FrancophonIA/ELRC3.0 huggingface dataset:
English: Aliud Pharma Gmbh &Co. Kg. Gottlieb-Daimler Str. 19 89150 Laichingen Germany
Slovenian: Aliud Pharma Gmbh &Co. Kg. Gottlieb-Daimler Str. 19 89150 Laichingen Nemčija
English: S.C. Antibiotice S.A. Str. Valea Lupului Nr.1 Iasi
Slovenian: Str. Valea Lupului Nr.1 Iasi
English: 3640 Ae Mijdrecht
Slovenian: 3640 Ae Mijdrecht Nozozemska
English: D- 85737 Ismaning Germany
Slovenian: D- 85737 Ismaning Nemčija
English: D-85737 Ismaning Germany
Slovenian: D-85737 Ismaning Nemčija
English: Aliud Pharma Gmbh & Co.Kg Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Slovenian: Aliud Pharma Gmbh & Co.Kg Gottlieb-Daimler-Str. 19 D-89150 Laichingen Nemčija
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLETFOR SYSTEMIC FORMULATIONS OF PIROXICAM CONTAINING MEDICINAL PRODUCTS
Slovenian: DOPOLNILA, KI JIH JE TREBA DODATI USTREZNIM POGLAVJEM V NAVODILU ZA UPORABO PRI ZDRAVILIH ZA SISTEMSKO UPORABO, KI VSEBUJEJO PIROKSIKAM
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS Whereas
Slovenian: PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
English: Your doctor will adjust your treatment to the lowest dose that best controls your symptoms.
Slovenian: Določil vam bo najmanjši odmerek, ki učinkovito odpravlja simptome.
English: The review found that limited epidemiological data and spontaneous adverse drug reaction data provided a signal of increased risk of gastrointestinal and skin reactions (including life-threatening bullous reactions) relative to other nonselective NSAIDs.
Slovenian: Pregled je pokazal, da omejeni epidemiološki podatki in podatki iz spontanih poročil o neželenih učinkih zdravila nakazujejo na povečano tveganje gastrointestinalnih in kožnih reakcij (vključno s smrtno nevarnimi buloznimi reakcijami), povezanih z drugimi neselektivnimi NSAID-i. CHMP je menil, da je ocena vzbudila pomisleke glede razmerja med koristmi in tveganji za piroksikam, ter je skladno s tem obvestil Evropsko komisijo.
English: Docpharma N.V. Ambachtenlaan B-3001 Heverlee Belgium
Slovenian: Ambachtenlaan B-3001 Heverlee Belgija
English: Pfizer Limited Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Slovenian: Pfizer Limited Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS Velika Britanija
English: Nycomed Belgium N.V. Gentsesteenweg 615 B-1080 Brussels Belgium
Slovenian: Gentsesteenweg 615 B-1080 Brussels Belgija
English: Hotemin 10 mg capsule
Slovenian: Hotemin 10 mg Kapsula
English: Flamatrol 10mg Capsules
Slovenian: Flamatrol 10mg Kapsulas
English: United Kingdom Clonmel Healthcare Limited Waterford Road
Slovenian: Clonmel Healthcare Limited Waterford Road Clonmel, Co. Tipperary, Irska
English: The possible need for combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered.
Slovenian: Skrbno moramo presoditi o morebitni potrebi po kombiniranem zdravljenju z zdravili z zaščitnim delovanjem na želodec (na primer mizoprostolom ali zaviralci protonske črpalke) (glejte poglavje
English: Katwijk Farma B.V. Postbus 408
Slovenian: Katwijk Farma B.V.
English: Flamatrol 20mg Capsules
Slovenian: Flamatrol 20mg Kapsulas
English: Hotemin 20 mg capsule
Slovenian: Hotemin 20 mg Kapsula
English: 20MG/ML Solution for injection Intramuscular use
Slovenian: 20MG/ML Raztopina za injiciranje Intramuskularna uporaba
English: − the benefits of piroxicam outweigh the risks in the symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis;
Slovenian: − koristi piroksikama pri simptomatskem lajšanju osteoartritisa, revmatoidnega artritisa ali ankilozirajočega spondilitisa so večje od z njim povezanih tveganj;
English: Kent CT 13 9 NJ United Kingdom
Slovenian: Kent Ct13 9nj Velika Britanija
English: Aktuapharma N.V. Ambachtenlaan 13e B-3001 Leuven Belgium
Slovenian: Ambachtenlaan 13e B-3001 Leuven Belgija
English: S.C. Mark Pharmaceutics S.R.L.
Slovenian: Mark Pharmaceutics S.R.L.
English: Solution for injection Intramuscular use
Slovenian: Raztopina za injiciranje Intramuskularna uporaba
English: 10 mg/cap Hard capsules
Slovenian: 10 mg/cap Kapsula, trda
English: 1x50 g/0,5 g Dermálny krém topical use
Slovenian: 1x50 g/0,5 g Krema
English: Evidence from observational studies suggests that piroxicam may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs.
Slovenian: Podatki iz opazovalnih raziskav kažejo, da bi bil lahko piroksikam v primerjavi z drugimi nesteroidnimi antirevmatiki povezan z velikim tveganjem resnih toksičnih učinkov na prebavila.
English: Zerospam20 mg/cap Hard capsules
Slovenian: Zerospam20 mg/cap Kapsula, trda
English: Feldene 10 Mg Capsules
Slovenian: Feldene 10 Mg Kapsulas
English: As with other NSAIDs, the use of piroxicam in combination with protective agents (e.g. misoprostol or proton pump inhibitors) must be considered for these atrisk patients.
Slovenian: Pri teh bolnikih s povečanim tveganjem moramo enako kot pri zdravljenju z drugimi nesteroidnimi antirevmatiki presoditi o uporabi piroksikama v kombinaciji z zdravili z zaščitnim delovanjem (na primer mizoprostolom ali zaviralci protonske črpalke).
English: 20 mg/sachet Grannules for oral solution
Slovenian: 20 mg/sachet Zrnca za peroralno raztopino
English: Felcam20 mg/sup Suppository
Slovenian: Felcam20 mg/sup Svečka
English: United Kingdom Neolab Limited 57 High Street
Slovenian: Cipla (Uk) Limited 53a High Street Esher
English: Feldene 20mg Capsules
Slovenian: Feldene 20mg Kapsulas
English: Quimifar, S.A. Comadran 37
Slovenian: Quimifar, S.A.
English: 20 mg/cap Hard capsules
Slovenian: 20 mg/cap Kapsula, trda
English: Estonia
Slovenian: Estinija
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET Note: These sections of the Summary of Product Characteristics are the ones that were annexed to the Commission Decision on this Article 31 referral.
Slovenian: Opomba: Ta razdelek Povzetka glavnih značilnosti zdravila je bil priložen k odločbi Komisije v zvezi z napotitvenim postopkom, ki je bil sprožen v skladu s členom 31.
English: Basildon, Essex SS14 3FR United Kingdom
Slovenian: Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR Velika Britanija
English: 20 mg/sup Suppository
Slovenian: 20 mg/sup Svečka
English: 20 mg/ml, 1ml Solution for injection Intramuscular use
Slovenian: 20 mg/ml, 1ml Raztopina za injiciranje Intramuskularna uporaba
English: Piroxicam 10mg Capsules Bp
Slovenian: Piroxicam 10mg Kapsulas Bp
English: Eurogenerics S.A.
Slovenian: Eurogenerics N.V.
English: Piroxicam Beral Dispersible 20 Mg, Comprimé
Slovenian: Piroxicam Beral Dispersible 20 Mg, Comprimé Dispersible Sécable
English: Piroxicam 20mg Capsules Bp
Slovenian: Piroxicam 20mg Kapsulas Bp
English: Piroxicam Innotech International 10 Mg, Gélule
Slovenian: Piroxicam Innotech International 10 Mg,
English: 20 mg/3 mg Granules for oral solution
Slovenian: 20 mg/3 mg Zrnca za peroralno raztopino
English: Piroxicam Capsules Bp 20mg
Slovenian: Piroxicam Kapsulas Bp 20mg
English: Highfield, Cheadle SK8 3GY
Slovenian: Cheadle Royal Business Park Highfield, Cheadle Sk8 3gy Veliak Britanija
English: Piroxicam Capsules Bp 10mg
Slovenian: Piroxicam Kapsulas Bp 10mg
English: Piroxicam Capsules 10mg
Slovenian: Piroxicam Kapsulas 10mg
English: Torrex Chiesi Pharma Gmbh Gonzagagasse 16/16
Slovenian: Torrex Chiesi Pharma Gmbh
English: Sanofi-Synthelabo B.V. Postbus 2043
Slovenian: Sanofi-Synthelabo B.V.
English: Tablets
Slovenian: Tablets uporaba
English: Via Palermo 26 A 43100, Parma Italy
Slovenian: Via Palermo 26 A 43100, Parma Italija
English: Mobilat P Cream 5 mg/g
Slovenian: Mobilat P Krema
English: Piroxicam Capsules 20mg
Slovenian: Piroxicam Kapsulas 20mg
English: United Kingdom Tillomed Laboratories Limited
Slovenian: Generics Uk Limited
English: Esplanade Heysel B 22 B-1020 Bruxelles Belgium
Slovenian: Eurogenerics S.A. Esplanade Heysel B 22 B-1020 Bruxelles Belgija
English: Esplanade Heysel, B 22 B-1020 Bruxelles Belgium
Slovenian: Eurogenerics S.A. Esplanade Heysel, B 22 B-1020 Bruxelles Belgija
English: United Kingdom Actavis Uk Limited Whiddon Vally
Slovenian: Actavis Uk Limited Whiddon Vally Barnstaple Devon Ex32 8ns United Kingdom
English: Teva Generics Belgium N.V. Laarstraat 16
Slovenian: Teva Generics Belgium N.V.
English: Combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should also be carefully considered for all patients and in particular for the elderly.
Slovenian: Pri vseh bolnikih, še zlasti pa pri starejših, je treba temeljito pretehtati tudi kombinirano zdravljenje z učinkovinami za zaščito prebavnega trakta (npr. z mizoprostolom ali zaviralci protonske črpalke).
English: Merck NM P.O.Box 23033 S-10435 Stockholm Sweden
Slovenian: Merck NM P.O.Box 23033
English: Piroxicam 10mg Capsules
Slovenian: Piroxicam 10mg Kapsulas
English: Pharmachemie B.V. Postbus 552
Slovenian: Pharmachemie B.V.
English: Piroxicam 20mg Capsules
Slovenian: Piroxicam 20mg Kapsulas
English: United Kingdom Trinity-Chiesi Pharmaceuticals Limited Cheadlw Royal Business Park
Slovenian: Trinity-Chiesi Pharmaceuticals Limited Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY Velika Britanija
English: Tablet for oral solution Oral use
Slovenian: Peroralna suspenzija Peroralna uporaba
English: Box 1161
Slovenian: Telčská 114000
English: Euro-Medic N.V. Astridlaan 20
Slovenian: Euro-Medic N.V.
English: 20124 Milano Italy
Slovenian: 20158 Milano Italija uporaba
English: Rectal
Slovenian: Rektalna
English: Effervescent tablets
Slovenian: Gastrorezistentna tableta
English: Eye drops, solution Ocular use
Slovenian: Kapljice za oko, raztopina
English: Via Palermo, 26/A 43100 Parma Italy
Slovenian: Via Palermo, 26/A 43100 Parma Italija
English: Surrey KT20 7NS
Slovenian: Surrey Kt10 9qr Velika Britanija
English: Injection 20mg/Ml
Slovenian: Intramuscular Intramuskularna uporaba 20mg/Ml
English: Hotemin Injection 20 mg/ml -1ml Solution for injection Intramuscular use
Slovenian: 20 mg/ml -1ml Raztopina za injiciranje Intramuskularna uporaba
English: 7-9, Avenue François-Vincent Raspail Bp 32, 94111 Arcueil Cedex France
Slovenian: Bp 32, 94111 Arcueil Cedex Francija
English: 55216, Ingelheim Am Rhein Germany
Slovenian: 55216, Ingelheim Am Rhein Nemčija
English: Ratiopharm 20 Mg Comprimidos
Slovenian: Ratiopharm 10 Mg Comprimidos uporaba
English: Feldene Dispersible Tablets-20 Mg
Slovenian: Feldene Tableta za peroralno suspenzijos-20 Mg
English: Gerakas 15344 Greece
Slovenian: Marathonos 106 Gerakas 15344 Grčija uporaba
English: D-55216 Ingelheim am Rhein Germany
Slovenian: D-55216 Ingelheim Am Rhein Nemčija
English: D-55216 Ingelheim Am Rhein Germany
Slovenian: D-55216 Ingelheim am Rhein Nemčija
English: Docpharma S.A. Ambachtenlaan 13h B-3001 Heverlee Belgium
Slovenian: Docpharma S.A. Ambachtenlaan 13h
English: Dispersible tablet
Slovenian: Šumeča tableta
English: 55216 Ingelheim Am Rhein Germany
Slovenian: 55216 Ingelheim Am Rhein Madžarska
English: Egis Pharmaceuticals Plc Kereszturi Ut 30-38 H-1106 Budapest Hungary
Slovenian: Egis Pharmaceuticals Plc Kereszturi Ut 30-38
English: Cutaneous use
Slovenian: Okularna uporaba
English: Dental treatment and in the course of infections Relief of fever and pain associated with acute upper respiratory tract inflammation.
Slovenian: 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
English: Via Di Scandicci, 37
Slovenian: Via Di Scandicci, 37 50143 Firenze
English: Anfarm Hellas Ae K. Palaiologou & Perikleous 27
Slovenian: Anfarm Hellas Ae
English: 50143 Firenze Italy
Slovenian: 00144 Rome Italija
English: Bruschettini SRL Via Isonzo 4 16147 Genova Italy
Slovenian: Bruschettini SRL Via Isonzo 4
English: Viale Bodio, 37/B 20158 Milano
Slovenian: Viale G. Rictrda, 7 20143 Milano
English: Chiesi España, S.A. Av. Berlin, 38-48 7ª Planta
Slovenian: Av. Berlin, 38-48 7ª Planta 08029 Barcelona Španija uporaba
English: Dispersible Tablet
Slovenian: Žvečljiva Tableta
English: Feldene Intramuscular
Slovenian: Hotemin Intramuskularna uporaba
English: Egis Pharmaceuticals Ltd. Keresztúri Út 30-38 1106 Budapest Hungary
Slovenian: Egis Pharmaceuticals Ltd. Keresztúri Út 30-38
English: Piroxicam Dispersible Tablets 10mg
Slovenian: Piroxicam Tableta za peroralno suspenzijos 10mg
English: Strength Pharmaceutical Form Route of Administration Immediate Packaging
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
English: MA (EU) Number Name
Slovenian: Številka EU
English: The average improvement was about 1.4 points.
Slovenian: V povprečju je prišlo do izboljšanja za približno 1,4 točke.
English: The patients had an average of 0.08 serious infections per year.
Slovenian: Bolniki so imeli v povprečju 0,08 resne okužbe na leto.
English: Further information can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Privigen.
Slovenian: Nadaljnje informacije za zdravilo Privigen so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Privigen.
English: What measures are being taken to ensure the safe and effective use of Privigen?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Privigen?
English: The European Medicines Agency concluded that Privigen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: 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.
English: Other information about Privigen
Slovenian: Druge informacije o zdravilu Privigen
English: Privigen received a marketing authorisation valid throughout the EU on 25 April 2008.
Slovenian: Zdravilo Privigen je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 25. aprila 2008.
English: What is Privigen and what is it used for?
Slovenian: Kaj je zdravilo Privigen in za kaj se uporablja?
English: An overview of Privigen and why it is authorised in the EU
Slovenian: Pregled zdravila Privigen in zakaj je odobreno v EU
English: Privigen was not compared to other treatments in the studies.
Slovenian: Zdravila Privigen v študijah niso primerjali z drugimi zdravili.
English: Privigen is a medicine used to support the immune system (the body's natural defences) in two main groups of patients:
Slovenian: Zdravilo Privigen se uporablja kot podpora imunskemu sistemu (naravnemu obrambnemu mehanizmu telesa) pri dveh glavnih skupinah bolnikov:
English: What are the risks associated with Privigen?
Slovenian: Kakšna tveganja so povezana z zdravilom Privigen?
English: Since this is below the predefined threshold of one serious infection per year, this indicates that the medicine is effective as replacement therapy.
Slovenian: 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.
English: The dose may need to be adjusted for patients depending on their response.
Slovenian: Bolnikom bo glede na njihov odziv odmerek morda treba prilagoditi.
English: As for all medicines, data on the use of Privigen are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Privigen stalno spremljajo.
English: 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.
Slovenian: V tej tretji študiji se je 17 (61 %) od 28 bolnikov odzvalo na zdravljenje z izboljšanjem za vsaj eno točko na lestvici prizadetosti.
English: Why is Privigen authorised in the EU?
Slovenian: Zakaj je zdravilo Privigen odobreno v EU?
English: This confirmed that Privigen is effective in immunomodulation.
Slovenian: To potrjuje, da je zdravilo Privigen učinkovito pri imunomodulaciji.
English: The dose and frequency of infusions (how often it is given) depend on the disease being treated.
Slovenian: Odmerek in pogostost infuzije sta odvisna od zdravljene bolezni.
English: Privigen was given on two consecutive days.
Slovenian: Zdravilo Privigen se je dajalo dva dni zapored.
English: 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.
Slovenian: 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.
English: Side effects reported with Privigen are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Privigen, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Da bi zmanjšala to tveganje, je družba, ki trži zdravilo Privigen, naredila nekaj sprememb pri načinu proizvodnje zdravila, in izvaja študijo spremljanja učinka sprememb.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: For more information about using Privigen, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Privigen glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: • 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).
Slovenian: • pri bolnikih, pri katerih obstaja nevarnost okužbe zaradi nezadostnega števila protiteles (imenovanih tudi imunoglobulini, tj. beljakovine v krvi, ki pomagajo telesu pri premagovanju bolezni).
English: What benefits of Privigen have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Privigen izkazalo v študijah?
English: Privigen works by restoring abnormally low IgG levels to their normal range in the blood.
Slovenian: Zdravilo Privigen deluje tako, da nenormalno nizko koncentracijo IgG vrne v območje njene normalne vrednosti v krvi.
English: The medicine is available as a solution for infusion (drip) into a vein.
Slovenian: Zdravilo je na voljo kot raztopina za infundiranje (kapalno infuzijo) v veno.
English: 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.
Slovenian: 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.
English: The main measure of effectiveness was the highest blood platelet level that was achieved in the week after Privigen was given.
Slovenian: Glavno merilo učinkovitosti je bila najvišja koncentracija trombocitov v krvi, dosežena v tednu po uporabi zdravila Privigen.
English: 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).
Slovenian: Zdravilo Privigen se ne sme uporabljati pri bolnikih s hiperprolinemijo tipa I ali II (dedno motnjo, ki povzroča visoke ravni aminokisline prolin v krvi).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The active substance in Privigen, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood).
Slovenian: Zdravilna učinkovina zdravila Privigen, humani polispecifični imunoglobulin, je visoko prečiščena beljakovina, pridobljena iz človeške plazme (dela krvi).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: In the first study, Privigen was used in 80 patients with PID, with the medicine being infused every three or four weeks.
Slovenian: 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.