FrancophonIA/ELRC3.0 huggingface dataset:
English: Lixiana 30 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172).
Croatian: Lixiana 30 mg: hipromeloza (E464), makrogol 8000, titanijev dioksid (E171), talk, karnauba vosak, željezov oksid crveni (E172).
English: Haemodialysis
Croatian: Trombocitopenija
English: EU/1/15/993/017 14 film-coated tablets
Croatian: EU/1/15/993/017 14 filmom obloženih tableta
English: Lixiana 60 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide yellow (E172).
Croatian: Lixiana 60 mg: hipromeloza (E464), makrogol 8000, titanijev dioksid (E171), talk, karnauba vosak, željezov oksid žuti (E172).
English: EU/1/15/993/007 56 film-coated tablets
Croatian: EU/1/15/993/007 56 filmom obloženih tableta
English: Lixiana 30 mg: Each tablet contains 30 mg edoxaban (as tosilate).
Croatian: Lixiana 30 mg: Jedna tableta sadrži 30 mg edoksabantosilata.
English: EU/1/15/993/019 30 film-coated tablets
Croatian: EU/1/15/993/019 30 filmom obloženih tableta
English: Lixiana 60 mg: Each tablet contains 60 mg edoxaban (as tosilate).
Croatian: Lixiana 60 mg: Jedna tableta sadrži 60 mg edoksabantosilata.
English: Table 8: Number of Fatal Bleeding Events by creatinine clearance category in ENGAGE AFTIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Croatian: Tablica 8: Broj krvarenja sa smrtnim ishodom prema kategoriji klirensa kreatinina u ispitivanju ENGAGE AF-TIMI 48, analiza sigurnosti tijekom liječenjaa Podskupina prema CrCL (ml/min)
English: Tell your doctor immediately if you have taken too many Lixiana tablets.
Croatian: Ako ste uzeli previše tableta Lixiane, odmah obavijestite liječnika.
English: Discontinue Lixiana and start the non-VKA anticoagulant at the time of the next scheduled dose of Lixiana.
Croatian: Prekinite primjenu Lixiane i započnite s primjenom antikoagulansa koji nije AVK kad bi prema rasporedu bilo vrijeme za sljedeću dozu Lixiane.
English: Table 7: Number of Major Bleeding Events by creatinine clearance category in ENGAGE AFTIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Croatian: Tablica 7: Broj velikih krvarenja prema kategoriji klirensa kreatinina u ispitivanju ENGAGE AF-TIMI 48, analiza sigurnosti tijekom liječenjaa Podskupina prema CrCL (ml/min)
English: • other medicines to reduce blood clotting (e.g. heparin, clopidogrel or vitamin K antagonists such as warfarin, acenocoumarol, phenprocoumon or dabigatran, rivaroxaban, apixaban)
Croatian: K kao što su varfarin, acenokumarol, fenprokumon ili dabigatran, rivaroksaban,
English: Macroscopic haematuria/urethral haemorrhage
Croatian: Poremećaji bubrega i mokraćnog sustava Makroskopska hematurija/uretralno krvarenje
English: EU/1/15/993/004 14 film-coated tablets
Croatian: EU/1/15/993/004 14 filmom obloženih tableta
English: EU/1/15/993/006 30 film-coated tablets
Croatian: EU/1/15/993/006 30 filmom obloženih tableta
English: EU/1/15/993/022 84 film-coated tablets
Croatian: EU/1/15/993/022 84 filmom obložene tablete
English: EU/1/15/993/005 28 film-coated tablets
Croatian: EU/1/15/993/005 28 filmom obloženih tableta
English: Lixiana 15 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Croatian: Lixiana 15 mg: Jezgra tablete: manitol (E421), prethodno geliran škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b).
English: Lixiana 60 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Croatian: Lixiana 60 mg: Jezgra tablete: manitol (E421), prethodno geliran škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b).
English: Package leaflet: Information for the user Lixiana 15 mg film-coated tablets
Croatian: Uputa o lijeku: Informacija za korisnika Lixiana 15 mg filmom obložene tablete Lixiana 30 mg filmom obložene tablete Lixiana 60 mg filmom obložene tablete edoksaban
English: EU/1/15/993/018 28 film-coated tablets
Croatian: EU/1/15/993/018 28 filmom obloženih tableta
English: EU/1/15/993/021 60 film-coated tablets
Croatian: EU/1/15/993/021 60 filmom obloženih tableta
English: Investigations Liver function test abnormal
Croatian: Pretrage Poremećeni nalazi pretraga jetrenih funkcija
English: Lixiana 60 mg film-coated tablets
Croatian: Lixiana 60 mg filmom obložene tablete edoksaban
English: Lixiana 30 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Croatian: Lixiana 30 mg: Jezgra tablete: manitol (E421), prethodno geliran škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b).
English: EU/1/15/993/009 84 film-coated tablets
Croatian: EU/1/15/993/009 84 filmom obložene tablete
English: EU/1/15/993/023 90 film-coated tablets
Croatian: EU/1/15/993/023 90 filmom obloženih tableta
English: EU/1/15/993/008 60 film-coated tablets
Croatian: EU/1/15/993/008 60 filmom obloženih tableta
English: Subcutaneous anticoagulant (i.e.: LMWH, fondaparinux): Discontinue subcutaneous anticoagulant and start Lixiana at the time of the next scheduled subcutaneous anticoagulant dose.
Croatian: Zamjena parenteralnih antikoagulansa (npr. heparina) lijekom Lixiana Prestanite uzimati antikoagulans (npr. heparin) i počnite uzimati Lixianu u vrijeme kad ste prema rasporedu trebali uzeti sljedeću dozu antikoagulansa.
English: EU/1/15/993/002 10 film-coated tablets
Croatian: EU/1/15/993/002 10 filmom obloženih tableta
English: Lixiana 30 mg film-coated tablets
Croatian: Lixiana 30 mg filmom obložene tablete edoksaban
English: NAME OF THE MEDICINAL PRODUCT Lixiana 15 mg film-coated tablets edoxaban
Croatian: Lixiana 15 mg filmom obložene tablete edoksaban
English: EU/1/15/993/024 98 film-coated tablets
Croatian: EU/1/15/993/024 98 filmom obloženih tableta
English: What Lixiana looks like and contents of the pack Lixiana 15 mg film-coated tablets are orange, round-shaped (6.7 mm diameter) and debossed with “DSC L15” on one side.
Croatian: Lixiana 15 mg filmom obložene tablete su narančaste i okrugle (6,7 mm u promjeru) s utisnutom oznakom „DSC L15“ na jednoj strani.
English: Ciclosporin, dronedarone, erythromycin, ketoconazole
Croatian: Niska tjelesna težina ≤ 60 kg Inhibitori P-gp-a ciklosporin, dronedaron, eritromicin, ketokonazol
English: Or scan the QR code with your smartphone:
Croatian: www.dspatient.eu ili skenirajte pametnim telefonom ovaj QR kod za brzo povezivanje: umetnuti QR kod
English: ≥ 30 to ≤ 50 1,302 9 > 50 to ≤ 70 2,093 8 > 70 to ≤ 90 1,661 10 > 90 to ≤ 110 927 2 > 110 to ≤ 130 497 1
Croatian: ≥ 30 do ≤ 50 1302 9 > 50 do ≤ 70 2093 8 > 70 do ≤ 90 1661 10 > 90 do ≤ 110 927 2 > 110 do ≤ 130 497 1
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 60 mg edoxaban (as tosilate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 60 mg edoksabana (u obliku tosilata).
English: Do not take Lixiana if you are pregnant or breast-feeding.
Croatian: Ako ste trudni ili dojite, nemojte uzimati Lixianu.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg edoxaban (as tosilate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 30 mg edoksabana (u obliku tosilata).
English: Lixiana film-coated tablets edoxaban
Croatian: Lixiana filmom obložene tablete edoksaban
English: EU/1/15/993/003 10 film-coated tablets
Croatian: EU/1/15/993/003 10 filmom obloženih tableta
English: • Guidance on switching from or to Lixiana treatment
Croatian: • smjernice za zamjenu drugog lijeka Lixianom i obrnuto
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg edoxaban (as tosilate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 15 mg edoksabana (u obliku tosilata).
English: Changing from Lixiana to parenteral anticoagulants (e.g. heparin)
Croatian: Supkutani antikoagulans (tj. niskomolekularni heparin (LMWH), fondaparinuks):
English: Changing from vitamin K antagonists (e.g. warfarin) to Lixiana
Croatian: Zamjena lijeka Lixiana antagonistima vitamina K (npr. varfarinom) Ako trenutno uzimate Lixianu u dozi od 60 mg:
English: Lixiana 60 mg once daily is recommended during concomitant use with the following P-gp inhibitors:
Croatian: Tijekom istovremene primjene sa sljedećim inhibitorima P-gp-a, preporučuje se primijeniti Lixianu u dozi od 60 mg jedanput na dan:
English: Stop taking Lixiana and start the parenteral anticoagulant (e.g. heparin) at the time of the next scheduled dose of Lixiana.
Croatian: Zamjena lijeka Lixiana parenteralnim antikoagulansima (npr. heparinom) Prestanite uzimati Lixianu i počnite uzimati parenteralni antikoagulans (npr. heparin) u vrijeme kad ste prema rasporedu trebali uzeti sljedeću dozu Lixiane.
English: EU/1/15/993/011 98 film-coated tablets
Croatian: EU/1/15/993/012 98 filmom obloženih tableta
English: Magyarország MSD Pharma Hungary Kft. Tel.: +36 1 888-5300
Croatian: Tel.: +36 1 888-5300
English: EU/1/15/993/010 90 film-coated tablets
Croatian: EU/1/15/993/011 90 filmom obloženih tableta
English: Lixiana 30 mg once daily must be administered during concomitant use with the following P-gp inhibitors:
Croatian: Tijekom istovremene primjene sa sljedećim inhibitorima P-gp-a, Lixiana se mora primijeniti u dozi od 30 mg jedanput na dan:
English: Table 5: Number of Ischaemic Strokes/SEE by creatinine clearance category in ENGAGE AFTIMI 48, mITT Analysis Set Overall Study CrCL subgroup (mL/min)
Croatian: Tablica 5: Broj ishemijskih moždanih udara/SED-a prema kategoriji klirensa kreatinina u ispitivanju ENGAGE AF-TIMI 48, analiziran u mITT u cjelokupnom ispitivanju
English: Edoxaban
Croatian: Dojenje
English: Additional data from an extension of this study in children aged 13 to 18 years confirmed the initial results.
Croatian: Dodatni podatci iz nastavka ovog ispitivanja provedenog na djeci u dobi od 13 do 18 godina potvrdili su početne rezultate.
English: Strensiq has been authorised under ‘exceptional circumstances'.
Croatian: Strensiq je odobren u „iznimnim okolnostima”.
English: Strensiq (asfotase alfa)
Croatian: Strensiq (asfotaza alfa)
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu308594.
Croatian: Više informacija o statusu lijeka za rijetku bolest možete naći ovdje: ema.europa.eu/medicines/human/orphan-designations/eu308594.
English: The study also looked at other measures of effectiveness such as growth in height.
Croatian: U ispitivanju su također istražene druge mjere djelotvornosti poput rasta.
English: What is Strensiq and what is it used for?
Croatian: Što je Strensiq i za što se primjenjuje?
English: The effectiveness of Strensiq was also generally supported by several additional small studies.
Croatian: Djelotvornost lijeka Strensiq bila je također načelno podržana s nekoliko dodatnih manjih ispitivanja.
English: Given that hypophosphatasia is an extremely rare disease, data in this population will likely remain limited.
Croatian: Uzimajući u obzir to da je hipofosfatazija iznimno rijetka bolest, izgledno je da će podatci u ovoj populaciji ostati ograničeni.
English: The medicine is available as a solution for injection.
Croatian: Dostupan je kao otopina za injekciju.
English: In the historical controls, most children did not experience similar improvements in their joints or gain in height over a comparable period of time.
Croatian: U povijesnim kontrolnim podatcima većina djece nije iskusila slična poboljšanja u zglobovima niti narasla tijekom usporedivog razdoblja.
English: The Agency noted that hypophosphatasia is a serious and life-threatening disease for which no treatment is authorised.
Croatian: Agencija je zaključila da je hipofosfatazija ozbiljna i po život opasna bolest za koju nema odobrene terapije.
English: Although the main study was small and did not directly compare Strensiq with another treatment or with untreated patients, the Agency considered that the improvement seen in the bones and the apparent growth was relevant.
Croatian: Iako je glavno ispitivanje bilo malo i u njemu nije izravno uspoređeno djelovanje lijeka Strensiq s nekom drugom terapijom ili s neliječenim bolesnicima, Agencija je zaključila da su uočeno poboljšanje u kostima i očit rast relevantni.
English: Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.
Croatian: Svake godine Europska agencija za lijekove procjenjuje sve nove informacije koje postanu dostupne te se ovaj sažetak po potrebi ažurira.
English: What measures are being taken to ensure the safe and effective use of Strensiq?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Strensiq?
English: The most common side effects with Strensiq (which may affect more than 1 in 10 people) are headache, erythema (reddening of the skin), pain in arms and legs, fever, irritability, injection site reactions (such as pain, rash and itching) and contusion (bruising).
Croatian: Najčešće nuspojave lijeka Strensiq (koje se mogu javiti u više od 1 na 10 osoba) jesu glavobolja, eritem (crvenilo kože), bol u rukama i nogama, vrućica, razdražljivost, reakcije na mjestu injekcije (poput boli, osipa i svrbeži) i kontuzije (masnice).
English: The main measure of effectiveness of the medicine was the improvement in x-ray appearance of the wrists and knee joints before and after treatment with Strensiq.
Croatian: Glavno mjerilo djelotvornosti lijeka bilo je poboljšanje u rendgenskom pojavljivanju zglobova ruke i koljena bolesnika prije i nakon terapije lijekom Strensiq.
English: As the amount given depends on the patient's bodyweight, the doctor will need to adjust the dose as the patient's weight changes, particularly in growing children.
Croatian: Budući da količina koja se primjenjuje ovisi o tjelesnoj težini bolesnika, liječnik treba prilagoditi dozu ovisno o promjenama u tjelesnoj težini bolesnika, posebice u djece u razvoju.
English: The enzyme ‘tissue non-specific alkaline phosphatase' (ALP) plays a key role in creating and maintaining healthy bones, and managing calcium and phosphate in the body.
Croatian: Enzim „nespecifična alkalna fosfataza” (ALP) ima ključnu ulogu i stvaranju i održavanju zdravih kostiju te u održavanju kalcija i fosfata u organizmu.
English: Patients with hypophosphatasia cannot make enough working ALP, which leads to weak bones.
Croatian: Bolesnici sa hipofosfatazijom ne mogu stvoriti dovoljno funkcionirajućeg ALP-a, što rezultira slabim kostima.
English: X-rays of children given Strensiq were also compared with similar x-rays available from 16 children who had not received Strensiq (‘historical controls').
Croatian: Rendgenske snimke djece koja su primala Strensiq također su uspoređene sa sličnim rendgenskim snimkama snimljenima u 16-ero djece koja nisu primila lijek Strensiq („povijesni kontrolni podatci”).
English: It is given by injection under the skin either six times a week (in a dose of 1 mg per kilogram bodyweight) or three times a week (in a dose of 2 mg/kg).
Croatian: Primjenjuje se supkutano injekcijom šest puta na tjedan (u dozi od 1 mg po kilogramu tjelesne težine) ili tri puta na tjedan (u dozi od 2 mg/kg).
English: This is because it has not been possible to obtain complete information about Strensiq due to the rarity of the disease.
Croatian: Razlog tome je nemogućnost dobivanja potpunih informacija o lijeku Strensiq zbog male učestalosti bolesti.
English: Strensiq received a marketing authorisation valid throughout the EU on 28 August 2015.
Croatian: Lijek Strensiq dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 28. kolovoza 2015.
English: Side effects reported with Strensiq are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Strensiq pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: This material will include a self-injection guide for patients, as well as an injection guide for parents or caregivers of children with the condition.
Croatian: Taj će materijal uključiti vodič za samoubrizgavanje za bolesnike kao i vodič za davanje injekcija za roditelje ili pružatelje skrbi djece s ovom bolešću.
English: Strensiq has been studied in one main study in 13 children between 6 and 12 years of age.
Croatian: Lijek Strensiq ispitivan je u jednom glavnom ispitivanju koje je obuhvatilo 13-ero djece u dobi od 6 do 12 godina.
English: Patients were given either 2 mg/kg or 3 mg/kg Strensiq three times a week for 24 weeks.
Croatian: Bolesnici su primili 2 mg/kg ili 3 mg/kg lijeka Strensiq tri puta na tjedan tijekom 24 tjedana.
English: An overview of Strensiq and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Strensiq i zašto je odobren u EU-u
English: Asfotase alfa, the active substance in Strensiq, is a version of the human ALP enzyme and serves as a replacement, thereby increasing levels of working ALP.
Croatian: Asfotaza alfa, djelatna tvar lijeka Strensiq, modificirana je verzija ljudskog enzima ALP-a i služi kao zamjena za neispravan enzim, time povećavajući razine funkcionirajućeg ALP-a.
English: Since Strensiq has been authorised under exceptional circumstances, the company that markets Strensiq will set up a registry of patients with hypophosphatasia to collect information on the disease and on the long-term safety and effectiveness of Strensiq.
Croatian: Budući da je lijek Strensiq odobren u iznimnim okolnostima, tvrtka koja stavlja lijek Strensiq u promet uspostavit će registar bolesnika s hipofosfatazijom kako bi prikupila informacije o bolesti te o dugoročnoj sigurnosti i djelotvornosti lijeka.
English: Regarding safety, injection site reactions and other side effects were considered manageable with the recommendations in place.
Croatian: U pogledu sigurnosti zaključeno je da se reakcije na mjestu injekcije i druge nuspojave mogu kontrolirati s obzirom na izdane preporuke.
English: Hypophosphatasia is a rare inherited disease of the bones which can lead to early loss of teeth, malformed bones, frequent bone fractures, and difficulty breathing.
Croatian: Hipofosfatazija je rijetka nasljedna bolest kostiju koja može rezultirati ranim gubitkom zubi, deformiranim kostima, čestim frakturama kostiju i otežanim disanjem.
English: What are the risks associated with Strensiq?
Croatian: Koji su rizici povezani s lijekom Strensiq?
English: Hypophosphatasia is rare, and Strensiq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 3 December 2008.
Croatian: Hipofosfatazija je rijetka bolest, a lijek Strensiq je dobio status „lijeka za rijetku bolesti” 3. prosinca 2008.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Strensiq 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 Strensiq također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: The company that markets Strensiq will provide patients and carers with educational materials to ensure that the medicine is used correctly and to minimise the risk of medication errors.
Croatian: Tvrtka koja stavlja lijek Strensiq u promet dostavit će bolesnicima i pružateljima skrbi materijale za obuku kako bi se osiguralo ispravno korištenje lijeka i smanjio rizik od medikacijske pogreške.
English: As for all medicines, data on the use of Strensiq is continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Strensiq kontinuirano se prate.
English: Strensiq is a medicine used long-term to treat patients with hypophosphatasia that started in childhood.
Croatian: Strensiq je lijek koji se dugoročno primjenjuje za liječenje bolesnika s hipofosfatazijom koja se javlja u djetinjstvu.
English: Some of the studies also looked at the dose of 1 mg/kg Strensiq given six times a week.
Croatian: Pojedina su ispitivanja također istražila dozu od 1 mg/kg lijeka Strensiq koji se davao šest puta na tjedan.
English: Further information on Strensiq can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Strensiq
Croatian: Više informacija o lijeku Strensiq nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Strensiq Ovaj pregled informacija posljednji je put ažuriran u 10.
English: Strensiq can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing metabolic or bone disorders.
Croatian: Lijek Strensiq izdaje se samo na liječnički recept, a liječenje treba započeti liječnik s iskustvom u upravljanju metaboličkim ili koštanim poremećajima.
English: The European Medicines Agency decided that Strensiq's benefits are greater than its risks and it be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Strensiq nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: For more information about using Strensiq, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Strensiq pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Why is Strensiq authorised in the EU?
Croatian: Zašto je lijek Strensiq odobren u EU-u?
English: Other information about Strensiq
Croatian: Ostale informacije o lijeku Strensiq
English: What information is still awaited for Strensiq?
Croatian: Koje se još informacije očekuju o lijeku Strensiq?
English: This study showed that children given Strensiq had an improvement in their joint structure as demonstrated by x-rays and most of them seemed to gain in height.
Croatian: U ovom ispitivanju utvrđeno je da se u djece koja su primala lijek Strensiq poboljšala struktura zglobova, što je potvrđeno rendgenskim snimkama, a većina njih je i narasla.
English: What benefits of Strensiq have been shown in studies?
Croatian: Koje su koristi od lijeka Strensiq utvrđene u ispitivanjima?
English: Strensiq contains the active substance asfotase alfa.
Croatian: Strensiq sadrži djelatnu tvar asfotaza alfa.
English: How does Strensiq work?
Croatian: Kako djeluje Strensiq?
English: How is Strensiq used?
Croatian: Kako se Strensiq primjenjuje?
English: For the full list of side effects and restrictions with Strensiq, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Strensiq potražite u uputi o lijeku.
English: These signs disappear without further treatment.
Croatian: Ovi se znakovi povlače bez daljnjeg liječenja.
English: This summary was last updated in March 2016.
Croatian: Sažetak je posljednji put ažuriran u 3-2016.
English: Profender emodepside / praziquantel
Croatian: Profender emodepsid/prazikvantel
English: For lungworms two treatments are needed two weeks apart.
Croatian: Za plućne gliste potrebne su dvije terapije u razmaku od dva tjedna.
English: The full EPAR for Profender can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Profender nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The person giving the dose should not smoke, eat or drink, and should wash their hands thoroughly after use.
Croatian: Osoba koja daje dozu ne smije pušiti, jesti ili piti te treba temeljito oprati ruke nakon uporabe VMP-a.
English: Profender should not be allowed to enter surface water, as it may be harmful for aquatic organisms.
Croatian: Ne smije se dozvoliti da Profender dođe u površinske vode jer može štetno djelovati na vodene organizme.
English: No side effects have been reported in dogs.
Croatian: U pasa nisu zabilježene nuspojave.
English: The European Commission granted a marketing authorisation valid throughout the EU for Profender on 27 July 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Profender na snazi u Europskoj uniji od 27. srpnja 2005.