FrancophonIA/ELRC3.0 huggingface dataset:
English: In very rare cases there might also be some temporary itchiness, inflammation or hair loss at the place where the product has been applied to the cat's skin.
Croatian: U vrlo rijetkim slučajevima može doći i do privremenog svrbeža, upale ili gubitka dlaka na mjestu na kojem je proizvod primijenjen na mačkinoj koži.
English: Profender should not be used in young animals (cats under 8 weeks of age or weighing less than 0.5 kg, or puppies under 12 weeks of age or weighing less than 1 kg).
Croatian: VMP Profender ne smije se primjenjivati u mladih životinja (mačaka u dobi do 8 tjedana starosti ili koje teže manje od 0,5 kg ili štenadi u dobi do 12 tjedana starosti ili koja teže manje od 1 kg).
English: Users should also wash their hands after giving Profender as tablets to a dog.
Croatian: Korisnici također moraju oprati ruke nakon što psima daju tablete Profender.
English: If accidental exposure occurs, the eyes should be rinsed with water or the skin washed with soap and water.
Croatian: Ako dođe do slučajnog izlaganja proizvodu, oči treba isprati vodom, a kožu sapunom i vodom.
English: The correct number of tablets or half tablets to use is calculated based on the dog's weight.
Croatian: Točan broj tableta ili polovica tableta koje treba primijeniti izračunava se na temelju tjelesne težine psa.
English: In cats, in very rare cases, the cat might salivate or vomit after treatment.
Croatian: U mačaka, u vrlo rijetkim slučajevima, mačka može lučiti slinu ili povraćati nakon primanja terapije.
English: Over 90% of cats and 99% of dogs had no roundworm or tapeworm infection after treatment with Profender.
Croatian: Više od 90 % mačaka i 99 % pasa nije bilo zaraženo oblićima ili trakavicama nakon liječenja VMP-om Profender.
English: Other information about Profender:
Croatian: Ostale informacije o VMP-u Profender:
English: Profender is an antiparasitic medicine that contains two active substances, emodepside and praziquantel.
Croatian: Profender je antiparazitski VMP koji sadrži dvije djelatne tvari, emodepsid i prazikvantel.
English: What are the precautions for the person who gives the medicine or comes into contact with the animal?
Croatian: Koje mjere opreza mora poduzeti osoba koja primjenjuje veterinarskomedicinski proizvod ili dolazi u kontakt sa životinjom?
English: The solvent in Profender spot-on solution may stain certain materials including leather, fabrics, plastics and finished surfaces, so contact between the product and such surfaces should be avoided.
Croatian: Otapalo u spot-on otopini Profender može zamrljati određene materijale poput kože, tkanina, plastike i obrađenih površina i stoga je potrebno izbjegavati kontakt proizvoda i takvih površina.
English: Mild and short-lived signs relating to the nervous system such as ataxia (inability to co-ordinate muscle movements) or tremor (shaking) may occur in very rare cases.
Croatian: U vrlo rijetkim slučajevima mogu se javiti blagi i kratkotrajni znakovi u vezi sa živčanim sustavom kao što su ataksija (nemogućnost da se koordinira kretnjama mišića) ili tremor (tresavica).
English: Profender is a medicine used to treat cats and dogs that have, or are at risk of catching, “mixed” (caused by more than one parasite) parasitic infections.
Croatian: Profender je VMP koji se koristi za liječenje mačaka i pasa koji imaju ili su izloženi riziku od „mješovitih” (koje uzrokuje više parazita) parazitskih infekcija.
English: Why is Profender approved?
Croatian: Zašto je Profender odobren?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Profender's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Profender nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: The effectiveness of each of the products against the specified roundworms and tapeworms was investigated in both laboratory studies and in large field studies (one for the spot-on for cats and another for the tablets for dogs) carried out at several different places across Europe.
Croatian: Djelotvornost svakog od proizvoda protiv određenih oblića i trakavica ispitivana je kako u okviru laboratorijskih ispitivanja tako i u velikim terenskim ispitivanjima (jedno za spot-on otopine za mačke, a drugo za tablete za pse) koja su provedena na nekoliko različitih mjesta diljem Europe.
English: What is Profender and what is it used for?
Croatian: Što je Profender i za što se koristi?
English: This is a summary of the European public assessment report (EPAR) for Profender.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o veterinarsko-medicinskom proizvodu Profender.
English: Emodepside interferes with certain specific receptors in the nervous systems of roundworms, which results in their subsequent paralysis and death.
Croatian: Emodepsid ometa određene specifične receptore u živčanim sustavima oblića što uzrokuje njihovu paralizu i umiranje.
English: The results from the laboratory studies and from the field studies, in both cats and dogs, showed that Profender was as effective as the comparator medicine.
Croatian: Rezultati laboratorijskih i terenskih ispitivanja, i u mačaka i u pasa, pokazali su da je PMV Profender jednako djelotvoran kao usporedni lijek.
English: The laboratory study showed Profender to reduce the worm count in the lungs by more than 99%.
Croatian: Laboratorijsko je ispitivanje pokazalo da VMP Profender smanjuje broj glista u plućima za više od 99 %.
English: In each of the field studies, animals of various breeds, age groups and different weights that were naturally infected with roundworms or tapeworms in their guts, were treated either with Profender or another approved worming medicine (selamectin in cats, and milbemycin oxime and praziquantel in dogs).
Croatian: U svakom od terenskih ispitivanja životinje raznih pasmina, dobnih skupina i različitih tjelesnih težina čija su crijeva bila prirodnim putem zaražena oblićima ili trakavicama bile su liječene ili VMP-om Profender ili drugim odobrenim lijekom protiv glista (selamektinom u mačaka te milbemicin oksimom i prazikvantelom u pasa).
English: The two active substances in Profender interact with different parts of the parasites systems.
Croatian: Dvije djelatne tvari u VMP-u Profender djeluju na različite dijelove sustava parazita.
English: When giving Profender spot-on solution, skin contact with the pipette contents should be avoided and animals should not be stroked, groomed or allow to groom each other, until the application site is dry.
Croatian: Prilikom primjene spot-on otopine Profender, potrebno je izbjegavati kontakt pipete s kožom i životinje se ne smiju gladiti, dotjerivati niti se ne smije dozvoliti da one dotjeruju jedna drugu sve dok mjesto primjene VMP-a ne bude suho.
English: These effects are thought to occur as a result of the cat licking the application site straight after treatment.
Croatian: Smatra se da se takvi znakovi javljaju kao posljedica toga što mačka liže mjesto primjene VMP-a odmah nakon primanja terapije.
English: The effectiveness was measured by looking at the number of worm eggs or parts of tapeworms passed out in the animal's faeces after treatment.
Croatian: Djelotvornost je mjerena brojem jajašaca glista ili dijelova trakavica izašlih kroz izmet životinja nakon primanja terapije.
English: What are the risks associated with Profender?
Croatian: Koji su rizici povezani s VMP-om Profender?
English: It is not intended to provide practical use on how to use Profender.
Croatian: Svrha sažetka nije davati praktične savjete o načinu primjene VMP-a Profender.
English: For lungworms in cats a laboratory study together with a field study showed Profender to reduce the number of larvae passed in the animal's faeces by more than 99%.
Croatian: U pogledu plućnih glista u mačaka, laboratorijsko ispitivanje, zajedno s terenskim ispitivanjem, pokazalo je da PMV Profender smanjuje broj ličinaka koje izađu kroz izmet životinja za više od 99 %.
English: Profender can only be obtained with a prescription.
Croatian: Profender se izdaje samo na liječnički recept.
English: The appropriate quantity of Profender (either the contents of one full pipette or the volume measured by the vet) is applied onto the cat's skin, after parting the fur on the back of its neck at the base of its head.
Croatian: Odgovarajuća količina VMP-a Profender (ili sadržaj jedne potpuno napunjene pipete ili volumen koji izmjeri veterinar) primjenjuje se na mačkinu kožu nakon razdvajanja krzna na stražnjem dijelu njezina vrata ispod potiljka glave.
English: Praziquantel damages the skin-like outer layer of tapeworms, leading to their paralysis and death.
Croatian: Prazikvantel oštećuje vanjski sloj trakavica koji izgleda kao koža što uzrokuje njihovu paralizu i umiranje.
English: Profender works for infections caused by certain types of roundworms, tapeworms, as well as lungworms in cats.
Croatian: Profender djeluje na infekcije uzrokovane određenim vrstama oblića i trakavica te plućnih glista u mačaka.
English: Profender tablets are available in three different strengths to cover a range of dog weights (small, medium or large dogs).
Croatian: Tablete Profender dostupne su u tri različite jačine za potrebe različitih tjelesnih težina pasa (male pse, pse srednje veličine i velike pse).
English: What is Profender?
Croatian: Što je Profender?
English: Profender is given as a single treatment for roundworms and tapeworms.
Croatian: Profender se daje kao jedna terapija za obliće i trakavice.
English: As with other products of this type, Profender should be used on sick or ill cats or dogs only after a risk-benefit assessment by the vet. Profender should not be used for any other animal species.
Croatian: Kao i u slučaju drugih proizvoda ove vrste, VMP Profender smije se primjenjivati u oboljelih mačaka ili pasa samo nakon što veterinar provede procjenu rizika i koristi.
English: Profender is available as a solution for use on cats, and as modified release tablets for dogs.
Croatian: Profender je dostupan u obliku otopine za primjenu u mačaka te u obliku tableta s prilagođenim otpuštanjem za pse.
English: What benefits of Profender have been shown in studies?
Croatian: Koje su koristi VMP-a Profender utvrđene u ispitivanjima?
English: Profender solution is packed as spot-on pipettes, which are already filled with the correct amount of Profender needed to treat one cat (3 sizes of pipette for different cat weights) and as a multidose bottle for use only in a veterinary surgery, where the vet will measure the exact volume of Profender needed for each cat before application.
Croatian: Profender pakirana je obliku spot-on pipeta koje su već napunjene odgovarajućom količinom VMP-a Profender potrebnom za liječenje jedne mačke (postoje tri veličine pipeta za različite tjelesne težine mačaka) te u obliku bočice s više doza za primjenu samo u veterinarskoj kirurgiji pri čemu veterinar izmjeri točan volumen VMP-a Profender potreban za svaku mačku prije primjene.
English: Dogs are treated using Profender modified-release tablets, which are given by mouth when the dog is fasting.
Croatian: Psi se liječe primjenom tableta Profender s prilagođenim otpuštanjem koje se daju u usta između obroka.
English: For practical information about using Profender, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Profender 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 Profender, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Profender vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Cats are treated using the Profender spot-on solution range.
Croatian: Mačke se liječe primjenom spot-on otopine Profender koja se primjenjuje u više različitih odgovarajućih doza.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom bottle for use only in a veterinary surgery, where the vet will measure the exact volume of Profender needed for each cat before application.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: How is Profender used?
Croatian: Kako se Profender koristi?
English: How does Profender work?
Croatian: Kako djeluje Profender?
English: Talk to your doctor if you have any concerns.
Croatian: Obratite se svom liječniku ako imate bilo kakvih pitanja.
English: Instructions for Use
Croatian: Upute za uporabu
English: The frequency of these types of events is not known (cannot be estimated from available data).
Croatian: Učestalost ovih vrsta događaja nije poznata (ne može se procijeniti iz dostupnih podataka).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● Ujedinjena Kraljevina
English: Adopted at the 30 November - 3 December 2015 PRAC
Croatian: Usvojeno na sjednici PRAC-a 30. studenog - 3. prosinca 2015.
English: TACHOSIL (Human fibrinogen, human thrombin)Intestinal obstruction (EPITT no 18373)
Croatian: 2. TACHOSIL (ljudski fibrinogen, ljudski trombin)intestinalna opstrukcija (EPITT br. 18373)
English: For tibolone containing products
Croatian: Za lijekove koji sadrže tibolon
English: After pressing TachoSil to the wound, the glove or the pad must be removed carefully.
Croatian: Nakon što se TachoSil pritisne na ranu, rukavica ili jastučić moraju se pažljivo ukloniti.
English: To prevent the development of tissue adhesions at undesired sites, ensure tissue areas outside the desired application area are adequately cleansed before administration of TachoSil (see section 6.6).
Croatian: Kako bi se spriječilo lijepljenje za tkiva na neželjenim mjestima, prije primjene TachoSila osigurajte da su tkivna područja izvan željenog područja primjene odgovarajuće očišćena (vidjeti dio 6.6).
English: For DUAVIVE product
Croatian: Za DUAVIVE
English: What you need to know before TachoSil is used Warnings and precautions
Croatian: Što morate znati prije nego počnete primjenjivati TachoSil Upozorenja i mjere opreza
English: Your surgeon will make sure to clean the operating area when applying TachoSil to reduce this risk.
Croatian: Prilikom primjene TachoSila Vaš će se kirurg pobrinuti da se područje koje će se operirati očisti radi smanjenja tog rizika.
English: Summary of product characteristics (SmPC) section 4.4: Special warnings and precautions for use
Croatian: Sažetak opisa svojstava lijeka (SPC) dio 4.4.: Posebna upozorenja i mjere opreza pri uporabi
English: It is important to note that failure to adequately clean adjacent tissues may cause adhesions (see section 4.4).
Croatian: Važno je napomenuti da neodgovarajuće čišćenje okolnih tkiva može uzrokovati lijepljenje (vidjeti dio 4.4).
English: The effect of DUAVIVE on the risk of ovarian cancer is unknown.
Croatian: Učinak lijeka DUAVIVE na rizik od nastanka raka jajnika nije poznat.
English: Hormone replacement therapy (HRT) medicinal products, which are not pharmaceutical forms for vaginal use, containing oestrogens or combined oestrogens-progestagens (tibolone containing products also concerned); DUAVIVE (bazedoxifene, oestrogens conjugated) - Increased risk of ovarian cancer (EPITT no 18258)
Croatian: Lijekovi za hormonsku nadomjesnu terapiju (HNT) koji nisu farmaceutski oblici za vaginalnu uporabu, a koji sadrže estrogene ili kombinaciju estrogena i progestagena (to uključuje i lijekove koji sadrže tibolon); DUAVIVE (bazedoksifen, konjugirani estrogeni) - povećani rizik od nastanka raka jajnika (EPITT br. 18258)
English: Pressure is applied with moistened gloves or a moist pad.
Croatian: Pritisak se primjenjuje vlažnim rukavicama ili vlažnim jastučićem.
English: Frequency ‘unknown': Intestinal obstruction (in abdominal surgeries) General disorders and administration site conditions: Frequency ‘unknown': Adhesions
Croatian: Poremećaji probavnog sustava: 'Nepoznata' učestalost: Intestinalna opstrukcija (u abdominalnoj kirurgiji) Opći poremećaji i reakcije na mjestu primjene: 'Nepoznata' učestalost: Lijepljenje
English: Ovarian cancer is rare - much rarer than breast cancer.
Croatian: Rak jajnika rijetko se pojavljuje - mnogo je rjeđi od raka dojke.
English: It is important to note that failure to adequately clean adjacent tissues may cause adhesions.
Croatian: Važno je napomenuti da neodgovarajuće čišćenje okolnih tkiva može uzrokovati lijepljenje.
English: To avoid TachoSil from being pulled loose it may be held in place at one end, e.g. with a pair of forceps.
Croatian: Kako se Tachosil ne bi otrgnuo, može se s jedne strane pridržati, npr. pincetom.
English: Due to the strong affinity of collagen to blood, TachoSil may also stick to surgical instruments, or gloves or adjacent tissues covered with blood.
Croatian: Zbog jakog afiniteta kolagena prema krvi TachoSil se može zalijepiti i za kirurške instrumente, ili rukavice ili okolna tkiva prekrivena krvlju.
English: A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56).
Croatian: Meta-analiza 52 epidemiološke studije ukazala je na povećani rizik od nastanka raka jajnika u žena koje trenutno primaju hormonsku nadomjesnu terapiju (HNT) u usporedbi sa ženama koje nikada nisu primale hormonsku nadomjesnu terapiju (HNT) (RR 1,43, 95 %CI, 1,31-1,56).
English: Cleanse surgical instruments, or gloves and adjacent tissues, if necessary.
Croatian: Očistite kirurške instrumente, ili rukavice i okolna tkiva, ako je potrebno.
English: TachoSil may stick to surgical instruments, or gloves or adjacent tissues covered with blood.
Croatian: TachoSil se može lijepiti za kirurške instrumente, ili rukavice ili okolna tkiva prekrivena krvlju.
English: Other adverse reactions have been reported in association with oestrogen and oestrogenprogestogen treatment:
Croatian: Zabilježene su i druge nuspojave povezane s liječenjem estrogenom i kombinacijom estrogena i progestagena:
English: This can be avoided by cleansing surgical instruments, and gloves and adjacent tissues before application.
Croatian: To se može izbjeći tako da se kirurški instrumenti i rukavice te okolna tkiva očiste prije primjene.
English: In the Million Women Study, taking 5 years of HRT tibolone resulted in 1 extra case per 2500 users (see Section 4.4).
Croatian: Studija „Milijun žena” pokazala je da petogodišnje primanje hormonske nadomjesne terapije (HNT) uzimanje tibolona rezultira jednim dodatnim slučajem na 2500 korisnica (vidjeti dio 4.4.).
English: Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestagen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
Croatian: Epidemiološki dokazi na osnovi velike meta-analize ukazuju na blago povećani rizik u žena koje uzimaju hormonsku nadomjesnu terapiju (HNT) koja sadrži samo estrogen ili kombinaciju estrogena i progestagena, što postaje vidljivo unutar 5 godina uporabe, dok se rizik s vremenom smanjuje nakon prestanka primanja terapije.
English: With use of X, the increased risk of ovarian cancer is similar to other types of HRT.
Croatian: Uz uporabu X-a, povećani rizik od nastanka raka jajnika sličan je rizicima kod drugih vrsta hormonske nadomjesne terapije (HNT).
English: Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
Croatian: Epidemiološki dokazi na osnovi velike meta-analize ukazuju na blago povećani rizik u žena koje uzimaju hormonsku nadomjesnu terapiju (HNT) koja sadrže samo estrogen, što postaje vidljivo unutar 5 godina uporabe, dok se rizik s vremenom smanjuje nakon prestanka primanja terapije.
English: In the Million Women Study, it was shown that the relative risk for ovarian cancer with use of tibolone was similar to the risk associated with use of other types of HRT.
Croatian: Studija „Milijun žena” pokazala je da je relativni rizik od nastanka raka jajnika kod uporabe tibolona sličan riziku povezanom s uporabom drugih vrsta hormonske nadomjesne terapije (HNT).
English: Events of adhesions to gastrointestinal tissues leading to gastrointestinal obstruction have been reported with use in abdominal surgery carried out in proximity to the bowel.
Croatian: Prilikom uporabe u abdominalnoj kirurgiji koja se provodila blizu crijeva prijavljeni su događaji lijepljenja za gastrointestinalna tkiva, koji su doveli do gastrointestinalne opstrukcije.
English: Scar tissues can cause surfaces in your bowel to stick together, which can lead to blockage of the bowel.
Croatian: Ožiljkasta tkiva mogu uzrokovati lijepljenje površina u crijevu, što može dovesti do začepljenja crijeva.
English: Long-term (at least 5-10 years) use of oestrogen-only HRT products has been associated with a slightly increased risk of ovarian cancer (see section 4.8).
Croatian: Dugotrajna uporaba (najmanje 5-10 godina) lijekova za hormonsku nadomjesnu terapiju (HNT) koji sadrže samo estrogen povezuje se s blago povećanim rizikom od nastanka raka jajnika (vidjeti dio 4.8.).
English: This study showed that the relative risk for ovarian cancer with tibolone was similar to the risk with other types of HRT.
Croatian: Studija je pokazala da je relativni rizik od nastanka raka jajnika kod uporabe tibolona sličan riziku kod drugih vrsta hormonske nadomjesne terapije (HNT).
English: For women who have been taking HRT for 5 years, there will be between 2 and about 3 cases per 21000 users (i.e. up to about 1 extra case).
Croatian: U žena koje primaju hormonsku nadomjesnu terapiju (HNT) 5 godina bit će između 2 i otprilike 3 slučaja na 21000 korisnica (tj. otprilike do jedan dodatni slučaj).
English: After abdominal surgery and if TachoSil sticks to nearby tissues, it is possible that scar tissues can develop in the operated area.
Croatian: Nakon kirurškog zahvata i uporabe TachoSila u nekih je bolesnika moguć razvoj ožiljkastih tkiva.
English: For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users.
Croatian: U žena u dobi od 50 do 54 godine koje primaju hormonsku nadomjesnu terapiju (HNT) 5 godina to rezultira otprilike jednim dodatnim slučajem na 2000 korisnica.
English: BEFORE YOU TAKE X
Croatian: 2. ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI X Rak jajnika
English: SmPC section 4.4: Special warnings and precautions for use Ovarian cancer
Croatian: SPC dio 4.8.: Nuspojave Rak jajnika
English: Some other studies, including the WHI trial, suggest that use of combined HRTs may be associated with a similar or slightly smaller risk (see Section 4.8).
Croatian: Neke druge studije, uključujući studiju WHI, ukazuju na to da se primjena kombiniranih hormonskih nadomjesnih terapija (HNT) može biti povezana sa sličnim ili neznatno manjim rizikom (vidjeti dio 4.8.).
English: For oestrogen only and combined oestrogen-progestagen HRT products
Croatian: Za lijekove za hormonsku nadomjesnu terapiju (HNT) koji sadrže samo estrogen ili kombinaciju estrogena i progestagena
English: Some other studies, including the WHI trial, suggest that the long-term use of combined HRTs may confer be associated with a similar, or slightly smaller risk (see Section 4.8).
Croatian: Neke druge studije, uključujući studiju WHI, ukazuju na to da dugotrajna uporaba kombiniranih hormonskih nadomjesnih terapija (HNT) može prouzročiti biti povezana sa sličnim ili neznatno manjim rizikom (vidjeti dio 4.8.).
English: BEFORE YOU TAKE DUVAVIVE
Croatian: 2. ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI DUVAVIVE Rak jajnika