natgillin/translations-raw huggingface dataset:
Rapilysin 10 U powder and solvent for solution for injection. 
IME ZDRAVILA Rapilysin 10 enot prašek in vehikel za raztopino za injiciranje
How to store Rapilysin 
Shranjevanje zdravila Rapilysin
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 29. avgust 1996
In the event of overdosage there may be an increased risk of bleeding. 
Če ste prejeli večji odmerek zdravila Rapilysin kot bi smeli: Pri prevelikem odmerjanju morda obstaja povečano tveganje za krvavitev.
Rapilysin 10 U powder and solvent for solution for injection Reteplase Intravenous use 
Navodilo za uporabo Rapilysin 10 enot prašek in vehikel za raztopino za injiciranje reteplaza
Package leaflet: Information for the user Rapilysin 10 U powder and solvent for solution for injection reteplase 
IME ZDRAVILA IN POT(I) UPORABE Rapilysin 10 enot prašek in vehikel za raztopino za injiciranje reteplaza za intravensko uporabo
Readministration 
Ponovno dajanje
METHOD AND ROUTE(S) OF ADMINISTRATION 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo
Contents of the pack and other information What Rapilysin contains 
Shranjevanje zdravila Rapilysin Vsebina pakiranja in dodatne informacije
Powder and solvent for injection (contains 2x [0.56 g of powder in a vial and 10 ml solvent in a prefilled syringe with reconstitution spike and needle]) 
FARMACEVTSKA OBLIKA IN VSEBINA Prašek in vehikel za injiciranje (vsebina: dve viali z 0,56 g praška, dve napolnjeni injekcijski brizgi z
6.6 Special precautions for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Poročali so o inkompatibilnosti med nekaterimi napolnjenimi steklenimi injekcijskimi brizgami
Cardiac disorders3 
Srčne bolezni3
INFORMATION IN BRAILLE 
OVOJNINAH Nalepka na viali
Because thrombolytic therapy increases the risk of bleeding, reteplase is contra-indicated in the following situations: - known haemorrhagic diathesis - patients with current concomitant therapy with oral anticoagulants (e.g. warfarin sodium) - intracranial neoplasm, arteriovenous malformation or aneurysm - neoplasm with increased bleeding risk - history of cerebrovascular accident - recent (< 10 days) prolonged and vigorous external heart massage - severe uncontrolled hypertension - active peptic ulceration - portal hypertension (oesophageal varices) - severe liver or renal dysfunction - acute pancreatitis, pericarditis, bacterial endocarditis 
- cerebrovaskularni inzult v preteklosti, - nedavna (< 10 dni) podaljšana in intenzivna zunanja masaža srca, - huda nenadzorovana hipertenzija,
1 vial + 1 ampoule l t o r 
1 viala + 1 ampula o ā
Fill volume (concentration) 
Volumen polnjenja (koncentracija)
Package size 
Velikost pakiranj
Invented name 
Številka EMA Izmišljeno ime
1 vial + 1 sachet 
1 viala + 1 vrečica
Immediate Packaging 
Velikost pakiranja:
Strength Pharmaceutical Form 
EU Številka Zaščiteno ime Jakost Farmacevtska oblika
--¹ Each dose of vaccine suspension (3 ml) contains: 
Vsak odmerek suspenzije za cepljenje (3 ml) vsebuje: − skupaj 1.25x1011 bakterij naslednjih sevov:
Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated) 
Vibrio cholerae O1 Inaba, biotip El Tor (inaktiviran s formalinom)
Content (concentration) 
Vsebina
Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated) 
Vibrio cholerae O1 Ogawa, klasični biotip (inaktiviran s toploto)
Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 31.25x109 bacteria - Recombinant cholera toxin B subunit (rCTB) 1 mg 
− Rekombinantna podenota toksina kolera B (rCTB)
Prolonged-release tablet Oral use blister (OPA/Alu/DES/PE-Alu) Initiation pack: 21 tablets (7 x 0.26 mg + 
0,26 mg + 0,52 mg + 1,05 mg tableta s podaljšanim sproščanjem začetno pakiranje: 21 tablet (7 x 0,26 mg + 7 x 0,52 mg + 7 x
The procedure was concluded and on 16 March 2015 the European Commission adopted a Decision 
Postopek se je zaključil in 16. marca 2015 je Evropska komisija sprejela sklep
Indications for prevention and prophylaxis can no longer be justified. 
Indikaciji za preprečevanje in profilakso ne moreta biti več utemeljeni.
programmes and thus compromises public health and food safety. 
in tako ogrozi javno zdravje in varnost hrane.
isolates from pigs and chickens with up to 77% classified as resistant. 
iz prašičev in piščancev, pri čemer jih je bilo do 77 % razvrščenih med odporne.
Quality, target animal safety, user safety, environmental risk and residues were not assessed in this referral procedure. 
Kakovost, varnost ciljnih živalskih vrst, varnost uporabnikov, okoljsko tveganje in ostanki se v tem napotitvenem postopku niso ocenjevali.
Following a request from the European Commission, in July 2013 the CVMP and CHMP adopted scientific advice and detailed considerations on colistin 
Na zahtevo Evropske komisije sta odbora CVMP in CHMP julija 2013 sprejela znanstveno mnenje in podrobne ocene o kolistinu
Romania COOPHAVET SAS Herblon 
Romunija COOPHAVET SAS Herblon
Specific control programmes for salmonellosis in food-producing animals have been implemented in EU countries. 
V državah EU so uvedeni posebni nadzorni programi za salmonelozo pri živalih za proizvodnjo živil.
Colistin is also used in human medicine. 
Kolistin se uporablja tudi v humani medicini.
“Transfer of resistance either on mobile genetic elements (such as plasmids) between bacteria or from animals to humans has not been reported.” 
„O prenosu odpornosti bodisi z mobilnimi genetskimi elementi (kot so plazmidi) med bakterijami bodisi z živali na ljudi niso poročali.“
Also, some Salmonella subtypes have reduced sensitivity to colistin. 
Poleg tega imajo nekateri podtipi rodu Salmonella zmanjšano občutljivost za kolistin.
Romania SC ROMVAC COMPANY SA 
Romunija SC ROMVAC COMPANY SA
The end result is an unnecessary use of colistin. 
Končni rezultat je nepotrebna uporaba kolistina.
, polymyxins were the fifth most sold group of antimicrobials (6%), after tetracyclines (37%), penicillins (24%), sulfonamides (10%) and macrolides (7%). 
, so bili polimiksini peta najbolj prodajana skupina protimikrobnih sredstev (6 %) za tetraciklini (37 %), penicilini (24 %), sulfonamidi (10 %) in makrolidi (7 %).
CENAVISA, S.A. Camí Pedra Estela s/n. Reus (Tarragona) 
Camí Pedra Estela s/n. Reus (Tarragona)
In the light of the increase in bacterial resistance to antimicrobial substances, discussions are ongoing in the EU and on an international level on how to contain and minimise this phenomenon for the benefit of human and animal health. 
Glede na povečanje bakterijske odpornosti proti protimikrobnim sredstvom v EU in na mednarodni ravni potekajo razprave o tem, kako ta pojav obvladati in zmanjšati v korist zdravja ljudi in živali.
Colistin has been used since the 1950s both in human and veterinary medicine 
Kolistin se uporablja od 50. let 20. stoletja v humani in veterinarski medicini
In relation to the total weight of animals ‘at risk' of treatment across 26 EU/EEA countries for which veterinary sales data were available 
V povezavi s skupno težo „ogroženih“ živali zaradi zdravljenja v 26 državah EU/EGP, za katere so bili na voljo podatki o prodaji zdravil v veterinarski medicini
Additionally, it was agreed that the suggested dose of 50,000 IU per kg body weight twice daily was reasonable. 
Dogovorjeno je bilo tudi, da je predlagani odmerek 50 000 i.e. na kg telesne mase dvakrat na dan smiseln.
Human infections with such highly resistant bacteria are associated with higher patient morbidity and mortality, higher costs and longer length of hospital stay 
Okužbe pri ljudeh s tako zelo odpornimi bakterijami so povezane z višjo obolevnostjo in umrljivostjo bolnikov, višjimi stroški in daljšo ležalno dobo
Until recently, polymyxin resistance had involved only chromosomal mutations but had never been reported via horizontal gene transfer. 
Do nedavnega je odpornost proti polimiksinom vključevala samo kromosomske mutacije, nikoli pa niso poročali o horizontalnem prenosu genov.
Treatment failures could compromise foal health in these cases. 
V teh primerih neuspešno zdravljenje lahko ogrozi zdravje žrebet.
Farma vet Ltd. 40 Otec Paisii str. Shumen 
Bolgarija Farma vet Ltd. 40 Otec Paisii str.
Specifically, in EU countries with known higher consumptions of colistin products, minimum inhibitory concentration (MIC) distributions were higher for Salmonella spp. 
V državah EU z znano večjo porabo zdravil s kolistinom so bile namreč porazdelitve minimalne inhibitorne koncentracije (MIK) višje pri izolatih Salmonella spp.
This means that with the lack of international standard techniques for colistin susceptibility testing no agreed standards exist for in vitro synergy evaluation for colistin combinations. 
To pomeni, da zaradi pomanjkanja mednarodnih standardnih tehnik za testiranje občutljivosti za kolistin ni dogovorjenih standardov za vrednotenje sinergije in vitro za kombinacije s kolistinom.
Romania Lavet Pharmecuticals LTD. 
Romunija Lavet Pharmecuticals LTD.
This is a very different situation in Europe since colistin has traditionally only been used in veterinary medicine and not critically important for human health. 
Za Evropo to pomeni precej drugačne razmere, saj se je kolistin tradicionalno uporabljal samo v veterinarski medicini in ni bil kritično pomemben za zdravje ljudi.
In the present procedure no data or evidence was presented for the indication of salmonellosis in any target species. 
V trenutnem postopku niso bili pri nobeni ciljni vrsti predstavljeni podatki ali dokazi za indikacijo salmoneloze.
Pharmagal spol. 
Slovaška Pharmagal spol.
In view of the information available in the reports of the EMA European Surveillance of Veterinary Antimicrobial Consumption 
Glede na razpoložljive informacije v poročilih evropskega sistema za nadzor rabe protimikrobnih sredstev v veterinarski medicini agencije EMA
No specific reasons could be identified for the need of a colistin combination product for food-producing animals in the EU with either an improvement of activity (synergistic or additive activity), or broadening of the activity spectrum. 
Ni bilo mogoče najti posebnega razloga za potrebo po kombiniranem zdravilu s kolistinom pri živalih za proizvodnjo živil v EU, ne kot izboljšano delovanje (sinergistično ali aditivno delovanje) ne kot razširitev spektra delovanja.
3 restricting the indications, target species, and duration of treatment of the concerned products, as well as adding prudent use warnings to the product information. 
3, ki omejuje indikacije, ciljne vrste in trajanje zdravljenja za zadevna zdravila ter s katerim je bilo v informacije o zdravilu dodano opozorilo o preudarni uporabi.
Some of the products included in the scope of this referral procedure are indicated for use in foals. 
Nekatera izmed zdravil, ki so zajeta v ta napotitveni postopek, so indicirana za uporabo pri žrebetih.
Thus, it is no longer the case that colistin-resistant bacteria in animals are unrelated to public health and the example found in China does demonstrate that transferable mcr-1 gene colistin resistance can occur in food animals and meat products and potentially constitute a public health risk. 
Torej ne velja več, da bakterije pri živalih, odporne proti kolistinu, niso povezane z javnim zdravjem, in primer, odkrit na Kitajskem, kaže, da se prenosljivi gen mcr-1 za odpornost proti kolistinu lahko pojavi pri živalih za prehrano in mesnih izdelkih ter lahko pomeni tveganje za javno zdravje.
Scientific conclusions and grounds for the withdrawal of the marketing authorisations 
Znanstveni zaključki in podlaga za umik dovoljenj za promet z zdravilom
More virulent strains resulting in more severe disease can further lead to septicaemia and/or immunosuppression with the result of either multi-organ disease or polymicrobial infections. 
Virulentnejši sevi, ki povzročajo hujšo bolezen, lahko nadalje privedejo do septikemije in/ali imunosupresije, kar ima za posledico bodisi večorgansko bolezen ali polimikrobne okužbe.
In May 2014 the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing colistin as sole active substance for oral administration to food-producing species (EMEA/V/A/106). 
Maja 2014 je Evropska komisija sprožila napotitveni postopek v skladu s členom 35 Direktive 2001/82/ES za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin kot edino zdravilno učinkovino, za peroralno dajanje vrstam za proizvodnjo živil (EMEA/V/A/106).
The CVMP considered that the end result of using colistin combination products instead of monotherapy is an unnecessary use of colistin. 
Odbor CVMP je menil, da je končni rezultat uporabe kombiniranih zdravil s kolistinom namesto monoterapije nepotrebna uporaba kolistina.
Due to colistin's new status as critically important in human medicine, the public health impact of the current or future use of colistin products in animals needs to be re-assessed at this time. 
Zaradi novega statusa kolistina kot kritično pomembnega v humani medicini je treba zdaj ponovno oceniti vpliv trenutne ali prihodnje uporabe zdravil s kolistinom pri živalih na javno zdravje.
In light of the renewed use of colistin use in human medicine and its critical importance for public health then it is essential to ensure prudent use of the substance in veterinary medicine in order to avoid an increase in the development of antimicrobial resistance. 
Glede na obnovljeno uporabo kolistina v humani medicini in njegov kritični pomen za javno zdravje je nujno zagotoviti preudarno uporabo te učinkovine v veterinarski medicini, da se izognemo povečanemu razvoju protimikrobne odpornosti.
The risk to public health identified is that treatment of clinical or subclinical Salmonella infections with the objective to reduce the number of bacteria can interfere with EU control 
Ugotovljeno tveganje za javno zdravje je, da zdravljenje kliničnih ali subkliničnih okužb z vrstami rodu Salmonella z namenom zmanjšanja števila bakterij lahko ovira
A substantial change has occurred over the last five years regarding the importance of colistin in human and veterinary medicine - from a molecule used only in veterinary medicine, colistin has become a critically important molecule in human medicine. 
V zadnjih petih letih je prišlo do precejšnje spremembe pomena kolistina v humani in veterinarski medicini - kolistin je bil sprva molekula, ki se je uporabljala samo v veterinarski medicini, zdaj pa je kritično pomembna v humani medicini.
The disk diffusion test is applied routinely worldwide yet is seldom reliable due to the inability of colistin to regularly diffuse in the agar and produce a consistent concentration gradient. 
Disk difuzijski test se uporablja rutinsko po vsem svetu, vendar je redko zanesljiv, ker kolistin po agarju ne difundira enakomerno in ne povzroči enakomernega koncentracijskega gradienta.
It belongs to the polymyxin therapeutic class and is identical to polymyxin E. Colistin is used for the treatment and prevention of diseases caused by sensitive bacteria (e.g. Escherichia coli) in pigs, poultry, rabbits, cattle, sheep and goats. 
Spada v terapevtski razred polimiksinov in je identičen polimiksinu E. Kolistin se uporablja za zdravljenje in preprečevanje bolezni, ki jih povzročajo občutljive bakterije (npr. Escherichia coli) pri prašičih, perutnini, kuncih, govedu, ovcah in kozah.
Proprietary data, scientific references and expert reports were provided in this Article 35 referral procedure in support of some indications of some of the products included in the scope of the procedure. 
V tem napotitvenem postopku v skladu s členom 35 so bili predloženi zaščiteni podatki, znanstvene reference in strokovna poročila, ki podpirajo nekatere indikacije za nekatera izmed zdravil, ki jih zajema ta postopek.
There are also products available for parenteral, intramammary and intrauterine administration, which are not within the scope of this referral. 
Na voljo so tudi zdravila za parenteralno, intramamarno in intrauterino dajanje, ki niso zajeti v to napotitev.
In this context, colistin combination products are not utilised under prudent use principles nor fulfil the criteria outlined in the fixed combinations guideline for the approval of these products. 
V tem kontekstu se kombinirana zdravila s kolistinom ne uporabljajo po načelu preudarne uporabe in ne izpolnjujejo meril, navedenih v smernici o zdravilih s fiksno kombinacijo, ki veljajo za odobritev teh zdravil.
and P. aeruginosa), including those displaying carbapenem resistance, as well as certain Mycobacterium spp. 
in P. aeruginosa), vključno s tistimi, ki so odporne proti karbapenemom, in proti nekaterim vrstam rodu Mycobacterium spp.
• the CVMP considered that the development of antimicrobial resistance to colistin is considered a risk for human health as colistin is also used as a last resort treatment in human medicine in the context of treatment of specific highly drug-resistant bacterial infections; 
• odbor CVMP je menil, da razvoj protimikrobne odpornosti proti kolistinu velja za tveganje za zdravje ljudi, saj se kolistin uporablja tudi kot zadnja možnost zdravljenja v humani medicini v okviru zdravljenja specifičnih, izjemno odpornih bakterijskih okužb;
Polymyxins are active particularly against a wide range of species of Gram-negative bacilli (e.g. E. coli, Salmonella spp. 
Polimiksini delujejo zlasti proti širokemu spektru vrst po Gramu negativnih bacilov (npr. E. coli, Salmonella spp.
Overall summary of the scientific evaluation of all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally (see Annex I) 
Splošni povzetek znanstvenega vrednotenja vseh zdravil za uporabo v veterinarski medicini, ki vsebujejo kolistin v kombinaciji z drugimi protimikrobnimi sredstvi, za peroralno dajanje (glejte Prilogo I)
This advice critically reviewed information on the use of colistin in food-producing animals in the EU, its effect on the development of resistance to this category of antimicrobial agents in bacterial species that are of importance for human and animal health, and the possible impact on human and animal health. 
V okviru priprave mnenja so kritično pregledali informacije o uporabi kolistina pri živalih za proizvodnjo živil v EU, njegov učinek na razvoj odpornosti proti tej kategoriji protimikrobnih sredstev pri bakterijskih vrstah, ki so pomembne za zdravje ljudi in živali, in morebiten vpliv na zdravje ljudi in živali.
In a previous Article 35 referral procedure for all veterinary medicinal products containing colistin to be administered orally the Committee agreed a harmonised indication, a limitation of the duration of treatment up to 7 days and warning sentences on prudent use. 
V predhodnem napotitvenem postopku v skladu s členom 35 za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin, za peroralno dajanje je odbor soglašal z usklajeno indikacijo, omejitvijo trajanja zdravljenja na do 7 dni in opozorilnimi stavki o preudarni uporabi.
Also, the previous Article 35 referral procedure confirmed a dose of 100,000 IU colistin per kg body weight daily for calves, lambs and pigs, and a dose of 75,000 IU colistin per kg body weight daily in poultry for 3-5 consecutive days. 
Poleg tega je predhodni napotitveni postopek v skladu s členom 35 potrdil odmerek 100 000 i.e. kolistina na kg telesne mase na dan za teleta, jagnjeta in prašiče ter odmerek 75 000 i.e. kolistina na kg telesne mase na dan pri perutnini 3-5 dni zaporedoma.
Administer the dose subdivided into two administrations each day, dissolved in drinking water or in milk. 
odmerek razdelite na dva na dan, raztopljena v vodi za pitje ali mleku
10.5 MIU/ syringe 0.216 g/ syringe 4.2 g/ syringe 
10.5 MIU/ syringe 0.216 g/ syringe 4.2 g/ syringe peroralna pasta žrebeta, teleta peroralna uporaba
On the status of colistin as a critically important antimicrobial in human medicine, the advice stated: 
V mnenju je glede statusa kolistina kot kritično pomembnega protimikrobnega sredstva v humani medicini navedeno:
Previous CVMP conclusions applicable to colistin combination products 
Predhodni zaključki odbora CVMP, ki veljajo za kombinirana zdravila s kolistinom
The use of combination products represents a risk of unnecessary use of colistin in cases where no additional benefit has been shown over the use of one substance alone. 
Uporaba kombiniranih zdravil pomeni tveganje za nepotrebno uporabo kolistina v primerih, kjer ni dodatne prednosti pred uporabo kolistina samega.
The bactericidal effect of colistin (and polymyxin B) is the result of an interaction with divalent cations of the outer bacterial membrane, which causes a disruption of the cell structure, leakage of the cell contents and thereby cell lysis 
Baktericidni učinek kolistina (in polimiksina B) je rezultat medsebojnega delovanja z divalentnimi kationi zunanje bakterijske membrane, kar povzroči razpad celične strukture, uhajanje celične vsebine in posledično celično lizo
Thus, the use of colistin in foals is considered to present a serious risk in relation to target animal safety and foals cannot be supported as a target animal species for colistin combination products. 
Zato velja, da uporaba kolistina pri žrebetih pomeni resno tveganje v povezavi z varnostjo ciljne živalske vrste, in tako žrebet ni mogoče podpreti kot ciljne živalske vrste za kombinirana zdravila s kolistinom.
It is recognised that colistin combination products could be efficacious for the treatment and metaphylaxis of gastrointestinal diseases caused by E. coli susceptible to both active substances in piglets, poultry, neonatal calves and lambs, provided the dose and duration of treatment are adjusted according to those previously recommended by CVMP. 
Priznava se, da bi kombinirana zdravila s kolistinom lahko bila učinkovita pri zdravljenju in metafilaksi bolezni prebavil, ki jih povzroča E. coli, občutljiva za obe zdravilni učinkovini, pri prašičkih, perutnini, novorojenih teletih in jagnjetih, pod pogojem, da se odmerek in trajanje zdravljenja prilagodita v skladu s tistimi, ki jih je predhodno priporočil odbor CVMP.
As even a limited use of colistin combinations products is deemed to lead to unnecessary use of colistin and could potentially contribute to the development of antimicrobial resistance, the measures discussed above were not considered sufficient to mitigate the identified risk. 
Ker tudi omejena uporaba kombiniranih zdravil s kolistinom pomeni nepotrebno uporabo kolistina in lahko potencialno prispeva k razvoju protimikrobne odpornosti, zgoraj obravnavani ukrepi niso obveljali za zadostne, da bi lahko zmanjšali ugotovljeno tveganje.
While in cases involving other substances used in veterinary medicine there were still therapeutic options for human medicine, in this case any potential food-chain related contributions to colistin resistance in human medicine would lead to no therapeutic options for human infections against MDR, XDR and PDR bacteria. 
V primerih, ki vključujejo druge učinkovine, ki se uporabljajo v veterinarski medicini, v humani medicini še vedno obstajajo terapevtske možnosti, v tem primeru pa lahko vsak morebiten prispevek k odpornosti proti kolistinu v prehranski verigi v humani medicini privede do pomanjkanja terapevtskih možnosti za okužbe pri ljudeh z bakterijami MDR, XDR in PDR.
A recent global increase in Gram-negative bacteria in human medicine that are multidrug-resistant (MDR), extensively drug-resistant (XDR) and pandrug-resistant (PDR) 
Nedaven svetovni porast po Gramu negativnih bakterij v humani medicini, ki so večkratno odporne (MDR), izredno odporne (XDR) in panrezistentne (PDR)
No published data is available that has identified the mechanism by which synergism could occur for colistin combinations. 
Ni objavljenih podatkov, ki bi ugotovili mehanizem, po katerem bi pri kombinacijah s kolistinom prišlo do sinergije.