natgillin/translations-raw huggingface dataset:
Gerakas 15344 Greece 
Marathonos 106 Gerakas 15344 Grčija uporaba
D-55216 Ingelheim am Rhein Germany 
D-55216 Ingelheim Am Rhein Nemčija
D-55216 Ingelheim Am Rhein Germany 
D-55216 Ingelheim am Rhein Nemčija
Docpharma S.A. Ambachtenlaan 13h B-3001 Heverlee Belgium 
Docpharma S.A. Ambachtenlaan 13h
Dispersible tablet 
Šumeča tableta
55216 Ingelheim Am Rhein Germany 
55216 Ingelheim Am Rhein Madžarska
Egis Pharmaceuticals Plc Kereszturi Ut 30-38 H-1106 Budapest Hungary 
Egis Pharmaceuticals Plc Kereszturi Ut 30-38
Cutaneous use 
Okularna uporaba
Dental treatment and in the course of infections Relief of fever and pain associated with acute upper respiratory tract inflammation. 
akutna faza protina primarna dismenoreja pooperativna bolečina stomatološki posegi in med okužbami zmanjšanje vročine in bolečine pri akutnem vnetju zgornjih dihalnih poti akutna mišično-skeletna obolenja (na primer burzitis, tendinitis) akutne motnje po poškodbah radikulalgija
Via Di Scandicci, 37 
Via Di Scandicci, 37 50143 Firenze
Anfarm Hellas Ae K. Palaiologou & Perikleous 27 
Anfarm Hellas Ae
50143 Firenze Italy 
00144 Rome Italija
Viale Bodio, 37/B 20158 Milano 
Viale G. Rictrda, 7 20143 Milano
Chiesi España, S.A. Av. Berlin, 38-48 7ª Planta 
Av. Berlin, 38-48 7ª Planta 08029 Barcelona Španija uporaba
Dispersible Tablet 
Žvečljiva Tableta
Feldene Intramuscular 
Hotemin Intramuskularna uporaba
Piroxicam Dispersible Tablets 10mg 
Piroxicam Tableta za peroralno suspenzijos 10mg
Strength Pharmaceutical Form Route of Administration Immediate Packaging 
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
MA (EU) Number Name 
Številka EU
The average improvement was about 1.4 points. 
V povprečju je prišlo do izboljšanja za približno 1,4 točke.
The patients had an average of 0.08 serious infections per year. 
Bolniki so imeli v povprečju 0,08 resne okužbe na leto.
Further information can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Privigen. 
Nadaljnje informacije za zdravilo Privigen so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Privigen.
What measures are being taken to ensure the safe and effective use of Privigen? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Privigen?
The European Medicines Agency concluded that Privigen's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Privigen večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
Other information about Privigen 
Druge informacije o zdravilu Privigen
Privigen received a marketing authorisation valid throughout the EU on 25 April 2008. 
Zdravilo Privigen je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 25. aprila 2008.
What is Privigen and what is it used for? 
Kaj je zdravilo Privigen in za kaj se uporablja?
An overview of Privigen and why it is authorised in the EU 
Pregled zdravila Privigen in zakaj je odobreno v EU
Privigen was not compared to other treatments in the studies. 
Zdravila Privigen v študijah niso primerjali z drugimi zdravili.
Privigen is a medicine used to support the immune system (the body's natural defences) in two main groups of patients: 
Zdravilo Privigen se uporablja kot podpora imunskemu sistemu (naravnemu obrambnemu mehanizmu telesa) pri dveh glavnih skupinah bolnikov:
What are the risks associated with Privigen? 
Kakšna tveganja so povezana z zdravilom Privigen?
Since this is below the predefined threshold of one serious infection per year, this indicates that the medicine is effective as replacement therapy. 
Ker je ta vrednost nižja od mejne vrednosti, ki je enaka eni resni okužbi na leto, to kaže, da je zdravilo kot nadomestno zdravljenje učinkovito.
The dose may need to be adjusted for patients depending on their response. 
Bolnikom bo glede na njihov odziv odmerek morda treba prilagoditi.
As for all medicines, data on the use of Privigen are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Privigen stalno spremljajo.
In this third study, 17 (61%) of the 28 patients responded to treatment with an improvement of at least one point on the disability scale. 
V tej tretji študiji se je 17 (61 %) od 28 bolnikov odzvalo na zdravljenje z izboljšanjem za vsaj eno točko na lestvici prizadetosti.
Why is Privigen authorised in the EU? 
Zakaj je zdravilo Privigen odobreno v EU?
This confirmed that Privigen is effective in immunomodulation. 
To potrjuje, da je zdravilo Privigen učinkovito pri imunomodulaciji.
The dose and frequency of infusions (how often it is given) depend on the disease being treated. 
Odmerek in pogostost infuzije sta odvisna od zdravljene bolezni.
Privigen was given on two consecutive days. 
Zdravilo Privigen se je dajalo dva dni zapored.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Privigen have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Privigen upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Side effects reported with Privigen are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Privigen, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
As human normal immunoglobulin has been used to treat these diseases for a long time, and in accordance with current guidelines, only three small studies were needed to establish the effectiveness and safety of Privigen in patients. 
Ker se humani polispecifični imunoglobulin že dlje časa uporablja za zdravljenje teh bolezni, so za potrditev učinkovitosti in varnosti zdravila Privigen pri bolnikih v skladu z veljavnimi smernicami zadostovale tri manjše študije.
The company that markets Privigen has made some changes in the way it is produced to reduce this risk and is performing a study to monitor the effect of the changes. 
Da bi zmanjšala to tveganje, je družba, ki trži zdravilo Privigen, naredila nekaj sprememb pri načinu proizvodnje zdravila, in izvaja študijo spremljanja učinka sprememb.
The most common side effects with Privigen (seen in more than 1 patient in 10) are headache, nausea, pain (including in the back, neck, limbs, joints and face), fever, chills and a flu-like illness. 
Najpogostejši neželeni učinki zdravila Privigen (ki se pojavijo pri več kot 1 bolniku od 10) so glavobol, navzeja, bolečina (tudi v hrbtu, vratu, udih, sklepih in obrazu), povišana telesna temperatura, mrzlica in gripi podobna bolezen.
Privigen can only be obtained with a prescription and treatment for patients with a lack of antibodies should be started and monitored by a doctor experienced in treating such conditions. 
Predpisovanje in izdaja zdravila Privigen je le na recept, zdravljenje bolnikov s pomanjkanjem protiteles pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem tovrstnih stanj.
For more information about using Privigen, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Privigen glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
• Patients who are at risk of infection because they do not have enough antibodies (also called immunoglobulins, proteins in the blood that help the body to fight disease). 
• pri bolnikih, pri katerih obstaja nevarnost okužbe zaradi nezadostnega števila protiteles (imenovanih tudi imunoglobulini, tj. beljakovine v krvi, ki pomagajo telesu pri premagovanju bolezni).
What benefits of Privigen have been shown in studies? 
Kakšne koristi je zdravilo Privigen izkazalo v študijah?
Privigen works by restoring abnormally low IgG levels to their normal range in the blood. 
Zdravilo Privigen deluje tako, da nenormalno nizko koncentracijo IgG vrne v območje njene normalne vrednosti v krvi.
The medicine is available as a solution for infusion (drip) into a vein. 
Zdravilo je na voljo kot raztopina za infundiranje (kapalno infuzijo) v veno.
These comprise patients with primary immune thrombocytopenia (ITP), who do not have enough platelets (components in the blood that help it to clot) and who are at high risk of bleeding; patients with Guillain-Barré syndrome or chronic inflammatory demyelinating polyneuropathy (CIDP), inflammatory disorders of the nerves that result in muscle weakness and numbness; patients with Kawasaki disease, a disease mainly seen in children which causes inflammation of blood vessels; and patients with multifocal motor neuropathy (MMN), nerve damage which causes weakness of the arms and legs. 
Ta skupina vključuje bolnike s primarno imunsko trombocitopenijo (ITP), ki nimajo dovolj trombocitov (sestavin v krvi, ki prispevajo k strjevanju krvi) in pri katerih obstaja veliko tveganje za krvavitve, bolnike z Guillain-Barréjevim sindromom ali kronično vnetno demielinizacijsko polinevropatijo (CIDP), tj. vnetnim obolenjem živcev, ki povzroča slabitev in otrplost mišic, bolnike s Kawasakijevim sindromom, tj. boleznijo, ki je prisotna predvsem pri otrocih in povzroča vnetje krvnih žil, in bolnike z multifokalno motorično nevropatijo (MN), tj. poškodbo živcev, ki povzroča oslabelost rok in nog.
The main measure of effectiveness was the highest blood platelet level that was achieved in the week after Privigen was given. 
Glavno merilo učinkovitosti je bila najvišja koncentracija trombocitov v krvi, dosežena v tednu po uporabi zdravila Privigen.
Privigen must not be used in patients with hyperprolinaemia type I or II (a genetic disorder causing high levels of the amino acid proline in the blood). 
Zdravilo Privigen se ne sme uporabljati pri bolnikih s hiperprolinemijo tipa I ali II (dedno motnjo, ki povzroča visoke ravni aminokisline prolin v krvi).
In this study, 46 (81%) of the 57 patients had a platelet count above 50 million platelets per millilitre at least once during the study. 
V tej študiji je bila pri 46 (81 %) od 57 bolnikov koncentracija trombocitov vsaj enkrat v času trajanja študije nad 50 milijonov trombocitov na mililiter.
Some side effects are more likely with a high rate of infusion, in patients with low immunoglobulin levels, or in patients who have not received human normal immunoglobulin before or for a long time. 
Nekateri neželeni učinki so verjetnejši pri uporabi visoke hitrosti infundiranja, pri bolnikih z nizko ravnjo imunoglobulina ali bolnikih, ki v preteklosti niso prejemali humanega polispecifičnega imunoglobulina ali ga niso prejemali dolgo.
The active substance in Privigen, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood). 
Zdravilna učinkovina zdravila Privigen, humani polispecifični imunoglobulin, je visoko prečiščena beljakovina, pridobljena iz človeške plazme (dela krvi).
Privigen must not be used in people who are hypersensitive (allergic) to normal human immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA. 
Zdravila Privigen ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) humani polispecifični imunoglobulin ali katero koli drugo sestavino zdravila, ter bolniki, ki so alergični na druge vrste imunoglobulinov, še posebno, če imajo pomanjkanje (zelo nizko raven) imunoglobulina A (IgA) ter imajo protitelesa proti IgA.
The main measure of effectiveness was the number of patients who showed improvement of their disability, measured by a decrease on a 10point scale of disability in their arms and legs. 
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je prišlo do izboljšanja prizadetosti rok in nog, merjene z zmanjšanjem na 10-stopenjski lestvici prizadetosti.
In the first study, Privigen was used in 80 patients with PID, with the medicine being infused every three or four weeks. 
V prvi študiji je bilo zdravilo Privigen uporabljeno pri 80 bolnikih s sindromom primarne imunske pomanjkljivosti, pri čemer se je zdravilo infundiralo vsake tri ali štiri tedne.
These also include people who have developed a lack of antibodies after birth (secondary immunodeficiency syndrome, SID), who have low levels of certain antibodies (called IgG) and who suffer from infections that are severe, keep coming back, and are not cured by medicines used to treat infections. 
To lahko vključuje tudi osebe, pri katerih je pomanjkanje protiteles nastopilo po rojstvu (sindrom sekundarne imunske pomanjkljivosti, SID), ki imajo nizke ravni določenih protiteles (imenovanih IgG) in ki trpijo zaradi hudih, ponavljajočih se okužb ter jih ne moremo zdraviti z drugimi zdravili za zdravljenje okužb.
The second study looked at using Privigen in 57 patients with ITP. 
V drugi študiji so proučevali uporabo zdravila Privigen pri 57 bolnikih s primarno imunsko trombocitopenijo.
A third study examined the use of Privigen for immunomodulation in 28 patients with CIDP who were given Privigen every three weeks over a period of 24 weeks. 
V tretji študiji so proučevali uporabo zdravila Privigen za imunomodulacijo pri 28 bolnikih s kronično vnetno demielinizacijsko polinevropatijo, ki so zdravilo v obdobju 24 tednov prejemali vsake tri tedne.
How is Privigen used? 
Kako se zdravilo Privigen uporablja?
For the full list of all side effects with Privigen, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Privigen, glejte navodilo za uporabo.
Haemolysis (breakdown of red blood cells) is an uncommon side effect in patients given human normal immunoglobulin (occurring with less than 1 dose in 100). 
Redek neželeni učinek pri bolnikih, ki prejemajo humani polispecifični imunoglobulin (ki se pojavi pri manj kot 1 odmerku od 100), je hemoliza (razkroj rdečih krvnih celic).
Severe haemolysis has previously been reported to be slightly more frequent with Privigen than with some other products containing the same active substance. 
V primerjavi z nekaterimi drugimi zdravili, ki vsebujejo enako učinkovino, so pri jemanju zdravila Privigen nekoliko pogosteje poročali o pojavu hujše oblike hemolize.
How does Privigen work? 
Kako zdravilo Privigen deluje?
O MA (EU) number (Invented) name 
(Izmišljeno) ime
Co. Down BT35 6JP Northern Ireland 
Co. Down BT35 6JP Severna Irska
Combimox was authorised in the United Kingdom on 9 May 2003 under Article 13(1) of Directive 2001/82/EC. 
Zdravilo Combimox je bilo odobreno v Združenem kraljestvu dne 9. maja 2003 v skladu s členom 13(1) Direktive 2001/82/ES.
The application was submitted to the Concerned Member State, Ireland, under the mutual recognition procedure. 
Vloga je bila predložena zadevni državi članici, Irski, po postopku z medsebojnim priznavanjem.
Consequently the matter was referred to the CVMP 
Zato je bila zadeva napotena na CVMP.
• the efficacy of Combimox was not confirmed; 
• Učinkovitost zdravila Combimox ni bila potrjena.
Ireland considered that the authorisation of Combimox may present a potential serious risk to human and animal health since the safety and efficacy of the product had not been sufficiently demonstrated. 
Irska je menila, da bi odobritev zdravila Combimox lahko predstavljala možno resno tveganje za zdravje ljudi in živali, saj varnost in učinkovitost zdravila nista bili ustrezno dokazani.
Therefore the CVMP concluded that the particulars submitted in support of the application do not comply with Article 13 of Directive 2001/82/EC and recommended the refusal of granting the Marketing Authorisation in the Concerned Member State and the suspension of the existing Marketing Authorisation in the Reference Member State. 
CVMP je zato sklenil, da predloženi podatki v podporo vlogi niso v skladu s členom 13 Direktive 2001/82/ES, ter priporočil zavrnitev odobritve dovoljenja za promet z zdravilom v zadevnih državah članicah in začasni umik obstoječega dovoljenja za promet z zdravilom v referenčni državi članici.
The applicant presented comparative viscosity data between the ‘old' and ‘new' formulations of Combimox. 
Predlagatelj je predstavil primerjalne podatke o viskoznosti med „staro“ in „novo“ formulacijo zdravila Combimox.
The CVMP was asked to give its opinion on the concerns raised by Ireland and to conclude on the benefit/risk balance for Combimox. 
CVMP je bil naprošen, da poda mnenje v zvezi z zadržki, ki jih je izrazila Irska, in sprejme sklep glede razmerja med tveganji in koristmi za zdravilo Combimox.
During the procedure, there was disagreement between the Reference Member State and Concerned Member State on the applicability of demonstrating systemic bioequivalence for a locally-applied, locally-acting product, as well as an additional concern on the adequacy of the proposed withdrawal period. 
Med postopkom je prišlo do nesoglasja med referenčno državo članico in zadevnimi državami članicami glede uporabnosti dokazovanja sistemske biološke enakovrednosti za lokalno uporabljeno in lokalno delujoče zdravilo, pojavili pa so se tudi dodatni zadržki glede ustreznosti predlagane karence.
Not established 
Ni ugotovljeno
Scientific conclusions and grounds for refusal of the granting of the marketing authorisation(s) 
Znanstveni zaključki in podlaga za zavrnitev podelitve dovoljenj(a) za promet z zdravilom
Appropriate clinical data should be provided to confirm the efficacy of Combimox Lactating Cow Intramammary Suspension. 
Predložiti je treba ustrezne klinične podatke za potrditev učinkovitosti zdravila Combimox Lactating Cow Intramammary Suspension.
An additional issue reviewed by the CVMP was a change in the formulation of Combimox during development to increase the stability of the product, which was identified as potentially affecting the release of the active substances from the product into the tissue. 
Dodatno vprašanje, ki ga je CVMP preučil, je bila sprememba formulacije zdravila Combimox med razvojem, s čimer so želeli povečati stabilnost zdravila in za kar je bilo ugotovljeno, da bi lahko vplivalo na sproščanje zdravilne učinkovine iz zdravila v tkivo.
It was concluded that, although Combimox was shown to be similar to the reference product with respect to formulation, particle size and viscosity, this could only be seen as supportive in this case and could not substitute clinical studies to demonstrate efficacy. 
Sklenjeno je bilo, da je bilo sicer dokazano, da je zdravilo Combimox podobno referenčnemu zdravilu glede formulacije, velikosti delcev in viskoznosti, vendar pa so v tem primeru to lahko le podporni podatki in ne morejo nadomestiti kliničnih študij za dokazovanje učinkovitosti.
When preparing the approach used to investigate similarity in terms of efficacy for Combimox, the applicant had not pursued conducting comparative clinical studies since it was expected that clinical trials would not be sensitive enough to pick up differences between Combimox and the reference product. 
Predlagatelj pri pripravi pristopa, ki ga je uporabil za preučevanje podobnosti v zvezi z učinkovitostjo zdravila Combimox, ni izvedel primerjalnih kliničnih študij, saj je bilo pričakovano, da klinični preskusi ne bodo dovolj občutljivi, da bi odkrili razlike med zdravilom Combimox in referenčnim zdravilom.
Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals 
Intramamarna uporaba pri govedu v obdobju laktacije z odmerkom treh brizg na prizadeto četrtino, ki se daje samostojno vsakih 12 ur
In support of Combimox, studies were submitted to compare milk and plasma pharmacokinetics between the generic and reference products. 
V podporo zdravilu Combimox so bile predložene študije, v katerih so primerjali farmakokinetiko pri mleku in plazmi med generičnimi in referenčnimi zdravili.
The applicant further claimed that the formulation of Combimox was sufficiently similar to the reference product to allow a waiver from the need to present in vivo data. 
Predlagatelj je trdil tudi, da je formulacija zdravila Combimox dovolj podobna referenčnemu zdravilu, da dopušča opustitev potrebe po predstavitvi podatkov in vivo.
The results of the milk studies demonstrated that the concentrations of the active substances were similar to those of the reference product following the intramammary infusion of Combimox, although it was noted that there was considerable inter-quarter and inter-animal variability in each of the pharmacokinetic parameters measured. 
Rezultati študij pri mleku so pokazali, da so bile koncentracije zdravilne učinkovine po intramamarni infuziji zdravila Combimox podobne kot pri referenčnem zdravilu, čeprav je bilo ugotovljeno, da so se pri vsakem merjenem farmakokinetičnem parametru pojavljale bistvene razlike med četrtinami in živalmi.
Combimox is intended for the treatment of mastitis in lactating cows caused by the major pathogens commonly occurring from the bovine udder (Staphylococci, Streptococci and Escherichia coli). 
Zdravilo Combimox je namenjeno zdravljenju mastitisa pri kravah v obdobju laktacije, ki ga povzročajo poglavitni patogeni, ki se običajno pojavljajo na vimenu govedi (stafilokoki, streptokoki in Escerichia coli).
Combimox Lactating Cow Intramammary Suspension (hereinafter referred to as Combimox) is an intramammary suspension containing amoxicillin (as amoxicillin trihydrate), clavulanic acid (as potassium clavulanate) and prednisolone. 
Zdravilo Combimox Lactating Cow Intramammary Suspension (v nadaljevanju zdravilo Combimox) je intramamarna suspenzija, ki vsebuje amoksicilin (v obliki amoksicilin trihidrata), klavulansko kislino (v obliki kalijevega klavulanata) in prednizolon.
Combimox is presented in unit-dose syringes as an oily suspension to be administered via the intramammary route. 
Zdravilo Combimox je na voljo v enoodmernih brizgah kot oljna suspenzija, ki se daje po intramamarni poti.
• the proposed withdrawal period for Combimox was insufficiently substantiated; 
• Predlagana karenca za zdravilo Combimox ni bila ustrezno utemeljena.
This study also served to provide data on the residues of amoxicillin and clavulanic measured in the (udder) quarter milk samples obtained at regular timepoints after infusion of Combimox and the reference product. 
S to študijo so dobili tudi podatke o ostankih amoksicilina in klavulanske kisline, izmerjenih v vzorcih mleka iz četrtin (vimen), ki so bili pridobljeni v rednih obdobjih po infundiranju zdravila Combimox in referenčnega zdravila.
When asked to further substantiate this claim, the applicant provided comparative data on the physico-chemical characteristics of the product, including viscosity, particle size and dissolution in milk, between Combimox and the reference product. 
Ko so od predlagatelja zahtevali, da to trditev podrobneje utemelji, je predložil primerjalne podatke med zdravilom Combimox in referenčnim zdravilom o fizikalno-kemičnih lastnostih zdravila, vključno z viskoznostjo, velikostjo delcev in raztapljanjem v mleku.
Overall summary of the scientific evaluation of Combimox Lactating Cow Intramammary Suspension 
Splošni povzetek znanstvenega vrednotenja zdravila Combimox Lactating Cow Intramammary Suspension
Lactating cattle 
Govedo v obdobju laktacije
Grounds for refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisation 
Podlaga za zavrnitev odobritve dovoljenja za promet z zdravilom in začasni umik obstoječih dovoljenj za promet z zdravilom
Three comparative pharmacokinetic studies were carried out with Combimox and the reference product, all with a two-period cross-over design. 
Izvedene so bile tudi tri navzkrižne primerjalne farmakokinetične študije z dvema obdobjema, v katerih so primerjali zdravilo Combimox in referenčno zdravilo.
Overall safety conclusions 
Splošni zaključki glede varnosti
c. All marketing authorisation holders should implement risk minimisation measures. 
c. Vsi imetniki dovoljenj za promet z zdravili morajo izvajati ukrepe za zmanjšanje tveganja.