FrancophonIA/ELRC3.0 huggingface dataset:
English: This summary is not intended to provide practical advice on how to use medicines containing capsicum.
Croatian: Svrha ovog sažetka nije pružanje praktičnih savjeta o načinu uporabe lijekova koji sadrže paprikin plod.
English: Information on the use and licensing of capsicum medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju lijekova koji sadrže paprikin plod u državama članicama EU-a treba zatražiti od nadležnih nacionalnih tijela.
English: Further information on the HMPC assessment of capsicum medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Dodatne informacije o HMPC-ovoj ocjeni lijekova koji sadrže paprikin plod, uključujući pojedinosti zaključaka Povjerenstva, nalaze se u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Any applications for the licensing of medicines containing capsicum have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže paprikin plod moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: The HMPC concluded that, on the basis of its well-established use, capsicum can be used for the relief of muscle pain, such as low back pain.
Croatian: HMPC je zaključio da se, na temelju dobro utvrđene primjene, paprikin plod može koristiti za ublažavanje mišićne boli, poput boli u donjem dijelu leđa.
English: Further information on the risks associated with capsicum medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više informacija o rizicima povezanim s lijekovima koji sadrže paprikin plod, uključujući odgovarajuće mjere opreza za njihovu sigurnu uporabu, nalazi se u monografiji u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Capsaicin is a selective agonist of the ‘transientreceptor-potential-vanilloid-1' (TRPV1) receptor.
Croatian: Kapsaicin je selektivan agonist receptora TRPV1 (engl. transient-receptor-potential-vanilloid-1).
English: The HMPC conclusions on the use of capsicum medicines relief of muscle pain are based on their ‘wellestablished use' in this condition.
Croatian: Zaključci HMPC-a o uporabi lijekova koji sadrže paprikin plod za ublažavanje mišićne boli temelje se na njihovoj „provjerenoj medicinskoj uporabi“ u navedenom stanju.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing capsicum.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže paprikin plod.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of capsicum.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske uporabe paprikinog ploda.
English: Capsicum medicines must not be used in patients allergic to other sources of capsaicin and capsaicinlike compounds (e.g. paprika or chilli) and must not be applied onto broken skin, wounds and eczema.
Croatian: Lijekovi koji sadrže paprikin plod ne smiju se koristiti u bolesnika koji su alergični na druge izvore kapsaicina i spojeve slične kapsaicinu (primjerice paprika ili čili) te se ne smiju primjenjivati na ispucanu kožu, rane i ekceme.
English: How does capsicum work as a medicine?
Croatian: Kako paprikin plod djeluje kao lijek?
English: Herbal medicines containing capsicum are usually available in a medicated plaster or in semi-solid forms to be applied to the skin (such as creams).
Croatian: Biljni lijekovi koji sadrže paprikin plod najčešće su dostupni u ljekovitim naljepcima (flasterima) ili u polukrutim oblicima za primjenu na kožu (poput krema).
English: What is capsicum?
Croatian: Što je paprikin plod?
English: Detailed instructions on how to use capsicum medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljne upute o načinu primjene lijekova koji sadrže paprikin plod kao i tko ih može koristiti dostupne su u uputi o lijeku priloženoj uz lijek.
English: What are the risks associated with capsicum medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže paprikin plod?
English: Capsicum medicines can cause reddening and a burning sensation on the areas of the skin where they are applied.
Croatian: Lijekovi koji sadrže paprikin plod mogu uzrokovati crvenilo i osjećaj pečenja na područjima kože na kojima se primjenjuju.
English: For more information about treatment with capsicum medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže paprikin plod pročitajte u uputi o lijeku priloženoj uz lijek, odnosno obratite se svojem liječniku ili ljekarniku.
English: Other information about capsicum medicines
Croatian: Ostale informacije o lijekovima koji sadrže paprikin plod
English: For practical information about using capsicum medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o uporabi lijekova koji sadrže paprikin plod bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: What evidence supports the use of capsicum medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže paprikin plod?
English: Capsicum is the common name for the fruits of the plant Capsicum annuum L. var. minimum (Miller) Heiser and Capsicum frutescens L. These are types of peppers that are cultivated or gathered to obtain the plant parts for medicinal use.
Croatian: Paprikin plod zajednički je naziv za plodove biljke Capsicum annuum L. var. minimum (Miller) Heiser i Capsicum frutescens L.
English: How are capsicum medicines approved in the EU?
Croatian: Kako se u Europskoj uniji odobravaju lijekovi koji sadrže paprikin plod?
English: Date of last renewal: 18/04/2016
Croatian: Datum zadnje obnove: 18/04/2016
English: The level of efficacy for other species may differ from that observed in cattle.
Croatian: Razina učinkovitosti u drugih vrsta može se razlikovati od one uočene kod goveda.
English: Rectal temperatures should then return to normal values.
Croatian: Rektalna temperatura trebala bi se zatim vratiti na normalne vrijednosti.
English: Interactions with other medical products and other forms of interaction:
Croatian: Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05/08/2011
Croatian: Datum prvog odobrenja: 05/08/2011
English: EU/2/11/130/002
Croatian: EU/2/11/130/001 EU/2/11/130/002 EU/2/11/130/003
English: Keep out of the sight and reachof children.
Croatian: Čuvati izvan pogleda i dosega djece.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari (uključujući adjuvanse) navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko-medicinskim proizvodima.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatna tvar koja se sastoji od tvari biološkog podrijetla, namijenjena je za stvaranje aktivne imunosti, na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
English: Adjuvants: Aluminium hydroxide (Al3+)
Croatian: Adjuvansi: Aluminijev hidroksid (Al3+)
English: 1st injection: from 2.5 months of age.
Croatian: 1. injekcija: nakon navršenih 2,5 mjeseci starosti.
English: Pharmacotherapeutic group: Inactivated viral vaccines - Bluetongue virus.
Croatian: IMUNOLOŠKA SVOJSTVA Farmakoterapijska grupa: inaktivirana virusna cjepiva - virus bolesti plavog jezika.
English: Shelf life after first opening the immediate packaging: use immediately after broaching.
Croatian: Rok valjanosti nakon prvog otvaranja unutarnjeg pakovanja: primijeniti odmah nakon otvaranja.
English: PACKAGE LEAFLET: Zulvac1 Bovis suspension for injection for cattle
Croatian: Zulvac 1 Bovis suspenzija za injekciju za goveda
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1 x 20ml, 1 x 100ml and 1 x 240ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija 1 x 20 ml, 1 x 100 ml i 1 x 240 ml
English: No information is available on the use of the vaccine in animals with maternally derived antibodies.
Croatian: Nisu dostupne informacije o primjeni cjepiva na životinjama kod kojih su antitijela prenesena s majke.
English: A slight to moderate increase of local reactions may commonly be observed after a 2-fold overdose lasting for a maximum of 56 days.
Croatian: Obično se može primijetiti blaga do umjerena lokalna reakcija nakon primjene dvostruke doze, a može potrajati najviše 56 dana.
English: Duration of immunity: 12 months after completion of the primary vaccination scheme.
Croatian: Trajanje imunosti: 12 mjeseci nakon završetka primarne sheme cijepljenja.
English: In this category of animals, the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
Croatian: U ovoj kategoriji životinja cjepivo bi trebalo primjenjivati samo u skladu s procjenom odgovornog veterinara o odnosu koristi i rizika i/ili u skladu s odlukama nacionalnog nadležnog tijela o trenutačnim smjernicama cijepljenja protiv virusa bolesti plavog jezika (engl.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. Once broached use immediately.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi poslije
English: The use in lactating animals is therefore not recommended.
Croatian: Stoga nije preporučena upotreba kod životinja u laktaciji.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of the immunological veterinary medicinal products on the whole or part of their territory if it is established that:
Croatian: Sukladno članku 71. Direktive 2001/82/EZ i Europskog Parlamenta i Vijeća s izmjenama i dopunama, države članice, u skladu s nacionalnim zakonodavstvom mogu zabraniti proizvodnju, uvoz, posjedovanje,
English: Onset of immunity: 15 days after completion of the primary vaccination scheme.
Croatian: Početak imunosti: 15 dana nakon završetka primarne sheme cijepljenja.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: a) The administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Croatian: kontrolu ili iskorjenjivanje bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živih životinja ili hrani ili drugim proizvodima dobivenim od tretiranih životinja. b) je bolest, za koju je proizvod namijenjen da pruži imunost, u velikoj mjeri odsutna s odnosnog područja.
English: Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1
Croatian: Djelatna tvar: Inaktivirani virus bolesti plavog jezika, serotip 1, soj BTV-1/ALG2006/01 E1
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml and 240ml
Croatian: PODACI KOJI SE NALAZE NA UNUTARNJEM PAKOVANJU Etiketa bočice od 100 ml i 240 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 20ml
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: No data is available on safety in lactating animals.
Croatian: Podaci o neškodljivosti za životinje u laktaciji nisu dostupni.
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Croatian: Ako se primjenjuje na ostalim domaćim ili divljim preživačima za koje se smatra da su izloženi infekciji, potreban je velik oprez.
English: For active immunisation of cattle from 2 and a half months of age for the prevention* of viraemia caused by Bluetongue Virus (BTV), serotypes 1.
Croatian: Za aktivnu imunizaciju goveda starijih od 2,5 mjeseca radi sprečavanja* viremije uzrokovane virusom plavog jezika (BTV), serotipa 1. *(Ciklična vrijednost (Ct) ≥ 36 validiranom metodom RT-PCR koja ukazuje da viralni genom nije prisutan).
English: ATCvet code: QI02AA08 To stimulate active immunity against Bluetongue Virus, serotype 1 in cattle.
Croatian: Za stimulaciju aktivne imunosti goveda protiv virusa bolesti plavog jezika, serotipa 1.
English: After second and third vaccination a rectal temperature increase of up to 1.3°C and 2.8°C respectively may occur very commonly one day after the injection and then rectal temperatures return to normal values.
Croatian: Nakon drugog i trećeg cijepljenja može vrlo često doći do povišenja rektalne temperature od 1,3 °C do 2,8 °C jedan dan nakon cijepljenja, a zatim se rektalna temperatura vraća na normalne vrijednosti.
English: 6.5 Nature and composition of immediate packaging
Croatian: 6.5 Osobine i sastav unutarnjeg pakovanja Kartonska kutija s jednom staklenom bočicom tipa
English: 4.2 Indications for use, specifying the target species For active immunisation of cattle from 2 and a half months of age for the prevention* of viraemia caused by Bluetongue Virus (BTV), serotype 1.
Croatian: Za aktivnu imunizaciju goveda starijih od 2,5 mjeseca radi sprečavanja* viremije uzrokovane virusom bolesti plavog jezika (BTV), serotipa 1. *(Ciklična vrijednost (Ct) ≥ 36 validiranom metodom RT-PCR koja ukazuje da viralni genom nije prisutan).
English: Ctra.
Croatian: EXP.
English: After administration of a two-fold overdose, a rectal temperature increase up to 2.1 ºC may occur 1 day after the injection and then rectal temperatures return to normal values.
Croatian: Jedan dan nakon primjene dvostruke doze može doći do prolaznog povišenja rektalne temperature do 2,1°C koja se nakon toga vraća u normalu.
English: After first vaccination a rectal temperature increase of up to 1.6°C may occur very commonly the 3rd day after the injection.
Croatian: NUSPOJAVE Treći dan nakon prvog cijepljenja, vrlo često može doći do povišenja rektalne temperature do 1,6 °C.
English: WITHDRAWAL PERIOD(S) Zero days.
Croatian: 4.11 Karencija Nula dana.
English: The recommended dose of Stocrin for adults is 600 mg once a day.
Croatian: Preporučena doza lijeka Stocrin za odrasle osobe je 600 mg jedanput na dan.
English: In patients aged 3 to 17 years, the dose depends on body weight.
Croatian: U bolesnika u dobi od tri do 17 godina doza ovisi o tjelesnoj težini.
English: The full EPAR for Stocrin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Stocrin nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Stocrin
Croatian: Ostale informacije o lijeku Stocrin
English: What measures are being taken to ensure the safe and effective use of Stocrin?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Stocrin?
English: What is Stocrin and what is it used for?
Croatian: Što je Stocrin i za što se koristi?
English: It is recommended that Stocrin be taken on an empty stomach and without food, preferably at bedtime.
Croatian: Preporučuje se da se Stocrin uzme na prazan želudac i bez hrane, po mogućnosti prije odlaska na počinak.
English: This is a summary of the European public assessment report (EPAR) for Stocrin.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Stocrin.
English: The dose of Stocrin may need to be adjusted in patients taking certain other medicines at the same time.
Croatian: Doza lijeka Stocrin možda će se trebati prilagoditi u bolesnika koji istovremeno uzimaju određene lijekove.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stocrin on 28 May 1999.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Stocrin u promet koje je na snazi u Europskoj uniji od 28. svibnja 1999.
English: Stocrin can affect the electrical activity of the heart and so must also not be used in patients with heart problems such as changes in heart rhythm and activity, slow heart rate or heart failure or other conditions that can affect the heart's electrical activity, or who have close relatives that have died suddenly from a heart condition or were born with heart problems.
Croatian: Lijek Stocrin može utjecati na električnu aktivnost srca, stoga se također ne smije primjenjivati u bolesnika s problemima sa srcem kao što su promjene srčanog ritma i aktivnosti, usporen rad srca ili zatajenje srca, bolesnika s drugim bolestima koje mogu utjecati na električnu aktivnost srca, ili bolesnika čiji su članovi bliske rodbine iznenada umrli od bolesti srca ili su rođeni sa srčanim problemima.
English: What are the risks associated with Stocrin?
Croatian: Koji su rizici povezani s lijekom Stocrin?
English: Why is Stocrin approved?
Croatian: Zašto je lijek Stocrin odobren?
English: In all of the studies, the main measure of effectiveness was the number of patients with undetectable levels of HIV-1 in their blood (viral loads) after 24 or 48 weeks of treatment:
Croatian: Glavno mjerilo učinkovitosti u svim ispitivanjima bio je broj bolesnika s nemjerljivom razinom virusa HIV-1 u krvi (virusno opterećenje) nakon 24 ili 48 tjedana liječenja:
English: It is not intended to provide practical advice on how to use Stocrin.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Stocrin.
English: The most common side effect with Stocrin (seen in more than 1 patient in 10) is rash.
Croatian: Najčešća nuspojava lijeka Stocrin (uočena u više od 1 na 10 bolesnika) jest osip.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stocrin have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Stocrin nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Stocrin is also commonly associated with dizziness, headache, nausea (feeling sick) and tiredness.
Croatian: Liječenje lijekom Stocrin također je često povezano s vrtoglavicom, glavoboljom, mučninom (osjećaj slabosti) i umorom.
English: It is available as capsules, tablets and oral solution and must be given in combination with other antiviral medicines.
Croatian: Dostupan je u obliku kapsula, tableta i oralne otopine, a mora se primjenjivati u kombinaciji s drugim antivirusnim lijekovima.
English: Stocrin does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Croatian: Lijekom Stocrin ne liječi se infekcija HIV-om ni AIDS, no njegovom primjenom može se obuzdavati narušavanje imunosnog sustava i izbjeći razvoj infekcija i bolesti povezanih s AIDS-om.
English: By blocking this enzyme, Stocrin, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Blokiranjem ovog enzima, Stocrin, koji se uzima zajedno s drugim antivirusnim lijekovima, smanjuje koncentraciju HIV-a u krvi te je održava na niskoj razini.
English: The active substance in Stocrin, efavirenz, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Croatian: Djelatna tvar lijeka Stocrin, efavirenz, jest nukleozidni inhibitor reverzne transkriptaze (NNRTI).
English: Similarly, it must not be used in patients with altered levels of salts (electrolytes) such as potassium or magnesium in their blood.
Croatian: Slično tome, lijek se ne smije primjenjivati u bolesnika s promijenjenim razinama soli u krvi (elektrolita), kao što su kalij ili magnezij.
English: Stocrin must be avoided if patients are taking certain medicines because it can increase their side effects or reduce their effectiveness, or because the combination may increase effects on the heart.
Croatian: U bolesnika koji uzimaju određene lijekove, primjena lijeka Stocrin mora se izbjegavati jer može povećati nuspojave tih lijekova ili umanjiti njihovu djelotvornost, ili zbog toga što kombinacija lijekova može imati pojačane učinke na srce.
English: It also noted that there is little information on the benefits of treatment that includes a protease inhibitor in patients who have been treated with Stocrin in the past but which stopped working, although there is no evidence to suggest that protease inhibitors may not work in these patients.
Croatian: Također je uočeno da nema dovoljno informacija o koristima liječenja koje uključuje inhibitor proteaze u bolesnika koji su prethodno liječeni lijekom Stocrin ali je liječenje prestalo djelovati, iako ne postoje dokazi koji ukazuju na to da inhibitori proteaze ne bi djelovali u tih bolesnika.
English: Stocrin must not be used in patients with severe liver disease.
Croatian: Lijek Stocrin ne smije se primjenjivati u bolesnika koji boluju od teške bolesti jetre.
English: Taking Stocrin with food may lead to an increase in the frequency of side effects.
Croatian: Uzimanje lijeka Stocrin s hranom može dovesti do povećane učestalosti nuspojava.
English: The European Medicines Agency decided that Stocrin's benefits are greater than its risks in antiviral combination treatment of HIV-infected adults, adolescents, and children three years of age and older and recommended that it be approved for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Stocrin nadmašuju s njim povezane rizike u antivirusnom kombiniranom liječenju odraslih osoba, adolescenata i djece u dobi od tri godine i starije koji su zaraženi HIV-om, te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
English: For patients who are unable to swallow the capsules or tablets, Stocrin can be given using the oral solution.
Croatian: U bolesnika koji ne mogu progutati kapsule ili tablete lijek Stocrin može se primjenjivati u obliku oralne otopine.