FrancophonIA/ELRC3.0 huggingface dataset:
English: Cialis can also be used in men to treat the signs and symptoms of benign prostatic hyperplasia (enlarged prostate gland that is not cancerous), which involve problems with the flow of urine.
Croatian: Cialis se također primjenjuje u muškaraca za liječenje znakova i simptoma benigne prostatične hiperplazije (povećanje prostate koje nije benigno), što uključuje probleme s protokom urina.
English: It must also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy, NAION).
Croatian: Lijek također ne smiju uzimati bolesnici koji su doživjeli gubitak vida zbog problema s dotokom krvi u očni živac (nearteritička prednja ishemička neuropatija ili NAION).
English: Once-a-day dosing of Cialis was studied in three further studies lasting 12 to 24 weeks and involving a total of 853 patients.
Croatian: Jedno od ovih ispitivanja obuhvatilo je samo dijabetičke muškarce Jednom dnevno doziranje lijeka Cialis ispitano je u tri daljnja ispitivanja koja su trajala od 12 do 24 tjedana, i obuhvatila su ukupno 853 bolesnika.
English: For the full list of all side effects reported with Cialis, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Cialis potražite u uputi o lijeku.
English: What is Cialis used for?
Croatian: Za što se Cialis koristi?
English: How does Cialis work?
Croatian: Kako djeluje Cialis?
English: What benefit has Cialis shown during the studies?
Croatian: Koje su koristi lijeka Cialis utvrđene u ispitivanjima?
English: How is Cialis used?
Croatian: Kako se Cialis koristi?
English: How has Cialis been studied?
Croatian: Kako je Cialis ispitivan?
English: Do not give this medicine to children under 12 years old.
Croatian: Nemojte davati ovaj lijek djeci mlađoj od 12 godina.
English: Before you begin
Croatian: Prije početka
English: • Wash your hands carefully.
Croatian: • Pažljivo operite ruke.
English: Genotoxic and carcinogenic potential is not expected.
Croatian: Ne očekuje se genotoksični i kancerogeni potencijal.
English: Data in patients older than 65 years are limited.
Croatian: Podaci za bolesnike starije od 65 godina su ograničeni.
English: Elderly (≥65 years old)
Croatian: Stariji bolesnici (≥ 65 godina)
English: This is the end which has no needle.
Croatian: To je kraj koji nema iglu.
English: This testing should be provided free of charge.
Croatian: To testiranje potrebno je osigurati besplatno.
English: The efficacy and safety in adolescent patients were consistent with that seen in adults.
Croatian: Djelotvornost i sigurnost kod adolescentnih bolesnika bile su u skladu s onom opaženom kod odraslih osoba.
English: Sanofi-Chimie Route d'Avignon Aramon 30390 France
Croatian: Sanofi-Chimie Route d'Avignon Aramon 30390 Francuska
English: If you use more Ruconest than you should
Croatian: Ako ste primijenili više Ruconesta nego što ste trebali
English: Date of first authorisation: 28 October 2010 Date of latest renewal: 18 September 2015
Croatian: Datum posljednje obnove: 18. rujna 2015.
English: Ruconest should not be administered simultaneously with tPA.
Croatian: Ruconest se ne smije primijeniti istodobno s tPA.
English: Other medicines and Ruconest
Croatian: Drugi lijekovi i Ruconest
English: What Ruconest is and what it is used for
Croatian: Što je Ruconest i za što se koristi
English: Within a single kit box, different components may have different expiry dates.
Croatian: U jednoj kutiji kompleta različite komponente mogu imati različite rokove valjanosti.
English: Step 9: Required components
Croatian: 9. korak: Potrebne komponente
English: = body weight (kg)
Croatian: = tjelesna težina (kg)
English: The table below shows the results (primary and secondary endpoints) of the two randomized controlled trials:
Croatian: U tablici ispod prikazani su rezultati (primarne i sekundarne mjere ishoda) dva randomizirana kontrolirana ispitivanja:
English: Small amounts of foam are acceptable.
Croatian: Mala je količina pjene prihvatljiva.
English: The adapter must remain in its plastic packaging.
Croatian: Nastavak mora ostati u plastičnom pakiranju.
English: 5711 CP Someren The Netherlands
Croatian: 5711 CP Someren Nizozemska
English: The elimination half-life of conestat alfa was approximately 2 hours.
Croatian: Poluvrijeme eliminacije konestata alfa bilo je oko 2 sata.
English: Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Croatian: rijetko (≥1/10 000 do <1/1000) vrlo rijetko (<1/10 000) nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Paediatric population The safety and efficacy of Ruconest in children (age 0 to 12 years) have not yet been established.
Croatian: Sigurnost i djelotvornost Ruconesta u djece (u dobi od 0 do 12 godina) nisu još ustanovljene.
English: No formal distribution studies have been performed.
Croatian: Nisu provedena nikakva formalna ispitivanja distribucije.
English: There is no rationale for patients older than 65 years to respond differently to Ruconest.
Croatian: Nema osnove za pretpostavku da bi bolesnici stariji od 65 godina drukčije odgovorili na Ruconest.
English: This may indicate that you have developed an allergy to Ruconest.
Croatian: To može značiti da ste razvili alergiju na Ruconest.
English: No recommendation on a dose adjustment can be made.
Croatian: Nije moguće dati preporuku o prilagodbi doze.
English: Contents of the pack and other information What Ruconest contains
Croatian: Sadržaj pakiranja i druge informacije Što Ruconest sadrži
English: The medicinal product should be used immediately (see section 6.3).
Croatian: Lijek je potrebno primijeniti odmah (vidjeti dio 6.3).
English: Always use this medicine exactly as described in this leaflet or as your doctor or nurse have told you.
Croatian: Uvijek uzimajte ovaj lijek kako je opisano u ovoj uputi ili kako Vam je savjetovao Vaš liječnik ili medicinska sestra.
English: Determine the patient's body weight.
Croatian: Utvrdite tjelesnu težinu bolesnika.
English: What Ruconest looks like and contents of the pack
Croatian: Kako Ruconest izgleda i sadržaj pakiranja
English: It is very important that the prepared solution is injected directly into a vein and not into an artery or the surrounding tissue.
Croatian: Vrlo je važno pripremljenu otopinu ubrizgati izravno u venu, a ne u arteriju ili okolno tkivo.
English: Step 14: Documenting the administration Please record (e.g. in your diary):
Croatian: 14. korak: Bilježenje primjene Zabilježite (npr. u svoj dnevnik):
English: Do not mix or administer Ruconest with other medicines or solutions.
Croatian: Nemojte miješati niti primjenjivati Ruconest s drugim lijekovima ili otopinama.
English: • Inspect vials and other components.
Croatian: • Pregledajte bočice i druge komponente:
English: Talk to your doctor before using Ruconest.
Croatian: Obratite se svom liječniku prije nego primijenite Ruconest.
English: • Response to treatment
Croatian: • Odgovor na liječenje
English: Do not reuse equipment.
Croatian: Nemojte ponovno upotrebljavati pribor.
English: • If there is no blood in the tubing, remove the needle, repeat all steps from beginning of step 11 and reposition the needle.
Croatian: • Ako u cjevčici nema krvi, uklonite iglu, ponovite sve korake od početka 11. koraka i ponovno namjestite iglu.
English: Mostly a single dose is sufficient, but a second dose may be needed.
Croatian: U većini slučajeva dovoljna je jedna doza, ali možda će Vam biti potrebna i druga doza.
English: What Ruconest is and what it is used for What you need to know before you use Ruconest How to use Ruconest
Croatian: Što je Ruconest i za što se koristi Što morate znati prije nego počnete primjenjivati Ruconest Kako primjenjivati Ruconest
English: Chemical and physical in-use stability has been demonstrated for 48 hours between 5˚C and 25˚C.
Croatian: Dokazana kemijska i fizikalna stabilnost lijeka u primjeni je 48 sati na temperaturi između 5˚C i 25˚C.
English: If undissolved powder is still present, repeat the procedure.
Croatian: Ako još ima neotopljenoga praška, ponovite postupak.
English: If you are receiving tissue type plasminogen activator as acute treatment for blood clots, you should not be treated with Ruconest at the same time.
Croatian: Ako primate tkivni aktivator plazminogena kao akutno liječenje protiv krvnih ugrušaka, ne biste istodobno smjeli biti liječeni Ruconestom.
English: The incidence of adverse reactions was similar for all dose groups and did not increase upon repeated administrations.
Croatian: Incidencija nuspojava bila je slična u svim doznim skupinama i nije se povećavala pri ponovljenim primjenama.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: The distribution volume of conestat alfa was approximately 3 L, comparable to plasma volume.
Croatian: Volumen distribucije konestata alfa iznosio je približno 3 l, što je usporedivo s volumenom plazme.
English: In one animal study reproductive toxicity was observed (see section 5.3).
Croatian: U jednom ispitivanju na životinjama primijećena je reproduktivna toksičnost (vidjeti dio 5.3).
English: In the study in rats there were no malformed fetuses in either the conestat alfa or the control group.
Croatian: U ispitivanju na štakorima nije bilo deformiranih fetusa ni u grupi koja je primala konestat alfa, niti u kontrolnoj grupi.
English: Ruconest is not recommended for use during pregnancy or breast-feeding, unless the treating physician judges the benefits to outweigh the possible risks.
Croatian: Primjena Ruconesta ne preporučuje se tijekom trudnoće i dojenja osim u slučajevima kada liječnik procjenjuje da su koristi veće od mogućih rizika.
English: Hypersensitivity reactions cannot be excluded.
Croatian: Nije moguće isključiti reakcije preosjetljivosti.
English: - all vials must be sealed with plastic lid and aluminium cap and without visible damage, such as cracks in glass.
Croatian: - sve bočice moraju biti zatvorene plastičnim poklopcem i aluminijskim zatvaračem i bez vidljivih oštećenja, poput pukotina u staklu.
English: C1INH exerts an inhibitory effect on several proteases (target proteases) of the contact and complement systems.
Croatian: C1INH ima inhibitorni učinak na nekoliko proteaza (ciljne proteaze) sustava kontakta i komplemenata.
English: • After disinfection, do not touch the stoppers with your fingers or anything else.
Croatian: • Nakon dezinfekcije ne dirajte čepove prstima niti ičim drugim.
English: This can lead to repeated attacks of swelling, pain in the abdomen, difficulty breathing and other symptoms.
Croatian: To može dovesti do ponavljanih napada s oticanjem, bolovima u trbuhu, otežanim disanjem i drugim simptomima.
English: • Ensure the kit package is complete and contains all components listed in section 6 of this leaflet.
Croatian: • Pobrinite se da je pakiranje s kompletom potpuno i da sadrži sve komponente navedene u dijelu 6. ove upute o lijeku.
English: • Repeat steps 4 and 5 if you need to prepare a second solution.
Croatian: • Ponovite 4. i 5. korak ako trebate pripremiti drugu otopinu.
English: • Do not use the prepared solution if it is cloudy, contains particles or has changed colour.
Croatian: • Nemojte primjenjivati pripremljenu otopinu ako je mutna, sadrži čestice ili ako je promijenila boju.
English: Dose calculation
Croatian: Izračun doze
English: • If you need to use a second powder and solvent vial, repeat the above steps.
Croatian: • Ako trebate upotrijebiti i drugu bočicu s praškom i otapalom, ponovite prethodne korake.
English: From a microbiological point of view, the medicinal product should be used immediately.
Croatian: S mikrobiološkog stajališta lijek je potrebno primijeniti odmah.
English: • Immediately after removing the needle, press the sterile pad on the injection site for a few minutes to reduce bleeding.
Croatian: • Odmah nakon izvlačenja igle pritisnite sterilni jastučić na mjesto injekcije nekoliko minuta kako biste smanjili krvarenje.
English: No clinical information on overdose is available.
Croatian: Nisu dostupni klinički podaci o predoziranju.
English: The expiry date on the outer carton reflects the date of the component with the shortest shelf-life.
Croatian: Rok valjanosti na vanjskoj kutiji odnosi se na datum naveden na komponenti s najkraćim rokom valjanosti.
English: • The risk of formation of anti-C1INH antibodies and therefore the potential risk of formation of neutralising antibodies.
Croatian: • Rizik od stvaranja anti-C1INH antitijela, a time i potencijalni rizik od stvaranja neutralizirajućih antitijela.
English: All adapters supplied with the kit are identical.
Croatian: Svi nastavci koji se nalaze u kompletu su identični.
English: Repeat steps 3 and 4 if you need to prepare a second solution (this requires a second kit).
Croatian: Ponovite 3. i 4. korak ako trebate pripremiti drugu otopinu (za to je potreban drugi komplet za primjenu).
English: These patients have a shortage of the C1 inhibitor protein in their blood.
Croatian: Ovi bolesnici imaju nedostatak proteina inhibitora C1 u krvi.
English: Preclinical data do not indicate any safety concern for the use of conestat alfa in humans based on studies of safety pharmacology, single-dose toxicity, two-week sub-chronic toxicity and local tolerance in various animal species including rats, dogs, rabbits and cynomolgus monkeys.
Croatian: Neklinički podaci ne ukazuju na sigurnosni rizik primjene konestata alfa za ljude na temelju ispitivanja sigurnosne farmakologije, toksičnosti jedne doze, subkronične dvotjedne toksičnosti i lokalne tolerancije provedenim na različitim životinjskim vrstama, uključujući štakore, pse, kuniće i dugorepe makakije.
English: After swirling, leave the vial on the surface for several minutes until the solution has become clear.
Croatian: Nakon vrtnje ostavite bočicu na površini nekoliko minuta dok se otopina ne razbistri.
English: • Leave the packaging on the adapter until you attach the syringe in steps 4 and 5.
Croatian: • Ostavite pakiranje na nastavku dok ne pričvrstite štrcaljku u 4. i 5. koraku.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Ruconest in one or more subsets of the paediatric population in treatment of acute angioedema attacks (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja Ruconesta u jednoj ili više podskupina pedijatrijske populacije u liječenju akutnih napada angioedema (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If you plan becoming pregnant, discuss with your doctor before starting to use Ruconest.
Croatian: Ako planirate imati dijete, obratite se svom liječniku za savjet prije nego počnete primjenjivati
English: • Fold down the yellow protection cap over the needle.
Croatian: • Presavijte žuti zaštitni poklopac preko igle.
English: Before Ruconest can be administered, the powder needs to be dissolved in the solvent included in the package (see section 3).
Croatian: Prije nego se Ruconest može primijeniti, prašak se mora otopiti u otapalu iz pakiranja (vidjeti dio 3).
English: Step 13: After administration
Croatian: 13. korak: Nakon primjene
English: In case of anaphylactic reactions or shock, emergency medical treatment should be administered.
Croatian: U slučaju anafilaktičkih reakcija ili šoka, potrebno je poduzeti hitne mjere liječenja.
English: The complement component (protein) C4, is a substrate for activated C1s.
Croatian: Komponenta komplementa (protein) C4 supstrat je za aktivirani C1s.
English: Based on the known pharmacology and adverse reaction profile of Ruconest, effects on the ability to drive and use machines are not expected.
Croatian: Na temelju poznatog farmakološkog profila i profila nuspojava Ruconesta, ne očekuju se učinci na sposobnost upravljanja vozilima i rada sa strojevima.
English: 2333 CR Leiden The Netherlands
Croatian: 2333 CR Leiden Nizozemska
English: • The existence of a post marketing registry in which healthcare professionals are encouraged to enter patients.
Croatian: • Postojanje registra nakon stavljanja lijeka u promet, za koji se potiče zdravstvene radnike da upisuju bolesnike.
English: One case of hypersensitivity was observed in clinical trials with Ruconest.
Croatian: Zabilježen je jedan slučaj preosjetljivosti u kliničkim ispitivanjima s Ruconestom.
English: 84 kg and above
Croatian: 84 kg i više
English: An additional dose of 50 U/kg was administered for 13/133 (10%) attacks.
Croatian: Dodatna doza od 50 U/kg primjenjena je u 13/133 (10%) slučajeva napada.
English: Prior to launch of the product in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the National Competent Authority (NCA).
Croatian: Prije stavljanja lijeka na tržište u svakoj državi članici, nositelj odobrenja za stavljanje lijeka u promet usuglasit će sadržaj i oblik edukacijskih materijala s nacionalnim regulatornim tijelom.
English: The most common adverse reaction observed after administration of Ruconest is headache.
Croatian: Najčešća nuspojava zabilježena nakon primjene Ruconesta je glavobolja.
English: After dissolving the powder in water for injections, the solution is clear and colourless.
Croatian: Nakon otapanja praška u vodi za injekcije otopina je bistra i bezbojna.
English: Step 11: Preparing the injection site
Croatian: 11. korak: Priprema mjesta za davanje injekcije
English: If these symptoms occur after administration, they should alert their physician.
Croatian: Ako se ovi simptomi pojave nakon primjene, bolesnici bi trebali obavijestiti svog liječnika.
English: • 1 infusion set with 35 cm tubing and 25G needle
Croatian: • 1 set za infuziju s cjevčicom od 35 cm i iglom od 25G
English: Pharming Group N.V., Darwinweg 24, NL-2333 CR LEIDEN, The Netherlands
Croatian: Pharming Group N.V., Darwinweg 24, NL-2333 CR LEIDEN, Nizozemska
English: Preparation of solution Step 1: Cleaning and other requirements
Croatian: Korak: Čišćenje i drugi zahtjevi
English: Do not shake.
Croatian: Nemojte mućkati.
English: The results of the open label studies were consistent with the above findings and support the repeated use of Ruconest in the treatment of subsequent attacks of angioedema.
Croatian: Rezultati otvorenih ispitivanja bili su konzistentni s gore navedenim podacima i podržavaju ponovljenu primjenu Ruconesta u liječenju naknadnih napada angioedema.
English: 4.6 Fertility, pregnancy and lactation
Croatian: 4.6 Plodnost, trudnoća i dojenje Trudnoća i dojenje
English: Potential risks associated with home-treatment are related to the administration itself as well as the handling of adverse reactions, particularly hypersensitivity.
Croatian: Mogući rizici u vezi s liječenjem kod kuće odnose se na samu primjenu kao i na postupanje s nuspojavama, osobito s preosjetljivošću.
English: Never use any kit component after the expiry date stated on the big outer carton.
Croatian: Nikada ne upotrebljavajte niti jednu komponentu kompleta nakon isteka roka valjanosti navedenog na velikoj vanjskoj kutiji.
English: • Educational material for non-Healthcare Professionals.
Croatian: • edukacijske materijale za osobe koje nisu zdravstveni radnici
English: • Educational material for the Healthcare Professional.
Croatian: • edukacijske materijale za zdravstvenoga radnika
English: • Take the syringe with solvent that you prepared in step 4.
Croatian: • Uzmite štrcaljku s otapalom koju ste pripremili u 4. koraku.
English: In a rabbit embryotoxicity study an increase in the incidence of fetal cardiac vessel defects (1.12% in the treatment group versus 0.03% in historical controls) was observed for animals that were administered conestat alfa.
Croatian: U ispitivanju embriotoksičnosti kod kunića uočeno je povećanje učestalosti defekata fetalnih srčanih žila (1,12% u grupi koja je primala lijek nasuprot 0,03% u povijesnim kontrolnim grupama) u životinja kojima je primjenjivan konestat alfa.
English: • For some patients the physician may decide that Ruconest may be administered outside of a clinic setting by a non-Healthcare Professional such as a family member or by self-administration.
Croatian: • Za neke bolesnike liječnik može odrediti da Ruconest izvan klinike smije primijeniti osoba koja nije zdravstveni radnik, poput člana obitelji ili sam bolesnik.
English: • That patients with clinical evidence of cow's milk allergy may have antibodies cross reacting with the rabbit milk impurities in Ruconest.
Croatian: • Bolesnici s klinički dokazanom alergijom na kravlje mlijeko mogu imati antitijela koja križno reagiraju s onečišćenjima mlijeka kunića u Ruconestu.
English: The efficacy and safety of Ruconest as a treatment of acute angioedema attacks in patients with HAE has been evaluated in two double blind randomized placebo controlled and four open label clinical studies.
Croatian: Djelotvornost i sigurnost Ruconesta kao lijeka za akutne napade angioedema u bolesnika s nasljednim angioedemom procijenjena je u dva dvostruko slijepa randomizirana klinička ispitivanja kontrolirana placebom i četiri otvorena klinička ispitivanja.
English: Although cross-reactivity between cow milk and rabbit milk is considered unlikely, the possibility of such a cross-reactivity in a patient who has evidence of clinical allergy to cow milk cannot be excluded and the patient should be observed for signs and symptoms of hypersensitivity following Ruconest administration.
Croatian: Iako se križna reaktivnost između kravljeg mlijeka i mlijeka kunića ne smatra vjerojatnom, mogućnost takve križne reaktivnosti u bolesnika s dokazanom kliničkom alergijom na kravlje mlijeko nije moguće isključiti pa po primjeni Ruconesta bolesnika treba pratiti na znakove i simptome preosjetljivosti.
English: Pharmacotherapeutic group: Other haematological agents, drugs used in hereditary angioedema, ATC code: B06AC04.
Croatian: Farmakoterapijska skupina: Ostali hematološki pripravci, lijekovi za liječenje nasljednog (hereditarnog) angioedema, ATK oznaka: B06AC04.
English: • 1 vial of 2100 U powder
Croatian: • 1 bočicu s 2100 U praška
English: The table below lists all adverse reactions occurring within 7 days after treatment with Ruconest, as reported in the six treatment studies.
Croatian: U tablici u nastavku navedene su sve nuspojave koje se javljaju unutar 7 dana od liječenja Ruconestom, koje su prijavljene u šest ispitivanja primjene lijeka.
English: While keeping it vertical, slowly draw in 14 ml solvent.
Croatian: Dok ga držite okomito, polako uvucite 14 ml otapala.
English: • If blood is present, gently inject the solution into the vein, as shown in the picture.
Croatian: • Ako ima krvi, nježno ubrizgajte otopinu u venu kako je prikazano na slici.
English: • Feel, with your other hand, for an appropriate vein.
Croatian: • Drugom rukom napipajte prikladnu venu.
English: • The importance of monitoring for clinical signs and symptoms of hypersensitivity and that patients should immediately seek medical care if they develop such symptoms during or after receiving
Croatian: • Upozorenje o važnosti praćenja kliničkih znakova i simptoma preosjetljivosti te potrebi da bolesnici odmah potraže liječničku pomoć ako razviju takve simptome tijekom ili nakon primanja Ruconesta.
English: As a result they may suffer from uncontrolled activation of contact and complement systems, with formation of inflammatory mediators, which clinically becomes manifest as the occurrence of acute angioedema attacks.
Croatian: Zbog toga su podložni nekontroliranoj aktivaciji sustava kontakta i komplemenata praćenoj stvaranjem medijatora upale, što se klinički manifestira pojavom akutnih napada angioedema.
English: • Next, put the self-adhesive plaster on the injection site.
Croatian: • Nakon toga stavite samoljepljivi flaster na mjesto davanja injekcije.