FrancophonIA/ELRC3.0 huggingface dataset:
English: • numbness, tingling, pricking sensation, sensitivity to touch or muscle weakness You may need additional medicines if you develop any of these symptoms.
Croatian: • utrnulost, trnci, osjećaj bockanja, osjetljivost na dodir ili slabost u mišićima.
English: First dose level reduction: Possible dose reduction: Second dose level reduction:
Croatian: Prvo smanjenje razine doze: Drugo smanjenje razine doze: 175
English: In the study, 35% of the patients in the paclitaxel micellar group and 30% of the patients in the solvent-based paclitaxel group, respectively, received GCSF to treat neutropenia.
Croatian: U okviru ispitivanja primijenjen je G-CSF za liječenje neutropenije u 35 % bolesnica u skupini liječenoj micelarnim paklitakselom te u 30 % bolesnica u skupini liječenoj paklitakselom u otopini.
English: Uncommon: Vaginal haemorrhage, pelvic pain, breast pain
Croatian: Manje često: vaginalno krvarenje, bol u zdjelici, bol u dojci
English: These patients should be vigilantly monitored by physicians for the occurrence of cardiac events.
Croatian: Liječnici trebaju posebno obratiti pozornost na pojavu srčanih tegoba u takvih bolesnika.
English: One vial of powder contains 60 mg paclitaxel.
Croatian: Jedna bočica praška sadrži 60 mg paklitaksela.
English: • severe nausea, vomiting or diarrhoea
Croatian: • teški oblici mučnine, povraćanja ili proljeva
English: One vial contains 60 mg of paclitaxel.
Croatian: Jedna bočica sadrži 60 mg paklitaksela.
English: The true incidence, severity and time to onset of hypersensitivity reactions due to Apealea could not be established during clinical development due to the combination treatment with carboplatin.
Croatian: Zbog kombiniranog liječenja s karboplatinom tijekom kliničkog razvoja lijeka nije bilo moguće utvrditi stvarnu incidenciju, težinu i vrijeme javljanja reakcija preosjetljivosti na lijek Apealea.
English: Uncommon: Depression, insomnia, anxiety Nervous system disorders Very common: Peripheral sensory neuropathya,b, neuropathy peripherala,b
Croatian: periferna senzorna neuropatijaa,b, periferna neuropatijaa,b
English: Almost all patients treated with Apealea had neutropenia of some grade, 79% of the patients had grade 3 or 4.
Croatian: Poremećaji krvi i limfnog sustava Gotovo svi bolesnici liječeni lijekom Apealea imali su određeni stupanj neutropenije, a 79 %
English: Apealea: solvent-based paclitaxel:
Croatian: Apealea: paklitaksel u otopini:
English: To keep the generation of foam to a minimum, do not shake the vial.
Croatian: Nemojte tresti bočicu da se smanji stvaranje pjene.
English: Uncommon: Status epilepticus, coma, cerebrovascular accident, peripheral sensorimotor neuropathy, lethargy, hypotonia, neurotoxicity, polyneuropathy, polyneuropathy in malignant disease, burning sensation, somnolence, cognitive disorder, facial palsy, encephalopathy, hydrocephalus
Croatian: hipotonija, neurotoksičnost, polineuropatija, polineuropatija kod zloćudne bolesti, peckanje, somnolencija, kognitivni poremećaj, paraliza lica,
English: • Common (may affect up to 1 in 10 people):
Croatian: • Česte nuspojave (mogu se pojaviti u do 1 na 10 osoba):
English: Excipients
Croatian: Opažanjea
English: Hypoaesthesia, dizziness, paraesthesia, peripheral motor neuropathy, dysgeusia, headache
Croatian: hipoestezija, omaglica, parestezija, periferna motorička neuropatija, disgeuzija, glavobolja Manje često: epileptički status, koma, cerebrovaskularni incident,
English: • previously had nausea, vomiting and diarrhoea during cancer treatment
Croatian: • ako ste tijekom prethodnog liječenja raka osjećali mučninu, povraćali i imali proljev.
English: Uncommon: Death, multi-organ failure, oedema, administration site pain, catheter site haemorrhage, catheter site oedema, local swelling, generalised oedema, hernia, chest pain, influenza like illness, localised oedema, hypothermia, chills, feeling hot
Croatian: generalizirani edem, hernija, bol u prsima, bolest slična gripi, lokalizirani edem, hipotermija, zimica, osjećaj vrućine
English: Uncommon: Angioedema, rash generalised, skin discolouration, hyperhidrosis, rash papular, dermatitis bullous, swelling face, pigmentation disorder, dry skin, cold sweat, livedo reticularis, nail disorder, pruritus allergic, skin disorder
Croatian: Manje često: angioedem, generalizirani osip, diskoloracija kože, hiperhidroza, papularni osip, bulozni dermatitis,
English: Solvent-based paclitaxel
Croatian: Paklitaksel u otopini
English: • joint or muscle pain or discomfort
Croatian: • bol ili nelagoda u zglobovima ili mišićima
English: • cough
Croatian: (CTCAE).
English: Most hypersensitivity reactions related to Apealea were mild to moderate (see section 4.4).
Croatian: Većina reakcija preosjetljivosti povezanih s primjenom lijeka Apealea bile su blage do umjerene
English: Overall survival
Croatian: Ukupna stopa preživljenja
English: • abdominal pain, constipation, wind
Croatian: • abdominalna bol, konstipacija, vjetrovi • suha usta, upala sluznice usne šupljine
English: Heart failure has been observed in some patients receiving Apealea.
Croatian: U nekih bolesnika koji su primali lijek Apealea zabilježeno je zatajenje srca.
English: • chest pain or discomfort
Croatian: • bol ili nelagoda u prsima
English: Antiemetics and antinauseants
Croatian: artralgijaa, mijalgijaa
English: Therefore, caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.
Croatian: Stoga je potreban oprez prilikom primjene paklitaksela istodobno s lijekovima za koje je utvrđeno da inhibiraju CYP2C8 ili CYP3A4 (primjerice ketokonazol i drugi imidazolni antifungici,
English: − N-(all-trans-retinoyl)-L-cysteic acid methyl ester sodium salt
Croatian: Natrijeva sol metil estera N-(sav-trans-retinoil)-L-cisteinske kiseline
English: Uncommon: Disseminated intravascular coagulationa, pancytopenia, haematotoxicity, coagulopathy
Croatian: pancitopenija, hematotoksičnost, koagulopatija
English: • cancer of the fallopian tubes (the connection between the ovaries and the womb) It is used when other therapies have not worked.
Croatian: • rak jajovoda (veza između jajnika i maternice).
English: favours Apealea favours solvent-based paclitaxel
Croatian: Prednost paklitakselu u otopini
English: Dyspnoea, nasal congestion
Croatian: encefalopatija, hidrocefalus
English: − muscle weakness, cramps or spasms
Croatian: − slabost u mišićima, grčevi ili spazam mišića
English: Uncommon: Abdominal distension, gastritis, abdominal discomfort, abdominal pain lower, dyspepsia, faecaloma, intestinal functional disorder, gingival bleeding, haematochezia, paraesthesia oral
Croatian: Manje često: abdominalna distenzija, gastritis, nelagoda u abdomenu, bol u donjem dijelu abdomena,
English: Non-Caucasian patients
Croatian: Bolesnici koji nisu bijele rase
English: • have a count of white blood cells called neutrophils below 1.5 × 109/L before start of the therapy
Croatian: • ako prije početka liječenja imate broj bijelih krvnih stanica naziva neutrofili manji od
English: • low level of white blood cells called leukocytes and granulocytes
Croatian: Česte nuspojave (mogu se pojaviti u do 1 na 10 osoba): • niska razina bijelih krvnih stanica naziva leukociti i granulociti
English: • hernia
Croatian: • hernija (kila)
English: However, also see text under section 4.4.
Croatian: Međutim, također pogledajte tekst pod odjeljkom 4.4.
English: This is similar to that seen in most of the earlier studies.
Croatian: To je slično onome što je opaženo u većine prijašnjih ispitivanja.
English: Do not eat, drink or smoke while handling the product.
Croatian: Nemojte jesti, piti ili pušiti tijekom rukovanja proizvodom.
English: Contact with skin and eyes should be avoided.
Croatian: Treba izbjegavati kontakt s kožom i očima.
English: No other source of drinking water should be available.
Croatian: Ne smije biti dostupan nikakav drugi izvor vode za piće.
English: The uptake of water should be monitored frequently.
Croatian: Unos vode treba često nadzirati.
English: Chickens were authorised as a target species in Belgium, France, Hungary and Poland.
Croatian: Pilići kao ciljna vrsta životinja odobreni su u Belgiji, Francuskoj, Mađarskoj i Poljskoj.
English: Human and animal bacteria share the same resistance determinants.
Croatian: Ljudske i životinjske bakterije imaju iste determinante rezistencije.
English: ATC Vet Code: QJ01FF02
Croatian: ATCvet kod: QJ01FF02
English: 00330 Helsinki
Croatian: 00330 Helsinki Finska
English: Andrew Street London EC4A 3AE United Kingdom
Croatian: Andrew Street London EC4A 3AE Velika Britanija
English: 92240 Malakoff France
Croatian: 92240 Malakoff
English: Poland Zoetis Polska Sp. z o.o.
Croatian: Zoetis Polska Sp. z o.o.
English: • The restriction of the indications to those that are adequately substantiated by efficacy data;
Croatian: • ograničavanjem indikacija na one koje su odgovarajuće potvrđene podacima o djelotvornosti;
English: Where possible, therapy should be based on local (regional,
Croatian: Gdje je moguće, liječenje treba temeljiti na lokalnim (regionalnim,
English: Germany Zoetis Deutschland GmbH
Croatian: Njemačka Zoetis Deutschland GmbH
English: Once diluted or reconstituted according to directions: use within 24 hours.
Croatian: Jednom razrijeđen ili rekonstituiran u skladu s uputama: upotrijebiti unutar 24 sata.
English: In order to obtain the correct dosage, the concentration of the lincomycin has to be adjusted accordingly.
Croatian: Kako bi dobile ispravnu dozu, koncentracija linkomicina mora se prilagoditi u skladu s tim.
English: The possible risk for the environment has not been considered as part of this referral.
Croatian: Mogući rizik za okoliš nije se smatrao dijelom ovog arbitražnog postupka.
English: Dosing guidance and recommended doses:
Croatian: Upute za doziranje i preporučene doze:
English: However, also see text under Special warnings for each target species.
Croatian: Međutim, također pogledajte tekst pod Posebna upozorenja za svaku ciljnu vrstu.
English: The concentration to be used depends on the actual body weight and the water consumption of the animals and can be calculated according to the following formula:
Croatian: Koncentracija koja će se koristiti ovisi o stvarnoj tjelesnoj masi i potrošnji vode od strane životinja i može se izračunati prema sljedećoj formuli:
English: Both of these studies included 1116 birds which were divided into treatment and negative control groups.
Croatian: Oba ispitivanja uključila su 1116 pilića koji su podijeljeni u liječenu skupinu i negativnu kontrolnu skupinu.
English: Zoetis France 10 rue Raymond David
Croatian: Francuska Zoetis Francuska 10 rue Raymond David
English: The number of animals (18 castrated males and 18 females) included in the study and their weights (36.5 to 71 kg) were adequate.
Croatian: Broj životinja (18 kastriranih mužjaka i 18 ženki) uključenih u ispitivanje i njihove težine (od 36,5 do 71 kg) bile su odgovarajuće.
English: There is no specific antidote, treatment is symptomatic.
Croatian: Nema specifičnog antidota, liječenje je simptomatsko.
English: As the conclusions from the aforementioned referral procedure (EMEA/V/A/110) can be extrapolated to the current
Croatian: Kako se zaključci iz prethodno navedenog arbitražnog postupka (EMEA/V/A/110) mogu proširiti i na
English: In case of insufficient uptake of water, pigs should be treated parenterally.
Croatian: U slučaju nedovoljnog unosa vode, svinje treba liječiti parenteralno.
English: 6.2 Major incompatibilities
Croatian: 6.2 Inkompatibilnosti
English: In both studies significant differences were noted in mortality rates between birds treated with lincomycin (0% and 0.7%, respectively) and negative controls (14% and 7.5%, respectively).
Croatian: U oba ispitivanja uočene su značajne razlike u stopama smrtnosti između pilića liječenih linkomicinom (0 % i 0,7 %) i negativne kontrolne skupine (14 % i 7,5 %).
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina veterinarsko medicinskih proizvoda, životinjskih vrsta, puteva primjene, nositelja odobrenja za stavljanje u promet u Državama članicama
English: The elimination half-life of lincomycin is greater than 3 hours.
Croatian: Eliminacijski poluživot linkomicina veći je od 3 sata.
English: Care should be taken not to raise and inhale any dust.
Croatian: Treba poduzeti mjere kako se ne bi podizala i udisala prašina.
English: As such, these data are considered to support extrapolation of the findings from the abovementioned studies conducted in the USA in the 1980s to the current EU situation.
Croatian: Za takve podatke smatralo se da podupiru ekstrapolaciju podataka dobivenih u prethodno spomenutim ispitivanjima provedenima u SAD-u tijekom 1980.-ih na podatke o sadašnjoj situaciji u Europskoj uniji.
English: The presence of the disease in the group must be established before the product is used.
Croatian: Prije upotrebe proizvoda u grupi se mora utvrditi prisutnost bolesti.
English: Metabolites comprised more than 75% of total residues in the liver.
Croatian: Metaboliti čine više od 75% od ukupnih rezidua u jetri.
English: The potential risk of resistance development, which might impact product efficacy, and overall animal and human health, is limited through:
Croatian: Potencijalni rizik od razvoja rezistencije, koji može utjecati na djelotvornost lijeka te ukupno zdravlje životinja i ljudi, ograničen je:
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
Croatian: 13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA
English: These conditions are usually self correcting within 5-8 days without discontinuing the lincomycin treatment.
Croatian: Ova stanja obično prolaze sama od sebe unutar 5-8 dana, bez prekida liječenja linkomicinom.
English: The slaughter times (0 hours after 3 days of medication and 0, 6, 12 and 24 hours after 21 days of medication) were well distributed to support the proposed zero-day withdrawal period.
Croatian: Vremena klanja (0 sati nakon 3 dana liječenja i 0, 6, 12 i 24 sata nakon 21 dana liječenja) bila su dobro raspoređena da potkrijepe predloženo razdoblje karencije od nula dana.
English: Risk management or mitigation measures
Croatian: Mjere za upravljanje rizikom ili ublažavanje rizika
English: This product contains lincomycin and lactose monohydrate, either of which can cause allergic reactions in some people.
Croatian: Ovaj proizvod sadrži linkomicin i laktozu monohidrat, od kojih oba mogu izazvati alergijske reakcije kod nekih osoba.
English: People with known hypersensitivity to lincomycin or any other lincosamide, or to lactose monohydrate, should avoid contact with the veterinary medicinal product.
Croatian: Osobe s poznatom preosjetljivošću na linkomicin, ili bilo koji drugi linkozamid, ili na laktozu monohidrat, trebaju izbjegavati kontakt s veterinarsko medicinskim proizvodom.
English: The bioequivalence between the soluble powder and the premix formulation was investigated in two studies, but could not be formally demonstrated.
Croatian: Bioekvivalencija između topljivog praška i formulacije za premiks ispitivana je u dva ispitivanja, ali nije mogla biti formalno dokazana.
English: This evaluation focuses on issues in regards to the harmonisation that may change the benefit-risk balance.
Croatian: Ova procjena usredotočena je na pitanja povezana s usklađivanjem koja mogu promijeniti omjer koristi i rizika.
English: In case of accidental overdose, the treatment must be stopped and restarted at the recommended dose level.
Croatian: U slučaju nehotičnog predoziranja liječenje se mora prekinuti i ponovno započeti u preporučenoj razini doze.
English: Levels were detectable for 12 to 16 hours, with peak concentrations occurring at 4 hours.
Croatian: Razine su se mogle detektirati od 12 do 16 sati, s pojavom vršnih koncentracija nakon 4 sata.
English: The main areas of disharmony in the existing product information relate to:
Croatian: Glavna područja neusklađenosti u postojećim informacijama o VMP-u odnose se na:
English: Indeed, there was evidence, albeit from a subclinical infection model, that MIC values above those for the apparent wild-type population do not necessarily correlate to a lack of clinical effectiveness of lincomycin (Lanckriet et al., 2010)2.
Croatian: Zapravo, postojao je dokaz - iako iz modela supkliničke infekcije, da vrijednosti MIK-a iznad onih za populaciju prividno divljeg tipa nisu nužno u korelaciji s nedostatkom kliničke učinkovitosti linkomicina (Lanckriet et al., 2010)2.
English: Average daily water intake (litre/animal)
Croatian: Prosječni dnevni unos vode za piće (litre/životinji)
English: The daily amount is to be added to the drinking water in such a way that all medication will be consumed within 24 hours.
Croatian: Dnevna količina mora se dodati u vodu za piće tako da se sva količina veterinarsko medicinskog proizvoda potroši unutar 24 sata.
English: Approximately 50% of lincomycin is metabolised in the liver.
Croatian: Približno 50% linkomicina se metabolizira u jetri.
English: The medicated water should be the only source of drinking water for the animals for the entire duration of the treatment period.
Croatian: Voda s veterinarsko medicinskim proizvodom treba životinjama biti jedini izvor vode za piće tijekom cijelog razdoblja liječenja.
English: • The inclusion of information about resistance status and warnings about prudent use as regards resistance, in SPC sections 4.4 ‘Special warnings for each target species', 4.5 (i) ‘Special precautions for use in animals' and 5.1 ‘Pharmacodynamic properties'.
Croatian: • uključivanjem informacija o statusu rezistencije i upozorenja o racionalnoj primjeni s obzirom na rezistenciju u sažetak opisa svojstava VMP-a u dijelove 4.4 „Posebna upozorenja za svaku od ciljnih vrsta životinja”, 4.5 (i.) „Posebne mjere opreza prilikom primjene na životinjama” i 5.1 „Farmakodinamička svojstva”.
English: Allergic/hypersensitive reactions occur on rare occasions.
Croatian: Alergijske reakcije/reakcije preosjetljivosti javljaju se u rijetkim slučajevima.
English: The doses used in these studies were in line with the proposed dose of 10 mg/kg body weight.
Croatian: Doze upotrijebljene u tim ispitivanjima bile su u skladu s predloženom dozom od 10 mg/kg tjelesne težine.
English: It was calculated that a concentration of 16.9 mg/l was the minimal dose that would give the maximum effect; this corresponds with a calculated dose of 3.9 mg/kg body weight.
Croatian: Izračunato je da je koncentracija od 16,9 mg/l minimalna doza kojom će se postići maksimalni učinak; to odgovara izračunatoj dozi od 3,9 mg/kg tjelesne težine.
English: Lincomycin and one unknown metabolite comprised >50% of the muscle residue at zero hours.
Croatian: Linkomicin i jedan nepoznati metabolit sačinjavaju >50% mišićnih rezidua tijekom nultih sati.
English: Ireland Zoetis Belgium S.A 2nd Floor, Building 10
Croatian: Zoetis Belgium S.A 2nd Floor, Building
English: High concentrations of the active form are observed in the intestine.
Croatian: Visoke koncentracije djelatnog oblika zamijećene su u crijevima.
English: The European Commission referred the issue due to divergent national decisions having been taken by the Member States (EU/EEA) resulting in discrepancies in the product information for Lincocin and its associated names (thereafter called Lincocin).
Croatian: Europska komisija uputila je ovaj predmet na arbitražu zbog različitih nacionalnih odluka država članica (EU/EGP) koje su dovele do neslaganja u informacijama o VPM-u za Lincocin i pridružena imena (dalje u tekstu Lincocin).
English: The minimum effective dose would appear to be approximately 4 mg/kg per kg of body weight and selection of this dose would result in a maximal therapeutic index.
Croatian: Minimalna učinkovita doza bila bi približno 4 mg/kg po kg tjelesne težine i izbor ove doze rezultirao bi maksimalnim terapijskim indeksom.
English: After the end of the medication period, the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.
Croatian: Po završetku razdoblja liječenja, potrebno je sustav za opskrbu vodom očistiti na odgovarajući način, kako bi se izbjegao unos subterapijskih količina djelatne tvari.
English: The intake of medicated water depends on the physiological and clinical condition of the animals.
Croatian: Unos vode s veterinarsko medicinskim proizvodom ovisi o fiziološkom i kliničkom stanju životinja.
English: Shelf life of the veterinary medicinal product as packaged for sale: 5 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 5 godina.
English: If respiratory symptoms develop following exposure, seek medical advice and show this warning to the physician.
Croatian: Ako se nakon izlaganja razviju dišni simptomi potražite savjet liječnika i pokažite mu ovo upozorenje.
English: To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Croatian: Kako bi osigurali pravilno doziranje, potrebno je odrediti tjelesnu masu što je preciznije moguće da bi se izbjeglo subdoziranje.
English: However, as the dosing regimens and indications have not been extended, there is no increase in the exposure of the environment to the active substance.
Croatian: Međutim, kako dozni režimi i indikacije nisu prošireni, izloženost okoliša djelatnoj tvari nije povećana.
English: • The revised harmonised SPC of Lincocin contains the necessary information to ensure the safe and effective use of the product.
Croatian: • Revidirani usklađeni sažetak opisa svojstava za Lincocin sadrži informacije koje su potrebne da se osigura njegova sigurna i učinkovita primjena.
English: Similar results were observed following single oral doses of 4.4 and 11.0 mg/kg body weight in pigs.
Croatian: Slični rezultati uočeni su nakon jednokratne oralne doze od 4,4 i 11,0 mg/kg tjelesne mase u svinja.
English: Lincomycin may be either bactericidal or bacteriostatic.
Croatian: Linkomicin može biti ili baktericidan ili bakteriostatski.
English: The referral leads to full harmonisation of the product information.
Croatian: Arbitražni postupak rezultira potpunom usklađenošću informacija o lijeku.
English: For example, the results of the study conducted by the marketing authorisation holder in 2016 with 92 European isolates showed a MIC range of 0.5 μg/ml to >256 μg/ml and a tri-modal MIC distribution for lincomycin against C. perfringens (peaks at 1 μg/ml, 8 μg/ml and >256 μg/ml), with the majority of isolates falling outside the apparent wild-type population.
Croatian: Primjerice, rezultati ispitivanja koje je proveo nositelj odobrenja 2016. na 92 europska izolata pokazali su raspon MIK-a od 0,5 μg/ml do >256 μg/ml i tromodalnu distribuciju MIK-a za linkomicin protiv C. perfringens (vrhovi na 1 μg/ml, 8 μg/ml i >256 μg/ml), s tim da je većina izolata izvan populacije prividno divljeg tipa.
English: Animal species
Croatian: Životinjske vrste
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi iza oznake EXP.
English: Resistance can be a direct concern when affecting zoonotic pathogens such as Campylobacter and Enterococcus, or can be transferred horizontally to human pathogens via mobile genetic elements.
Croatian: Rezistencija može biti izravni razlog za zabrinutost kada utječe na zoonotske patogene kao što su Campylobacter i Enterococcus, a može se vodoravno prenijeti na ljudske patogene putem mobilnih genetskih elemenata.