5%, 0.7%, 0.9%, and 0.6%, respectively.
Croatian: incidencija povišenih vrijednosti AST-a 0,7%, incidencija povišenih vrijednosti ALT-a 0,9%, a incidencija povišenih vrijednosti bilirubina 0,6%.
English: If you are not sure, talk to your doctor before having JEVTANA.
Croatian: porazgovarajte s liječnikom prije nego što primite lijek JEVTANA.
English: Contains an overfill.
Croatian: Sadrži dodatnu količinu punjenja.
English: Number of patients with deaths (%) Median survival (months) (95% CI) Hazard Ratio (HR)1 (95% CI)
Croatian: Ukupno preživljenje broj umrlih bolesnika (%) medijan preživljenja (mjeseci) (95% CI)
English: The PSA response was 39.2% in patients on JEVTANA arm (95%CI: 33.9-44.5) versus 17.8% of patients on mitoxantrone (95%CI: 13.7-22.0), p=0.0002.
Croatian: 39,2% u bolesnika liječenih lijekom JEVTANA (95% CI: 33,9-44,5) u odnosu na 17,8% u bolesnika liječenih mitoksantronom (95% CI: 13,7-22,0), p = 0,0002.
English: Always dilute the concentrate for solution for infusion with the entire supplied solvent before adding to infusion solution.
Croatian: Prije dodavanja lijeka u infuzijsku otopinu potrebno je uvijek razrijediti koncentrat za otopinu za infuziju cjelokupnim priloženim otapalom.
English: Step 2.3
Croatian: Korak 2.3
English: Co-administration with strong CYP3A inhibitors should be avoided since they may increase the plasma concentrations of cabazitaxel (see sections 4.2 and 4.5).
Croatian: Potrebno je izbjegavati istodobnu primjenu sa snažnim inhibitorima CYP3A jer oni mogu povisiti koncentraciju kabazitaksela u plazmi (vidjeti dijelove 4.2 i 4.5).
English: • skin feeling hot or flushed
Croatian: • osjećaj užarenosti ili crvenila na koži
English: Co-administration with strong CYP3A inducers should be avoided since they may decrease plasma concentrations of cabazitaxel (see sections 4.2 and 4.5).
Croatian: Potrebno je izbjegavati istodobnu primjenu sa snažnim induktorima CYP3A jer oni mogu sniziti koncentraciju kabazitaksela u plazmi (vidjeti dijelove 4.2 i 4.5).
English: Shelf life and special precautions for storage
Croatian: Rok valjanosti i posebne mjere za čuvanje lijeka
English: The adverse reactions reported at rates of at least 5% higher in patients 65 years of age or greater compared to younger patients were diarrhoea (42.9% vs. 32.6%), fatigue (30.2% vs. 19.4%), asthenia (22.4% vs. 13.1%), constipation (20.2% vs. 12.6%), clinical neutropenia (12.9% vs. 6.3%), febrile neutropenia (11.2% vs. 4.6%) and dyspnoea (9.5% vs. 3.4%).
Croatian: naspram 32,6%), umor (30,2% naspram 19,4%), astenija (22,4% naspram 13,1%), konstipacija (20,2% naspram 12,6%), klinička neutropenija (12,9% naspram 6,3%), febrilna neutropenija (11,2% naspram 4,6%) i dispneja (9,5% naspram 3,4%).
English: Step 2.4
Croatian: Korak 2.4
English: Gastrointestinal (GI) hemorrhage and perforation, ileus, colitis, including fatal outcome, have been reported in patients treated with cabazitaxel (see section 4.8).
Croatian: U bolesnika liječenih kabazitakselom prijavljeni su gastrointestinalno krvarenje i perforacija, ileus, kolitis, uključujući slučajeve sa smrtnim ishodom (vidjeti dio 4.8).
English: There was no statistically difference with regards to the other secondary endpoints (PFS, tumour and pain response, tumour and pain progression, and four subcategories of FACT-P).
Croatian: (preživljenje bez progresije bolesti, učinak liječenja na tumor i bol, progresija tumora i boli te četiri FACT-P (engl.
English: Step 1.5
Croatian: Korak 1.5
English: • low blood potassium
Croatian: • niska razina kalija u krvi
English: The most commonly (≥10%) occurring adverse reactions in all grades were anaemia (97.3%), leukopenia (95.7%), neutropenia (93.5%), thrombocytopenia (47.4%), and diarrhoea (46.6%).
Croatian: (95,7%), neutropenija (93,5%), trombocitopenija (47,4%) i proljev (46,6%).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL for SOLVENT
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: Very common Common disorders
Croatian: Common Terminology
English: Dose modifications should be made if patients experience the following adverse reactions (Grades refer to Common Terminology Criteria for Adverse Events [CTCAE 4.0]): Table 1 - Recommended dose modifications for adverse reaction in patients treated with cabazitaxel
Croatian: Dozu je potrebno prilagoditi ako se u bolesnika pojave sljedeće nuspojave (stupnjevi su određeni prema verziji 4,0 Zajedničkih terminoloških kriterija za nuspojave (engl.
English: Premedication The recommended premedication regimen should be performed at least 30 minutes prior to each administration of JEVTANA with the following intravenous medicinal products to mitigate the risk and severity of hypersensitivity:
Croatian: Radi smanjivanja rizika i težine reakcija preosjetljivosti, potrebno je primijeniti preporučenu premedikaciju najmanje 30 minuta prije svake primjene lijeka JEVTANA i to intravenskom primjenom sljedećih lijekova:
English: From a microbiological point of view, the concentrate-solvent mixture should be used immediately.
Croatian: S mikrobiološkog stajališta, pripremljenu otopinu koncentrata i otapala treba primijeniti odmah.
English: One ml of concentrate contains 40 mg cabazitaxel.
Croatian: Jedan ml koncentrata sadrži 40 mg kabazitaksela.
English: If co-administration with a strong CYP3A inhibitor cannot be avoided, close monitoring for toxicity and a cabazitaxel dose reduction should be considered (see sections 4.2 and 4.5).
Croatian: Ako se ne može izbjeći istodobna primjena sa snažnim inhibitorima CYP3A, potrebno je pomno pratiti toksičnost te razmotriti smanjenje doze kabazitaksela (vidjeti dijelove 4.2 i 4.5).
English: Psychiatric disorders Anxiety Confusional state Nervous system Dysgeusia
Croatian: Psihijatrijski poremećaji anksioznost smetenost
English: Delay treatment until improvement or resolution, and until neutrophil count is >1,500 cells/mm3, then reduce cabazitaxel dose from 25 mg/m2 to
Croatian: Febrilna neutropenija ili neutropenijska infekcija Odgoditi liječenje do poboljšanja ili oporavka te dok broj neutrofila ne dosegne > 1500 stanica/mm3, a zatim smanjiti dozu kabazitaksela s 25 mg/m2 na 20 mg/m2.
English: Vistor hf.
Croatian: 1 HR (engl.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2)
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta tinitus vrtoglavica
English: • you are allergic (hypersensitive) to cabazitaxel, to other taxanes, or polysorbate 80 or any of the other excipients of this medicine (listed in section 6),
Croatian: • ako ste alergični (preosjetljivi) na kabazitaksel, druge taksane ili polisorbat 80 ili neki drugi sastojak ovog lijeka (naveden u dijelu 6), • ako imate premalo bijelih krvnih stanica (broj neutrofila manji ili jednak 1500/mm3)
English: Step 1.3
Croatian: Korak 1.3
English: NAME OF THE MEDICINAL PRODUCT JEVTANA 60 mg concentrate and solvent for solution for infusion.
Croatian: JEVTANA 60 mg koncentrat i otapalo za otopinu za infuziju.
English: Step 2.2
Croatian: Korak 2.2
English: There was no significant difference in overall survival in this group of patients (HR (95%CI) 0.96 (0.49-1.86)).
Croatian: (HR (95% CI): 0,96 (0,49-1,86)).
English: Grade >2 peripheral neuropathy
Croatian: Periferna neuropatija stupnja ≥ 2
English: Leukopeniaa
Croatian: Proljev
English: All patients should be pre-medicated prior to the initiation of the infusion of cabazitaxel (see section 4.2).
Croatian: U svih je bolesnika potrebno provesti premedikaciju prije početka primjene infuzije kabazitaksela
English: Delay treatment until improvement or resolution, then reduce cabazitaxel dose from 25 mg/m2 to
Croatian: Odgoditi liječenje do poboljšanja ili oporavka, a zatim smanjiti dozu kabazitaksela s 25 mg/m2 na 20 mg/m2.
English: Step 1.2
Croatian: Korak 1.2
English: Each 1.5 ml vial of concentrate contains 60 mg cabazitaxel.
Croatian: Jedna bočica s 1,5 ml koncentrata sadrži 60 mg kabazitaksela.
English: NAME OF THE MEDICINAL PRODUCT JEVTANA 60 mg concentrate and solvent for solution for infusion cabazitaxel
Croatian: JEVTANA 60 mg koncentrat i otapalo za otopinu za infuziju kabazitaksel
English: Inspect the concentrate vial and the supplied solvent.
Croatian: Pregledajte bočicu s koncentratom lijeka i priloženo otapalo.
English: Step 1.4
Croatian: Korak 1.4
English: • Concentrate: 1.5 ml of concentrate in a 15 ml clear glass vial (type I) closed with a grey chlorobutyl rubber closure sealed by an aluminium cap covered with a light green plastic flip-off cap. Each vial contains 60 mg cabazitaxel per 1.5 ml nominal volume (fill volume: 73.2 mg of cabazitaxel/1.83 ml).
Croatian: • koncentrat: 1,5 ml koncentrata u prozirnoj staklenoj bočici od 15 ml (staklo tip I), zatvorenoj sivim gumenim zatvaračem (klorobutil guma), aluminijskim prstenom i svijetlozelenim plastičnim
English: Upper respiratory tract infection Herpes zoster Candidiasis
Croatian: Infekcije i infestacije septički šok sepsa celulitis infekcija mokraćnih putova gripa cistitis infekcija gornjih dišnih putova herepes zoster kandidijaza
English: This overfill ensures that after dilution with the ENTIRE contents of the accompanying solvent, there is solution containing 10 mg/ml cabazitaxel.
Croatian: Dodatna količina osigurava da se nakon razrjeđenja CJELOKUPNIM sadržajem priloženog otapala postigne koncentracija pripremljene otopine od 10 mg/ml kabazitaksela.
English: This overfill ensures that after initial dilution with the ENTIRE content of the solvent vial, the concentration of cabazitaxel is 10 mg/ml.
Croatian: Dodatna količina punjenja osigurava da nakon početnog razrjeđenja CJELOKUPNIM sadržajem bočice otapala koncentracija kabazitaksela bude 10 mg/ml.
English: Step 1.1
Croatian: Korak 1.1
English: The safety of JEVTANA in combination with prednisone or prednisolone was evaluated in 371 patients with metastatic castration resistant prostate cancer who were treated with 25 mg/m2
Croatian: Sažetak sigurnosnog profila Sigurnost primjene lijeka JEVTANA u kombinaciji s prednizonom ili prednizolonom ocijenjena je u randomiziranom, otvorenom, kontroliranom kliničkom ispitivanju faze III na 371 bolesniku s metastatskim karcinomom prostate rezistentnim na kastraciju liječenom kabazitakselom u dozi od 25 mg/m2 jedanput svaka 3 tjedna.
English: System Organ Class Adverse reaction
Croatian: Klasifikacije organskih sustava
English: Neuropathy peripheral Peripheral sensory neuropathy Dizziness Headache Paraesthesia Lethargy
Croatian: Poremećaji živčanog sustava disgeuzija periferna neuropatija periferna senzorna neuropatija omaglica glavobolja parestezije
English: Aseptically withdraw the required amount of concentrate-solvent mixture (10 mg/ml of cabazitaxel), with a graduated syringe fitted with a needle.
Croatian: Pomoću graduirane štrcaljke s iglom aseptički izvucite odgovarajući volumen mješavine koncentrata i otapala (10 mg/ml kabazitaksela).
English: Hypoaesthesia Sciatica
Croatian: Često letargija hipoestezija ishijalgija
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate and solvent for solution for infusion.
Croatian: Lijek JEVTANA je koncentrat i otapalo za otopinu za infuziju (sterilni koncentrat).
English: METHOD OF ADMINISTRATION Dilute with the ENTIRE supplied solvent.
Croatian: Razrijediti s CJELOKUPNIM priloženim otapalom.
English: Delay treatment until neutrophil count is >1,500 cells/mm3, then reduce cabazitaxel dose from 25 mg/m2 to 20 mg/m2.
Croatian: > 1500 stanica/mm3, a zatim smanjiti dozu kabazitaksela s 25 mg/m2 na 20 mg/m2.
English: PVC infusion containers or polyurethane infusion sets should not be used for the preparation and administration of the infusion solution.
Croatian: Za pripremu i primjenu otopine za infuziju ne smiju se koristiti infuzijski spremnici od PVC-a niti poliuretanski infuzijski setovi.
English: Pyrexia
Croatian: Hematurija
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release
Croatian: Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
English: Frequency not known (cannot be estimated from the available data): • interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing).
Croatian: • intersticijska bolest pluća (upala pluća koja uzrokuje kašalj i otežano disanje).
English: • you have kidney problems.
Croatian: • ako imate probleme s bubrezima.
English: Therefore concomitant administration of strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital) should be avoided as a decrease of plasma concentrations of cabazitaxel may occur (see sections 4.2 and 4.4).
Croatian: rifampin, rifabutin, rifapentin, fenobarbital) jer može doći do smanjenja koncentracije kabazitaksela u plazmi (vidjeti dijelove 4.2 i 4.4).
English: Unopened vials 3 years.
Croatian: 3 godine.
English: Bone marrow suppression
Croatian: Supresija koštane srži
English: EXP Read the leaflet for the shelf life of the diluted solution.
Croatian: Pročitajte Uputu o lijeku za navode o roku valjanosti razrijeđene otopine.
English: Haematuria
Croatian: Nuspojave
English: Preparation and administration precautions
Croatian: Mjere opreza prilikom pripreme i primjene lijeka
English: The concentrate solution and the solvent should be clear.
Croatian: Otopina u bočici s koncentratom i otapalo moraju biti bistri.
English: Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at ambient temperature (15°C - 30°C) including the 1-hour infusion time and for 48 hours at refrigerated conditions including the 1-hour infusion time.
Croatian: (15°C - 30°C), uključujući u to i 1-satnu infuziju te 48 sati ako se čuva u hladnjaku, uključujući u to i
English: Other laboratory abnormalities
Croatian: Ostala laboratorijska odstupanja
English: • urinary incontinence
Croatian: Eastern Cooperative Oncology Group)
English: cabazitaxel once every three weeks in a randomised open label, controlled phase III study.
Croatian: U multicentričnom, multinacionalnom, randomiziranom, otvorenom ispitivanju neinferiornosti faze III
English: The active substance is cabazitaxel.
Croatian: Djelatna tvar je kabazitaksel.
English: PSA secondary endpoints were positive in the JEVTANA arm.
Croatian: Sekundarne mjere ishoda s obzirom na PSA bile su pozitivne u skupini koja je primala lijek JEVTANA.
English: Secondary endpoints included Progression Free Survival [PFS (defined as time from randomization to tumour progression, Prostatic Specific Antigen (PSA) progression, pain progression, or death due to any cause, whichever occurred first], Tumour Response Rate based on Response Evaluation Criteria in Solid Tumours (RECIST), PSA Progression (defined as a ≥25% increase or >50% in PSA non-responders or responders respectively), PSA response (declines in serum PSA levels of at least 50%), pain progression [assessed using the Present Pain Intensity (PPI) scale from the McGill-Melzack questionnaire and an Analgesic Score (AS)] and pain response (defined as 2-point greater reduction from baseline median PPI with no concomitant increase in AS, or reduction of ≥50% in analgesic use from baseline mean AS with no concomitant increase in pain).
Croatian: Prostatic Specific Antigen - prostata specifični antigen) , progresije boli ili smrti zbog bilo kojeg uzroka, štogod se dogodilo prvo], stopa tumorskog odgovora na temelju kriterija za ocjenu odgovora kod solidnih tumora (engl.
English: Diarrhoea
Croatian: Premedikacija
English: Febrile neutropenia or neutropenic infection
Croatian: • bubrežna bolest ili tegobe s bubrezima
English: Oropharyngeal pain Pneumonia
Croatian: Oštećenje bubrežne funkcije
English: Weight decreased Aspartate aminotransferase increased
Croatian: Pretrage gubitak težine povišene vrijednosti aspartat aminotransferaze povišene vrijednosti transaminaza a na temelju laboratorijskih vrijednosti * vidjeti opširnije u daljnjem tekstu
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane anoreksija dehidracija hiperglikemija hipokalijemija
English: How to store JEVTANA
Croatian: Kako čuvati lijek JEVTANA
English: • painful or frequent urination
Croatian: • bolno ili učestalo mokrenje
English: METHOD AND ROUTE(S) OF ADMINISTRATION Single-use vials.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: Each vial of concentrate contains 60 mg cabazitaxel.
Croatian: Jedna bočica koncentrata sadrži 60 mg kabazitaksela.
English: In a non-inferiority, multicenter, multinational, randomized, open label phase III study (EFC11785 study), 1200 patients with metastatic castration resistant prostate cancer, previously treated with a docetaxel-containing regimen, were randomized to receive either cabazitaxel 25 mg/m2 (n=602) or 20 mg/m2 (n=598) dose.
Croatian: (EFC11785 ispitivanje), 1200 bolesnika s metastatskim karcinomom prostate rezistentnim na kastraciju, prethodno liječenih kemoterapijskim protokolom koji je uključivao docetaksel,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION JEVTANA 60 mg sterile concentrate cabazitaxel
Croatian: JEVTANA 60 mg sterilni koncentrat kabazitaksel
English: Nausea
Croatian: Nuspojava
English: Decreased appetite Vomiting
Croatian: Hematurija Astenija Smanjeni apetit
English: • haemorrhoids
Croatian: • grčevi mišića
English: Haemorrhoids
Croatian: Cijepljenje
English: Muscle spasms Myalgia Musculoskeletal chest pain Flank pain
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva bol u leđima artralgija bol u ekstremitetima mišićni spazmi mijalgija mišićno-koštana bol u prsnom košu bol u slabinama
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava neutropenijaa* anemijaa leukopenijaa trombocitopenijaa febrilna neutropenija
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja kašalj orofaringealna bol pneumonija
English: Conjunctivitis Lacrimation increased
Croatian: Statistički značajno veći postotak
English: Cabazitaxel is minimally excreted through the kidney.
Croatian: Bolesnici s oštećenjem bubrežne funkcije Kabazitaksel se minimalno izlučuje putem bubrega.
English: Slovenija sanofi-aventis d.o.o.
Croatian: Ελλάδα sanofi-aventis AEBE
English: Tofacitinib - Angioedema (EPITT no 18904)
Croatian: Tofacitinib - angioedem (EPITT br. 18904)
English: Posology and method of administration, and/or 4.4.
Croatian: 4.2. Doziranje i način primjene, i/ili 4.4.
English: Insulin (pre-filled pens and cartridges): insulin aspart; insulin bovine; insulin degludec; insulin degludec, insulin aspart; insulin degludec, liraglutide; insulin detemir; insulin glargine; insulin glulisine; insulin human (rDNA); insulin human, insulin isophane; insulin lispro; insulin porcinePotential increased risk of medication error associated with withdrawing insulin from pre-filled pens and cartridges, leading to dysglycaemia (EPITT no 18893)
Croatian: Inzulin (napunjene brizgalice i ulošci): inzulin aspart; goveđi inzulin; inzulin degludek; inzulin degludek, inzulin aspart; inzulin degludek, liraglutid; inzulin detemir; inzulin glargin; inzulin glulizin; humani inzulin (rDNK); humani inzulin, inzulin izofan; inzulin lispro; svinjski insulinPotencijalni povećani rizik od medikacijske pogreške povezane s izvlačenjem inzulina iz napunjenih brizgalica i uložaka, koja uzrokuje disglikemiju (EPITT br. 18893)
English: Allergic reactions included angioedema and urticaria; serious reactions have occurred.
Croatian: Alergijske reakcije uključivale su angioedem i urtikariju; javile su se ozbiljne reakcije.
English: Adopted at the 27-30 November 2017 PRAC
Croatian: Usvojeno na sjednici PRAC-a 27. - 30. studenoga 2017.
English: Frequency ‘not known': hypersensitivity; angioedema; urticaria
Croatian: Poremećaji imunološkog sustava Učestalost „nepoznato”: preosjetljivost; angioedem; urtikarija
English: If any serious allergic or anaphylactic reaction occurs, tofacitinib should be discontinued immediately.
Croatian: U slučaju nastanka bilo koje ozbiljne alergijske ili anafilaktičke reakcije, potrebno je odmah prestati s uzimanjem tofacitiniba.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/611010/2017
Croatian: Novi tekst informacija o lijeku - izvadci iz preporuka PRAC-a vezanih uz signale EMA/PRAC/813952/2017
English: Other side effects which have been observed with XELJANZ are listed below.
Croatian: Druge nuspojave koje su zabilježene s lijekom XELJANZ navedene su u nastavku.
English: In post-marketing experience, cases of hypersensitivity associated with tofacitinib administration have been reported.
Croatian: U razdoblju nakon stavljanja lijeka u promet prijavljeni su slučajevi preosjetljivosti povezani s primjenom tofacitiniba.
English: Special warnings and precautions for use
Croatian: Posebna upozorenja i mjere opreza pri uporabi Preosjetljivost
English: Special precautions for disposal and other handling The following text and any related package leaflet text should be removed: ‘If the <pen / infusion pump> malfunctions (see instructions for using the pen / infusion pump), the solution may be drawn from the cartridge into a syringe (suitable for an insulin with 100 units/mL) and injected.'
Croatian: Potrebno je ukloniti sljedeći tekst i njemu odgovarajući tekst u uputi o lijeku: „Ako <brizgalica / infuzijska pumpa> ne radi ispravno (vidjeti upute za uporabu brizgalice / infuzijske pumpe), otopina inzulina se može iz uloška uvući u štrcaljku (prikladnu za inzulin koncentracije 100 jedinica/ml) i injicirati.”
English: <If administration by syringe, <intravenous injection> or <infusion pump> is necessary, a vial should be used.>>
Croatian: < Ako je potrebna primjena pomoću štrcaljke, <intravenske injekcije> ili <infuzijske pumpe> potrebno je koristiti bočicu.>>
English: Not known (frequency cannot be estimated from the available data): hives (itchy, bumpy rash)
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): koprivnjača (uzdignuti osip koji svrbi)
English: Special warnings and precautions for use <<Product name in cartridges> is only suitable for subcutaneous injections from a reusable pen.
Croatian: Posebna upozorenja i mjere opreza pri uporabi <<Naziv lijeka u ulošcima> je prikladan samo za potkožne injekcije iz brizgalice za višekratnu uporabu.
English: Standard (100 units/mL) and lower (< 100 units/mL) strength insulin products The text to be adapted to individual products is in bold.
Croatian: Inzulinski lijekovi standardne (100 jedinica/ml) i manje (< 100 jedinica/ml) jačine
English: <Product name in pre-filled pen> is only suitable for injecting just under the skin.
Croatian: <Naziv lijeka u napunjenoj brizgalici> je prikladan samo za ubrizgavanje neposredno pod kožu.
English: <<Product name in pre-filled pen> is only suitable for subcutaneous injections.
Croatian: <<Naziv lijeka u napunjenoj brizgalici> je prikladan samo za potkožne injekcije.
English: How to use <product name> <Product name in cartridges> is only suitable for injecting just under the skin using a reusable pen.
Croatian: Što morate znati prije nego počnete primjenjivati <naziv lijeka>, i 3. Kako primjenjivati <naziv lijeka> <Naziv lijeka u ulošcima> je prikladan samo za ubrizgavanje neposredno pod kožu pomoću brizgalice za višekratnu uporabu.
English: Rabbits need to be revaccinated every year.
Croatian: Kuniće treba ponovo cijepiti svake godine.
English: This overview was last updated in September 2019.
Croatian: Pregled je posljednji put ažuriran u rujnu 2019.
English: Protection starts at three weeks and lasts for one year.
Croatian: Zaštita započinje u trećem tjednu i traje godinu dana.
English: It is given to rabbits from five weeks of age as a single injection under the skin.
Croatian: Daje se kunićima starijima od pet tjedana tako da im se ubrizga jednokratna injekcija pod kožu.