FrancophonIA/ELRC3.0 huggingface dataset:
English: cells/kg in ≤ 4 apheresis days with Mozobil and G-CSF (n=130; 86.7%) than with placebo and G-CSF (n=70; 47.3%), p<0.001.
Croatian: ≤ 4 afereze i uspješno usađivanje a p-vrijednost izračunata je primjenom Pearsonovog hi-kvadrat testa bstatistički je značajno više bolesnika postiglo ≥ 5 x 106 stanica/kg u ≤ 4 dana afereze kod primjene lijeka Mozobil i G-CSF-a (n = 89; 59,3%) nego kod primjene placeba i G-CSF-a (n = 29; 19,6%), p < 0,001; statistički je značajno više bolesnika postiglo ≥ 2 x 106 stanica/kg u ≤ 4 dana afereze kod primjene lijeka Mozobil i G-CSF-a (n = 130; 86,7%) nego kod primjene placeba i G-CSF-a (n = 70; 47,3%), p<0,001.
English: Common Dizziness, headache
Croatian: dispepsija, distenzija abdomena, konstipacija,
English: cells/kg in ≤ 4 apheresis days and successful engraftment Patients achieving ≥ 2 x 10
Croatian: Bolesnici koji su postigli ≥ 5 x 106 stanica/kg u ≤ 4 dana afereze i uspješno usađivanje
English: Proportion a in Placebo and G-CSF (n=150
Croatian: Udioa kod primjene placeba i G-CSF-a (n=150b)
English: Mean (SD)
Croatian: Medijan Srednja vrijednost (SD) Medijan Srednja vrijednost (SD)
English: Common Hyperhidrosis, erythema Musculoskeletal and connective tissue disorders Common Arthralgia, musculoskeletal pain General disorders and administration site conditions Very common Injection and infusion site reactions Common Fatigue, malaise
Croatian: Opći poremećaji i reakcije na mjestu primjene vrlo često reakcije na mjestu primjene injekcije i infuzije često umor, malaksalost
English: VIAL
Croatian: Spol
English: Pins and needles and numbness are common in patients being treated for cancers.
Croatian: Trnci i utrnulost česti su u bolesnika koji se liječe od raka i javljaju se u otprilike jednog na pet bolesnika.
English: Tumour cell mobilisation in leukaemia patients
Croatian: Mobilizacija tumorskih stanica u bolesnika s limfomom i multiplim mijelomom
English: Proportion a in Placebo and G-CSF (n=142
Croatian: Udioa kod primjene placeba i G-CSF-a (n=142b)
English: Paediatric patients (1 to less than 18 years) Mozobil is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either: - pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or - who previously failed to collect sufficient haematopoietic stem cells (see section 4.2).
Croatian: - preemptivno, kada se očekuje da će broj cirkulirajućih matičnih stanica na predviđeni dan prikupljanja, nakon odgovarajuće mobilizacije G-CSF-om (s ili bez kemoterapije), biti nedovoljan s obzirom na željeni prinos krvotvornih matičnih stanica, ili
English: Tel: +39 059 349 811
Croatian: Sanofi S.p.A Tel : +39 059 349 811
English: What Mozobil contains - The active substance is plerixafor.
Croatian: - Djelatna tvar je pleriksafor.
English: Renal impairment
Croatian: Trnci i utrnulost
English: In pivotal clinical studies supporting the use of Mozobil, all patients received daily morning doses of 10 g/kg G-CSF for 4 consecutive days prior to the first dose of plerixafor and on each morning prior to apheresis.
Croatian: U pivotalnim kliničkim ispitivanjima lijeka Mozobil svi su bolesnici primali jutarnju dozu G-CSF-a od
English: Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 1600
Croatian: Τηλ: +30 210 900 1600
English: How to store Mozobil
Croatian: Moguće nuspojave Kako čuvati Mozobil
English: Reporting of side effects
Croatian: Mjera ishoda za djelotvornostb
English: Eesti sanofi-aventis Estonia OÜ Tel. +372 6 273 488
Croatian: Slovenija sanofi-aventis d.o.o. Tel: +386 1 560 4800
English: Further information on Veyvondi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Veyvondi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Treatment with Veyvondi was successful in 95% of patients (20 out of 22).
Croatian: Liječenje lijekom Veyvondi bilo je uspješno u 95 % bolesnika (20 od 22).
English: The main measure of effectiveness was based on an assessment of how well the treatment worked.
Croatian: Glavno mjerilo djelotvornosti temeljilo se na procjeni bolesnika o uspješnosti liječenja.
English: Veyvondi (vonicog alfa)
Croatian: Veyvondi (vonikog alfa)
English: A total of 193 bleeding episodes were recorded, and Veyvondi was rated ‘excellent' or ‘good' at treating around 98% of bleedings.
Croatian: Zabilježene su ukupno 193 epizode krvarenja, a Veyvondi je ocijenjen kao „odličan” ili „dobar” u liječenju otprilike 98 % krvarenja.
English: The dose and frequency of treatment depend on the type and seriousness of the bleeding episode or extent of the surgery, and the patient's condition and body weight.
Croatian: Doza i učestalost terapije ovise o tipu i ozbiljnosti epizode krvarenja ili opsega kirurškog zahvata te bolesnikova stanja i tjelesne težine.
English: What measures are being taken to ensure the safe and effective use of Veyvondi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Veyvondi?
English: The most common side effects with Veyvondi (which may affect up to 1 in 10 patients) are dizziness, vertigo (a spinning sensation), dysgeusia (taste disturbances), tremor, rapid heartbeat, deep venous thrombosis (blood clot in a deep vein, usually in the leg), hypertension (high blood pressure), hot flush, vomiting, nausea (feeling sick), pruritus (itching), chest discomfort, sensations like numbness, tingling, pins and needles at the site of infusion, and an abnormal reading on the electrocardiogram (ECG).
Croatian: Najčešće nuspojave lijeka Veyvondi (koje se mogu pojaviti u manje od 1 na 10 osoba) jesu omaglica, vrtoglavica, disgeuzija (poremećaj osjeta okusa), tremor, brzi otkucaji srca, duboka venska tromboza (krvni ugrušci u dubokim venama, obično u nozi), hipertenzija (visoki krvni tlak), navale vrućine, povraćanje, mučnina, pruritus (svrbež), nelagoda u prsnom košu, osjeti poput utrnulosti, trnci i bockanje na mjestu primjene infuzije te odstupanja od normalnih vrijednosti u nalazima elektrokardiograma (EKG).
English: In the 15 major and minor surgeries that occurred during the study, Veyvondi was rated as excellent or good at preventing bleeding episodes for all 15 surgeries.
Croatian: U 15 većih i manjih kirurških zahvata koji su provedeni tijekom ispitivanja, Veyvondi je bio ocijenjen kao odličan ili dobar za sprječavanje epizoda krvarenja u svih 15 kirurških zahvata.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Veyvondi have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Veyvondi nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The second study involved 15 patients who were given Veyvondi to prevent bleeding during surgery, including major surgery such as knee replacement.
Croatian: Drugo ispitivanje uključilo je 15 bolesnika koji su primili Veyvondi za sprječavanje krvarenja tijekom kirurškog zahvata, uključujući veliki kirurški zahvat kao što je zamjena koljena.
English: Other information about Veyvondi
Croatian: Ostale informacije o lijeku Veyvondi
English: Side effects reported with Veyvondi are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Veyvondi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: As for all medicines, data on the use of Veyvondi are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Veyvondi kontinuirano se prate.
English: The European Medicines Agency decided that Veyvondi's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Veyvondi nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The side effects with Veyvondi were considered typical for this type of medicine.
Croatian: Nuspojave lijeka Veyvondi smatraju se tipičnima za tu vrstu lijeka.
English: The active substance in Veyvondi, vonicog alfa, works in the body in the same way as natural von Willebrand factor.
Croatian: Djelatna tvar lijeka Veyvondi, vonikog alfa, djeluje u tijelu na jednak način kao i prirodni von Willebrandov faktor.
English: However EMA decided that, as for similar medicines, Veyvondi should be used only when desmopressin (the main treatment for von Willebrand disease) cannot be used or is not working well enough.
Croatian: Međutim, kao i za slične lijekove, EMA je zaključila da se Veyvondi smije primjenjivati samo kada se ne može primjenjivati desmopresin (glavna terapija protiv von Willebrandove bolesti) ili kada on ne djeluje dovoljno dobro.
English: Why is Veyvondi authorised in the EU?
Croatian: Zašto je lijek Veyvondi odobren u EU-u?
English: Veyvondi is a medicine used to control bleeding in patients with von Willebrand disease (an inherited bleeding disorder), who cannot be treated with another medicine called desmopressin or when desmopressin is ineffective.
Croatian: Veyvondi je lijek koji se koristi za kontrolu krvarenja u bolesnika s von Willebrandovom bolešću (nasljedni poremećaj krvarenja) koji se ne mogu liječiti drugim lijekom pod nazivom desmopresin ili kada liječenje desmopresinom nije učinkovito.
English: What is Veyvondi and what is it used for?
Croatian: Što je Veyvondi i za što se primjenjuje?
English: Veyvondi was also effective for preventing and treating bleeding related to surgery.
Croatian: Lijek Veyvondi bio je učinkovit i u sprječavanju i liječenju krvarenja povezanog s kirurškim zahvatom.
English: What are the risks associated with Veyvondi?
Croatian: Koji su rizici povezani s lijekom Veyvondi?
English: It is used ‘on demand' to treat bleeding episodes and is also used to prevent and treat bleeding during surgery.
Croatian: Primjenjuje se prema potrebi za liječenje epizoda krvarenja, a koristi se i za sprječavanje i liječenje krvarenja tijekom kirurškog zahvata.
English: The benefits of Veyvondi in controlling bleeding have been shown in two main studies involving 52 patients with von Willebrand disease.
Croatian: Koristi lijeka Veyvondi u kontroli krvarenja utvrđene su u dva glavna ispitivanja u koja su bila uključena 52 bolesnika s von Willebrandovom bolešću.
English: The following side effects may occur during treatment with Veyvondi: hypersensitivity (allergic) reactions, thromboembolic events (problems due to the formation of blood clots in the blood vessels), development of inhibitors (antibodies) against von Willebrand factor, causing the medicine to stop working and resulting in a loss of bleeding control.
Croatian: Tijekom liječenja lijekom Veyvondi mogu se pojaviti sljedeće nuspojave: reakcije preosjetljivosti (alergijske reakcije), tromboembolijski poremećaji (problemi zbog stvaranja krvnih ugrušaka u krvnim žilama), razvoj inhibitora (protutijela) protiv von Willebrandovog faktora što uzrokuje prestanak djelovanja lijeka i rezultira gubitkom kontrole krvarenja.
English: For more information about using Veyvondi, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Veyvondi pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Patients with von Willebrand disease lack von Willebrand factor, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Croatian: U bolesnika s von Willebrandovom bolešću postoji manjak von Willebrandovog faktora, bjelančevine potrebne za normalno zgrušavanje krvi, a posljedica je njihova veća sklonost krvarenju.
English: The first study involved 37 patients who were given Veyvondi for the treatment of bleeding episodes.
Croatian: Prvo je ispitivanje obuhvatilo 37 bolesnika koji su primili Veyvondi za liječenje epizoda krvarenja.
English: An overview of Veyvondi and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Veyvondi i zašto je odobren u EU-u
English: It replaces the missing protein, thereby helping the blood to clot and giving temporary control of the bleeding disorder.
Croatian: Ona nadomješta bjelančevinu koji nedostaje i time pomaže zgrušavanju krvi te omogućuje privremenu kontrolu poremećaja krvarenja.
English: Veyvondi contains the active substance vonicog alfa.
Croatian: Veyvondi sadržava djelatnu tvar vonikog alfa.
English: Veyvondi can only be obtained with a prescription and treatment should be supervised by a doctor experienced in treating patients with bleeding disorders.
Croatian: Veyvondi se izdaje samo na liječnički recept, a liječenje treba provoditi pod nadzorom liječnika s iskustvom u liječenju poremećaja krvarenja.
English: Veyvondi is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Croatian: Lijek Veyvondi dostupan je u obliku praška i otapala koji se izmiješaju da bi se pripremila otopina za intravensku injekciju.
English: Veyvondi must not be used in patients who have had allergic reactions to mouse or hamster proteins.
Croatian: Veyvondi se ne smije primjenjivati u bolesnika koji imaju alergijske reakcije na bjelančevine miša ili hrčka.
English: How does Veyvondi work?
Croatian: Kako djeluje Veyvondi?
English: Veyvondi was shown to be effective in treating bleeding episodes in patients with von Willebrand disease.
Croatian: Pokazalo se da lijek Veyvondi učinkovito liječi epizode krvarenja u bolesnika s von Willebrandovom bolešću.
English: How is Veyvondi used?
Croatian: Kako se Veyvondi koristi?
English: What benefits of Veyvondi have been shown in studies?
Croatian: Koje su koristi od lijeka Veyvondi utvrđene u ispitivanjima?
English: For the full list of side effects of Veyvondi, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Veyvondi potražite u uputi o lijeku.
English: Slight bleeding is normal.
Croatian: Lagano krvarenje je normalno.
English: Your doctor will advise you on suitable methods.
Croatian: Liječnik će Vas savjetovati o odgovarajućim metodama.
English: The available medical guidelines should also be taken into account.
Croatian: Treba uzeti u obzir i postojeće medicinske smjernice.
English: Important instructions for use.
Croatian: Važne upute za uporabu.
English: Read carefully.
Croatian: Pažljivo pročitajte.
English: WAIT until blue indicator stops moving
Croatian: PRIČEKAJTE dok se plavi indikator ne prestane pomicati
English: The following information is intended for healthcare professionals only
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima :
English: After that you will receive a dose every 4 weeks.
Croatian: Nakon toga ćete primati dozu lijeka svaka 4 tjedna.
English: Important instructions for use Please read these instructions carefully and follow them step by step.
Croatian: "Važne upute za uporabu" Pažljivo pročitajte ove upute i slijedite ih korak po korak.
English: Most of these reactions were mild to moderate.
Croatian: Većina tih reakcija je bila blaga do umjerena.
English: • Show this card to any doctor involved in your treatment.
Croatian: • Pokažite ovu karticu svakom liječniku koji sudjeluje u Vašem liječenju.
English: In most people, joint symptoms develop gradually over several years.
Croatian: U većine ljudi se simptomi na zglobovima razvijaju postupno tijekom nekoliko godina.
English: Find a comfortable space with a clean, flat, working surface.
Croatian: Pronađite udobno mjesto s čistom i ravnom radnom površinom.
English: Abatacept is the first selective co-stimulation modulator.
Croatian: Abatacept je prvi selektivni modulator kostimulacije.
English: You will hear a click as the injection begins.
Croatian: Čut ćete 'klik' kad injekcija započne.
English: Hold it firmly.
Croatian: Čvrsto ga držite.
English: This procedure is referred to as an infusion.
Croatian: Taj se postupak naziva infuzijom.
English: Studies in adult mice and monkeys have not demonstrated similar findings.
Croatian: Ispitivanja na odraslim miševima i majmunima nisu pokazala slične rezultate.
English: However, for microbiological reasons, it is to be used immediately.
Croatian: Međutim, zbog mikrobioloških razloga, mora se upotrijebiti odmah.
English: If you have active psoriatic arthritis you will first be given other medicines.
Croatian: Ako imate aktivni psorijatični artritis, prvo ćete primiti druge lijekove.
English: Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
Croatian: Preporučuje se periodički pregled kože za sve bolesnike, a osobito one s faktorima rizika za razvoj raka kože.
English: The ACRP responses and inactive disease results were maintained through 2 years.
Croatian: Rezultati za ACRP odgovore i neaktivnu bolest održali su se tijekom 2 godine.
English: Other medicines and ORENCIA
Croatian: Drugi lijekovi i ORENCIA
English: The relevance of these results to humans is unknown.
Croatian: Nije poznat značaj tih rezultata za ljude.
English: ACR30 65 ACR50 50 ACR70 28 ACR90 13 Inactive disease
Croatian: ACR30 65 ACR50 50 ACR70 28 ACR90 13 Neaktivna bolest
English: BEFORE YOU BEGIN:
Croatian: PRIJE NEGO ŠTO POČNETE:
English: Do not attempt to remove it.
Croatian: Nemojte ga pokušavati ukloniti.
English: Don't touch the needle or let it touch any surfaces.
Croatian: Nemojte dodirivati iglu niti dopustiti da dodirne bilo kakvu površinu.
English: NA 24%§§
Croatian: ND 24%§§
English: If you do not respond well enough to these medicines, you may be given ORENCIA to:
Croatian: Ako ne odgovorite dovoljno dobro na te lijekove, možete primiti lijek ORENCIA za:
English: Period Cb (day 1765)
Croatian: Razdoblje Cb (1765. dan)
English: Always handle the ORENCIA syringe carefully, especially when you are around other people, and children.
Croatian: Uvijek rukujte oprezno sa štrcaljkom lijeka ORENCIA, osobito ako ste okruženi drugim ljudima i djecom.
English: Talk to your doctor if you have any questions about giving yourself an injection.
Croatian: Obratite se svom liječniku ako imate bilo kakvih pitanja o tome kako ćete si sami dati injekciju.
English: Always hold the syringe by its body.
Croatian: Uvijek držite štrcaljku za njezino tijelo.
English: You may see a small air bubble.
Croatian: Možda ćete vidjeti mali mjehurić zraka.
English: There is no need to remove the air bubble.
Croatian: Nema potrebe da odstranjujete taj mjehurić zraka.
English: The final concentration of abatacept in the bag or bottle will depend upon the amount of active substance added, but will be no more than 10 mg/mL.
Croatian: Konačna koncentracija abatacepta u vrećici ili boci ovisit će o količini dodane djelatne tvari, ali neće biti veća od 10 mg/ml.
English: It is used in combination with a medicine called methotrexate.
Croatian: Primjenjuje se u kombinaciji s lijekom koji se zove metotreksat.
English: Doctor's Name: ____________________
Croatian: Ime liječnika: ______________________
English: BEFORE YOU BEGIN
Croatian: PRIJE NEGO ŠTO POČNETE
English: What ORENCIA is and what it is used for 2.
Croatian: Što je ORENCIA i za što se koristi 2.
English: ORENCIA is available in the following presentations:
Croatian: ORENCIA je dostupna u sljedećim pakiranjima:
English: However, the number of patients that developed antibodies was too limited to make a definitive assessment.
Croatian: Međutim, broj bolesnika koji su razvili protutijela bio je premalen za definitivnu ocjenu.
English: Wash your hands well with soap and water to prepare for injection.
Croatian: Dobro operite ruke sapunom i vodom da biste se pripremili za injekciju.
English: End of Period Ba (day 169)
Croatian: Kraj Razdoblja Ba (169. dan)
English: Date of first authorisation: 21 May 2007 Date of latest renewal: 21 May 2012
Croatian: Datum posljednje obnove odobrenja: 21. svibnja 2012.
English: ORENCIA, in combination with methotrexate, is indicated for:
Croatian: ORENCIA je, u kombinaciji s metotreksatom, indicirana za:
English: Start:
Croatian: Početak:
English: Ask your doctor, nurse, or pharmacist about national and local laws regarding the proper disposal of medical products that contain needles.
Croatian: Upitajte svog liječnika, medicinsku sestru ili ljekarnika što nalažu nacionalni i lokalni propisi o pravilnom zbrinjavanju lijekova koji sadrže igle.
English: This alert card contains important safety information that you need to be aware of before you are given ORENCIA and during treatment with ORENCIA.
Croatian: Ova kartica s upozorenjima sadrži važne sigurnosne informacije, kojih morate biti svjesni prije nego što primite lijek ORENCIA i tijekom liječenja lijekom ORENCIA.
English: Recommended dose in adults
Croatian: Preporučena doza u odraslih
English: If the dose is missed by more than three days, the patient should be instructed when to take the next dose based on medical judgment (condition of the patient, status of disease activity, etc).
Croatian: Ako se doza propusti za više od 3 dana, bolesnika treba uputiti kada da primijeni sljedeću dozu na temelju medicinske procjene (stanje bolesnika, stupanj aktivnosti bolesti, itd.).
English: After proper training, you can give the injection to yourself, or it can be given by another person, for example a family member or friend.
Croatian: Nakon odgovarajuće obuke možete si injekcije davati sami ili Vam ih može davati druga osoba, primjerice član obitelji ili prijatelj.
English: You do not need to remove it.
Croatian: Ne morate ga uklanjati.
English: Press button, HOLD for 15 seconds AND watch window.
Croatian: Pritisnite tipku, DRŽITE JE PRITISNUTOM 15 sekundi I promatrajte prozor.
English: The most frequently reported event with abatacept (1-2%) was dizziness.
Croatian: Najčešće prijavljena nuspojava kod primjene abatacepta (1-2%) bila je omaglica.
English: Patient's Name: ____________________
Croatian: Ime bolesnika: ______________________
English: For full-dose delivery, hold the Pre-filled Pen in place for 15 seconds AND wait until blue indicator stops moving in window.
Croatian: Da biste primijenili cijelu dozu, držite napunjenu brizgalicu na mjestu 15 sekundi I pričekajte dok kroz prozor ne vidite da se plavi indikator prestao pomicati.
English: This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 1,7% maksimalnog preporučenog dnevnog unosa natrija za odraslu osobu.
English: It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had TB.
Croatian: Vrlo je važno obavijestiti liječnika ako ste ikada bolovali od tuberkuloze ili bili u bliskom kontaktu s osobom koja je bolovala od tuberkuloze.
English: 30 Minutes
Croatian: 30 minuta
English: Study SC-I
Croatian: Ispitivanje SC-I
English: The clinical significance of this observation is unknown (see section 5.3).
Croatian: Klinički značaj toga nalaza nije poznat (vidjeti dio 5.3).
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate,nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: DAS28 response
Croatian: DAS28 odgovor
English: ORENCIA is given to you into a vein, usually in your arm, over a period of 30 minutes.
Croatian: ORENCIA se primjenjuje u venu, obično na ruci, tijekom razdoblja od 30 minuta.
English: Health-related outcomes and quality of life
Croatian: Ishodi vezani uz zdravlje i kvaliteta života
English: Estimate of difference (95% CI)
Croatian: Procjena razlike (95% CI)
English: No systemic hypersensitivity reactions were reported.
Croatian: Nisu prijavljene sistemske reakcije preosjetljivosti.
English: Non-clinical studies relevant for use in the paediatric population
Croatian: Neklinička ispitivanja relevantna za primjenu u pedijatrijskoj populaciji