FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP noted that patients already taking the two active substances in separate tablets may be more likely to adhere to their treatment if prescribed Twynsta.
Croatian: CHMP je zaključio kako je izglednije da će se bolesnici koji već uzimaju dvije djelatne tvari kao zasebne tablete pridržavati terapije ako im se propiše samo Twynsta.
English: Other information about Twynsta:
Croatian: Ostale informacije o lijeku Twynsta
English: Twynsta is used in patients whose blood pressure is not adequately controlled by amlodipine alone.
Croatian: Twynsta se primjenjuje u bolesnika čiji se krvni tlak ne može primjereno kontrolirati samo terapijom amlodipinom.
English: The Committee decided that Twynsta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi lijeka Twynsta nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: In one main study, 1,461 adults with hypertension were treated with combinations of telmisartan and amlodipine, with telmisartan or amlodipine alone, or with placebo (a dummy treatment).
Croatian: U jednom glavnom ispitivanju, 1. 61 odraslih osoba s hipertenzijom liječeno je kombinacijama telmisartana i amlodipina, monoterapijom telmisartana ili amlodipina ili placebom (liječenjem bez djelatne tvari).
English: Twynsta can also be used in place of treatment with telmisartan and amlodipine in patients who are taking both medicines as separate tablets.
Croatian: Twynsta se može također koristiti umjesto terapije telmisartanom i amlodipinom u bolesnika koji uzimaju ova lijeka kao zasebne tablete.
English: In the first study, the falls in diastolic blood pressure seen in patients taking combinations of telmisartan and amlodipine were greater than those seen in patients taking only one of the active substances or placebo.
Croatian: U prvom ispitivanju, pad u dijastoličkom krvnom tlaku u bolesnika koji su uzimali kombinaciju telmisartana i amlodipina bio je veći od onoga koji je uočen u bolesnika koji su uzimali samo jednu djelatnu tvar ili placebo.
English: Twynsta is a medicine that contains two active substances, telmisartan and amlodipine.
Croatian: Twynsta je lijek koji sadrži dvije djelatne tvari, telmisartan i amlodipin.
English: For a patient who has been taking telmisartan and amlodipine as separate tablets, the dose of Twynsta to be taken depends on the doses of telmisartan and amlodipine that he or she was taking before.
Croatian: U slučaju bolesnika koji su uzimali telmisartan i amlodipin kao zasebne tablete, doza lijeka Twynsta koja će se uzimati ovisi o dozama telmisartana i amlodipina koje je bolesnik uzimao ranije.
English: Twynsta must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Croatian: Twynsta se ne smije uzimati u kombinaciji s lijekovima koji sadrže aliskiren (također se koristi za liječenje esencijalne hipertenzije) kod bolesnika s dijabetesom tipa 2 ili umjerenim do teškim oštećenjem bubrega.
English: Why has Twynsta been approved?
Croatian: Zašto je lijek Twynsta odobren?
English: Twynsta contains two active substances, telmisartan and amlodipine.
Croatian: Twynsta sadrži dvije djelatne tvari, telmisartan i amlodipin.
English: The full EPAR for Twynsta can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Twynsta nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Više informacija o terapiji lijekom Twynsta pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: For the full list of all side effects reported with Twynsta, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Twynsta potražite u uputi o lijeku.
English: Twynsta is used to treat essential hypertension (high blood pressure) in adults (aged 18 years or over).
Croatian: Twynsta se koristi za liječenje esencijalne hipertenzije (visokog krvnog tlaka) u odraslih osoba (u dobi od 18 godina ili starijih). „Esencijalno” znači da ne postoji očiti uzrok hipertenzije.
English: What is Twynsta used for?
Croatian: Za što se Twynsta koristi?
English: What benefit has Twynsta shown during the studies?
Croatian: Koje su koristi lijeka Twynsta utvrđene u ispitivanjima?
English: How is Twynsta used?
Croatian: Kako se Twynsta koristi?
English: How has Twynsta been studied?
Croatian: Kako je Twynsta ispitivan?
English: How does Twynsta work?
Croatian: Kako djeluje Twynsta?
English: ATCvet code: QI06AH09.
Croatian: ATCvet kod: QI06AH09.
English: Date of first authorisation: 23/02/2005 Date of last renewal: 25/01/2010
Croatian: Datum prvog odobrenja: 23/02/2005 Datum posljednje obnove: 25/01/2010
English: Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju:18 mjeseci.
English: SC.
Croatian: s.c.
English: EXP (mm/yyyy)
Croatian: EXP {mm/gggg}
English: EU/2/04/052/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/052/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Croatian: EU/2/04/052/001 Liofilizat (10 bočica s po 1 dozom) + otapalo (10 bočica od 1 ml) EU/2/04/052/002 Liofilizat (50 bočica s po 1 dozom) + otapalo (50 bočica od 1 ml)
English: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50 FCV (431 and G1 strains) ............................................................................................... ≥ 2.0 ELISA U. FPV (PLI IV) .................................................................................................................... ≥ 103.5 CCID50.
Croatian: FHV (soj F2) ..................................................................................................................... ≥ 104,9 CCID50 FCV (soj 431 i G1) .......................................................................................................... ≥ 2,0 ELISA U. FPV (PLI IV) ..................................................................................................................... ≥ 103,5 CCID50.
English: In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days).
Croatian: U normalnim uvjetima primjene, povremeno se mogu javiti apatija i anoreksija, kao i hipertermija (obično u trajanju 1 ili 2 dana).
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs.
Croatian: Aktivna imunizacija mačaka starijih od 8 tjedana: - protiv virusnog rinotraheitisa mačaka za smanjenje kliničkih znakova, - protiv infekcije kalici virusom za smanjenje kliničkih znakova, - protiv panleukopenije mačaka za sprječavanje smrtnosti i kliničkih znakova.
English: 4.2 Indications for use
Croatian: 4.2 Indikacije za primjenu
English: 4.5 Special precautions for use Special precautions for use in animals
Croatian: 4.5 Posebne mjere predostrožnosti za primjenu Posebne mjere predostrožnosti za primjenu na životinjama
English: Water for injection ....................................................................................................................... q.s.
Croatian: Voda za injekcije .......................................................................................................................... q.s. 1 ml
English: Where high levels of maternal antibodies against rhinotracheitis, calicivirosis or panleucopenia components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Croatian: Kada se očekuje prisutnost visoke razine majčinih antitijela protiv komponenti rinotraheitisa, kaliciviroze ili panleukopenije (npr. kod mačića u dobi 9-12 tjedana porijeklom od mačaka cijepljenih prije graviditeta i/ili s poznatim ili suspektnim prethodnim izlaganjem patogenima), prvo cijepljenje treba odgoditi do dobi od 12 tjedana.
English: No effects other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
Croatian: Nisu primijećene nikakve druge nuspojave osim onih spomenutih u odjeljku 4.6 “Nuspojave”, te hipertermije koja može izuzetno trajati 5 dana.
English: No effect other than those already mentioned in section on “Adverse reactions” have been observed after the administration of several doses, except hyperthermia that may exceptionally last 5 days.
Croatian: Nisu primijećene nikakve druge nuspojave osim onih spomenutih u odjeljku “Nuspojave” nakon primjene nekoliko doza, osim hipertermije koja iznimno može trajati 5 dana.
English: Lyophilisate (10x1 dose) + solvent (10x1 ml) Lyophilisate (50x1 dose) + solvent (50x1 ml)
Croatian: Liofilizat (10 x 1 doza) + otapalo (10 x 1 ml) Liofilizat (50 x 1doza) + otapalo (50 x 1 ml)
English: 1 cell culture infective dose 50%.
Croatian: 1 količina virusa koja zarazi 50 posto stanica kulture u koju je dodan virus
English: Per dose of 1 ml: Lyophilisate:
Croatian: Po dozi od 1 ml: Liofilizat:
English: Manufacturer responsible for the batch release: MERIAL
Croatian: Nositelj odobrenja za proizvodnju odgovornog za puštanje serije u promet: MERIAL
English: Revaccination: - the first revaccination must be carried out one year after the primary vaccination course, - subsequent revaccinations must be carried out at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Croatian: Docjepljivanje: - prva revakcinacija mora se provesti jednu godinu nakon prvog cijepljenja, - Naknadne revakcinacije moraju biti provedene u intervalima od najviše tri godine za komponentne rinotraheitisa i kalici virusa i panleukopenije.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administrated with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Croatian: Dostupni su podaci o sigurnosti i učinkovitosti koji pokazuju da se ova vakcina može miješati i primijeniti s Merialovom vakcinom protiv mačje leukemije i/ili primijeniti isti dan, ali se ne smije miješati s Merialovom vakcinom protiv bjesnoće.
English: Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination schedule:
Croatian: Nakon rekonstitucije liofilizata otapalom injicirajte supkutano jednu dozu (1 ml) cjepiva, prema slijedećem rasporedu cijepljenja:
English: The use is not recommended during lactation
Croatian: Ne preporuča se primjena tijekom laktacije
English: The duration of immunity after the last re-vaccination is 3 years for rhinotracheitis, calicivirosis and panleucopenia components.
Croatian: Trajnost imuniteta nakon zadnje re-vakcinacije je 3 godine protiv komponenti rinotraheitisa, kalici virusa i panleukopenije.
English: Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent.
Croatian: Pakovanje sadrži 50 bočica s 1 dozom liofilizata i 50 bočica s 1 ml otapala.
English: Pack containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent.
Croatian: Pakovanje sadrži 10 bočica s 1 dozom liofilizata i 10 bočica s 1 ml otapala.
English: Casein hydrolysate Collagen hydrolysate Dipotassium phosphate Potassium dihydrogen phosphate Potassium hydroxide Sodium chloride
Croatian: Kalij dihidrogenfosfat Kalij hidroksid Natrij klorid
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Croatian: 14. RIJEČI “ČUVATI IZVAN PODGLADA I DOSEGA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Pack of 10 bottles of lyophilisate and 10 bottles of solvent Pack of 50 bottles of lyophilisate and 50 bottles of solvent
Croatian: Pakovanje od 10 bočica liofilizata i 10 bočica otapala Pakovanje od 50 bočica liofilizata i 50 bočica otapala
English: Lyophilisate:
Croatian: Liofilizat :
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo smije biti pomiješano s cjepivom protiv mačje leukemije tvrtke Merial i/ili primijenjeno istog dana ali ne i pomiješano s cjepivom protiv bjesnoće tvrtke Merial.
English: Laboratoire Porte des Alpes Rue de l'aviation
Croatian: Rue de l'Aviation
English: Special precautions for storage
Croatian: 11. POSEBNE MJERE PREDOSTROŽNOSTI ZA ČUVANJE
English: EXP (mm/yyyy) Once reconstituted use immediately.
Croatian: EXP {mm/gggg} Nakon rekonstitucije odmah primijeniti.
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for the rhinotracheitis, calicivirus and panleucopenia components.
Croatian: Pokazalo se da imunitet nastupa 1 tjedan nakon prvog cijepljenja protiv komponenti rinotraheitisa, kalicivirusa i panleukopenije.
English: Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous
Croatian: Dinatrij hidrogenortofosfat Monokalij fosfatanhidrid
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Croatian: NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE VMP U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE
English: Stimulates active immunity against feline rhinotracheitis virus, feline calicivirus, and feline panleucopenia virus.
Croatian: Potiče aktivni imunitet protiv virusnog rinotraheitisa mačaka, kaliciviroze mačaka i virusa panleukopenije mačaka.
English: Purevax RCP lyophilisate and solvent for suspension for injection
Croatian: Purevax RCP, liofilizat i otapalo za suspenziju za injekcije
English: Purevax RCP lyophilisate and solvent for suspension for injection.
Croatian: Purevax RCP liofilizat i otapalo za suspenziju za injekcije.
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... ≥ 2.0 ELISA U. Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Croatian: Inaktivirani antigeni kalicivirus mačaka (soj FCV 431 i FCV G1) ................................
English: For the full list of excipients, see section 6.1.
Croatian: 1 količina virusa koja zarazi 50 posto stanica kulture u koju je dodan virus Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: Vaccine against feline viral rhinotracheitis, feline calicivirosis and feline panleucopenia.
Croatian: Cjepivo protiv virusnog rinotraheitisa mačaka, kaliciviroze mačaka i panleukopenije mačaka.
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ................................... ≥ 2.0 ELISA U. Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Croatian: Atenuirani virus panleukopenije mačaka (PLI IV) ......................................................... ≥ 103,5 CCID501
English: The full EPAR for Nyxoid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Nyxoid nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Nyxoid is a ‘hybrid medicine'.
Croatian: Nyxoid je „hibridni lijek”.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but is given in a different way.
Croatian: To znači da je sličan „referentnom lijeku” koji sadržava istu djelatnu tvar, ali se primjenjuje na drugačiji način.
English: Nyxoid can be used in adults and adolescents from 14 years of age.
Croatian: Lijek Nyxoid može se primjenjivati u odraslih i adolescenata starijih od 14 godina.
English: This is a summary of the European public assessment report (EPAR) for Nyxoid.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Nyxoid.
English: What measures are being taken to ensure the safe and effective use of Nyxoid?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Nyxoid?
English: Why is Nyxoid approved?
Croatian: Zašto je Nyxoid odobren?
English: The most common side effect with Nyxoid (which may affect more than 1 in 10 people) is nausea (feeling sick).
Croatian: Najčešća nuspojava lijeka Nyxoid (može se javiti u više od 1 na 10 osoba) jest mučnina (osjećaj slabosti).
English: If the first dose works well but the patient later worsens a second dose should be given immediately in the other nostril.
Croatian: Ako prva doza ima djelotvoran učinak ali se stanje bolesnika kasnije pogorša, potrebno je odmah dati drugu dozu u drugu nosnicu.
English: Other information about Nyxoid
Croatian: Ostale informacije o lijeku Nyxoid
English: What is Nyxoid and what is it used for?
Croatian: Što je Nyxoid i za što se koristi?
English: The company that markets Nyxoid will issue educational materials, including a video, for healthcare professionals and for patients with detailed information on how to use the medicine.
Croatian: Tvrtka koja stavlja lijek Nyxoid u promet objavit će edukativne materijale, uključujući i video snimku, za zdravstvene radnike i bolesnike s detaljnim informacijama o načinu primjene lijeka.
English: The recommended dose is one spray into one nostril given immediately on suspecting an opioid overdose and while awaiting emergency services; if the first dose does not have an effect, a second dose should be given after 2-3 minutes in the other nostril.
Croatian: Preporučena doza je jedan potisak spreja u jednu nosnicu koji se daje odmah u slučaju sumnje na predoziranje opioidom, tijekom čekanja dolaska hitne službe; ako prva doza nije učinkovita, nakon dvije do tri minute treba dati drugu dozu u drugu nosnicu.
English: In addition, a study involving 38 healthy volunteers showed that, when given by a healthcare professional, Nyxoid 2 mg given as a spray into the nose produced a similar level of naloxone in the body as naloxone given in the usual dose of 0.4 mg by injection into a muscle.
Croatian: Osim toga, ispitivanje koje je uključivalo 38 zdravih dobrovoljaca pokazalo je da je doza od 2 mg lijeka Nyxoid u obliku spreja za nos koju je primijenio zdravstveni radnik dovela do slične razine naloksona u tijelu kao kod intramuskularne primjene uobičajene doze naloksona od 0,4 mg.
English: Therefore, the European Medicines Agency decided that Nyxoid's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je Europska agencija za lijekove zaključila da koristi od lijeka Nyxoid nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
English: Nyxoid is a nasal spray available in single-dose containers (1.8 mg).
Croatian: Lijek Nyxoid je sprej za nos, dostupan u jednodoznom spremniku (1,8 mg).
English: Naloxone, the active substance in Nyxoid, has been widely used in emergency medicine since the 1970s to treat opioid overdose.
Croatian: Nalokson, djelatna tvar lijeka Nyxoid, u širokoj je uporabi u hitnoj medicini od 1970-tih za liječenje predoziranja opioidima.
English: The company provided data from the published literature showing that naloxone is effective in treating opioid overdose when given by injection (the standard treatment for opioid overdose) as well as into the nose.
Croatian: Tvrtka je dostavila podatke iz objavljene literature koji pokazuju da je nalokson učinkovit u liječenju predoziranja opioidima kada se primjenjuje injekcijom (standardno liječenje predoziranja opioidima), kao i u slučaju primjene u nos.
English: Naloxone rapidly blocks these receptors, ending the opioid's effects such as slow breathing.
Croatian: Nalokson brzo blokira te receptore i poništava opioidne učinke poput usporenog disanja.
English: The company will also conduct a study on the effectiveness of Nyxoid when given by people with no medical training.
Croatian: Tvrtka će također provesti ispitivanje djelotvornosti lijeka Nyxoid kada ga primjenjuju osobe koje nemaju medicinsko obrazovanje.
English: Signs of overdose include pinpoint pupils, abnormally slow and irregular breathing, severe sleepiness and unresponsiveness to touch or loud noises.
Croatian: Znakovi predoziranja uključuju sužene zjenice, abnormalno sporo i nepravilno disanje, tešku pospanost i nereagiranje na dodir ili glasan zvuk.
English: Opioids work by attaching to and activating opioid receptors (targets) in the body.
Croatian: Opioidi djeluju vezivanjem na opioidne receptore (ciljeve) u tijelu i njihovim aktiviranjem.
English: It is not intended to provide practical advice on how to use Nyxoid.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Nyxoid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nyxoid have also 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 Nyxoid nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: What are the risks associated with Nyxoid?
Croatian: Koji su rizici povezani s lijekom Nyxoid?
English: Nyxoid is a medicine used for emergency treatment in case of known or suspected overdose of opioid drugs (such as heroin or morphine).
Croatian: Nyxoid je lijek koji se primjenjuje za hitno liječenje u slučaju poznatog predoziranja opioidima (kao što su heroin ili morfij) ili sumnje na predoziranje.
English: Compared with emergency treatments for opioid overdose given by injection, Nyxoid can be given by people with no medical training because it is sprayed into the nose.
Croatian: U usporedbi s hitnim liječenjem predoziranja opioidima koje se primjenjuje injekcijom, lijek Nyxoid mogu davati osobe koje nemaju medicinsko obrazovanje jer je u obliku spreja za nos.
English: There is also no risk of needle injury with Nyxoid, and this could encourage members of the public to provide treatment promptly.
Croatian: Kod lijeka Nyxoid također ne postoji rizik od ozljeda ubodom igle, što bi pripadnike javnosti moglo potaknuti na primjenu lijeka bez odlaganja.
English: The safety and effectiveness of naloxone as an antidote for opioid overdose are well known.
Croatian: Dobro je poznata sigurnost i djelotvornost naloksona kao antidota za predoziranje opioidima.
English: For practical information about using Nyxoid, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Nyxoid bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: How does Nyxoid work?
Croatian: Kako djeluje Nyxoid?
English: For the full list of all side effects and restrictions with Nyxoid, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni lijeka Nyxoid potražite u uputi o lijeku.
English: Nyxoid naloxone
Croatian: Nyxoid nalokson