FrancophonIA/ELRC3.0 huggingface dataset:
English: Rabigen SAG2 is a live modified rabies vaccine for oral administration to red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides).
Slovenian: Rabigen SAG2 je živo modificirano cepivo proti steklini, ki se lisicam (Vulpes vulpes) in rakunastim psom (Nyctereutes procyonoides) daje peroralno.
English: They are intended to be eaten by foxes / raccoon dogs.
Slovenian: Namen je, da jih pojedo lisice/rakunasti psi.
English: However rabies virus and attenuated rabies vaccine viruses do not usually accumulate in reproductive organs and are not known to directly affect reproductive functions.
Slovenian: Varnost cepiva pri brejih živalih in živalih v laktaciji ni bila preiskana, vendar pa se virusi stekline in živi, oslabljeni sevi virusa iz cepiva običajno ne nalagajo v reproduktivnih organih in ni znano da bi direktno vplivali na funkcije razmnoževanja.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Rabigen SAG2 peroralna suspenzija za lisice in rakunaste pse.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Priporoča se uporaba gumijastih rokavic.
English: For the active immunisation of red foxes and raccoon dogs to prevent infection by rabies virus.
Slovenian: Za aktivno imunizacijo lisic in rakunastih psov, da se prepreči okužba z virusom stekline.
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Slovenian: ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER NAČIN IN POT(I) UPORABE
English: They are intended to be eaten by foxes and raccoon dogs.
Slovenian: Namenjene so temu, da jih lisice in rakunasti psi pojedo.
English: Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
Slovenian: Rabigen SAG2 peroralna suspenzija za lisice in rakunaste pse
English: Vomiting due to gastric intolerance (potentially due to the aluminium/PVC sachet as part of the bait vaccine), in dogs which have accidentally ingested the bait, has been reported.
Slovenian: Pri psih, ki so vabo pomotoma zaužili, so poročali o bruhanju zaradi intolerance želodca (morda zaradi aluminijaste /PVC vrečke kot del vabe pri tem cepivu).
English: PACKAGE SIZE 200 (4 x 50) vaccinal baits.
Slovenian: 200 (4 x 50) cepilnih vab.
English: The minimum distribution rate is: - 13 baits per square km over the areas where fox /raccoon dog density indexes were equal or less than 3 foxes / raccoon dogs seen per 10 km.
Slovenian: Minimalna gostota polaganja je: - 13 vab na kvadratni kilometer na področjih, kjer so indeksi gostote lisic/rakunastih psov enaki ali manjši kot tri videne lisice/rakunasti psi na 10 km.
English: The import, sale, supply and/or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Slovenian: Uvoz, prodaja, oskrba in/ali uporaba tega veterinarskega proizvoda je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
English: Pharmacotherapeutic group: Live viral vaccines ATCvet code: QI07BD.
Slovenian: ATC vet oznaka: QI07BD.
English: TARGET SPECIES Red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides).
Slovenian: CILJNA ŽIVALSKA VRSTA Lisice (Vulpes vulpes) in rakunasti psi (Nyctereutes procyonoides).
English: Appetent matrix (bait) :
Slovenian: Okusna obloga (vaba):
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER VIRBAC S.A.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM VIRBAC S.A.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
English: Red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides).
Slovenian: Lisice (Vulpes vulpes) in rakunasti psi (Nyctereutes procyonoides).
English: EXPIRY DATE EXP: {month/year}
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
English: MANUFACTURER'S BATCH NUMBER BN: {number}
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Lot {številka}
English: BATCH NUMBER BN: {number}
Slovenian: ŠTEVILKA SERIJE Lot: {številka}
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 400 UNIT BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZLOŽENKA Z 400 CEPILNIMI VABAMI
English: NAME OF THE MARKETING AUTHORISATION HOLDER VIRBAC S.A.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM VIRBAC S.A.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 200 UNIT BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZLOŽENKA Z 200 CEPILNIMI VABAMI
English: 06516 Carros France
Slovenian: 06516 Carros
English: In the event of human exposure to the active ingredient of the vaccine, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: V primeru stika osebe z zdravilno učinkovino cepiva, se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko.
English: 1ère Avenue - 2065 m 06516 Carros,
Slovenian: 1ère Avenue - 2065 m 06516 Carros, Francija
English: The import, sale, supply and/or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory, see package insert for further information.
Slovenian: Uvoz, prodaja, oskrba in/ali uporaba tega veterinarskega proizvoda je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja.
English: - 20 baits per square km over the areas where fox / raccoon dog density indexes were more than 3
Slovenian: - 20 vab na kvadratni kilometer na področjih, kjer so indeksi gostote lisic/rakunastih psov večji kot tri videne lisice/rakunasti psi na 10 km.
English: Live attenuated rabies virus, SAG2 strain minimum 8 log10 CCID50*/dose
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilna(e) učinkovina(e): virus stekline, živ, oslabljeni, sev SAG2 najmanj 8 log10 CCID50*/odmerek * CCID50: 50% infektivni odmerek za celično kulturo Pomožne snovi:
English: For animal treatment only - to be supplied only on veterinary prescription.
Slovenian: Zdravilo se izda le na recept.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJE SPROŠČANJE SPROSTITEV SERIJE
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Active substance:
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Aktivna snov: virus stekline, živ, osljabljeni, sev SAG2.
English: PACKAGE LEAFLET
Slovenian: VELIKOST PAKIRANJA
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Active substance:
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Aktivna snov: virus stekline, živ, oslabljeni, sev SAG2.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ”
English: INDICATION
Slovenian: INDIKACIJA(E)
English: This was accompanied by improvements in symptoms and quality of life.
Slovenian: Hkrati so se izboljšali tudi njihovi simptomi in kakovost življenja.
English: The infusions are given in hospital but may be given at home if it has been shown that the patient is tolerating the infusions well.
Slovenian: Infuzija se daje v bolnišnici, vendar se lahko daje tudi doma, če se izkaže, da bolnik infuzijo dobro prenaša.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fabrazyme on 3 August 2001.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Fabrazyme, veljavno po vsej Evropski uniji, odobrila dne 3. avgusta 2001.
English: The infusion rate may be increased gradually with further infusions.
Slovenian: Hitrost infundiranja se lahko pri naslednjih infuzijah postopoma povečuje.
English: The full EPAR for Fabrazyme can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Fabrazyme je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: EPAR summary for the public agalsidase beta
Slovenian: Povzetek EPAR za javnost agalzidaza beta
English: This is a summary of the European public assessment report (EPAR) for Fabrazyme.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fabrazyme.
English: Other information about Fabrazyme
Slovenian: Druge informacije o zdravilu Fabrazyme
English: The effectiveness of Fabrazyme was also tested in 16 children aged between eight and 16 years who had Fabry disease.
Slovenian: Učinkovitost zdravila Fabrazyme so preizkušali tudi pri 16 otrocih s Fabryjevo boleznijo, starih od osem do 16 let.
English: People with Fabry disease may have a wide range of signs and symptoms, including severe conditions such as kidney failure, heart problems and stroke.
Slovenian: Ljudje s Fabryjevo boleznijo imajo lahko številne znake in simptome, pa tudi hude zdravstvene težave, kot so odpoved ledvic, težave s srcem in kap.
English: The most common side effects with Fabrazyme (seen in more than 1 patient in 10) are caused by the infusion rather than the medicine.
Slovenian: Najpogostejši neželeni učinki zdravila Fabrazyme (opaženi pri več kot 1 bolniku od 10) so bolj posledica infundiranja kot pa zdravila.
English: For more information about treatment with Fabrazyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Fabrazyme preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Fabrazyme is given once every two weeks as an infusion of 1 mg per kilogram body weight.
Slovenian: Zdravilo Fabrazyme se daje z infuzijo v odmerku 1 mg na kilogram telesne mase enkrat vsaka dva tedna.
English: Children treated with Fabrazyme also had decreases in levels of GL-3 in the blood, with all children having normal levels after 20 weeks of treatment.
Slovenian: Tudi pri otrocih, zdravljenih z zdravilom Fabrazyme, je prišlo do znižanja ravni GL-3 v krvi, pri čemer je bila pri vseh otrocih normalna raven dosežena po 20 tednih zdravljenja.
English: Patients with Fabry disease do not have enough of an enzyme called alpha-galactosidase A. This enzyme normally breaks down a fatty substance called globotriaosylceramide (GL-3 or Gb3).
Slovenian: Bolniki s Fabryjevo boleznijo nimajo dovolj encima, imenovanega alfa-galaktozidaza A. Ta encim običajno razgrajuje maščobno snov, imenovano globotriaozilceramid (GL-3 ali Gb3).
English: Fabrazyme has been investigated in three studies involving a total of 73 adults.
Slovenian: Zdravilo Fabrazyme je bilo raziskano v treh študijah, v katerih je sodelovalo 73 odraslih.
English: What benefit has Fabrazyme shown during the studies?
Slovenian: Kakšne koristi je zdravilo Fabrazyme izkazalo med študijami?
English: In the main study, Fabrazyme produced a highly significant and almost complete clearance of GL-3 in the kidney cells after 20 weeks of treatment: 69% of the patients treated with Fabrazyme had the best score for clearance, compared with none of the patients in the placebo group.
Slovenian: V glavni študiji je zdravilo Fabrazyme po 20 tednih zdravljenja prispevalo k zelo pomembnemu in skoraj popolnemu očistku GL-3 v celicah ledvic: 69 % bolnikov, zdravljenih z zdravilom Fabrazyme, je doseglo najboljši rezultat očistka, medtem ko v skupini bolnikov, zdravljenih s placebom, bolnikov s takšnim rezultatom ni bilo nobenih.
English: Enzyme replacement therapies provide patients with the enzyme they are lacking.
Slovenian: Encimske nadomestne terapije zagotavljajo bolnikom encim, ki jim ga primanjkuje.
English: Fabrazyme is intended for long-term use.
Slovenian: Zdravilo Fabrazyme je namenjeno dolgotrajni uporabi.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fabrazyme.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Fabrazyme, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The replacement enzyme helps to break down GL-3 and stops it building up in the patient's cells.
Slovenian: Nadomestni encim pomaga razgraditi GL-3 in preprečiti njegovo kopičenje v celicah bolnika.
English: In the main study, Fabrazyme was compared with placebo (a dummy treatment) in 58 patients.
Slovenian: V glavni študiji so zdravilo Fabrazyme primerjali s placebom (zdravilom brez zdravilne učinkovine) pri 58 bolnikih.
English: If the enzyme is not present, GL-3 cannot be broken down and it builds up in the body's cells, such as kidney cells.
Slovenian: Če encima primanjkuje, se GL-3 ne more razgraditi in se začne kopičiti v telesnih celicah, kot so na primer celice ledvic.
English: The study looked at the effects of the medicine on clearing GL-3 from the kidney.
Slovenian: V njej so proučevali učinke zdravila na odstranjevanje GL-3 iz ledvic.
English: Fabrazyme is designed to replace the human enzyme alpha galactosidase A, which is lacking in patients with Fabry disease.
Slovenian: Zdravilo Fabrazyme je zasnovano tako, da nadomesti človeški encim alfa galaktozidaza A, ki ga primanjkuje pri ljudeh s Fabryjevo boleznijo.
English: The active substance in Fabrazyme, agalsidase beta, is a copy of the human enzyme, produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce the enzyme.
Slovenian: Zdravilno učinkovino zdravila Fabrazyme, agalzidazo beta, ki je kopija človeškega encima, izdelujejo s „tehnologijo rekombinantne DNK“, pri kateri celica prejme gen (DNK), s katerim lahko tvori encim.
English: The CHMP decided that Fabrazyme's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zaključil je, da so koristi zdravila Fabrazyme večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: It is available as a powder to be made into a solution for infusion (drip) into a vein.
Slovenian: Na voljo je v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: Fabrazyme must not be used in people who are hypersensitive (allergic) to agalsidase beta or any of the other ingredients.
Slovenian: Zdravila Fabrazyme ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) agalzidazo beta ali katerokoli drugo sestavino zdravila.
English: What is the risk associated with Fabrazyme?
Slovenian: Kakšna tveganja so povezana z zdravilom Fabrazyme?
English: Fabrazyme is a medicine that contains the active substance agalsidase beta.
Slovenian: Fabrazyme je zdravilo, ki vsebuje zdravilno učinkovino agalzidaza beta.
English: Fabrazyme is an enzyme replacement therapy.
Slovenian: Zdravilo Fabrazyme je encimska nadomestna terapija.
English: The starting infusion rate should be no more than 0.25 mg per minute (15 mg per hour) to reduce the risk of infusion-related side effects.
Slovenian: Da se izognemo neželenim učinkom, povezanih z infuzijo, začetna hitrost infundiranja ne sme presegati 0,25 mg na minuto (15 mg na uro).
English: The CHMP decided that, for patients with Fabry disease, treatment with Fabrazyme might provide longterm clinical benefits.
Slovenian: CHMP je menil, da lahko zdravljenje z zdravilom Fabrazyme bolnikom s Fabryjevo boleznijo zagotovi dolgotrajne klinične koristi.
English: Why has Fabrazyme been approved?
Slovenian: Zakaj je bilo zdravilo Fabrazyme odobreno?
English: Fabrazyme is used to treat patients who have Fabry disease, a rare inherited disorder.
Slovenian: Zdravilo Fabrazyme se uporablja za zdravljenje bolnikov s Fabryjevo boleznijo, ki je redka dedna bolezen.
English: These include fever, chills, headache, paraesthesia (abnormal sensations like pins and needles), nausea (feeling sick), vomiting and feeling cold. For the full list of all side effects reported with Fabrazyme, see the package leaflet.
Slovenian: Neželeni učinki vključujejo povišano telesno temperaturo, glavobol, parestezijo (neobičajne telesne občutke, kot je mravljinčenje), navzejo (občutek slabosti), bruhanje in mrazenje.
English: Only a doctor who has experience in treating patients with Fabry disease or other inherited metabolic diseases should give Fabrazyme.
Slovenian: Zdravilo Fabrazyme lahko predpiše samo zdravnik, ki ima izkušnje z zdravljenjem bolnikov s Fabryjevo boleznijo ali drugimi dednimi presnovnimi boleznimi.
English: What is Fabrazyme used for?
Slovenian: Za kaj se zdravilo Fabrazyme uporablja?
English: How does Fabrazyme work?
Slovenian: Kako zdravilo Fabrazyme deluje?
English: How has Fabrazyme been studied?
Slovenian: Kako je bilo zdravilo Fabrazyme raziskano?
English: What is Fabrazyme?
Slovenian: Kaj je zdravilo Fabrazyme?
English: How is Fabrazyme used?
Slovenian: Kako se zdravilo Fabrazyme uporablja?
English: EU/1/12/751/001
Slovenian: EU/1/12/751/001 Zelboraf
English: 240 mg Film-coated tablet
Slovenian: 240 mg filmsko obložene tablete peroralno pretisni omot (alu/alu)
English: Strength Pharmaceutical Form Route of Administration
Slovenian: Izmišljeno ime Jakost Farmacevtska oblika Pot uporabe Ovojnina
English: This approach is considered acceptable.
Slovenian: Ta pristop se smatra kot sprejemljiv.
English: The treatment can be repeated if required.
Slovenian: Zdravljenje se po potrebi lahko ponovi.
English: No evidence of local intolerability was noted.
Slovenian: Dokazov o lokalni intoleranci niso opazili.
English: No quality aspects were the subject of disagreement during the Mutual Recognition procedure.
Slovenian: Vidiki kakovosti niso bili predmet nesoglasij med postopkom medsebojnega priznavanja.
English: The possible reasons for an increase or decrease are:
Slovenian: Možni vzroki za povečanje ali zmanjšanje učinka so:
English: An allergic reaction can cause any of the following symptoms:
Slovenian: Alergijske reakcije lahko povzročijo katere koli od naslednjih simptomov:
English: o Evaluation of the spread reactions, specifically as part of future studies.
Slovenian: o ovrednotenjem reakcij, povezanih s širjenjem, specifično kot del prihodnjih študij;
English: o Commitment to alert the National Competent Authorities if there is a significant change in reporting rate.
Slovenian: o zavezo k opozorilu pristojnih nacionalnih organov v primeru pomembne spremembe v pogostosti poročil.
English: During a Scientific Advice procedure in 2000, the EMEA did not require or recommend that further Phase II studies be conducted before the Phase III studies were performed.
Slovenian: Med postopkom znanstvenega svetovanja v letu 2000 EMEA ni zahtevala ali priporočila, da se pred izvedbo študij III. faze izvedejo nadaljnje študije II.
English: No statistical differences were found between both treatment groups.
Slovenian: Med obema zdravljenima skupinama niso opazili statističnih razlik.
English: Frequency by different indications
Slovenian: Pogostnost po različnih indikacijah
English: 1.3 RECOMMENDATION
Slovenian: 1.3 PRIPOROČILA
English: Your doctor will then take additional precautions.
Slovenian: Zdravnik bo poskrbel za dodatne previdnostne ukrepe;
English: Electromyographic guidance is not necessary.
Slovenian: Elektromiografsko vodenje ni nujno.
English: Normally, no additional benefit is conferred by treating more frequently than every three months.
Slovenian: Navadno ni pričakovati dodatnih koristi od zdravljenja pogosteje kot vsake tri mesece.
English: Nevertheless the product should be used immediately.
Slovenian: Kljub temu je treba zdravilo porabiti takoj.
English: The initial dose should not exceed 25 U per eye.
Slovenian: Začetni odmerek ne sme preseči 25 e. na oko.
English: If signs of intoxication appear, hospitalisation with general supportive measures is necessary.
Slovenian: Če se pojavijo znaki zastrupitve, je nujna hospitalizacija in splošni podporni ukrepi.
English: In addition to the list of follow-up measures discussed and requested by the CMDh, the CHMP requested the following follow-up measures to be submitted to the National Competent Authorities and to be assessed under the co-ordination of the RMS:
Slovenian: Poleg seznama nadaljnjih ukrepov, o katerih je razpravljal in jih zahteval CMDh, je CHMP zahteval naslednje nadaljnje ukrepe, ki jih je treba predložiti pristojnim nacionalnim organom in oceniti v koordinaciji referenčne države članice:
English: Safety profile
Slovenian: Varnostni profil
English: In case of an overdose the patient must be monitored medically for several days.
Slovenian: Pri prevelikem odmerjanju je treba bolnika nadzorovati več dni.
English: Against this background a further extensive dose-ranging program would not have been justifiable from an ethical point of view.
Slovenian: Glede na to nadaljnji razširjeni program za določitev razpona odmerjanja z etičnega vidika ni upravičen.
English: If no treatment effect occurs within a month after the initial injection, the following measures should be taken:
Slovenian: Če v enem mesecu od prvega injiciranja ni učinkov zdravljenja, je treba uporabiti naslednje ukrepe:
English: This list is not exhaustive as any of the muscles responsible for controlling head position may be involved and therefore require treatment.
Slovenian: Seznam ni dokončen, saj je lahko vpletena katera koli mišica, odgovorna za nadzor položaja glave, in torej potrebuje zdravljenje.
English: The incidence of Serious Adverse Events was low in all studies, with a similar frequency in both treatment groups.
Slovenian: Pogostost resnih neželenih dogodkov je bila majhna pri vseh študijah, s podobno pogostostjo v obeh zdravljenih skupinah.
English: Lack of data on repeated administration and the need for data on immunogenicity
Slovenian: Pomanjkanje podatkov o ponovljeni uporabi in potreba po podatkih o imunogenosti
English: OTHER SPECIAL WARNING(S); IF NECESSARY
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
English: However, there appears to be no additional benefit obtainable from injecting more than 5.0 U per site.
Slovenian: Vendar je videti, da ni dodatne koristi od injiciranja več kot 5,0 e. na mesto.
English: Very common: pain, local weakness
Slovenian: Zelo pogosti: bolečina, lokalna šibkost
English: In addition, at present there are three ongoing clinical studies with Xeomin:
Slovenian: Poleg tega trenutno potekajo tri klinične študije z zdravilom Xeomin:
English: • if you have or have had swallowing difficulties
Slovenian: • če imate ali ste imeli težave pri požiranju.
English: The clinical development program was composed by 5 studies provided in the following table:
Slovenian: Klinični razvojni program je sestavljalo 5 študij, navedenih v naslednji tabeli:
English: At repeat treatment sessions, the dose may be increased up to two-fold if the response to the initial treatment is considered insufficient - usually defined as an effect that does not last longer than two months.
Slovenian: Ob ponovnem zdravljenju se lahko odmerek poveča do dvakrat, če je ocenjeno, da odziv na prvo zdravljenje ni zadosten - to je po navadi opredeljeno kot učinek, ki ne traja več kot dva meseca.