FrancophonIA/ELRC3.0 huggingface dataset:
English: Ingelvac PCV Flex is a vaccine used to protect pigs from two weeks of age against porcine circovirus type 2 (PCV2).
Croatian: Ingelvac PCV Flex je cjepivo koje se primjenjuje za zaštitu svinja starijih od 2 tjedna od cirkovirusa svinja tipa 2 (PCV2).
English: This is a summary of the European public assessment report (EPAR) for Ingelvac PCV Flex.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) veterinarsko-medicinskog proizvoda Ingelvac PCV Flex.
English: For the full list of restrictions and all side effects reported with Ingelvac PCV Flex, see the package leaflet.
Croatian: Potpuni popis svih ograničenja i nuspojava zabilježenih pri primjeni VMP-a Ingelvac PCV Flex potražite u uputi o VMP-u.
English: What is Ingelvac PCV Flex and what is it used for?
Croatian: Što je VMP Ingelvac PCV Flex i za što se koristi?
English: It is not intended to provide practical advice on how to use Ingelvac PCV Flex.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a Ingelvac PCV Flex.
English: For practical information about using Ingelvac PCV Flex, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Ingelvac PCV Flex vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: For more information about treatment with Ingelvac PCV Flex, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Ingelvac PCV Flex vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Ingelvac PCV Flex is a vaccine.
Croatian: VMP Ingelvac PCV Flex je cjepivo.
English: Ingelvac PCV Flex has been studied in a number of trials involving pigs of various breeds.
Croatian: Proveden je niz ispitivanja VMP-a Ingelvac PCV Flex koja su uključivala svinje raznih pasmina.
English: Ingelvac PCV Flex porcine circovirus type 2 vaccine
Croatian: Ingelvac PCV Flex cjepivo protiv cirkovirusa svinja tipa 2
English: Ingelvac PCV Flex contains small amounts of a protein from PCV2.
Croatian: VMP Ingelvac PCV Flex sadrži male količine bjelančevine iz virusa PCV2.
English: What are the risks associated with Ingelvac PCV Flex?
Croatian: Koji su rizici povezani s VMP-om Ingelvac PCV Flex?
English: Why is Ingelvac PCV Flex approved?
Croatian: Zašto je VMP Ingelvac PCV Flex odobren?
English: Other information about Ingelvac PCV Flex:
Croatian: Ostale informacije o VMP-u Ingelvac PCV Flex
English: Ingelvac PCV Flex contains the active substance porcine circovirus type 2 ORF2 protein.
Croatian: VMP Ingelvac PCV Flex sadrži aktivnu djelatnu tvar cirkovirus svinja tipa 2, bjelančevinu ORF2.
English: What benefits of Ingelvac PCV Flex have been shown in studies?
Croatian: Koje su koristi VMP-a Ingelvac PCV Flex utvrđene u ispitivanjima?
English: How is Ingelvac PCV Flex used?
Croatian: Kako se VMP Ingelvac PCV Flex koristi?
English: How does Ingelvac PCV Flex work?
Croatian: Kako djeluje VMP Ingelvac PCV Flex?
English: This usually takes between 15 and 30 minutes.
Croatian: To obično traje 15 do 30 minuta.
English: Weight (kg)
Croatian: težina (kg)
English: There are no adequate and well-controlled studies in pregnant women.
Croatian: Nema adekvatnih i dobro kontroliranih ispitivanja na trudnicama.
English: Do not use a double dose to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu da bi nadoknadili zaboravljenu dozu.
English: You will receive appropriate training to enable you to do this.
Croatian: Dobit ćete prikladno educirani da bi to mogli napraviti.
English: Ask your doctor for advice before taking any medicine.
Croatian: Upitajte svog liječnika za savjet prije uzimanja bilo kojeg lijeka.
English: If you use more Silapo than you should
Croatian: Ako primijenite više Silapa nego što ste trebali
English: Long-term carcinogenicity studies have not been carried out.
Croatian: Dugoročna ispitivanja kancerogenosti nisu provedena.
English: Your doctor will decide if it is right for you to take them.
Croatian: Liječnik će odlučiti je li dobro za Vas da ih uzimate.
English: Do not to stop the treatment without consultation of your doctor.
Croatian: Nemojte prestati s liječenjem bez konzultacije s vašim liječnikom.
English: • Allergic reaction
Croatian: • alergijska reakcija
English: D-25436 Uetersen Germany
Croatian: D-25436 Uetersen Njemačka
English: These may be more common at the start of treatment.
Croatian: Oni mogu biti češći na početku liječenja.
English: Under no circumstances should you attempt to inject yourself unless you have been trained to do so.
Croatian: Ni pod kojim okolnostima ne smijete sami pokušati injicirati ukoliko niste za to obučeni.
English: Your healthcare professional will always record the exact product you are using.
Croatian: Zdravstveni djelatnik će uvijek zabilježiti točan proizvod koji primjenjujete.
English: Always follow these instructions when using Silapo:
Croatian: Uvijek slijedite ove upute kad koristite Silapo:
English: See also section 2.
Croatian: Vidjeti također dio 2.
English: These doses may not be as high as those received initially.
Croatian: Te doze možda neće biti tako visoke kao početne doze.
English: • you have unstable angina pectoris (new or increasing chest pain)
Croatian: • imate nestabilnu anginu pectoris (nova ili pojačavajuća bol u prsištu)
English: The dose should be administered over at least 1-5 minutes, depending on the total dose.
Croatian: Dozu treba primijeniti tijekom najmanje 1-5 minuta, ovisno o ukupnoj dozi.
English: Do not throw away any medicines via wastewater or household waste.
Croatian: Nikad nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: Hyperkalaemia has been observed in isolated cases.
Croatian: Hiperkalemija je primijećena u izoliranim slučajevima.
English: There is no accumulation: the levels remain the same, whether they are determined 24 hours after the first injection or 24 hours after the last injection.
Croatian: Nema nakupljanja: razine ostaju nepromijenjene bilo da su određene 24 sata nakon prve injekcije ili 24 sata nakon zadnje injekcije.
English: Studies in animals have shown reproduction toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: • you know or think it may have been accidentally frozen
Croatian: • ukoliko znate ili pretpostavljate da je došlo do nehotičnog zamrzavanja
English: • you had a heart attack or stroke in the month before your treatment
Croatian: • imali ste srčani udar ili moždani udar u mjesecu prije liječenja
English: The syringe is now ready for use.
Croatian: Štrcaljka je sada spremna za uporabu.
English: Date of first authorisation: 18 December 2007 Date of latest renewal: 20 December 2012
Croatian: Datum posljednje obnove odobrenja: 20. prosinca 2012
English: Its use in this indication must be balanced against the reported risk of thromboembolic events.
Croatian: Njegovu primjenu u ovoj indikaciji treba odvagnuti u odnosu na prijavljeni rizik tromboembolijskih događaja.
English: The apparent molecular weight of erythropoietin is 32 000-40 000 Dalton.
Croatian: Prividna molekularna težina eritropoetina je 32 000 - 40 000 Daltona.
English: Generally, children and adolescents under 30 kg body weight require higher maintenance doses than adults and children over 30 kg.
Croatian: Općenito, djeca i adolescenti ispod 30 kg tjelesne težine trebaju veće doze za održavanje od odraslih i djece iznad 30 kg.
English: Appropriate dose titration should be considered.
Croatian: Potrebno je razmotriti prikladno titriranje doze.
English: The treatment is divided into two stages:
Croatian: Liječenje je podijeljeno u dvije faze:
English: The treatment is divided into two stages: 1.
Croatian: Liječenje je podijeljeno u dvije faze: 1.
English: These changes are interpreted as being secondary to decreased maternal body weight gain.
Croatian: Smatra se da su te promjene sekundarne posljedice smanjenja tjelesne težine majke.
English: Depending on your individual situation a blood transfusion may be preferable.
Croatian: Ovisno o vašoj situaciji, transfuzija krvi može biti prihvatljivija.
English: Silapo must not be mixed with other medicinal products (see section 6.2).
Croatian: Silapo se ne smije miješati s drugim lijekovima (vidjeti dio 6.2).
English: Always use this medicine exactly as your doctor has told you.
Croatian: Uvijek upotrebljavajte Silapo točno onako kako vam je liječnik rekao.
English: Frequency estimate: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000), not known (frequency cannot be estimated from the available data).
Croatian: Učestalost nuspojava: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1 000 i <1/100); rijetko (≥1/10 000 i <1/1 000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti učestalost iz dostupnih podataka).
English: The protein moiety of the molecule contributes about 58% of total molecular weight and consists of 165 amino acids.
Croatian: Proteinski dio molekule doprinosi oko 58% ukupne molekularne težine i sadrži 165 aminokiselina.
English: Please discuss this with your doctor.
Croatian: Molimo vas da o tome porazgovarate sa svojim liječnikom.
English: What Silapo is and what it is used for
Croatian: Što je Silapo i za što se koristi
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek uzrokovati nuspojave iako se one neće pojaviti kod svakoga.
English: Your doctor will decide this.
Croatian: O tome će odlučiti Vaš liječnik.
English: Inject the solution as you have been shown by your doctor.
Croatian: Injicirajte otopinu onako kako vam je liječnik pokazao.
English: He/she will work out the correct dose of Silapo for you to use, how long the treatment should continue and by what route the medicine will be given.
Croatian: On/ona će odrediti ispravnu dozu Silapa koju ćete primjenjivati, kako dugo će trajati liječenje i kojim putem će se davati lijek.
English: • can't take medicines to thin the blood
Croatian: • • ne smijete uzimati lijekove za sprječavanje zgrušavanja krvi
English: As with all growth factors, there is a concern that epoetins could stimulate the growth of any type of malignancy.
Croatian: Kao i kod svih faktora rasta, postoji bojazan da bi epoetini mogli poticati rast bilo koje vrste malignih stanica.
English: In addition, special precaution should be taken in patients with predisposition for development of DVTs.
Croatian: Pored toga, potreban je poseban oprez u bolesnika s predispozicijom za razvoj DVT-a.
English: Additional supportive care should be provided as necessary.
Croatian: Potrebno osigurati dodatnu potpornu njegu ukoliko je neophodno.
English: Your doctor will check on this.
Croatian: Vaš će liječnik to provjeravati.
English: Take one sealed syringe blister and leave it to stand for a few minutes until it reaches room temperature prior to using it.
Croatian: Uzmite jedan zatvoreni blister sa štrcaljkom i ostavite nekoliko minuta prije upotrebe dok ne dosegne sobnu temperaturu.
English: • Increased blood pressure.
Croatian: • povišeni krvni tlak.
English: The following maintenance doses were observed in clinical trials after 6 months of treatment.
Croatian: U kliničkim ispitivanjima primijećene su slijedeće doze održavanja nakon 6-mjesečnog liječenja.
English: The injections can then be given by a doctor, trained nurse or other health care professional.
Croatian: Injekciju može dati liječnik, uvježbana medicinska sestra ili drugi zdravstveni djelatnik.
English: It may be necessary to add or increase anti-hypertensive treatment.
Croatian: Možda će biti potrebno uvesti ili pojačati antihipertenzivno liječenje.
English: All special warnings and precautions associated with autologous predonation programmes, especially routine volume replacement, should be respected.
Croatian: Potrebno je poštovati sve posebne mjere upozorenja i opreza povezane s autolognim predonacijskim programom, posebno rutinsku nadoknadu volumena.
English: These serious skin rashes are often preceded by fever and/or flu-like symptoms.
Croatian: Ovim ozbiljnim kožnim osipima često prethode vrućica i/ili simptomi nalik gripi.
English: 95% CI for Mean Prior Transfusions
Croatian: 95% CI, srednja vrijednost Prethodne transfuzije
English: • Problem with the blood that may cause pain, dark coloured urine or increased sensitivity of the skin to sunlight (porphyria)
Croatian: • problemi s krvlju koji mogu uzrokovati bol, tamno obojenje mokraće ili povećanu osjetljivost kože na sunčevu svjetlost (porfirija)
English: • Stroke (insufficient blood supply to the brain, which may lead to inability to move one or more limbs on one side of the body, inability to understand or formulate speech, or an inability to see one side of the visual field).
Croatian: • moždani udar (nedovoljna opskrba mozga krvlju, što može dovesti do nemogućnosti pokretanja jednog ili više udova, nemogućnosti razumijevanja ili formuliranja govora ili nemogućnosti vida na jednoj strani vidnog polja).
English: If you have these symptoms during injection into the vein, a slower delivery of the injection may help to avoid them in the future.
Croatian: Ako ste tijekom injiciranja u venu imali ove simptome, sporija brzina infuzije može Vam biti od pomoći kako biste ih izbjegli ubuduće.
English: Pharmacotherapeutic group: Other antianaemic preparations, erythropoietin ATC code: B03XA01
Croatian: Farmakoterapijska skupina: drugi antianemici, eritropoetin ATK oznaka: B03XA01
English: If you are receiving haemodialysis:
Croatian: Ako primate hemodijalizu:
English: It is recommended that initial erythroid response be assessed 8 to 12 weeks following initiation of treatment.
Croatian: Preporučuje se početni eritroidni odgovor procijeniti 8 do 12 tjedana nakon početka liječenja.
English: • Skin rashes and swelling around the eyes (oedema), which may result from an allergic reaction.
Croatian: • kožni osipi i oticanje oko očiju (edem), koji mogu biti rezultat alergijske reakcije.
English: • have severe heart disease
Croatian: • • imate tešku bolest srca
English: These increases in blood pressure can be treated with medicinal products.
Croatian: Takvo povećanje krvnog tlaka može se tretirati lijekovima.
English: This should improve during the course of the treatment.
Croatian: To bi se trebalo popraviti tijekom liječenja.
English: The dose you receive is based on your body weight in kilograms.
Croatian: Doza koju primate bazira se na vašoj tjelesnoj težini u kilogramima.
English: Dose increases and decreases should be done one dosing step at a time (see diagram below).
Croatian: Povećanja i smanjenja doze treba provoditi po jedan korak u određenom trenutku (vidjeti dijagram u nastavku).
English: D-61118 Bad Vilbel Germany
Croatian: D-61118 Bad Vilbel Njemačka
English: In case of larger volumes, more than one site should be chosen for the injection.
Croatian: U slučaju većih volumena, treba odabrati više mjesta za injiciranje.
English: What you need to know before you use Silapo
Croatian: Što morate znati prije nego počnete primjenjivati Silapo
English: However, since ciclosporin is bound by red blood cells there is potential for interactions with other medicinal products.
Croatian: Pa ipak, s obzirom da se ciklosporin veže za crvene krvne stanice postoji mogućnost interakcije s drugim lijekovima.
English: Contains phenylalanine, see leaflet for further information.
Croatian: Sadrži fenilalanin, za dodatne informacije pogledati Uputu o lijeku.
English: Each syringe should be used for a single injection only.
Croatian: Svaka štrcaljka namijenjena je samo za jedno injiciranje.
English: The therapeutic margin of erythropoietin is very wide.
Croatian: Terapijski raspon eritropoetina je vrlo širok.
English: This medicinal product is for single use only.
Croatian: Ovaj lijek namijenjen je samo za jednokratnu uporabu.
English: These decisions will be influenced by what is causing your anaemia.
Croatian: Na ove odluke utjecat će uzrok Vaše anemije.
English: You will receive Silapo during the 3 weeks before your surgery.
Croatian: Silapo ćete primati 3 tjedna prije Vaše operacije.
English: • have recently had a heart attack or stroke
Croatian: • • nedavno ste imali srčani ili moždani udar
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: These reports are based on in vitro findings from human tumour samples, but are of uncertain significance in the clinical situation.
Croatian: Ti izvještaji se baziraju na in vitro nalazima na ljudskim uzorcima tumora, ali su od nesigurnog značaja u kliničkim uvjetima.
English: The safety and efficacy of epoetin zeta in paediatrics have not been established.
Croatian: Sigurnost i djelotvornost epoetina zeta u pedijatrijskih bolesnika nisu ustanovljene.
English: The dose for children and adolescents is based on body weight in kilograms.
Croatian: Doza za djecu i adolescente bazira se na tjelesnoj težini u kilogramima.
English: Moreover, monitoring of the blood pressure is recommended particularly at the start of therapy.
Croatian: Osim toga, preporuča se pratiti krvni tlak, pogotovo na početku terapije.
English: • you are at risk of blood clots in the veins (deep venous thrombosis) - for example, if you have had clots before.
Croatian: • imate rizik od stvaranja krvnih ugrušaka u venama (duboka venska tromboza) - na primjer, ukoliko ste prije imali ugruške.
English: You should inform the doctor or nurse immediately if you think too much Silapo has been injected.
Croatian: Trebate odmah informirati liječnika ili medicinsku sestru ukoliko mislite da ste injicirali previše Silapa.
English: • If blood tests show your haemoglobin is too high before the operation, the treatment will be stopped.
Croatian: • Ako krvne pretrage pokažu da Vam je hemoglobin prije kirurškog zahvata previsok, liječenje će se prekinuti.
English: Extending dose intervals may require an increase in dose.
Croatian: Produljenje intervala doziranja može zahtijevati povišenje doze.
English: Two subjects had significant risk factors (atrial fibrillation, heart failure and thrombophlebitis).
Croatian: Dva ispitanika imala su značajne čimbenike rizika (fibrilacija atrija, zatajenje srca i tromboflebitis).
English: Epoetin zeta is a copy of the human protein erythropoietin and acts in the same way.
Croatian: Epoetin zeta je kopija ljudskog proteina eritropoetina i djeluje na isti način.
English: For intravenous or subcutaneous use.
Croatian: Za intravensku ili supkutanu primjenu.
English: Raised blood pressure may require treatment with medicines (or adjustment to any medicines you already take for high blood pressure).
Croatian: Povišeni krvni tlak može zahtijevati liječenje lijekovima (ili prilagodbu bilo kojeg lijeka kojeg već uzimate radi visokog krvnog tlaka).
English: There is no evidence to indicate that treatment with erythropoietin alters the metabolism of other medicinal products.
Croatian: Nema dokaza koji bi upućivali da liječenje eritropoetinom mijenja metabolizam drugih lijekova.
English: Silapo must not be shaken or mixed with any other liquid.
Croatian: Silapo se ne smije protresati ili miješati ni sa kojim drugim tekućinama.
English: Handling instructions for Silapo:
Croatian: Upute za uporabu Silapa:
English: If blood pressure cannot be well controlled, Silapo treatment should be discontinued.
Croatian: Ukoliko se krvni tlak ne može dobro kontrolirati, treba prekinuti primjenu Silapa.
English: The biological efficacy of erythropoietin has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
Croatian: Biološka djelotvornost eritropoetina dokazana je na različitim životinjskim modelima in vivo (normalni i anemični štakori, policitemični miševi).
English: If the solution is given into a vein, it should be injected over 1-5 minutes.
Croatian: Ako se otopina daje u venu, treba je injicirati kroz 1-5 minuta.
English: Silapo can be used to increase the yield of autologous blood from patients in a predonation programme.
Croatian: - Silapo se može koristiti za povećanje količine autologne krvi kod pacijenata u predonacijskom programu.
English: This is given twice a week.
Croatian: Daje se dva puta tjedno.
English: Based on the results from clinical trials with other authorised erythropoietins approximately 8% of patients treated with erythropoietin are expected to experience adverse reactions.
Croatian: Na temelju rezultata kliničkih ispitivanja s drugim odobrenim eritropoetiima, kod približno 8% pacijenata liječenih eritropoetinom mogu se očekivati neželjene reakcije.
English: The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 3 days (but not above 25°C).
Croatian: Štrcaljka se može izvaditi iz hladnjaka i ostaviti na sobnoj temperaturi jednokratno u trajanju do najviše 3 dana (ali ne iznad 25°C).
English: Although this complication is very rare, you should be aware that if you develop it, you would need to have regular blood transfusions, possibly lifelong, to treat your anaemia and the Silapo therapy would have to be discontinued.
Croatian: Iako je ova komplikacija vrlo rijetka, trebate biti svjesni da ćete ukoliko je razvijete, radi liječenja anemije morati primati redovne transfuzije krvi, moguće tijekom cijelog života, a terapija Silapom će se morati prekinuti.
English: Silapo must not be used if
Croatian: Silapo se ne smije upotrijebiti ako:
English: This is given 3 times a week.
Croatian: Daje se 3 puta tjedno.
English: • Feeling sick in your stomach
Croatian: • osjećaj mučnine u trbuhu
English: if you are due to have major elective orthopaedic surgery (such as hip or knee surgery), and you:
Croatian: - ako se pripremate za veliki elektivni ortopedski kirurški zahvat (kao što je operacija kuka ili koljena) i:
English: After your condition has been brought under control, you will receive regular doses of Silapo (3 times a week, or, if you have your injections under the skin, it may also be given once weekly or once every 2 weeks).
Croatian: Nakon što je vaše stanje dovedeno pod kontrolu, primat ćete uobičajene doze Silapa (3 puta tjedno ili, ako dobivate injekciju pod kožu, može Vam se dati jedanput tjedno ili jedanput svaka 2 tjedna).
English: Your doctor may decide to increase your heparin dose during dialysis.
Croatian: Vaš liječnik može odlučiti povećati dozu heparina koju primate tijekom dijalize.
English: in moderately anaemic patients who are going to have surgery and prior to it, donate blood so that their own blood can be given to them during or after surgery (autologous pre-donation).
Croatian: - kod umjereno anemičnih pacijenata kod kojih će se obaviti kirurški zahvat i koji će prije toga, donirati krv zato da im se vlastita krv može dati tijekom ili nakon operacije (autologna predonacija).
English: If Silapo is injected under the skin the amount injected in any one place should not exceed 1 ml.
Croatian: Ako se Silapo injicira pod kožu, injicirana količina u jedno mjesto ne bi trebala prijeći 1 ml.
English: In most cases, the ferritin values in the serum fall simultaneously with the rise in packed cell volume.
Croatian: U većini slučajeva, vrijednosti feritina u serumu padaju istodobno s porastom hematokrita.
English: The half-life is difficult to evaluate for the subcutaneous route and is estimated to be about 24 hours.
Croatian: Teško je procijeniti poluvijek nakon supkutane injekcije, a procjenjuje se da je oko 24 sata.
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Croatian: U četiri placebo kontrolirana ispitivanja, omjer rizika za ukupno preživljenje varirao je između 1,25 i 2,47 u korist kontrolne skupine.