FrancophonIA/ELRC3.0 huggingface dataset:
English: For Grade 3 or 4 transaminase or total bilirubin elevation, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju povišenja razine transaminaza ili ukupnog bilirubina 3. ili 4. stupnja, liječenje nivolumabom ili nivolumabom u kombinaciji s ipilimumabom mora se trajno prekinuti i treba uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 1 do 2 mg/kg/dan metilprednizolona.
English: For Grade 3 or 4 pneumonitis, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju pneumonitisa 3. ili 4. stupnja, liječenje nivolumabom ili nivolumabom u kombinaciji s ipilimumabom mora se trajno prekinuti i treba uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 2 do 4 mg/kg/dan metilprednizolona.
English: Patients with a baseline performance score ≥2, active brain metastases or leptomeningeal metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the clinical trials of urothelial carcinoma (see sections 4.5 and 5.1).
Croatian: U klinička ispitivanja kod karcinoma urotela nisu bili uključeni bolesnici s početnim funkcionalnim statusom ≥ 2, aktivnim metastazama u mozgu ili leptomeningealnim metastazama, aktivnom autoimunom bolešću ili medicinskim stanjima koja su zahtijevala primjenu sistemskih imunosupresiva (vidjeti dijelove 4.5 i 5.1).
English: The frequency of adverse events in the cardiac disorders system organ class regardless of causality was higher in the nivolumab group than in the chemotherapy group in post-CTLA4/BRAF inhibitor metastatic melanoma population.
Croatian: U populaciji bolesnika s metastatskim melanomom prethodno liječenih CTLA4/BRAF inhibitorom, učestalost nuspojava klasificiranih u skupinu srčanih poremećaja, neovisno o uzročnosti, bila je viša u skupini liječenoj nivolumabom nego u onoj koja je primala kemoterapiju.
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of advanced or metastatic non-squamous NSCLC were evaluated in a phase 3, randomised, open-label study (CA209057).
Croatian: Sigurnost i djelotvornost nivolumaba u dozi od 3 mg/kg kao monoterapije za liječenje uznapredovalog ili metastatskog neplanocelularnog NSCLC-a ispitivane su u randomiziranom, otvorenom ispitivanju faze 3 (CA209057).
English: If applicable, dilute with the required volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.
Croatian: Ako je potrebno, razrijedite ga potrebnim volumenom otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%) ili otopine glukoze za injekciju od 50 mg/ml (5%).
English: Odds ratio (95% CI) p-value
Croatian: Omjer izgleda (95% CI) p-vrijednost
English: For Grade 4 serum creatinine elevation, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju povišenja razine kreatinina 4. stupnja, liječenje nivolumabom ili nivolumabom u kombinaciji s ipilimumabom mora se trajno prekinuti i treba uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 1 do 2 mg/kg/dan metilprednizolona.
English: CA209205 Cohort Ba and CA209039
Croatian: Kohorta Ba iz ispitivanja CA209205 i bolesnici iz ispitivanja CA209039
English: Patients with a baseline performance score ≥ 2, active brain metastases or autoimmune disease, symptomatic interstitial lung disease, and patients who had been receiving systemic immunosuppressants prior to study entry were excluded from the pivotal clinical trials of NSCLC (see sections 4.5 and 5.1).
Croatian: U pivotalna klinička ispitivanja primjene kod NSCLC-a nisu bili uključeni bolesnici s početnim funkcionalnim statusom od ≥ 2, aktivnim metastazama u mozgu, autoimunom bolešću ili simptomatskom intersticijskom plućnom bolešću, kao ni bolesnici koji su prije uključivanja u ispitivanje primali sistemske imunosupresive (vidjeti dijelove 4.5 i 5.1).
English: Nivolumab+Ipilimumab (events: 63/155), median and 95% CI: N.A. (39.06, N.A.) ──Δ─── Nivolumab (events: 71/171), median and 95% CI: N.A. (40.21, N.A.) Ipilimumab (events: 103/164), median and 95% CI: 21.49 months (16.85, 29.08)
Croatian: Nivolumab + ipilimumab (događaji: 63/155), medijan i 95% CI: N.D. (39,06; N.D.) ──Δ─── Nivolumab (događaji: 71/171), medijan i 95% CI: N.D. (40,21; N.D.)
English: nivolumab Median OS (95% CI)
Croatian: nivolumab Medijan OS-a (95% CI)
English: The primary efficacy outcome measure was OS. Key secondary efficacy outcome measures were investigator-assessed PFS and ORR.
Croatian: Ključne sekundarne mjere ishoda za djelotvornost bile su PFS i ORR prema ocjeni ispitivača.
English: Severe nephritis and renal dysfunction have been observed with monotherapy treatment or nivolumab in combination with ipilimumab (see section 4.8).
Croatian: Kod liječenja nivolumabom u monoterapiji ili u kombinaciji s ipilimumabom primijećeni su težak nefritis i disfunkcija bubrega (vidjeti dio 4.8).
English: Severe hepatitis has been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8).
Croatian: Kod liječenja nivolumabom u monoterapiji ili u kombinaciji s ipilimumabom primijećen je težak hepatitis (vidjeti dio 4.8).
English: For symptomatic diabetes, nivolumab or nivolumab in combination with ipilimumab should be withheld, and insulin replacement should be initiated as needed.
Croatian: U slučaju simptomatskog dijabetesa, potrebno je odgoditi primjenu nivolumaba ili nivolumaba u kombinaciji s ipilimumabom i po potrebi uvesti inzulinsku nadomjesnu terapiju.
English: Hazard ratio 95% CI p-value
Croatian: Omjer hazarda (95% CI) p-vrijednost
English: Tell your doctor if you are on a low-sodium (low-salt) diet before you are given OPDIVO.
Croatian: Prije nego primite lijek OPDIVO, obavijestite svog liječnika ako ste na dijeti s niskim unosom natrija (soli).
English: Inflammation of the muscles such as myocarditis (inflammation of the heart muscle), myositis (inflammation of the muscles) and rhabdomyolysis (stiffness in muscles and joints, muscle spasm).
Croatian: Znakovi i simptomi teške kožne reakcije mogu uključivati osip, svrbež i ljuštenje kože (koje može biti smrtonosno). upalu mišića, kao što su miokarditis (upala srčanog mišića), miozitis (upala mišića) i rabdomioliza (ukočenost mišića i zglobova, grčenje mišića).
English: In-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
Croatian: Infuzija lijeka OPDIVO kompatibilna je sa: spremnicima od PVC-a poliolefinskim spremnicima staklenim bocama infuzijskim kompletima od PVC-a in-line filtrima koji imaju polietersulfonske membrane s veličinom pora od 0,2 µm do 1,2 µm
English: Sunitinib (events: 209/422), median and 95.0% CI: 26.97 (22.08, 34.83)
Croatian: Broj ispitanika pod rizikom Nivolumab + ipilimumab Sunitinib Nivolumab + ipilimumab (događaji: 166/425), medijan i 95,0% CI: ND (32,49; ND) Sunitinib (događaji: 209/422), medijan i 95,0% CI: 26,97 (22,08; 34,83)
English: Objective response (95% CI) Odds ratio (vs. ipilimumab) (99.5% CI) Complete response (CR) Partial response (PR) Stable disease (SD) Duration of response Median (range), months
Croatian: Potvrđen objektivan odgovor (IRRC) (95% CI) Potpun odgovor Djelomičan odgovor Stabilna bolest
English: 99.79% CI 95% CI
Croatian: Ukupno preživljenje Događaji Omjer hazarda 99,79% CI 95% CI p-vrijednost
English: Problems with your hormone producing glands (including the pituitary, the thyroid, the parathyroid and adrenal glands) that may affect how these glands work.
Croatian: Znakovi i simptomi mogu uključivati odstupanja u nalazima testova bubrežne funkcije ili smanjen volumen mokraće. tegobe sa žlijezdama koje proizvode hormone (uključujući hipofizu, štitnjaču, doštitne i nadbubrežne žlijezde), koje mogu utjecati na rad tih žlijezda.
English: Patients with a baseline performance score ≥ 2, active brain metastases or leptomeningeal metastases, autoimmune disease, and patients who had been receiving systemic immunosuppressants prior to study entry were excluded from the pivotal clinical trials of nivolumab or nivolumab in combination with ipilimumab (see sections 4.5 and 5.1).
Croatian: U pivotalna klinička ispitivanja nivolumaba ili nivolumaba u kombinaciji s ipilimumabom nisu bili uključeni bolesnici s početnim funkcionalnim statusom od ≥ 2, aktivnim metastazama u mozgu, ili leptomeningealnim metastazama, autoimunom bolešću, kao ni bolesnici koji su prije uključivanja u ispitivanje primali sistemske imunosupresive (vidjeti dijelove 4.5 i 5.1).
English: The primary efficacy outcome measure was OS. Key secondary efficacy outcome measures were investigator-assessed ORR and PFS.
Croatian: Ključne sekundarne mjere ishoda za djelotvornost bile su ORR i PFS prema ocjeni ispitivača.
English: • Adverse Reaction Management Guide
Croatian: • Vodič za zbrinjavanje nuspojava
English: ECOG PS 2 CNS Metastasis
Croatian: Sveukupno Funkcionalni ECOG status 2
English: Bristol-Myers Squibb Kft. Tel: +371 67708347
Croatian: Bristol-Myers Squibb spol. s r.o. Tel: +385 1 2078 508
English: Skin and subcutaneous tissue disorders Very common rashe, pruritus rashe, pruritus
Croatian: Poremećaji kože i potkožnog tkiva Vrlo često osipe, svrbež
English: Grade 4 rash
Croatian: Osip 4. stupnja
English: Bristol-Myers Squibb B.V. Tel: + 31 (0)30 300 2222
Croatian: Bristol-Myers Squibb spol. s r.o. Tel: + 386 1 2355 100
English: How to use OPDIVO 4.
Croatian: 3. Kako primjenjivati OPDIVO
English: Gastrointestinal disorders Very common diarrhoea, nausea Common colitisa, stomatitis, vomiting, abdominal pain, constipation, dry mouth Uncommon pancreatitis, gastritis Rare duodenal ulcer
Croatian: Manje često perforacija crijevaa, gastritis, duodenitis gastritis Poremećaji kože i potkožnog tkiva Vrlo često osipe, svrbež osipe, svrbež
English: Uncommon vasculitis Respiratory, thoracic and mediastinal disorders Common pneumonitisa,c, dyspnoeaa, cough Uncommon pleural effusion Rare lung infiltration
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Često pneumonitisa,c, dispnejaa, kašalj
English: Overall survival Events Hazard ratioa (95% CI) p-valueb Median (95% CI) (months) Rate (95% CI) at 6 months Rate (95% CI) at 12 months Rate (95% CI) at 18 months Progression-free survival Events Hazard ratio 95% CI p-value Median (95% CI) (months) Rate (95% CI) at 6 months Rate (95% CI) at 12 months Confirmed objective responsec (95% CI) Odds ratio (95% CI) Complete response (CR) Partial response (PR) Stable disease (SD) Median time to response Months (range) Median duration of response Months (range)
Croatian: Raspon Trajanje odgovora kod djelomične remisije (mjeseci) Medijan (95% CI) Raspon Medijan vremena do odgovora Mjeseci (raspon) Medijan trajanja praćenja Mjeseci (raspon) Preživljenje bez progresije bolesti Stopa (95% CI) u 12. mjesecu Stopa (95% CI) u 18. mjesecu
English: For Grade 4 diarrhoea or colitis, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju proljeva ili kolitisa 4. stupnja, liječenje nivolumabom ili nivolumabom u kombinaciji s ipilimumabom mora se trajno prekinuti i treba uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 1 do 2 mg/kg/dan metilprednizolona.
English: Decreased function of the parathyroid gland
Croatian: Oštećenje funkcije bubrega
English: Patients with any history of or concurrent brain metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the clinical trials of nivolumab or nivolumab in combination with ipilimumab (see sections 4.5 and 5.1).
Croatian: U klinička ispitivanja nivolumaba ili nivolumaba u kombinaciji s ipilimumabom nisu bili uključeni bolesnici s prethodnim ili postojećim metastazama u mozgu, aktivnom autoimunom bolešću ili medicinskim stanjima koja su zahtijevala primjenu sistemskih imunosupresiva (vidjeti dijelove 4.5 i 5.1).
English: Hazard ratioa 99.8% CI p-valueb, c
Croatian: 99,1% CI p-vrijednostb,h
English: Not known tumour lysis syndromei Hepatobiliary disorders Common hepatitisc hepatitisc
Croatian: Nepoznato sindrom tumorske lizei
English: Bristol-Myers Squibb Kft. Tel: + 40 (0)21 272 16 00
Croatian: Bristol-Myers Squibb Polska Sp. z o.o. Tel.: + 48 22 2606400
English: n ipilimumab Median OS (95% CI)
Croatian: n ipilimumab Medijan OS-a (95% CI)
English: Progression-free survival Events
Croatian: Preživljenje bez progresije bolesti
English: Diabetes (symptoms include excessive thirst, the passing of a greatly increased amount of urine, increase in appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable and generally unwell) or diabetic ketoacidosis (acid in the blood produced from diabetes).
Croatian: Znakovi i simptomi koji pokazuju da te žlijezde ne rade pravilno mogu uključivati izrazit umor, promjenu tjelesne težine ili glavobolju, snižene razine kalcija u krvi te smetnje vida. šećernu bolest (simptomi uključuju prekomjernu žeđ, mokrenje uvelike povećane količine mokraće, pojačan tek praćen gubitkom tjelesne težine, osjećaj umora, omamljenost, slabost, depresiju, razdražljivost i opće loše osjećanje) ili dijabetičku ketoacidozu (kiselinu u krvi koja nastaje kao posljedica šećerne bolesti). upalu kože, koja može uzrokovati tešku kožnu reakciju (poznatu pod nazivom toksična epidermalna nekroliza i Stevens-Johnsonov sindrom).
English: Not known pericardial disordersj Vascular disorders Common hypertension hypertension
Croatian: Nepoznato perikardijalni poremećajij Krvožilni poremećaji
English: Overall survivald
Croatian: Ukupno preživljenje Medijan
English: Nivolumab monotherapy should be withheld for Grade 3 diarrhoea or colitis, and corticosteroids initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju proljeva ili kolitisa 3. stupnja, potrebno je odgoditi primjenu nivolumaba u monoterapiji i uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 1 do 2 mg/kg/dan metilprednizolona.
English: Skin and subcutaneous tissue disorders Very common rashe, pruritus Common vitiligo, dry skin, erythema, alopecia Uncommon erythema multiforme, psoriasis, rosacea, urticaria Rare toxic epidermal necrolysisa,f, Stevens-Johnson syndromea,f Musculoskeletal and connective tissue disorders Common musculoskeletal paing, arthralgia Uncommon polymyalgia rheumatica, arthritis Rare
Croatian: Rijetko toksična epidermalna nekrolizaa,f, Stevens-Johnsonov sindroma,f Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često mišićno-koštana bolg, artralgija
English: Progression Free Survival per Investigator (Months) Number of Subjects at Risk Nivolumab + Ipilimumab
Croatian: Preživljenje bez progresije bolesti prema ispitivaču (mjeseci) Broj ispitanika pod rizikom
English: Everolimus 10 mg (events: 215/411), median and 95% CI: 19.55 (17.64, 23.06)
Croatian: Ipilimumab (događaji: 103/164), medijan i 95% CI: 21,49 mjeseci (16,85; 29,08)
English: OTHER
Croatian: Primjena
English: Ulcer of the small intestines
Croatian: Rijetko ulkus dvanaesnika
English: Immune-related adverse reaction leading to permanent discontinuation Pneumonitis
Croatian: Imunološki uzrokovan nefritis i bubrežna disfunkcija
English: Allergic reaction, reactions related to the infusion of the medicine Decreased secretion of hormones produced by adrenal glands (glands situated above the kidneys), underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain, swelling of the thyroid gland, diabetes Dehydration
Croatian: Imunološki uzrokovana nuspojava koja je dovela do trajnog prekida liječenja Pneumonitis Kolitis Hepatitis Nefritis i bubrežna disfunkcija Endokrinopatije Kožne reakcije Preosjetljivost/reakcija na infuziju Imunološki uzrokovana nuspojava koja je zahtijevala visoke doze kortikosteroidaa,b
English: Progression- free survival Rate (95% CI) at 12 months Rate (95% CI) at 18 months Overall survival
Croatian: Stopa (95% CI) u 12. mjesecu Stopa (95% CI) u 18. mjesecu
English: Nivolumab + ipilimumab (events: 166/425), median and 95.0% CI: NA (32.49, NA)
Croatian: Ipilimumab (događaji: 129/164), medijan i 95% CI: 3,91 (2,83; 4,17)
English: This overview was last updated in February 2019.
Croatian: Pregled informacija posljednji je put ažuriran u veljači 2019.
English: The medicine is available as a spot-on solution in 2 different concentrations (6% and 12%) and in tubes of various strengths (15, 30, 45, 60, 120, 240 and 360 mg).
Croatian: VMP je dostupan u obliku otopine za nakapavanje u dvije različite koncentracije (6 % i 12 %) i u kapaljkama različitih jačina (15, 30, 45, 60, 120, 240 i 360 mg).
English: Chanhold (selamectin)
Croatian: Chanhold (selamektin)
English: Further information on Chanhold can be found on the Agency's website: ema.europa.eu/Find medicines/veterinary/EPAR/chanhold.
Croatian: Više informacija o VMP-u Chanhold nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicines/veterinary/EPAR/chanhold.
English: The package leaflet contains detailed information on dosage and duration of treatment.
Croatian: Uputa o VMP-u sadržava detaljne informacije o doziranju i trajanju liječenja.
English: Information on the reference medicine can also be found on the Agency's website.
Croatian: Informacije o referentnom VMP-u također se nalaze na internetskim stranicama Agencije.
English: Selamectin activates special proteins called ‘chloride channels' on the surface of nerve and muscle cells of the parasite, allowing charged chloride particles to enter nerve cells and disrupting their normal electrical activity.
Croatian: Selamektin aktivira posebne bjelančevine pod nazivom „kloridni kanali” na površini živčanih i mišićnih stanica parazita, omogućujući nabijenim česticama klorida da uđu u živčane stanice i ometaju njihovu normalnu električnu aktivnost.
English: The strength used and the number of administrations depend on the weight and species of the animal being treated, and the type of parasite.
Croatian: Primijenjena jačina i broj primjena ovisi o težini i vrsti životinje koja se liječi te o vrsti parazita.
English: Chanhold received a marketing authorisation valid throughout the EU on 17 April 2019.
Croatian: VMP Chanhold dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 17/04/2019.
English: As for every medicine, the company provided studies on the quality of Chanhold.
Croatian: Kao i za svaki VMP, tvrtka je dostavila ispitivanja o kvaliteti VMP-a Chanhold.
English: This means that Chanhold contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Stronghold.
Croatian: To znači da Chanhold sadrži istu djelatnu tvar i djeluje na isti način kao i „referentni VMP” koji je već odobren u Europskoj uniji (EU) pod nazivom Stronghold.
English: There was no need for ‘bioequivalence' studies to investigate whether Chanhold is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Croatian: Nisu bila potrebna ispitivanja „bioekvivalencije” kako bi se istražilo apsorbira li se VMP Chanhold slično referentnom lijeku da bi se postigla ista razina djelatne tvari u krvi.
English: What is Chanhold and what is it used for?
Croatian: Što je Chanhold i za što se primjenjuje?
English: Other information about Chanhold
Croatian: Ostale informacije o VMP-u Chanhold
English: What are the benefits and risks of Chanhold?
Croatian: Koje su koristi i rizici od VMP-a Chanhold?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Chanhold has been shown to be comparable to Stronghold.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da je VMP Chanhold usporediv s VMP-om Stronghold.
English: This is because the composition of Chanhold is comparable to the reference medicine and when applied to the skin, the active substance in both products is expected to be absorbed in the same way.
Croatian: To je zbog toga što je sastav VMP-a Chanhold sličan sastavu referentnog lijeka i kada se primjenjuje na kožu, očekuje se da se djelatna tvar kod oba lijeka apsorbira na isti način.
English: Chanhold contains selamectin, which is an antiparasitic medicine that belongs to the ‘avermectin' class.
Croatian: Chanhold sadrži selamektin, lijek protiv parazita koji pripada razredu avermektina.
English: An overview of Chanhold and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Chanhold i zašto je odobren u EU-u
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Stronghold, and do not need to be repeated for Chanhold.
Croatian: Ispitivanja koristi i rizika od djelatne tvari u odobrenim primjenama već su provedena s referentnim VMP-om Stronghold i stoga ih nije potrebno ponavljati za VMP Chanhold.
English: It can also be used as part of a treatment for flea allergy dermatitis (skin inflammation), to prevent heartworm disease in cats and dogs, to treat ear mites in cats and dogs, to treat adult intestinal roundworms and intestinal hookworms in cats, to treat adult intestinal roundworms in dogs, to treat biting lice infestations in cats and dogs, to treat sarcoptic mange (scabies) in dogs.
Croatian: Može se primjenjivati i kao dio liječenja alergijskog dermatitisa (upale kože) uzrokovanog buhama, za sprječavanje bolesti srčanog crva u pasa i mačaka, za liječenje infestacije ušnim šugarcem u pasa i mačaka, za liječenje infestacije odraslim crijevnim oblićima i invazije crijevnim udičastim crvima u mačaka, za liječenje infestacije odraslim crijevnim oblićima u pasa, za liječenje infestacije paušima u pasa i mačaka, za liječenje sarkoptoze (šuge) u pasa.
English: Why is Chanhold authorised in the EU?
Croatian: Zašto je VMP Chanhold odobren u EU-u?
English: Chanhold is an antiparasitic medicine used to treat and prevent infestations with parasites that live on the skin or in the fur of cats and dogs, such as fleas and mites, as well as treating worm parasites that live inside the body.
Croatian: Chanhold je antiparazitski VMP koji se primjenjuje za liječenje i sprječavanje infestacija parazitima koji žive na koži ili u dlaci pasa i mačaka, kao što su buhe i šugarci, te oblićima koji žive unutar tijela.
English: Because Chanhold is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Chanhold generički VMP, smatra se da su njegove koristi i rizici isti kao i oni referentnog VMP-a.
English: Therefore, the Agency's view was that, as for Stronghold, the benefit of Chanhold outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je mišljenje Agencije da korist od VMP-a Chanhold, kao i kod VMP-a Stronghold, nadmašuje utvrđeni rizik te da može biti odobren za primjenu u EU-u.
English: How does Chanhold work?
Croatian: Kako djeluje Chanhold?
English: Chanhold contains the active substance selamectin and is a ‘generic medicine'.
Croatian: Chanhold sadrži djelatnu tvar selamektin te je „generički lijek”.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Chanhold, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava kao i u uputi o VMP-u Chanhold nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: EMA/152732/2019
Croatian: Chanhold (selamectin) EMA/254992/2019
English: For more information about using Chanhold, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a Chanhold pogledajte uputu o VMP-u odnosno obratite se veterinaru ili ljekarniku.