FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon suicidal ideation or suicide attempt (particularly in patients with a pre-existing history of depression or psychiatric illness)
Croatian: neuobičajeni snovi, depresija, anksioznost1, noćne more, poremećaj spavanja manje često suicidalne ideje ili pokušaj suicida (osobito u bolesnika s depresijom ili psihijatrijskom bolesti u anamnezi)
English: Since the dose of dolutegravir is 50 mg twice daily when coadministered with nevirapine, the coadministration of nevirapine with Triumeq is not recommended.
Croatian: Budući da doza dolutegravira pri istodobnoj primjeni s nevirapinom iznosi 50 mg dvaput na dan, ne preporučuje se istodobna primjena nevirapina i lijeka Triumeq.
English: hypertriglyceridaemia, hyperglycaemia
Croatian: manje često hipertrigliceridemija, hiperglikemija vrlo rijetko laktacidoza1
English: → Talk to your doctor for further advice on taking antacid medicines with Triumeq.
Croatian: Obratite se svom liječniku za dodatne savjete o uzimanju lijekova koji smanjuju količinu kiseline u želucu zajedno s lijekom Triumeq.
English: Since the dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin, the co-administration of rifampicin with Triumeq is not recommended.
Croatian: Budući da doza dolutegravira pri istodobnoj primjeni s rifampicinom iznosi 50 mg dvaput na dan, ne preporučuje se istodobna primjena rifampicina i lijeka Triumeq.
English: Treatment with Triumeq must be stopped without delay if HSR cannot be ruled out on clinical grounds, and therapy with Triumeq or other abacavir or dolutegravir containing products must never be re-initiated.
Croatian: Ako se klinički ne može isključiti reakcija preosjetljivosti, primjena lijeka Triumeq mora se bez odlaganja obustaviti te se više nikada ne smije ponovno započeti liječenje lijekom Triumeq ili drugim lijekovima koji sadrže abakavir ili dolutegravir.
English: AUC ↔ Cmax ↓35% Methadone: CL/F ↑22%
Croatian: metadon: CL/F ↑22%
English: Diagnosis of Abacavir Hypersensitivity Reaction Major symptoms associated with ABC HSR are fever (~80%), rash (~70%), gastrointestinal symptoms (>50%) such as nausea, abdominal pain, vomiting, and diarrhoea, generalise malaise, fatigue, and headache (~50%) and other symptoms (~30%) such as respiratory, mucosal, and musculoskeletal symptoms.
Croatian: opće malaksalosti, umor i glavobolja (~50%) te drugi simptomi (~30%), poput respiratornih simptoma, simptoma na sluznicama i mišićno-koštanih simptoma.
English: Film-coated tablet (tablet)
Croatian: Jedna filmom obložena tableta sadrži:
English: Dolutegravir ↓ AUC ↓ 57% Cmax ↓ 39% Cτ ↓ 75%
Croatian: efavirenz/dolutegravir dolutegravir ↓ AUC ↓ 57% Cmax ↓ 39% Cτ ↓ 75%
English: Table 7: Outcomes of randomized treatment of STRIIVING (snapshot algorithm) Study Outcomes (Plasma HIV-1 RNA <50 c/mL) at Week 24 and Week 48 - Snapshot Analysis (ITT-E Population)
Croatian: Ishodi ispitivanja (plazmatski HIV-1 RNK < 50 kopija/ml) u 24. tjednu i 48. tjednu - analiza podataka prikupljenih pri samo jednom posjetu (engl. snapshot analysis) (ITT-E populacija) Fiksna kombinacija ABC/DTG/3TC N=275 n (%)
English: Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with these metabolic inducers, DTG/ABC/3TC FDC is not recommended for patients taking these metabolic inducers.
Croatian: S obzirom da je preporučena doza dolutegravira 50 mg dvaput na dan kad se istodobno primjenjuje s navedenim metaboličkim induktorima, fiksna kombinacija dolutegravir/abakavir/lamivudin se ne preporučuje u bolesnika koji uzimaju navedene metaboličke induktore.
English: Oral administration of dolutegravir to pregnant rats at doses up to 1000 mg/kg daily from days 6 to 17 of gestation did not elicit maternal toxicity, developmental toxicity or teratogenicity (50 times the 50 mg human clinical exposure when administered in combination with abacavir and lamivudine based on AUC).
Croatian: 6. do 17. dana gestacije nije uzrokovala toksičnost za majku, razvojnu toksičnost niti teratogenost (izloženost 50 puta veća od kliničke izloženosti u ljudi pri primjeni doze od 50 mg u kombinaciji s abakavirom i lamivudinom, što je utvrđeno na temelju AUC-a).
English: NAME OF THE MEDICINAL PRODUCT Triumeq 50 mg/600 mg/300 mg tablets dolutegravir/abacavir/lamivudine
Croatian: Triumeq 50 mg/600 mg/300 mg tablete dolutegravir/abakavir/lamivudin
English: Rare side effects that may show up in blood tests are: • increase in an enzyme called amylase
Croatian: • povećanje razine enzima koji se zove amilaza
English: Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir, 600 mg abacavir (as sulfate) and 300 mg lamivudine.
Croatian: Jedna tableta sadrži 50 mg dolutegravira u obliku dolutegravirnatrija, 600 mg abakavira (u obliku abakavirsulfata) i 300 mg lamivudina.
English: Patients should be advised that Triumeq or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Croatian: Bolesnike se mora upozoriti da Triumeq ili bilo koja druga antiretrovirusna terapija ne može izliječiti
English: Dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% Cτ ↓ 38%
Croatian: darunavir+ritonavir/ dolutegravir dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% Cτ ↓ 38%
English: 2) you get one or more symptoms from at least TWO of the following groups - fever - shortness of breath, sore throat or cough - nausea or vomiting or diarrhoea or abdominal pain - severe tiredness or achiness or generally feeling ill
Croatian: - nedostatak zraka, grlobolja ili kašalj - mučnina ili povraćanje ili proljev ili bol u trbuhu - izrazit umor ili bolovi ili opće loše osjećanje
English: headache
Croatian: Nuspojava
English: Dolutegravir↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49%
Croatian: fosamprenavir+ritonavir/ dolutegravir dolutegravir↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49%
English: The apparent oral clearance (CL/F) is approximately 1 L/hr in HIV-infected patients based on a population pharmacokinetic analysis.
Croatian: Na temelju populacijske farmakokinetičke analize, prividni klirens nakon peroralne primjene (CL/F) u bolesnika s HIV infekcijom iznosi približno 1 l/h.
English: Very common side effects These may affect more than 1 in 10 people:
Croatian: Vrlo rijetke nuspojave Mogu se javiti u do 1 na 10 000 osoba:
English: Frequency
Croatian: Razno
English: Hepatic impairment Pharmacokinetic data has been obtained for dolutegravir, abacavir and lamivudine separately.
Croatian: Oštećenje jetrene funkcije Prikupljeni su farmakokinetički podaci za dolutegravir, abakavir i lamivudin kao zasebne djelatne tvari.
English: Oral administration of dolutegravir to pregnant rabbits at doses up to 1000 mg/kg daily from days 6 to 18 of gestation did not elicit developmental toxicity or teratogenicity (0.74 times the 50mg human clinical exposure when administered in combination with abacavir and lamivudine based on AUC).
Croatian: 6. do 18. dana gestacije nije uzrokovala razvojnu toksičnost niti teratogenost (izloženost 0,74 puta veća od kliničke izloženosti u ljudi pri primjeni doze od 50 mg u kombinaciji s abakavirom i lamivudinom, što je utvrđeno na temelju AUC-a).
English: Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection.
Croatian: U bolesnika s istodobnom infekcijom hepatitisom B i/ili C preporučuje se praćenje biokemijskih pokazatelja jetrene funkcije. (Vidjeti dio 'Bolesnici s kroničnim hepatitisom B ili C'
English: In vitro, lamivudine did not inhibit or induce CYP enzymes (such as CYP3A4, CYP2C9 or CYP2D6) and demonstrated no or weak inhibition of OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 or MATE2-K. Lamivudine is therefore not expected to affect the plasma concentrations of drugs that are substrates of these enzymes or transporters.
Croatian: In vitro, lamivudin nije inhibirao ni inducirao CYP enzime (kao što su CYP3A4, CYP2C9 ili CYP2D6) te nije inhibirao ili je slabo inhibirao OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 ili MATE2-K.
English: Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 6%
Croatian: Kortikosteroidi prednizon dolutegravir ↔ AUC ↑ 11% Cmax ↑ 6% Cτ ↑ 17%
English: Discontinued study/study drug for other reasons§ Missing data during window but on study
Croatian: Prekid sudjelovanja u ispitivanju/primjene ispitivanog lijeka zbog nuspojave ili smrti‡ Prekid sudjelovanja u ispitivanju/primjene ispitivanog lijeka zbog drugih razloga§ Nema podataka za promatrano razdoblje, ali bolesnik sudjeluje u ispitivanju
English: In vivo, dolutegravir did not have an effect on midazolam, a CYP3A4 probe.
Croatian: Učinak dolutegravira, abakavira i lamivudina na farmakokinetiku drugih lijekova In vivo dolutegravir nije utjecao na midazolam, probni supstrat za CYP3A4.
English: Table 5: Demographics and Week 48 virologic outcomes of randomized treatment of FLAMINGO (snapshot algorithm)
Croatian: Tablica 5: Demografske značajke i virološki ishodi u 48. tjednu randomiziranog liječenja u ispitivanju
English: Dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% Tenofovir ↔
Croatian: Nukleozidni inhibitori reverzne transkriptaze (NRTI) tenofovir emtricitabin, didanozin, stavudin, zidovudin dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% tenofovir ↔
English: The adjusted difference in proportion and 95% CI [ABC/DTG/3TC vs current ART] were 3.4%; 95% CI: [-9.1, 2.4].
Croatian: naspram dotadašnje antiretrovirusne terapije) iznosili su 3,4% odnosno 95% CI: (-9,1; 2,4).
English: asthenia, fever1, malaise1
Croatian: astenija, vrućica1, malaksalost1
English: Dolutegravir hypersensitivity
Croatian: Preosjetljivost na dolutegravir
English: Dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76%
Croatian: tipranavir+ritonavir/ dolutegravir dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76%
English: Investigations: Common:
Croatian: umor često:
English: NAME OF THE MEDICINAL PRODUCT Triumeq 50 mg/600 mg/300 mg film-coated tablets dolutegravir/abacavir/lamivudine
Croatian: Triumeq 50 mg/600 mg/300 mg filmom obložene tablete dolutegravir/abakavir/lamivudin
English: Psychiatric disorders:
Croatian: Psihijatrijski poremećaji: vrlo često:
English: Dolutegravir ↓ AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
Croatian: Antikonvulzivi karbamazepin/dolutegravir dolutegravir ↓ AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
English: Missing data during window but on study
Croatian: Nema podataka za promatrano razdoblje, ali bolesnik sudjeluje u ispitivanju
English: Darunavir ↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
Croatian: darunavir ↔ ritonavir ↔ (indukcija enzima UGT1A1 i CYP3A)
English: Vistor hf.
Croatian: Probir na HLA
English: Management of ABC HSR reaction
Croatian: Zbrinjavanje reakcije preosjetljivosti na abakavir
English: In the primary 48 weeks analysis, the proportion of patients with virologic suppression in the dolutegravir + ABC/3TC arm, was superior to the EFV/TDF/FTC arm, p=0.003, the same treatment difference was observed in subjects defined by baseline HIV RNA level (< or > 100,000 copies/mL).
Croatian: U primarnoj analizi 48 tjedana liječenja, udio bolesnika s virološkom supresijom u skupini liječenoj kombinacijom dolutegravir + ABC/3TC bio je superioran u odnosu na skupinu koja je primala
English: Discontinued study/study drug due to adverse event or death‡
Croatian: Prekid sudjelovanja u ispitivanju/primjene ispitivanog lijeka zbog nuspojave ili smrti‡ Prekid sudjelovanja u ispitivanju/primjene ispitivanog lijeka zbog drugih razloga§
English: What Triumeq looks like and contents of the pack Triumeq film-coated tablets are purple, biconvex, oval tablets, debossed with “572 Trı” on one side.
Croatian: Triumeq filmom obložene tablete su ljubičaste, bikonveksne, ovalne tablete s utisnutom oznakom
English: Very rare side effects that may show up in blood tests are: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Croatian: • nemogućnost koštane srži da proizvede nove crvene krvne stanice (izolirana aplazija crvenih krvnih stanica) Ako primijetite bilo koju nuspojavu
English: What Triumeq contains - The active substances are dolutegravir, abacavir and lamivudine.
Croatian: - Djelatne tvari su dolutegravir, abakavir i lamivudin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg dolutegravir (as sodium), 600 mg abacavir (as sulfate), 300 mg lamivudine.
Croatian: Jedna filmom obložena tableta sadrži 50 mg dolutegravira (u obliku dolutegravirnatrija), 600 mg abakavira (u obliku abakavirsulfata) i 300 mg lamivudina.
English: Virologic Success Virologic Failure Reasons Data in window not below threshold No Virologic Data Discontinued due to AE or death Discontinued for other reasons Missing data during window but on study ABC/DTG/3TC FDC = abacavir/dolutegravir/lamivudine fixed-dose combination; AE = adverse event; ART = antiretroviral therapy; HIV-1 = human immunodeficiency virus type 1; ITT-E = intent-to-treat exposed; W = week.
Croatian: ABC/DTG/3TC = abakavir/dolutegravir/lamivudin; HIV-1 = virus humane imunodeficijencije tipa 1; ITT-E (intent-to-treat exposed) = populacija predviđena za liječenje izložena lijeku.
English: Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with St. John's wort, DTG/ABC/3TC FDC is not recommended.
Croatian: S obzirom da je preporučena doza dolutegravira 50 mg dvaput na dan kad se primjenjuje istodobno s gospinom travom, fiksna kombinacija dolutegravir/abakavir/lamivudin se ne preporučuje.
English: Hepatic impairment
Croatian: • otežanim disanjem
English: Hypersensitivity reactions
Croatian: Klinički opis reakcija preosjetljivosti
English: Dolutegravir↓ (Not studied, decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is
Croatian: Biljni lijekovi gospina trava/dolutegravir dolutegravir↓ (nije ispitivano, očekuje se smanjenje koncentracije zbog indukcije enzima UGT1A1 i CYP3A,
English: De novo resistance in patients failing therapy in SINGLE, SPRING-2 and FLAMINGO
Croatian: De novo rezistencija u bolesnika s neuspješnim odgovorom na liječenje u ispitivanjima SINGLE,
English: Virologic Outcomes of Randomized Treatment of SINGLE at 48 Weeks (Snapshot algorithm)
Croatian: Tablica 3: Virološki ishodi randomiziranog liječenja u ispitivanju SINGLE nakon 48 tjedana
English: Abacavir
Croatian: triumeq
English: Antidiabetics Metformin/Dolutegravir
Croatian: Hematološki simptomi limfopenija
English: Effect of dolutegravir: NGMN ↔ AUC ↓ 2% Cmax ↓ 11%
Croatian: NGMN ↔ AUC ↓ 2% Cmax ↓ 11%
English: • muscle pain and discomfort
Croatian: • bol i nelagoda u mišićima
English: Dolutegravir
Croatian: Učinci dolutegravira:
English: Metformin ↑ Dolutegravir ↔ When co-administered with dolutegravir 50mg QD:
Croatian: Antidijabetici metformin/dolutegravir metformin ↑ dolutegravir ↔ Kad se istodobno primjenjuje s dolutegravirom 50 mg jedanput na dan: metformin
English: Do not take an antacid during the 6 hours before you take Triumeq, or for at least 2 hours after you take it. Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as Triumeq.
Croatian: Ne smijete uzeti antacid unutar 6 sati prije primjene lijeka Triumeq niti još najmanje 2 sata nakon njegove primjene.
English: If you have stopped taking Triumeq because of a hypersensitivity reaction, you must NEVER AGAIN take Triumeq, or any other medicine containing abacavir.
Croatian: Ako ste prestali uzimati Triumeq zbog reakcije preosjetljivosti, NIKADA VIŠE ne smijete uzeti
English: Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32%
Croatian: multivitaminski pripravci (koji sadrže kalcij, željezo i magnezij)/dolutegravir dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32%
English: Virologic Failure Reasons Data in window not below 50 c/mL threshold Discontinued for lack of efficacy Discontinued for other reason while not below threshold No Virologic Data
Croatian: Prekid liječenja zbog drugih razloga dok razina nije bila ispod granične vrijednosti
English: Contact your doctor immediately: 1 if you get a skin rash, OR 2 if you get symptoms from at least 2 of the following groups: fever shortness of breath, sore throat or cough nausea or vomiting, diarrhoea or abdominal pain severe tiredness or aches and pains, or generally feeling ill.
Croatian: vrućica nedostatak zraka, grlobolja ili kašalj mučnina ili povraćanje ili proljev ili bol u trbuhu izrazit umor ili tupi bolovi i probadanje ili opće loše osjećanje Liječnik će Vam možda savjetovati da prestanete uzimati Triumeq.
English: AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36%
Croatian: darunavir+ritonavir+etravirin/ dolutegravir dolutegravir ↓ AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36%
English: Female
Croatian: OBLIK
English: • stomach ache
Croatian: • glavobolja • proljev
English: • headache
Croatian: • glavoboljom
English: Dolutegravir ↔ AUC ↓ 4% Cmax ↔ 0% C24 ↓ 6%
Croatian: lopinavir+ritonavir/ dolutegravir lopinavir+ritonavir/ abakavir dolutegravir ↔ AUC ↓ 4% Cmax ↔ 0% C24↔↓ 6%
English: No recommendation on dose reduction is possible in patients with mild hepatic impairment due to substantial variability of abacavir exposure.
Croatian: Zbog znatne varijabilnosti u izloženosti abakaviru, ne može se dati preporuka za smanjenje doze u bolesnika s blagim oštećenjem jetrene funkcije.
English: Asymptomatic creatine phosphokinase (CPK) elevations mainly in association with exercise have also been reported with dolutegravir therapy.
Croatian: Tijekom terapije dolutegravirom prijavljena su i asimptomatska povećanja razine kreatin fosfokinaze,
English: fatigue
Croatian: Dojenje
English: This summary was last updated in October 2013.
Croatian: Sažetak je posljednji put ažuriran u listopadu 2013.
English: These clinical signs normally resolve without treatment.
Croatian: Ovi klinički znakovi normalno nestaju bez liječenja.
English: The vaccine also contains ‘adjuvants' to stimulate a better response.
Croatian: Cjepivo sadrži i „adjuvans” za stimulaciju boljeg odgovora.
English: This protects the pigs against the disease.
Croatian: Na taj se način svinje štite od bolesti.
English: Exceptionally, in some herds a large proportion of animals may react after vaccination.
Croatian: Iznimno, u pojedinim stadima veliki dio životinja može reagirati nakon cjepljenja.
English: Severe anaphylactic (allergic) reactions are uncommon but may be lethal.
Croatian: Ozbiljne anafilaktičje (alergijske) reakcije nisu uobičajene, no smrtonosne su.
English: The area of local tissue reactions is in general below 5 cm in diameter, but in some cases a larger swelling may occur.
Croatian: Područje lokalnih reakcija tkiva uglavnom je manje od 5 cm u promjeru, no u određenim slučajevima mogu nastupiti veća oticanja.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Suvaxyn PCV on 24 July 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji za proizvod Suvaxyn PCV dana 24. srpnja 2009.
English: Local tissue reactions in the form of swelling at the injection site are very common and may last for up to 26 days.
Croatian: Lokalne reakcije tkiva u obliku oticanja u mjestu injekcije vrlo su uobičajene te mogu trajati i do 26 dana.
English: The safety of the vaccine has been addressed in both laboratory and field conditions: a temporary increase in body temperature (up to 1.7°C) is very common during the first 24 hours after vaccination.
Croatian: Sigurnost cjepiva ispitana je u laboratorijskim i terenskim uvjetima: privremeno povećanje tjelesne temperature (do 1,7°C) uobičajeno je tijekom prva 24 sata nakon cjepljenja.
English: The effectiveness of Suvaxyn PCV has been studied in laboratory and field studies in a large number of pigs.
Croatian: Djelotvornost VMP-a Suvaxyn PCV ispitana je u laboratorijskim i terenskim ispitivanjima na velikom broju svinja.
English: Porcine circovirus recombinant virus (cpcv) 1-2, inactivated
Croatian: Rekombinirani cirkovirus svinja (cpcv) 1-2, inaktivirani
English: When a pig is given the vaccine, the immune system recognises the killed viruses as ‘foreign' and makes antibodies against them.
Croatian: Nakon što svinja primi cjepivo, imunosni sustav prepoznaje ubijene viruse kao „strano” tijelo i proizvodi protutijela protiv njih.
English: Immediate mild hypersensitivity-like reactions may occur commonly after vaccination (affecting up to 1 in 10 animals) resulting in short-lived clinical signs such as vomiting.
Croatian: Neposredne blage reakcije slične preosjetljivosti uobičajene su nakon cjepljenja (zahvaćaju do 1 u 10 životinja) i rezultiraju kratkoročnim kliničkim znakovima poput povraćanja.
English: In the future, the immune system will be able to recognise the protein from the disease-causing virus and produce antibodies more quickly when it is exposed to such viruses.
Croatian: Ubuduće imunosni sustav može prepoznati protein iz virusa koji uzrokuje bolest te brže proizvesti protutijela nakon što je izložen takvim virusima.
English: Suvaxyn PCV contains small amounts of a form of the pig virus that has been modified to produce a protein from the form of the virus that causes disease, but killed so that it does not cause the disease and cannot spread.
Croatian: Suvaxyn PCV sadrži male količine oblika virusa svinja koji je modificiran za stvaranje proteina iz oblika virusa koji uzrokuje bolest, no ubijen je tako da ne uzrokuje bolest i ne može se širiti.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Suvaxyn PCV exceed the risks for the approved indications and recommended that Suvaxyn PCV be given a marketing authorisation.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) zaključio je da koristi od VMP-a Suvaxyn PCV nadmašuju rizike za odobrene indikacije i preporučio je da se za VMP Suvaxyn PCV izda odobrenje za stavljanje VMP-a u promet.
English: These studies were well-designed to demonstrate the efficacy of the vaccine in the face of PMWS outbreaks: farms that were selected had a history of PMWS and the disease was confirmed to occur before starting of the respective studies, using internationally accepted standards.
Croatian: Ova su ispitivanja bila dobro osmišljena za demonstraiju djelotvornosti cjepiva u trenutku izbijanja SKOP-a: odabrane su farme kod kojih je prethodno izbijao SKOP te je bolest potvrđena prije započinjanja dotičnog ispitivanja primjenom međunarodno prihvaćenih standarda.
English: Suvaxyn PCV is a vaccine that contains a recombinant (modified) porcine circovirus which has been inactivated (killed).
Croatian: Suvaxyn PCV je cjepivo koje sadrži rekombinirani (modificirani) cirkovirus svinja koji je inaktiviran (ubijen).
English: Suvaxyn PCV is a suspension for injection.
Croatian: Suvaxyn PCV je suspenzija za injekciju.
English: This document is a summary of the European Public Assessment Report.
Croatian: Ovo je sažetak Europskoga javnog izvješća o procjeni veterinarsko-medicinskog proizvoda.
English: The withdrawal period for Suvaxyn PCV is zero days.
Croatian: Razdoblje karencije za Suvaxyn PCV je nula dana.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Croatian: Omjer koristi i rizika dostupan je u modulu znanstvene odluke ovog EPAR-a.
English: Other information about Suvaxyn PCV:
Croatian: Druge informacije o VMP-u Suvaxyn PCV:
English: It has been demonstrated that the vaccine, when administered as recommended to piglets from 3 weeks of age induces active immunisation against Porcine Circovirus Type 2 (PCV2) and is able to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues caused by porcine circovirus infection, as well as to reduce clinical signs -including loss of daily weight gain- and death associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Croatian: Dokazano je da cjepivo, ako se primjenjuje sukladno preporukama u prašćića starijih od 3 tjedana života, inducira imunizaciju protiv cirkovirusa svinja tip 2 (PCV2) i može smanjiti virusno opterećenje u krvi i limfnim tkivima, te lezije u limfnim tkivima povezane s infestacijom cirkovirusom u svinja te suzbiti kliničke znakove - uključujući gubitak dnevnog prirasta - i smrtnost uzrokovane sindromom kržljavosti odbijene prasadi (SKOP).