FrancophonIA/ELRC3.0 huggingface dataset:
English: These have generally occurred in patients suffering from advanced malignant diseases, having sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see section 4.4).
Croatian: Obično su se javili u bolesnika s uznapredovalom malignom bolesti, sepsom, bolesnika koji su uzimali kemoterapiju s više lijekova ili bolesnika na aferezi (vidjeti dio 4.4).
English: Information for injecting yourself
Croatian: Informacije za samoubrizgavanje
English: The solution is injected subcutaneously (SC).
Croatian: Otopina se injicira supkutano (s.c.).
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE
English: What Lonquex is and what it is used for What Lonquex is
Croatian: Što je Lonquex i za što se koristi Što je Lonquex
English: Odds ratio (lipegfilgrastim / placebo), CI and p-value out of multivariate logistic regression analysis
Croatian: Omjer šansi (lipegfilgrastim/placebo), CI i p-vrijednost iz multivarijatne logističke regresijske analize
English: Lonquex is a solution for injection (injection) in pre-filled syringe with a fixed injection needle in a blister.
Croatian: Lonquex je otopina za injekciju (injekcija) u napunjenoj štrcaljki sa pričvršćenom iglom koja se nalazi u blisteru.
English: Lipegfilgrastim is a covalent conjugate of filgrastim with a single methoxy polyethylene glycol (PEG) molecule via a carbohydrate linker consisting of glycine, N-acetylneuraminic acid and N-acetylgalactosamine.
Croatian: Lipegfilgrastim je kovalentni konjugat filgrastima i jedne molekule metoksipolietilenglikola (PEG) preko ugljikohidratne poveznice, koji se sastoji od glicina, N-acetilneuraminske kiseline i
English: If you forget to use Lonquex
Croatian: Ako ste zaboravili primijeniti Lonquex
English: • Put used syringes into the puncture-proof container and keep this container out of the sight and reach of children.
Croatian: - Odložite upotrijebljene štrcaljke u neprobojni spremnik i čuvajte ga izvan pogleda i dohvata djece.
English: Generally asymptomatic cases of splenomegaly have been reported after administration of lipegfilgrastim (see section 4.8) and infrequent cases of splenic rupture, including fatal cases, have been reported after administration of G-CSF or derivatives (see section 4.8).
Croatian: Nakon primjene lipegfilgrastima (vidjeti dio 4.8) bili su zabilježeni općenito asimptomatski slučajevi splenomegalije, a nakon primjene G-CSF ili derivata rijetki slučajevi rupture slezene, uključujući one sa smrtnim ishodom (vidjeti dio 4.8).
English: Capillary leak syndrome* Aortitis*
Croatian: Nepoznato sindrom povećane propusnosti kapilara*, aortitis*
English: Lipegfilgrastim is metabolised via intra- or extracellular degradation by proteolytic enzymes.
Croatian: Lipegfilgrastim se metabolizira putem unutarstanične ili izvanstanične razgradnje proteolitičkim enzimima.
English: Put everything you need within easy reach (the Lonquex pre-filled syringe, an alcohol wipe and a piece of gauze bandage or a sterile gauze swab).
Croatian: Postavite sve što Vam je potrebno na dohvat ruke (Lonquex napunjena štrcaljka, vatica natopljena alkoholom i mali zavoj od gaze ili sterilna gaza).
English: This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po napunjenoj štrcaljki, tj. zanemarive količine natrija.
English: In a phase 1 study of 21 children aged between 2 and 16 years with Ewing family of tumours or rhabdomyosarcoma, lipegfilgrastim was administered as a single subcutaneous dose of 100 μg/kg (up to a maximum of 6 mg, which is the fixed dose for adults) 24 hours after the end of the last chemotherapy treatment in week 1 of the regimen.
Croatian: U ispitivanju faze 1 u 21 djeteta u dobi između 2 i 16 godina s tumorom iz skupine Ewingovih tumora ili rabdomiosarkomom, lipegfilgrastim je bio primijenjen kao jedna supkutana doza od 100 μg/kg (do najviše 6 mg, što je fiksna doza za odrasle) 24 sata nakon završetka zadnje kemoterapije u 1. tjednu protokola.
English: In 2 studies (XM22-02 and XM22-03) in patients with breast cancer receiving chemotherapy consisting of doxorubicin and docetaxel, mean maximum blood concentrations of 227 and 262 ng/ml were reached after median times to maximum concentration (tmax) of 44 and 48 hours.
Croatian: U 2 ispitivanja (XM22-02 and XM22-03) u bolesnika s karcinomom dojke koji su primali kemoterapiju doksorubicinom i docetakselom, srednje maksimalne koncentracije u krvi od 227 i 262 ng/ml postignute su nakon medijana vremena do maksimalne koncentracije (tmax) od 44 odnosno 48 sati.
English: Sickle cell crisis has been associated with the use of G-CSF or derivatives in patients with sickle cell anaemia (see section 4.8).
Croatian: Bolesnici s anemijom srpastih stanica Kriza srpastih stanica je bila povezivana s primjenom G-CSF ili derivata u bolesnika s anemijom srpastih stanica (vidjeti dio 4.8).
English: The active substance is a covalent conjugate of filgrastim** with methoxy polyethylene glycol (PEG) via a carbohydrate linker.
Croatian: Djelatna tvar je kovalentni konjugat filgrastima** i metoksipolietilenglikola (PEG) preko ugljikohidratne poveznice.
English: Injection site reactions such as injection site induration and injection site pain may occur.
Croatian: Mogu nastati reakcije na mjestu injekcije, kao što su otvrdnuće na mjestu injekcije i bol na mjestu injekcije.
English: ITT = Intent-to-treat population (all randomised patients) SD = standard deviation d = days
Croatian: ITT = populacija koju se namjeravalo liječiti (svi randomizirani bolesnici)
English: Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 7).
Croatian: Dezinficirajte mjesto injiciranja na koži tako što ćete palcem i kažiprstom uhvatiti nabor kože, bez stiskanja, i obrisati ga pomoću vatice natopljene alkoholom (vidjeti sliku 7).
English: Dispose of this medicine as instructed by your doctor, pharmacist or nurse.
Croatian: Zbrinite ovaj lijek prema uputama Vašeg liječnika, ljekarnika ili medicinske sestre.
English: • Skin reactions, such as redness or rash.
Croatian: • glavobolja • kožne reakcije, kao što su crvenilo ili osip
English: Incidence (%) Odds ratio 95 % CI
Croatian: Incidencija (%) Omjer šansi 95% CI
English: The concentration is 20.9 mg/ml (i.e. 12.6 mg per pre-filled syringe) if the PEG moiety and the carbohydrate linker are included.
Croatian: Koncentracija je 20,9 mg/ml (tj. 12,6 mg po napunjenoj štrcaljki)
English: The most frequent undesirable effects are musculoskeletal pain and nausea.
Croatian: Najčešće su nuspojave mišićno-koštana bol i mučnina.
English: Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 6).
Croatian: Dezinficirajte mjesto injiciranja na koži tako što ćete palcem i kažiprstom uhvatiti nabor kože, bez stiskanja, i obrisati ga pomoću vatice natopljene alkoholom (vidjeti sliku 6).
English: One 6 mg dose of lipegfilgrastim (a single pre-filled syringe of Lonquex) is recommended for each chemotherapy cycle, given approximately 24 hours after cytotoxic chemotherapy.
Croatian: Po jednom ciklusu kemoterapije preporučuje se jedna doza od 6 mg lipegfilgrastima (jedna napunjena štrcaljka lijeka Lonquex), koja se daje približno 24 sata nakon citotoksične kemoterapije.
English: Hypokalaemia has been reported (see section 4.4).
Croatian: Zabilježena je hipokalemija (vidjeti dio 4.4).
English: Due to the neutrophil-mediated clearance mechanism, the pharmacokinetics of lipegfilgrastim is not expected to be affected by renal or hepatic impairment.
Croatian: Bolesnici s oštećenjem funkcije bubrega ili jetre Zbog mehanizma klirensa posredovanog neutrofilima, ne očekuje se da će na farmakokinetiku lipegfilgrastima utjecati oštećenje funkcije bubrega ili jetre.
English: In a study (XM22-04) in patients with non-small cell lung cancer receiving chemotherapy consisting of cisplatin and etoposide, the mean maximum blood concentration of 317 ng/ml was reached after a median tmax of 24 hours and the mean terminal half-life was approximately 28 hours after a single subcutaneous injection of 6 mg lipegfilgrastim during the first cycle of chemotherapy.
Croatian: U ispitivanju (XM22-04) u bolesnika s karcinomom pluća ne-malih stanica koji su primali kemoterapiju sastavljenu od cisplatina i etoposida, srednja maksimalna koncentracija u krvi od 317 ng/ml postignuta je nakon medijana tmax od 24 sata,a srednji terminalni poluvijek iznosio je približno 28 sati nakon jedne supkutane injekcije 6 mg lipegfilgrastima u prvom ciklusu kemoterapije.
English: Splenomegaly, generally asymptomatic, has been reported (see section 4.4).
Croatian: Zabilježena je splenomegalija, općenito asimptomatska (vidjeti dio 4.4).
English: Hypokalaemia may occur (see section 4.8).
Croatian: Može nastati hipokalemija (vidjeti dio 4.8).
English: See leaflet for further information.
Croatian: Za dodatne informacije pogledajte uputu o lijeku.
English: Filgrastim is an un-glycosylated recombinant methionyl human G-CSF.
Croatian: Filgrastim je neglikozilirani rekombinantni metionilni humani G-CSF.
English: How Lonquex works
Croatian: Kako Lonquex djeluje
English: Δ LS mean (least square mean difference lipegfilgrastim - placebo), CI and p-value out of multivariate Poisson regression analysis
Croatian: Δ LS srednja vrijednost (razlika srednje vrijednosti lipegfilgrastim - placebo procijenjene metodom najmanjih kvadrata), CI i p-vrijednost iz multivarijantne Poissonove regresijske analize
English: Package leaflet: Information for the user Lonquex 6 mg solution for injection in pre-filled syringe lipegfilgrastim
Croatian: Uputa o lijeku: Informacije za korisnika Lonquex 6 mg otopina za injekciju u napunjenoj štrcaljki lipegfilgrastim
English: Lonquex 6 mg injection lipegfilgrastim
Croatian: Lonquex 6 mg injekcija lipegfilgrastim s.c.
English: In a phase 1 study (see section 5.1), using a 10 mg/ml solution for subcutaneous injection specifically developed for the paediatric studies, the mean maximum blood concentrations (Cmax) were 243 ng/ml in the 2 to <6-year group, 255 ng/ml in the 6 to <12-year group and 224 ng/ml in the 12 to <18-year group after a single subcutaneous injection of 100 μg/kg (maximum 6 mg) lipegfilgrastim with the first cycle of chemotherapy.
Croatian: U ispitivanju faze 1 (vidjeti dio 5.1) uz primjenu otopine od 10 mg/ml za supkutanu injekciju, posebno pripremljene za pedijatrijska ispitivanja, srednje vrijednosti maksimalnih koncentracija u krvi (Cmax) nakon jedne supkutane injekcije od 100 μg/kg (najviše 6 mg) lipegfilgrastima uz prvi ciklus kemoterapije bile su 243 ng/ml u dobnoj skupini od 2 do < 6 godina, 255 ng/ml u dobnoj skupini od 6 do < 12 godina i 224 ng/ml u dobnoj skupini od 12 do < 18 godina.
English: • Inflammation of the blood vessels in the skin.
Croatian: (Sweetov sindrom) • upala krvnih žila u koži
English: Patients were randomised 1:1 to receive 6 mg lipegfilgrastim or 6 mg pegfilgrastim.
Croatian: Bolesnici su bili randomizirani 1:1 u skupinu koja je primala 6 mg lipegfilgrastima ili u skupinu koja je primala 6 mg pegfilgrastima.
English: Δ LS mean (least square mean difference lipegfilgrastim - pegfilgrastim) and CI out of multivariate Poisson regression analysis
Croatian: Δ LS srednja vrijednost (razlika srednje vrijednosti lipegfilgrastim - pegfilgrastim procijenjene metodom najmanjih kvadrata) i CI iz multivarijatne Poissonove regresijske analize.
English: Blood and lymphatic system disorders - Splenic rupture including some fatal cases (see section 4.4) - Sickle cell crisis in patients with sickle cell anaemia (see section 4.4)
Croatian: Poremećaji krvi i limfnog sustava ruptura slezene uključujući neke smrtne slučajeve (vidjeti dio 4.4)
English: Nausea was very commonly observed in patients receiving chemotherapy.
Croatian: U bolesnika koji su primali kemoterapiju vrlo često je opažena mučnina.
English: Urinalysis monitoring is recommended (see section 4.8).
Croatian: Preporučuje se praćenje analize mokraće (vidjeti dio 4.8).
English: Talk to your doctor, pharmacist or nurse BEFORE using Lonquex
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri PRIJE NEGO primijenite Lonquex • ako Vam se pojavi bol u gornjem lijevom dijelu trbuha ili na vrhu ramena.
English: Concomitant use of lipegfilgrastim with any chemotherapeutic medicinal product has not been evaluated in patients.
Croatian: Nije ispitivana istovremena primjena lipegfilgrastima s nekim kemoterapijskim lijekom u bolesnika.
English: Tell your doctor if you experience these symptoms.
Croatian: Ako osjetite ove simptome, obavijestite svog liječnika.
English: Hypokalaemia*
Croatian: Često hipokalemija*
English: • Bleeding from the lung.
Croatian: • krvarenje iz pluća
English: Renal and urinary disorders - Glomerulonephritis (see section 4.4)
Croatian: Poremećaji bubrega i mokraćnog sustava glomerulonefritis (vidjeti dio 4.4) Pedijatrijska populacija
English: Name and address of the manufacturers responsible for batch release
Croatian: Njemačka Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
English: Increased risk of disease progression or death was not observed with lipegfilgrastim.
Croatian: Uz lipegfilgrastim nije bio uočen povećan rizik napredovanja bolesti ili smrtnosti.
English: Study days, injection of lipegfilgrastim at day 0
Croatian: Dani ispitivanja, injekcija lipegfilgrastima 0. dana farmakodinamičkog učinka specifičnog za kuniće.
English: Each ml of solution for injection contains 10 mg of lipegfilgrastim.
Croatian: Jedan ml otopine za injekciju sadrži 10 mg lipegfilgrastima.
English: When to use Lonquex
Croatian: Kada primjenjivati Lonquex
English: Vascular disorders - Capillary leak syndrome Cases of capillary leak syndrome have been reported in postmarketing experience after administration of G-CSF or derivatives.
Croatian: Slučajevi sindroma povećane propusnosti kapilara nakon primjene G-CSF ili njegovih derivata prijavljeni su nakon stavljanja lijeka na tržište.
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after administration of lipegfilgrastim (see section 4.8).
Croatian: Nakon primjene lipegfilgrastima zabilježene su plućne nuspojave, osobito intersticijska pneumonija (vidjeti dio 4.8).
English: Thrombocytopenia and leukocytosis have been reported (see section 4.4).
Croatian: Zabilježene su trombocitopenija i leukocitoza (vidjeti dio 4.4).
English: p-value SN
Croatian: p-vrijednost TN
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and white blood cell count).
Croatian: U zdravih osoba i bolesnika oboljelih od raka nakon primjene G-CSF-a zabilježen je aortitis, čiji su simptomi uključivali vrućicu, bol u abdomenu, malaksalost, bol u leđima i povišene upalne markere (npr. C-reaktivni protein i broj leukocita).
English: Each pre-filled syringe contains 6 mg of lipegfilgrastim* in 0.6 ml solution.
Croatian: Jedna napunjena štrcaljka sadrži 6 mg lipegfilgrastima* u 0,6 ml otopine.
English: Each pre-filled syringe contains 6 mg lipegfilgrastim in 0.6 ml solution.
Croatian: Jedna napunjena štrcaljka sadrži 6 mg lipegfilgrastima u 0,6 ml otopine.
English: Lipegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance.
Croatian: Zahvaljujući svom smanjenom bubrežnom klirensu, lipegfilgrastim je dugotrajni oblik filgrastima.
English: Injection site reactions*
Croatian: Manje često reakcije na mjestu injekcije*
English: Lonquex 6 mg solution for injection in pre-filled syringe
Croatian: Lonquex 6 mg otopina za injekciju u napunjenoj štrcaljki
English: Each pre-filled syringe contains 6 mg lipegfilgrastim.
Croatian: Jedna napunjena štrcaljka sadrži 6 mg lipegfilgrastima.
English: Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely with other medicines like this one (e.g. filgrastim, lenograstim or pegfilgrastim of the group of G-CSFs).
Croatian: Tijekom primjene drugih lijekova sličnih ovome (npr. filgrastima, lenograstima ili pegfilgrastima iz skupine lijekova G-CSF) rijetko je zabilježena upala aorte (velike krvne žile koja prenosi krv iz srca u tijelo).
English: Possible side effects”).
Croatian: (vidjeti dio 4. „Moguće nuspojave”).
English: Lonquex 6 mg solution for injection in pre-filled syringe lipegfilgrastim
Croatian: Lonquex 6 mg otopina za injekciju u napunjenoj štrcaljki lipegfilgrastim
English: What Lonquex is used for
Croatian: Za što se Lonquex koristi
English: • Dispose of the full puncture-proof container as instructed by your doctor, pharmacist or nurse.
Croatian: - Zbrinite puni neprobojni spremnik prema uputama liječnika, ljekarnika ili medicinske sestre.
English: How to store Lonquex
Croatian: Kako primjenjivati Lonquex
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Lonquex Lijek čuvajte izvan pogleda i dohvata djece.
English: DSN
Croatian: TTN
English: • the abdomen (see grey areas in picture 3) avoiding the skin directly surrounding the navel.
Croatian: Najpogodnija mjesta da sami sebi primijenite injekciju su: - gornji dio bedara, - trbuh (vidjeti siva područja na slici 3) s time da morate izbjegavati kožu neposredno oko pupka.
English: • the abdomen (see grey areas in picture 4) avoiding the skin directly surrounding the navel.
Croatian: Najpogodnija mjesta da sami sebi primijenite injekciju su: - gornji dio bedara, - trbuh (vidjeti siva područja na slici 4) s time da morate izbjegavati kožu neposredno oko pupka.
English: Only for the pre-filled syringe with safety device: Important: read the package leaflet before handling syringe.
Croatian: Važno: prije rukovanja štrcaljkom pročitajte uputu o lijeku.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I
English: Leukocytosis may occur (see section 4.8).
Croatian: Može nastati leukocitoza (vidjeti dio 4.8).
English: Sodium hydroxide (for pH-adjustment) Sorbitol (E420)
Croatian: 6.1 Popis pomoćnih tvari ledena acetatna kiselina natrijev hidroksid (za podešavanje pH) sorbitol (E420) polisorbat 20 voda za injekcije
English: Each ml solution contains 10 mg lipegfilgrastim.
Croatian: Jedan ml otopine sadrži 10 mg lipegfilgrastima.
English: Lipegfilgrastim and filgrastim induced a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes.
Croatian: Farmakodinamički učinci Lipegfilgrastim i filgrastim su izazvali izrazito povećanje broja neutrofila u perifernoj krvi unutar
English: Musculoskeletal pains*
Croatian: Često trombocitopenija*
English: Each pre-filled syringe contains 0.6 ml of solution.
Croatian: Jedna napunjena štrcaljka sadrži 0,6 ml otopine.
English: In view of the possible risk of microbial contamination, Lonquex syringes are for single use only.
Croatian: štrcaljke Lonquexa namijenjene su samo za jednokratnu uporabu.
English: Table 3: DSN, SN and FN in cycle 1 of study XM22-04 (ITT) Placebo (n = 125)
Croatian: Tablica 3: Trajanje teške neutropenije (TTN), teška neutropenija (TN) i febrilna neutropenija (FN) u 1. ciklusu ispitivanja XM22-04 (ITT)
English: • Coughing up blood.
Croatian: • bol u prsištu • iskašljavanje krvi
English: How Lonquex is used
Croatian: Kako se Lonquex primjenjuje
English: SC
Croatian: S
English: Put everything you need within easy reach (the Lonquex pre-filled syringe, an alcohol wipe, a piece of gauze bandage or a sterile gauze swab and the puncture-proof container).
Croatian: (Lonquex napunjena štrcaljka, vatica natopljena alkoholom, mali zavoj od gaze ili sterilna gaza i neprobojni spremnik).
English: Teva Biotech GmbH Dornierstraße 10 D-89079 Ulm Germany
Croatian: Teva Biotech GmbH Dornierstraße 10
English: Vascular disorders
Croatian: Plućne nuspojave
English: The second pivotal (phase III) clinical study XM22-04 was a placebo-controlled study in 375 patients with non-small cell lung cancer receiving up to 4 cycles of chemotherapy consisting of cisplatin and etoposide.
Croatian: 375 bolesnika s karcinomom pluća ne-malih stanica koji su primali do 4 ciklusa kemoterapije koja se je sastojala od cisplatina i etopozida.
English: What the recommended dose is
Croatian: NAČIN PRIMJENE LIJEKA
English: Overweight patients
Croatian: Bolesnici prekomjerene tjelesne težine
English: Δ LS mean
Croatian: Δ LS srednja vrijednost
English: Frequency
Croatian: Sljedivost
English: Not known
Croatian: *Vidjeti dio
English: • Nausea.
Croatian: N-acetilgalaktozamina.
English: The warnings in the product literature remain appropriate.
Croatian: Upozorenja u literaturi proizvoda i dalje su odgovarajuća.
English: The assessment in phase II was required.
Croatian: Bila je potrebna procjena u fazi II.
English: Indirect or additional benefits
Croatian: Neizravne ili dodatne koristi
English: The reference Member State (RMS) is the Czech Republic and 10 concerned Member States (CMS) are involved: Austria, Denmark, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain and the United Kingdom.
Croatian: Referentna država članica (RMS) je Češka Republika, a 10 dotičnih država članica (CMS) su: Austrija, Danska, Francuska, Njemačka, Irska, Italija, Nizozemska, Portugal, Španjolska i Ujedinjeno Kraljevstvo.
English: Quality, Target animal safety, User safety, Residues, Resistance and Efficacy were not assessed in this referral procedure.
Croatian: Kvaliteta, sigurnost ciljnih životinja, sigurnost korisnika, rezidue, rezistencija i učinkovitost nisu ispitivane u ovom postupku upućivanja.
English: The Committee considered whether the environmental risk assessment can be completed based on the information available, or further data needs to be provided.
Croatian: Povjerenstvo je razmatralo da li se procjena rizika za okoliš može dovršiti na temelju dostupnih podataka ili će biti potrebno dostaviti dodatne podatke.
English: The Member States concerned failed to reach an agreement regarding the product and consequently the matter was referred to the CVMP on 11 July 2012.
Croatian: Države članice nisu uspjele postići dogovor u vezi veterinarsko-medicinskog proizvoda i kao posljedica toga predmet je proslijeđen Povjerenstvu za veterinarsko-medicinske proizvode 11. srpnja 2012.
English: Further assessment was required for algae, hence the applicant submitted advanced models for PECs in surfacewater (FOCUS).
Croatian: Bile su potrebne daljnje procjene za alge pa je stoga podnositelj zahtjeva predao napredne modele za PEC-ove u površinskim vodama (FOCUS).
English: The combination of active substances is included in veterinary medicinal products currently authorised in the European Union for use in cattle, pigs, dogs and cats.
Croatian: Kombinacija djelatnih tvari uključena je u veterinarsko-medicinski proizvod koji je trenutno odobren u Europskoj uniji za uporabu kod stoke, svinja, pasa i mačaka.
English: Strength Animal species
Croatian: Jačina Ciljne vrste životinja
English: No further risk management or mitigation measures are required as a consequence of this referral procedure.
Croatian: Nisu potrebne daljnje mjere upravljanja rizikom ili smanjenja rizika kao posljedica ovog postupka upućivanja.
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from the Czech Republic.
Croatian: S obzirom na predane podatke Povjerenstvo je o problemima istaknutim u obavijesti dobivenoj od Češke Republike donijelo sljedeće zaključke.
English: Assessment of the data submitted
Croatian: Procjena podnesenih podataka
English: The applicant did not propose any risk mitigation measures, because they did not identify any environmental risks.
Croatian: Podnositelj zahtjeva nije predložio nikakve mjere smanjenja rizika jer nisu identificirani nikakvi rizici za okoliš.