natgillin/translations-raw huggingface dataset:
Lokelma 5 g powder for oral suspension sodium zirconium cyclosilicate Oral use
Lokelma 5 g prašek za peroralno suspenzijo natrijev cirkonijev ciklosilikat peroralna uporaba
Lokelma 10 g powder for oral suspension sodium zirconium cyclosilicate Oral use
Lokelma 10 g prašek za peroralno suspenzijo natrijev cirkonijev ciklosilikat peroralna uporaba
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije z edemi povezani dogodki
Responses were larger in patients with more severe hyperkalaemia; serum potassium fell 0.8, 1.2 and 1.5 mmol/L in patients with baseline serum potassium < 5.5, 5.5-5.9 and ≥ 6 mmol/L, respectively.
Pri bolnikih z izhodiščnim kalijem v serumu < 5,5 mmol/l se je kalij znižal za 0,8 mmol/l, pri tistih s 5,5 do 5,9 mmol/l za 1,2 mmol/l in pri tistih z ≥ 6 mmol/l za 1,5 mmol/l.
Titrated dose Off treatment
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
OUTER CARTON
Predrtje črevesa
The active substance is sodium zirconium cyclosilicate.
Kaj vsebuje zdravilo Lokelma Učinkovina je natrijev cirkonijev ciklosilikat.
SACHET
IzOK
• The products can continue to be used as recommended.
• Zdravili se lahko še naprej uporabljata v skladu s priporočili.
20 February 2014 EMA/108793/20144
20. februar 2014 EMA/108793/2014
The marketing authorisation holder for both medicines is the same company, Bayer Pharma AG.
Imetnik dovoljenja za promet z obema zdraviloma je družba Bayer Pharma AG.
The CHMP considered the PRAC recommendations and agreed by consensus that they should be implemented.
Odbor CHMP je proučil priporočila odbora PRAC in soglasno sklenil, da se morajo izvajati.
The octocog alfa in these products has the same structure as natural factor VIII (‘full-length').
Oktokog alfa v teh zdravilih ima enako zgradbo kot naravni faktor VIII („celotne dolžine“).
Benefits continue to outweigh risks in previously untreated patients
Koristi so še naprej večje od tveganj pri predhodno nezdravljenih bolnikih
In this study, the incidence of inhibitor development ranged from 28.2% to 37.7% for all products.
Pogostnost nastanka zaviralcev v študiji je bila pri vseh zdravilih od 28,2 do 37,7 %.
The review of Kogenate Bayer and Helixate NexGen was initiated on 5 March 2013 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Pregled zdravil Kogenate Bayer in Helixate NexGen se je začel dne 5. marca 2013 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
• However, when all the evidence was assessed, including that from this study, there was not enough to support a genuine difference between the products.
• Vendar pa med ocenjevanjem vseh dokazov, tudi tistih iz omenjene študije, niso našli dovolj podatkov, ki bi dokazovali, da bi med zdravili zares obstajala razlika.
The frequency of inhibitor development in previously untreated patients has been amended in line with the current evidence to ‘very common'.
Pogostnost nastanka zaviralcev pri predhodno nezdravljenih bolnikih je bila v skladu s trenutnimi dokazi spremenjena v „zelo pogosto“.
Kogenate Bayer and Helixate NexGen are identical medicines that were authorised throughout the European Union (EU) on 4 August 2000.
Kogenate Bayer in Helixate NexGen sta identični zdravili, ki sta bili po vsej Evropski uniji (EU) odobreni dne 4. avgusta 2000.
However the product information has been updated to reflect the study results and ensure that healthcare professionals treating patients with haemophilia A are aware of them.
Vendar pa so bile informacije o zdravilu posodobljene z rezultati študije, da bi zagotovili, da bodo zdravstveni delavci, ki zdravijo bolnike s hemofilijo A, seznanjeni z njimi.
These may be extracted from human blood (‘plasma-derived'), produced as full-length recombinant products with varying degrees of exposure to other blood-derived proteins (first, second, or third generation), or may contain a shortened, but still active, recombinant form of the factor VIII molecule.
Ta zdravila se lahko pridobivajo iz človeške krvi („zdravila iz plazme“), izdelajo kot zdravila z rekombinantnim faktorjem celotne dolžine z različnimi stopnjami izpostavljenosti drugim beljakovinam iz krvi (prva, druga ali tretja generacija) ali pa vsebujejo krajšo, vendar še vedno aktivno rekombinantno obliko molekule faktorja VIII.
Alternative products containing various forms of factor VIII are available and may be used similarly.
Na voljo so tudi druga zdravila, ki vsebujejo različne oblike faktorja VIII in se uporabljajo na podoben način.
They contain a form of factor VIII, octocog alfa, produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced which makes them able to produce the clotting factor.
Zdravili vsebujeta obliko faktorja VIII, imenovanega oktokog alfa, ki se pridobiva z metodo, imenovano „tehnologija rekombinantne DNK“: izdelajo ga celice, v katere so vstavili gen (DNK), s pomočjo katerega lahko tvorijo faktor strjevanja krvi.
• Kogenate Bayer and Helixate NexGen can continue to be prescribed and used as appropriate in the management of haemophilia A. Existing risk minimisation measures are considered adequate and should be continued.
• Zdravili Kogenate Bayer in Helixate NexGen se lahko še naprej predpisujeta in uporabljata, kakor je primerno pri zdravljenju hemofilije A. Obstoječi ukrepi za zmanjšanje tveganja so bili ocenjeni kot zadostni in se morajo še naprej izvajati.
The CHMP opinion was then sent to the European Commission, which endorsed it and issued an EU-wide legally binding decision on 20 February 2014.
Odbor CHMP je nato mnenje posredoval Evropski komisiji, ki ga je potrdila in dne 20. februarja 2014 izdala pravno zavezujočo odločbo, ki velja za celotno EU.
These antibodies (factor VIII inhibitors) reduce the effectiveness of the medicine and make bleeding more likely.
Ta protitelesa (zaviralci faktorja VIII) zmanjšajo učinkovitost zdravila in povečajo verjetnost za krvavitve.
The CHMP opinion was forwarded to the European Commission, which endorsed it and issued a final legally binding decision, valid across the EU, on 20 February 2014.
Odbor CHMP je mnenje posredoval Evropski komisiji, ki ga je potrdila in dne 20. februarja 2014 izdala končni pravno zavezujoč sklep, ki velja za celotno EU.
In patients given Kogenate Bayer/Helixate NexGen, the incidence of inhibitor development was 64/183 (37.7%) when followed for up to 75 exposure days, of whom 40 had a high-titre inhibitor (25.2%).
Pri bolnikih, ki so prejemali zdravilo Kogenate Bayer ali Helixate NexGen in ki so jih spremljali do 75 dni izpostavljenosti, je bila incidenca nastanka zaviralcev 64/183 (37,7 %), od tega je 40 (25,2 %) bolnikov razvilo visok titer zaviralcev.
• Quality data presented by the marketing authorisation holder also indicated that the biophysical and biochemical characteristics of Kogenate Bayer and Helixate Nexgen have not significantly changed since the initial marketing authorisation.
• Podatki o kakovosti, ki jih je predložil imetnik dovoljenj za promet z zdraviloma, so pokazali tudi, da se biofizikalne in biokemične lastnosti zdravil Kogenate Bayer in Helixate NexGen od prvotne odobritve dovoljenja za promet niso bistveno spremenile.
• In addition, the product information for Kogenate Bayer and Helixate NexGen has been updated to reflect the results of the RODIN/PedNet study.
• Poleg tega so bile informacije o zdravilih Kogenate Bayer in Helixate NexGen posodobljene z rezultati študije RODIN/PedNet.
The Agency's recommendations are based on the results of the RODIN/PedNet study, preliminary findings from the European Haemophilia Safety Surveillance System (EUHASS) and all available data submitted from clinical trials, observational studies, published literature and quality data for Kogenate Bayer and Helixate NexGen with regards to its potential risk of inhibitor development in previously untreated patients (PUPs).
Priporočila agencije temeljijo na rezultatih študije RODIN/PedNet, predhodnih ugotovitvah iz evropskega sistema za spremljanje varnosti zdravil za hemofilijo (EUHASS) in vseh razpoložljivih predloženih podatkih iz kliničnih preskušanj, opazovalnih študij in objavljene literature ter podatkih o kakovosti zdravil Kogenate Bayer in Helixate NexGen, povezanih z možnim tveganjem za nastanek zaviralcev pri predhodno nezdravljenih bolnikih.
• However, when all the available data were considered, they were consistent with the general clinical experience that most inhibitors develop within the first 20 days of exposure and that factor VIII products did not differ from each other in terms of inhibitor development in PUPs.
• Vendar pa so po proučitvi vseh razpoložljivih podatkov ugotovili doslednost s splošnimi kliničnimi izkušnjami, da se zaviralci v glavnem razvijejo v prvih 20 dneh izpostavljenosti in da se zdravila s faktorjem VIII ne razlikujejo med seboj glede nastajanja zaviralcev pri predhodno nezdravljenih bolnikih.
About a third of all the children in the RODIN study developed factor VIII inhibitors against their medicine, which reduces the benefit and makes bleeding more likely.
V študiji RODIN so se pri približno tretjini vseh otrok razvili zaviralci faktorja VIII proti uporabljenemu zdravilu, ki zmanjšajo koristi zdravljenja in povečajo verjetnost za krvavitve.
The benefits of treatment with Kogenate Bayer or Helixate NexGen continue to outweigh their risks in previously untreated patients.
Koristi zdravljenja z zdraviloma Kogenate Bayer in Helixate NexGen so še naprej večje od z njima povezanih tveganj pri predhodno nezdravljenih bolnikih.
On 20 December 2013 the European Medicines Agency's Committee on Human Medicinal Products (CHMP) endorsed previous recommendations which concluded that the benefits of Kogenate Bayer and Helixate NexGen, so-called second generation factor VIII products, continue to outweigh their risks in previously untreated patients with the bleeding disorder haemophilia A, but that the product information for these medicines should be amended.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Evropski agenciji za zdravila je dne 20. decembra 2013 potrdil predhodna priporočila s sklepom, da so koristi zdravil Kogenate Bayer in Helixate NexGen, ki sta zdravili iz tako imenovane druge generacije faktorja VIII, še naprej večje od z njima povezanih tveganj pri predhodno nezdravljenih bolnikih z motnjo strjevanja krvi, hemofilijo A, vendar pa je treba spremeniti informacije o zdravilu za ti dve zdravili.
• Despite concerns raised by the RODIN/PedNet study, overall the current evidence does not confirm that there is an increased risk of inhibitor development against full-length second generation factor VIII products such as Kogenate Bayer and Helixate NexGen.
• Kljub zadržkom, ki jih je vzbudila študija RODIN/PedNet, trenutno razpoložljivi dokazi na splošno ne potrjujejo povečanega tveganja za nastanek zaviralcev zdravil iz druge generacije faktorja VIII celotne dolžine, kot sta Kogenate Bayer in Helixate NexGen.
• Concerns about a potentially increased risk of factor VIII inhibitor development with full-length second generation factor VIII products were originally raised by the RODIN/PedNet study.
• Zadržke zaradi možnega povečanega tveganja za nastanek zaviralcev faktorja VIII pri uporabi zdravil iz druge generacije faktorja VIII celotne dolžine je prvotno vzbudila študija RODIN/PedNet.
They are used to replace the factor VIII that is lacking in patients with haemophilia A, an inherited bleeding disorder.
Uporabljata se za nadomeščanje faktorja VIII, ki ga primanjkuje bolnikom s hemofilijo A, sicer prirojeno motnjo strjevanja krvi.
• Haemophilia A is an inherited bleeding disorder in which there is a lack of factor VIII, which is needed for blood to clot normally.
• Hemofilija A je prirojena motnja strjevanja krvi, za katero je značilno pomanjkanje faktorja VIII, ki je potreben za normalno strjevanje krvi.
CHMP confirms PRAC recommendations on Kogenate Bayer/Helixate NexGen
Odbor CHMP je potrdil priporočila odbora PRAC v zvezi z zdraviloma Kogenate Bayer in Helixate NexGen
The recommendations, issued by the Agency's Pharmacovigilance Risk Assessment Committee (PRAC), resulted from a review of the medicines which did not confirm a higher risk of developing a type of antibody (factor VIII inhibitors) against these medicines when compared with other factor VIII products.
Priporočila, ki jih je izdal Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri agenciji, so nastala na osnovi pregleda zdravil, ki ni potrdil povečanega tveganja za nastanek vrste protiteles (zaviralcev faktorja VIII) proti tema zdraviloma v primerjavi z drugimi zdravili, ki vsebujejo faktor VIII.
Kogenate Bayer and Helixate NexGen are known as second generation factor VIII products.
Kogenate Bayer in Helixate NexGen sta tako imenovani zdravili iz druge generacije faktorja VIII.
After reviewing current available data on the development of inhibitors in previously untreated patients, the PRAC decided that these data did not support a conclusion that Kogenate Bayer or Helixate NexGen were associated with an increased risk of developing factor VIII inhibitors compared with other products.
Potem ko je pregledal trenutno razpoložljive podatke o nastanku zaviralcev pri predhodno nezdravljenih bolnikih, je odbor PRAC sklenil, da podatki ne podpirajo zaključka, da sta zdravili Kogenate Bayer in Helixate NexGen povezani s povečanim tveganjem za nastanek zaviralcev faktorja VIII v primerjavi z drugimi zdravili.
The review by the PRAC was triggered by results from a study (the RODIN/PedNet study1) in previously untreated children with haemophilia A who were given different factor VIII products, as well as preliminary data from the European Haemophilia Safety and Surveillance System (EUHASS).
Pregled, ki ga je opravil odbor PRAC, je bil sprožen zaradi rezultatov študije (študija RODIN/PedNet1) pri predhodno nezdravljenih otrocih s hemofilijo A, ki so jim dajali različna zdravila, ki vsebujejo faktor VIII, in predhodnih podatkov iz evropskega sistema za spremljanje varnosti zdravil za hemofilijo (EUHASS).
• Different forms of factor VIII are available as medicines to replace the missing clotting factor.
• Za nadomeščanje manjkajočega faktorja strjevanja krvi so na voljo zdravila z različnimi oblikami faktorja VIII.
Although existing measures to minimise all the risks from using the products were considered adequate for both Kogenate Bayer and Helixate NexGen and should be continued, the PRAC recommended that the product information should be updated to reflect results from the RODIN study.
Obstoječi ukrepi za zmanjšanje vseh tveganj, povezanih z uporabo zdravil Kogenate Bayer in Helixate NexGen, so zadostni in se morajo še naprej izvajati, vendar pa je odbor PRAC priporočil, da se informacije o zdravilu dopolnijo z rezultati študije RODIN.
Post-hoc analysis of the study showed that PUPs with severe haemophilia A given Kogenate Bayer were more likely to develop inhibitors than those given another recombinant antihaemophilic factor VIII (adjusted hazard ratio, 1.60; 95%-CI: 1.08
Analiza študije post hoc je pokazala, da so se zaviralci pogosteje razvili pri predhodno nezdravljenih bolnikih s hudo hemofilijo A, ki so prejemali zdravilo Kogenate Bayer, kot pri tistih, ki so prejemali drug rekombinantni koagulacijski faktor VIII (prilagojeno razmerje tveganja, 1,60; 95-odstotni IZ: 1,08-2,37).
This was an observational study which examined inhibitor development in previously untreated patients (PUPs) with severe haemophilia A who were given recombinant or plasma-derived factor VIII products.
To je bila opazovalna študija, v kateri so raziskovali nastajanje zaviralcev pri predhodno nezdravljenih bolnikih s hudo hemofilijo A, ki so prejemali rekombinantna zdravila ali zdravila iz plazme, ki vsebujejo faktor VIII.
A study in previously untreated patients with haemophilia A, which compared several of these, seemed to show that patients who were given Kogenate Bayer or Helixate NexGen (full-length second generation products) were more likely to develop antibodies than those given another factor VIII (a third generation product).
Študija na predhodno nezdravljenih bolnikih s hemofilijo A, v kateri so primerjali več takih zdravil, je pokazala, da so se pri bolnikih, ki so prejemali zdravilo Kogenate Bayer ali Helixate NexGen (zdravili iz druge generacije faktorja VIII celotne dolžine), pogosteje razvila protitelesa kot pri tistih, ki so prejemali drug faktor VIII (zdravilo tretje generacije).
Untreated, the deficiency of factor VIII in these patients causes bleeding problems, including bleeding into joints, muscles, and internal organs that can lead to severe damage.
Če se motnja ne zdravi, se lahko zaradi pomanjkanja faktorja VIII pri teh bolnikih pojavijo težave s krvavitvami, ki vključujejo krvavitve v sklepe, mišice in notranje organe, kar lahko povzroči hude poškodbe.
Untreated, the deficiency of factor VIII causes bleeding problems, including bleeding into joints, muscles, and internal organs that can lead to severe damage.
Če se motnja ne zdravi, se lahko zaradi pomanjkanja faktorja VIII pojavijo težave s krvavitvami, ki vključujejo krvavitve v sklepe, mišice in notranje organe, kar lahko povzroči hude poškodbe.
This is a known risk for all factor VIII products but the authors of the study concluded that children given so-called second generation fulllength recombinant factor VIII products such as Kogenate Bayer or Helixate NexGen were more likely to develop antibodies than those given a third generation recombinant product.
To je znano tveganje pri vseh zdravilih, ki vsebujejo faktor VIII, vendar pa so avtorji študije zaključili, da so se protitelesa pogosteje razvila pri otrocih, ki so jim dajali zdravila iz tako imenovane druge generacije rekombinatnega faktorja VIII celotne dolžine, med katere sodita tudi zdravili Kogenate Bayer in Helixate NexGen, kot pri tistih, ki so prejemali rekombinantno zdravilo tretje generacije.
Factor VIII is lacking in patients with haemophilia A and is given to them to allow their blood to clot normally.
Bolniki s hemofilijo A imajo pomanjkanje faktorja VIII, zato ga morajo dodajati, da omogočijo normalno strjevanje krvi.
An increase in inhibitor formation was not seen with other recombinant or plasma-derived factor VIII products.
Pri drugih rekombinantnih zdravilih ali zdravilih iz plazme, ki vsebujejo faktor VIII, niso opazili povečanega nastajanja zaviralcev.
This summary was last updated on 18 August 2011.
Povzetek je bil nazadnje posodobljen dne 18. 08. 2011.
A second dose may be given after 24 hours if required.
Drugi odmerek se lahko po potrebi da po 24 urah.
Emdocam meloxicam
Emdocam meloksikam
Other information about Emdocam:
Druge informacije o zdravilu Emdocam:
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendation for authorisation and the conditions of use.
Njegov namen je pojasniti, kako je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) ocenil predloženo dokumentacijo, na podlagi česar je oblikoval priporočila za odobritev zdravila in njegovo uporabo.
In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
V zelo redkih primerih lahko pride do anafilaktoidnih reakcij, ki jih je treba zdraviti simptomatsko.
The withdrawal period is 15 days for cattle and five days for pigs and horses.
Karenca za govedo je 15 dni, za prašiče in konje pa 5 dni.
In horses, a transient swelling at the injection site can occur but resolves without intervention.
Pri konjih se na mestu injiciranja lahko pojavi prehodna oteklina, ki pa izzveni brez ukrepov.
The European Commission granted a marketing authorisation valid throughout the European Union, for Emdocam to Emdoka bvba on 18 August 2011.
Evropska komisija je dovoljenje za promet z zdravilom Emdocam, veljavno po vsej Evropski uniji, odobrila družbi Emdoka bvba dne 18. 08. 2011.
It is available as a clear yellow solution for injection (20 mg/ml).
Na voljo je v obliki prozorne rumene raztopine za injiciranje (20 mg/ml).
Milk can be taken five days after administration in cattle.
Mleko goveda se lahko pomolze pet dni po uporabi zdravila.
No studies in cattle, pigs and horses were required as Emdocam is given by injection and has a similar composition as the reference medicine, Metacam.
Študije pri govedu, prašičih in konjih niso bile potrebne, saj se zdravilo Emdocam daje z injiciranjem in ima podobno sestavo kot referenčno zdravilo Metacam.
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Emdocam.
Osebe, ki so preobčutljive za (alergične na) nesteroidna protivnetna zdravila, naj se izogibajo stiku z zdravilom Emdocam.
In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Govedo in prašiči dobro prenašajo podkožno, intramuskularno in intravensko dajanje; v kliničnih študijah so opazili samo rahlo prehodno oteklino na mestu injiciranja po podkožnem dajanju pri manj kot 10 % zdravljenega goveda.
It can be used with oral re-hydration therapy for diarrhoea in calves of over one week of age and in young, non-lactating cattle.
Uporablja se lahko s peroralnim rehidracijskim zdravljenjem pri driski pri teletih, starejših od enega tedna, in mladih govedih, ki niso v obdobju laktacije.
What benefit has Emdocam shown during the studies?
Kakšne koristi je zdravilo Emdocam izkazalo med študijami?
The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Razmerje med koristmi in tveganji najdete v znanstveni razpravi tega evropskega javnega poročila o oceni zdravila EPAR.
Emdocam is a medicine for cattle, pigs and horses that contains the active substance meloxicam.
Emdocam je zdravilo za govedo, prašiče in konje, ki vsebuje zdravilno učinkovino meloksikam.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the doctor.
V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Meloksikam deluje tako, da zavira encim, imenovan ciklooksigenaza, ki sodeluje pri nastajanju prostaglandinov.
Emdocam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Zdravilo Emdocam vsebuje meloksikam, ki spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSAID).
The Committee recommended that Emdocam be given a marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Emdocam.
What is the risk associated with Emdocam?
Kakšna tveganja so povezana z zdravilom Emdocam?
Emdocam is a ‘generic' medicine which means that Emdocam is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam).
Emdocam je generično zdravilo, kar pomeni, da je podobno referenčnemu veterinarskemu zdravilu, ki je že odobreno v EU (zdravilu Metacam).
In cattle it is used together with appropriate antibiotics, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways) and to treat acute mastitis (inflammation of the udder).
Pri govedu se uporablja z ustreznimi antibiotiki za zmanjšanje kliničnih znakov akutne okužbe dihal (okužbe pljuč in dihalnih poti) in zdravljenje akutnega mastitisa (vnetja vimena).
It is used in pigs to reduce the symptoms of lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move) and for the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome), together with appropriate antibiotic therapy.
Pri prašičih se uporablja za lajšanje simptomov ohromelosti in vnetja pri neinfekcijskih lokomotornih motnjah (bolezni, ki vplivajo na sposobnost gibanja) ter za zdravljenje bolezni, ki se pojavljajo po kotitvi, kot sta puerperalna septikemija in toksemija (sindrom mastitisa, metritisa in agalakcije),