natgillin/translations-raw huggingface dataset:
Rapilysin is presented as a powder and a solvent for injection (0.56 g powder in a vial and 10 ml solvent in a pre-filled syringe with a reconstitution spike and a needle-pack of 2)
Rapilysin je dostupan u obliku praška i otapala za injekciju u pakiranju po 2 (bočice sa 0,56 g praška, napunjene štrcaljke sa 10 ml otapala, pomagala za pripremu za primjenu i igle).
Heparin and acetylsalicylic acid are given before and after Rapilysin to reduce the risk of new blood clots forming.
Heparin i acetilsalicilatna kiselina daju se prije i nakon primjene lijeka Rapilysin da bi se smanjio rizik od stvaranja novih krvnih ugrušaka.
How to use Rapilysin
Kako primjenjivati Rapilysin
Adverse reactions seen with reteplase
Nuspojave uočene kod terapije reteplazom
• Bleeding in the digestive tract (e.g. bloody or black vomit, or stools) in the gums or in the urinary or genital tract
• krvarenje u probavnom traktu (npr. krvavo povraćanje ili crna stolica), mokraćnom ili genitalnom traktu te krvarenje desni
With the reconstitution spike and syringe still attached to the vial, swirl the vial gently to dissolve the Rapilysin 10 U powder.
Dok su pomagalo za rekonstituciju i štrcaljka spojeni s bočicom, nježno okrećite bočicu da se prašak lijeka Rapilysin 10 U otopi.
Protamine should be considered if heparin has been administered within 4 hours of the onset of bleeding.
Ako je heparin primijenjen unutar 4 sata nakon početka krvarenja, potrebno je razmotriti primjenu protamina.
Treatment of children with Rapilysin is not recommended.
Rapilysin se ne preporučuje.
Heparin and acetylsalicylic acid should be administered before and following the administration of Rapilysin to reduce the risk of re-thrombosis.
Heparin i acetilsalicilatna kiselina moraju se primjenjivati prije i nakon primjene lijeka Rapilysin da bi se smanjio rizik od ponovne tromboze.
If the solution is not clear and colourless it should be thrown away.
Ako otopina nije bistra i bezbojna, lijek nije za uporabu i potrebno ga je zbrinuti.
No other medicines should be injected through the line reserved for Rapilysin, neither at the same time, nor prior to, nor following Rapilysin injection.
Niti jedan drugi lijek ne smije se ubrizgati putem namijenjenim ubrizgavanju lijeka Rapilysin, ni istodobno, ni prije, ni nakon ubrizgavanja lijeka Rapilysin.
Rapilysin 10 U powder and solvent for solution for injection.
Rapilysin 10 U prašak i otapalo za otopinu za injekciju
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])
Prašak i otapalo za injekciju (sadrži 2 bočice sa 0,56 g praška, 2 napunjene štrcaljke sa 10 ml otapala, 2 pomagala za pripremu za primjenu i 2 igle)
Arrhythmias
Dojenje
Connect the syringe to the reconstitution spike and transfer the 10 ml of solvent into the vial of Rapilysin 10 U.
Spojite napunjenu štrcaljku s pomagalom za rekonstituciju i ubrizgajte 10 ml otapala u bočicu lijeka Rapilysin 10 U.
If the same line has to be used, this line (including Y-line) must be flushed thoroughly with a 0.9 % sodium chloride or 5 % glucose solution before and after the Rapilysin injection.
Ako se mora koristiti isti intravenski put, taj se put (uključujući Y-nastavak) mora temeljito isprati 0,9%-tnom otopinom natrijevog klorida ili 5%-tnom otopinom glukoze prije i nakon ubrizgavanja lijeka Rapilysin.
In those patients where the same line has to be used, this line (including Y-line) must be flushed thoroughly with a 0.9 % sodium chloride or 5 % glucose solution prior to and following the Rapilysin injection (see section 4.2 Posology and method of administration).
U bolesnika u kojih se mora koristiti isti intravenski put, taj se put (uključujući Y-nastavak) mora temeljito isprati 0,9%-tnom otopinom natrijevog klorida ili 5%-tnom otopinom glukoze prije i nakon ubrizgavanja lijeka Rapilysin (vidjeti dio 4.2 Doziranje i način primjene).
Available evidence on reteplase does not indicate an antibody-mediated origin of these hypersensitivity reactions.
Masna embolija koja može dovesti do odgovarajućih posljedica u pogođenim organima4 1. Dostupni dokazi o reteplazi ne upućuju da su te reakcije preosjetljivosti posredovane antitijelima.
Do not use Rapilysin
Nemojte primjenjivati Rapilysin:
This applies to all medicines including heparin and acetylsalicylic acid, which are given before and after Rapilysin to reduce the risk of new blood clots forming.
To se odnosi na sve lijekove, uključujući heparin i acetilsalicilatnu kiselinu, koji se daju prije i nakon primjene lijeka Rapilysin da bi se smanjio rizik od stvaranja novih krvnih ugrušaka.
How to store Rapilysin
Kako čuvati Rapilysin
delirium, agitation, confusion, depression, psychosis)
delirij, uznemirenost, smetenost, depresija, psihoze) • teška alergijska reakcija koja uzrokuje šok ili kolaps.
• Bleeding around the heart, in the abdomen, the brain or the eyes, under the skin, from the nose or as coughed up blood
• krvarenje oko srca, u trbuhu, mozgu, očima, potkožno ili iz nosa te iskašljavanje krvi • oštećenje srca ili srčanih zalistaka, krvni ugrušak u plućima, mozgu ili nekom drugom dijelu tijela • preosjetljivost (npr. alergijske reakcije).
- high likelihood of left heart thrombus, e.g. mitral stenosis with atrial fibrillation
- nedavno gastrointestinalno ili genitourinarno krvarenje (u zadnjih 10 dana) - velika vjerojatnost od pojave tromba u lijevom srcu, npr. mitralna stenoza s fibrilacijom atrija
Remove the tip cap from the syringe.
S vrha štrcaljke uklonite zatvarač.
It is strongly recommended that antiarrhythmic therapy for bradycardia and/or ventricular tachyarrhythmias (e.g. ventricular tachycardia or fibrillation) be available when reteplase is administered.
Tijekom primjene reteplaze svakako trebaju biti dostupni antiaritmici za liječenje bradikardije i/ili tahiaritmije klijetke (npr.
given as a bolus injection prior to reteplase therapy followed by an infusion of 1000 I.U.
Preporučena doza heparina iznosi 5000 IU, primijenjena kao bolusna injekcija prije reteplaze, nakon koje slijedi infuzija od 1000 IU po satu koja započinje nakon drugog bolusa reteplaze.
No other medicines should be injected through the line reserved for Rapilysin, either at the same time, or before or after Rapilysin injection.
Niti jedan drugi lijek ne smije se ubrizgavati intravenskim putem namijenjenim ubrizgavanju lijeka Rapilysin, ni istodobno, ni prije, ni nakon ubrizgavanja lijeka
The most frequent adverse drug reaction associated with reteplase treatment is haemorrhage.
Najčešća nuspojava povezana s liječenjem reteplazom je krvarenje.
given as a single injection before Rapilysin, followed by an infusion of 1000 I.U.
Preporučena doza heparina iznosi 5000 IU, primijenjena kao jednokratna injekcija prije lijeka Rapilysin, nakon koje slijedi infuzija od 1000 IU po satu koja započinje nakon druge injekcije lijeka
Name and address of the manufacturers of the biological active substance
Nazivi i adrese proizvođača biološke djelatne tvari Wacker Biotech GmbH
In those patients where the same line has to be used, this line (including Y-line) must be flushed thoroughly with a 0.9 % sodium chloride or 5 % glucose solution prior to and following the Rapilysin injection.
U bolesnika u kojih se mora koristiti isti intravenski put, taj se put (uključujući Y-nastavak) mora temeljito isprati 0,9%-tnom otopinom natrijevog klorida ili 5%-tnom otopinom glukoze prije i nakon ubrizgavanja lijeka Rapilysin.
Rapilysin 10 U powder and solvent for solution for injection Reteplase Intravenous use
Rapilysin 10 U prašak i otapalo za otopinu za injekciju Reteplaza za primjenu u venu
2 reconstitution spikes
2 pomagala za rekonstituciju
1 vial contains 10 U* reteplase ** in 0.56 g powder 1 prefilled syringe contains 10 ml water for injections.
1 napunjena štrcaljka sadrži 10 ml vode za injekcije.
Disconnect the syringe from the reconstitution spike.
Odvojite štrcaljku od pomagala za rekonstituciju.
Side effects of frequency not known (cannot be estimated from the available data) • Blockage of blood vessels due to cholesterol (fat)
Nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka)
There was increased local haemorrhage at the injection site.
Na mjestu davanja injekcije došlo je do povećanog lokalnog krvarenja.
Therefore, be sure to tell the medical staff if you experience pain during the injection.
Ako osjetite bol tijekom ubrizgavanja, odmah obavijestite medicinsko osoblje.
This applies to all products including heparin, and acetylsalicylic acid, which should be administered before and following the administration of reteplase to reduce the risk of re-thrombosis.
To se odnosi na sve lijekove, uključujući heparin i acetilsalicilatnu kiselinu, koji se moraju primjenjivati prije i nakon primjene reteplaze da bi se smanjio rizik od ponovne tromboze.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL OF THE VIAL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
Cardiac disorders3
Srčani poremećaji3
Dosage of Rapilysin
Doziranje lijeka Rapilysin
Islanda
Island
In the event of overdosage there may be an increased risk of bleeding.
- novotvorina s povećanim rizikom od krvarenja
• if you have a bleeding disorder.
Krvožilni poremećaji
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 u anamnezi - nedavna (<10 dana) produžena i intenzivna vanjska masaža srca - nekontrolirana teška hipertenzija
Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43(0)1 97007 0
Österreich ratiopharm Arzneimittel Vertriebs-GmbH
Wacker Biotech GmbH Heinrich-Damerow-Str. 4 06120 Halle
06120 Halle
Invented name
Novoizumlj eno ime
--¹ Each dose of vaccine suspension (3 ml) contains:
1 Jedna doza (3 ml) suspenzije cjepiva sadrži:
Content (concentration)
Sastav koncentracija
1 vial + 1 sachet
1 bočica + 1 vrećica
Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated)
Vibrio cholerae O1 Inaba, klasični biotip (inaktiviran toplinom)
Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 31.25x109 bacteria - Recombinant cholera toxin B subunit (rCTB) 1 mg
Vibrio cholerae O1 Inaba, biotip El Tor (inaktiviran formalinom) 31,25x109 bakterija Vibrio cholerae O1 Ogawa, klasični biotip (inaktiviran toplinom) 31,25x109 bakterija Vibrio cholerae O1 Ogawa, klasični biotip (inaktiviran formalinom) 31,25x109 bakterija
Pack size
vrećica
- A total of 1.25x10¹¹ bacteria of the following strains: Vibrio cholerae O1 Inaba, classical biotype (heat inactivated)
− ukupno 1,25x1011 bakterija sljedećih sojeva:
Prolonged-release tablet Oral use blister (OPA/Alu/DES/PE-Alu) Initiation pack: 21 tablets (7 x 0.26 mg +
Pakiranje za početno liječenje: 21 tablet (7x 0,26 mg + 7 x 0,52 mg + 7 x 1,05 mg)
EU/1/08/469/054 Oprymea 0.26 mg + 0.52 mg +
0,26 mg + 0,52 mg + 1,05 mg
Packaging
Veličina pakovanja
Package size l t o r
Daliresp 500 μg Filmom obložene tablete Kroz usta
The procedure was concluded and on 16 March 2015 the European Commission adopted a Decision
Postupak je zaključen te je 16. ožujka 2015. Europska komisija donijela Odluku
Rhone Vet Kft.
Mađarska Rhone Vet Kft.
Indications for prevention and prophylaxis can no longer be justified.
Indikacije za sprečavanje i profilaksu više se ne mogu opravdavati.
Colistin is also used in human medicine.
Kolistin se također upotrebljava u humanoj medicini.
Following a request from the European Commission, in July 2013 the CVMP and CHMP adopted scientific advice and detailed considerations on colistin
Na zahtjev Europske komisije CVMP i CHMP usvojili su u srpnju 2013. znanstveni savjet i detaljna razmatranja o kolistinu
programmes and thus compromises public health and food safety.
, čime se ugrožava javno zdravlje i sigurnost hrane.
29 avenue Tony Garnier
Francuska MERIAL 29 avenue Tony Garnier
Sales of combination products with colistin represented less than 10% of the overall sales of colistin (ESVAC, unpublished data).
Prodaja kombinacija proizvoda s kolistinom predstavljala je manje od 10 % cjelokupne prodaje kolistina (ESVAC, neobjavljeni podaci).
Romania COOPHAVET SAS Herblon
Rumunjska COOPHAVET SAS Herblon
“Transfer of resistance either on mobile genetic elements (such as plasmids) between bacteria or from animals to humans has not been reported.”
„Nije zabilježen prijenos rezistencije na mobilne genetičke elemente (kao što su plazmidi) između bakterija ili sa životinja na ljude.”
Kempf I et al. 2013 What do we know about resistance to colistin in Enterobacteriaceae in avian and pig production in Europe?
2013 What do we know about resistance to colistin in Enterobacteriaceae in avian and pig production in Europe?
Also, some Salmonella subtypes have reduced sensitivity to colistin.
Također, neke podvrste bakterije Salmonella smanjile su osjetljivost na kolistin.
Romania SC ROMVAC COMPANY SA
Rumunjska SC ROMVAC COMPANY SA
1ere Avenue 2065m L.I.D.
Francuska VIRBAC 1ere Avenue 2065m L.I.D.
In the present procedure no data or evidence was presented for the indication of salmonellosis in any target species.
U tom postupku nisu bili predstavljeni podaci ili dokazi za indikaciju salmoneloze u bilo kojoj ciljanoj vrsti.
Administer the dose subdivided into two administrations each day, dissolved in drinking water or in milk.
Primjenjivati dozu podijeljenu u dvije primjene na dan, otopljenu u vodi za piće ili u mlijeku.
LABORATORIOS MAYMO, S.A.
Španjolska LABORATORIOS MAYMO, S.A.
Colistin has been used since the 1950s both in human and veterinary medicine
Kolistin se od 1950-ih godina primjenjuje u humanoj i veterinarskoj medicini
LABORATOIRES BIOVE
Francuska LABORATOIRES BIOVE
Falagas ME et al. 2005 Colistin: the revival of polymyxins for the management of multidrug-resistant Gram-negative bacterial infections.
2005 Colistin: the revival of polymyxins for the management of multidrug-resistant Gram-negative bacterial infections.
Catry, B et al. 2015 Use of colistin-containing products within the European Union and European Economic Area (EU/EEA): development of resistance in animals and possible impact on human and animal health.
2015 Use of colistin-containing products within the European Union and European Economic Area (EU/EEA): development of resistance in animals and possible impact on human and animal health.
Fite A et al. 2013 Longitudinal analyses of gut mucosal microbiotas in ulcerative colitis in relation to patient age and disease severity and duration.
2013 Longitudinal analyses of gut mucosal microbiotas in ulcerative colitis in relation to patient age and disease severity and duration.
Liu YY et al. 2015 Emergence of plasmid-mediated colistin resistance mechanism MCR-1 in animals and human beings in China: a microbiological and molecular biological study.
2015 Emergence of plasmid-mediated colistin resistance mechanism MCR-1 in animals and human beings in China: a microbiological and molecular biological study.
A recent paper identified another risk of colistin products and Salmonella spp.
Najnovijim je dokumentom utvrđen još jedan rizik proizvoda koji sadržavaju kolistina i bakterije Salmonella spp.
Human infections with such highly resistant bacteria are associated with higher patient morbidity and mortality, higher costs and longer length of hospital stay
Humane infekcije takvim visoko rezistentnim bakterijama povezane su s većim morbiditetom i mortalitetom bolesnika, većim troškovima i duljim bolničkim liječenjem
Farma vet Ltd. 40 Otec Paisii str. Shumen
Bugarska Farma vet Ltd. 40 Otec Paisii str.
Specific control programmes for salmonellosis in food-producing animals have been implemented in EU countries.
Posebni programi nadzora za salmonelozu u životinja koje se upotrebljavaju za proizvodnju hrane provedeni su u svim zemljama EU-a.
Previous CVMP conclusions applicable to colistin combination products
Prethodni zaključci CVMP-a koji se primjenjuju na kombinirane proizvode kolistina
There are also products available for parenteral, intramammary and intrauterine administration, which are not within the scope of this referral.
Također su dostupni proizvodi za parenteralnu, intramamarnu i intrauterinu primjenu, koji nisu unutar područja ovoga postupka upućivanja.
No published data is available that has identified the mechanism by which synergism could occur for colistin combinations.
Nisu dostupni objavljeni podaci koji su utvrdili mehanizam kojim može doći do sinergizma za kombinacije kolistina.
Until recently, polymyxin resistance had involved only chromosomal mutations but had never been reported via horizontal gene transfer.
Sve donedavno rezistencija na polimiksin uključivala je samo mutacije kromosoma, ali nikad nije zabilježena putem horizontalnog prijenosa gena.
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.
Situacija u Europi se time uvelike promijenila jer se kolistin tradicionalno upotrebljavao samo u veterinarskoj medicini i nije bio od presudne važnosti za zdravlje ljudi.
Also, it is unclear whether at the time of systemic complications from colibacillosis the main clinical disease is still the gastrointestinal disease or the systemic complications.
Također, nije jasno je li u vrijeme sustavnih komplikacija uzrokovanih kolibacilozom glavna klinička bolest i dalje gastrointestinalna bolest ili sustavne komplikacije.
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.
S obzirom na povećanje bakterijske rezistencije na antimikrobne tvari, trenutačno se na razini EU-a i na međunarodnoj razini vode rasprave o tome kako tu pojavu obuzdati i smanjiti na najmanju moguću mjeru radi dobrobiti zdravlja ljudi i životinja.
Pardon B et al. 2012 Prospective study on quantitative and qualitative antimicrobial and anti-inflammatory drug use in white veal calves.
2012 Prospective study on quantitative and qualitative antimicrobial and anti-inflammatory drug use in white veal calves.
Scientific conclusions and grounds for the withdrawal of the marketing authorisations
Znanstveni zaključci i razlozi za povlačenje odobrenja za stavljanje lijeka u promet
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.
U tom kontekstu, kombinirani proizvodi koji sadržavaju kolistin ne koriste se u skladu s načelima oprezne uporabe i ne ispunjavaju kriterije naznačene u smjernicama za fiksne kombinacije za odobrenje tih proizvoda.
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, and marketing authorisation holders in the Member States
Popis naziva, farmaceutskih oblika, jačina veterinarskomedicinskih proizvoda, vrsta životinja, putova primjene i nositelja odobrenja za stavljanje lijeka u promet u državama članicama
Snitkin ES et al. 2013 Genomic insights into the fate of colistin resistance and Acinetobacter baumannii during patient treatment.
2013 Genomic insights into the fate of colistin resistance and Acinetobacter baumannii during patient treatment.
Callens B et al. 2012 Prophylactic and metaphylactic antimicrobial use in Belgian fattening pig herds.
2012 Prophylactic and metaphylactic antimicrobial use in Belgian fattening pig herds.
Several scientific reports and EU surveillance data have demonstrated continued very low level of resistance to colistin in food-producing animals, as well as reduced levels of resistance to several other antimicrobials used in colistin combination products, despite the wide use of these products in the EU for some years.
Nekoliko znanstvenih izvješća i EU-ovi podaci o nadzoru pokazali su neprekidnu vrlo nisku razinu rezistencije na kolistin u životinja koje se upotrebljavaju za proizvodnju hrane, kao i smanjene razine rezistencije na nekoliko drugih antimikrobnih sredstava koji se primjenjuju u kombiniranim proizvodima koji sadržavaju kolistin, unatoč širokoj primjeni tih proizvoda nekoliko godina.
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.
Ispitivanje difuzije diska rutinski se primjenjuje diljem svijeta, no rijetko je pouzdano zbog nemogućnosti redovite difuzije kolistina u agaru i proizvodnje dosljednog koncentracijskog gradijenta.
Colistin combination products are seen to serve a role for these more complex production-related diseases and clinical studies are available for some combinations, which demonstrated efficacy for some conditions.
Smatra se da kombinirani proizvodi koji sadržavaju kolistin imaju ulogu u ovim složenijim bolestima povezanima s proizvodnjom, a za neke su kombinacije dostupna klinička ispitivanja koja su pokazala učinkovitost za neka stanja.
Regarding combinations of colistin with other antimicrobials the advice indicates that “The marketing authorisations for these products should be reviewed and unless sound justification can be provided that the combination is in line with responsible use principles, combination products should be withdrawn.”
U pogledu kombinacija kolistina s drugim antimikrobicima, u savjetu se navodi da je „potrebno preispitati odobrenja za stavljanje na tržište za ove proizvode te da, ako se ne može pružiti ispravno opravdanje da je kombinacija u skladu s načelima odgovorne uporabe, kombinaciju proizvoda treba povući s tržišta.”
Romania Lavet Pharmecuticals LTD.
Rumunjska Lavet Pharmecuticals LTD.
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 kojom se ograničavaju indikacije, ciljane vrste i trajanje liječenja za dotične proizvode te kojom se informacijama o proizvodu dodaju upozorenja o opreznoj uporabi.
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 znači da uz nedostatak međunarodnih standardnih tehnika za ispitivanje osjetljivosti kolistina za kombinacije kolistina ne postoje dogovoreni standardi za in vitro sinergijsko ocjenjivanje.
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.
Primjena kombiniranih proizvoda predstavlja rizik od nepotrebne primjene kolistina u slučajevima u kojima nije pokazana dodatna prednost pred primjenom samo jedne tvari.
Since the discovery in China, MCR-1 plasmid-mediated colistin resistance has been reported in a number of countries worldwide.
Nakon otkrića u Kini MCR-1 rezistencija na kolistin posredovana plazmidima prijavljena je u brojnim zemljama diljem svijeta.