natgillin/translations-raw huggingface dataset:
The PRAC noted that the lactose used in these products is produced in accordance with the European Pharmacopoeia (Ph. 
Odbor PRAC je opozoril, da se laktoza, uporabljena v teh izdelkih, proizvaja v skladu z Evropsko farmakopejo (Ph.
In addition, it was noted that patients experiencing an allergic reaction may be more sensitive to exposure to a second allergen. 
Poleg tega je bilo izpostavljeno, da so bolniki, ki imajo alergijsko reakcijo, bolj občutljivi za izpostavitev drugemu alergenu.
monograph, which does not exclude traces of milk proteins. 
), kar ne izključuje sledi mlečnih beljakovin.
• The PRAC also notes that due to the limitations inherent to the emergency settings in which methylprednisolone-containing products are commonly used, these routine measures may not entirely eliminate the risk. 
• odbor prav tako ugotavlja, da zaradi omejitev, ki so značilne za nujna stanja, v katerih se običajno uporabljajo zdravila, ki vsebujejo metilprednizolon, ti rutinski ukrepi ne morejo popolnoma odpraviti tveganja.
A letter should also be disseminated to relevant HCPs to inform of the above mentioned risk and measures recommended to minimise it. 
Treba je tudi poslati dopis zadevnim zdravstvenim delavcem in jih obvestiti o omenjenem tveganju in priporočenih ukrepih za zmanjšanje tveganja.
The PRAC further considered that in the settings where these products are used, urgency or patients' condition may not always allow patients' medical history to be reviewed in details, hence potentially limiting the effectiveness of routine risk minimisation measures. 
Odbor PRAC je nadalje presodil, da v okoliščinah, v katerih se ta zdravila uporabljajo, nujnost ali stanje bolnika ne bosta vedno omogočala, da se bolnikova zdravstvena anamneza podrobno pregleda, kar lahko zmanjša učinkovitost rutinskih ukrepov za zmanjšanje tveganja.
Further, anaphylactic reactions caused by traces of milk proteins in the product may be misinterpreted as lack of therapeutic effect in acute allergic conditions. 
Poleg tega se lahko anafilaktične reakcije, ki jih povzročijo sledi mlečnih beljakovin v izdelku, napačno razumejo kot pomanjkanje terapevtskega učinka pri akutnih alergijskih stanjih.
On 21 November 2016 the Croatian NCA therefore triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of all medicinal products for intravenous or intramuscular administration containing lactose derived from bovine milk used in the treatment of acute allergy and anaphylactic shock and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked. 
Zato je hrvaški nacionalni pristojni organ 21. novembra 2016 sprožil napotitev v skladu s členom 31 Direktive 2001/83/ES zaradi farmakovigilančnih podatkov in odbor PRAC zaprosil, naj oceni vpliv navedenih pomislekov glede razmerja med tveganjem in koristmi zdravil za intravensko in intramuskularno uporabo, ki vsebujejo laktozo, pridobljeno iz kravjega mleka, in se uporabljajo za zdravljenje akutne alergije in anafilaktičnega šoka ter izda priporočilo o tem, ali je treba zadevna dovoljenja za promet z zdravilom ohraniti, spremeniti, začasno preklicati ali ukiniti.
In the interim, the above risk minimisation in the form of changes to the summary of product characteristics, labelling and package leaflet shall be implemented. 
V prehodnem obdobju se izvaja zgornji pristop zmanjšanja tveganja v obliki sprememb povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo.
Solu-Medrol 40 mg powder and solvent for solution for injection (hereinafter ‘Solu-Medrol') contains methylprednisolone and, as an excipient, lactose monohydrate derived from bovine milk. 
Zdravilo Solu-Medrol 40 mg prašek in vehikel za raztopino za injiciranje (v nadaljnjem besedilu „Solu-Medrol“) vsebuje metilprednizolon in pomožno snov laktozo monohidrat, pridobljeno iz kravjega mleka.
The benefits of methylprednisolone-containing products, either alone or as adjunctive therapy, in the treatment of acute allergic conditions have been established as reflected in treatment guidelines. 
Koristi zdravil, ki vsebujejo metilprednizolon, kot samostojno ali kot dodatno zdravljenje pri zdravljenju akutnih alergijskih stanj, so dokazane, kar se odraža v smernicah za zdravljenje.
In addition, healthcare professionals (HCPs) and patients should be informed of the risk and HCPs warned to consider allergy to cow's milk in case the symptoms of patients treated for acute allergy conditions worsen or if new allergic symptoms occur. 
Poleg tega morajo biti zdravstveni delavci in bolniki obveščeni o tveganju ter zdravstveni delavci opozorjeni, da upoštevajo alergijo na kravje mleko v primerih, ko se simptomi bolnikov, zdravljenih zaradi akutnih alergijskih stanj, poslabšajo ali se pojavijo novi alergijski simptomi.
The PRAC considered that methylprednisolone containing products formulated with lactose of bovine origin must not be used in patients allergic to cow's milk. 
Odbor je menil, da se zdravila, ki vsebujejo metilprednizolon, pripravljena z laktozo govejega izvora, ne smejo uporabljati pri bolnikih, alergičnih na kravje mleko.
• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for medicinal products containing lactose of bovine origin for intravenous/intramuscular (IV/IM) use in acute allergic conditions (see Annex I). 
• Odbor PRAC je obravnaval postopek iz člena 31 Direktive 2001/83/ES, ki izhaja iz farmakovigilančnih podatkov o zdravilih, ki vsebujejo laktozo govejega izvora, za intravensko/intramuskularno (i.v./i.m.)
MAHs should agree on the modalities of the transition to the lactose-free formulations with their national competent authorities at the time of the application for the new formulations. 
Imetniki dovoljenj za promet z zdravili se morajo o načinu prehoda na formulacije brez laktoze dogovoriti s pristojnimi nacionalnimi organi pri vlogi za nove formulacije.
Taking into account the severity and seriousness of conditions when methylprednisolone-containing products are used, the necessity for rapid management, the absence of a safe threshold of exposure and the population at risk, the PRAC considered that the traces of milk proteins shall be excluded from these methylprednisolone-containing products in order to fully address this risk. 
Ob upoštevanju resnosti stanj, pri katerih se uporabljajo zdravila, ki vsebujejo metilprednizolon, nujnosti hitre obravnave ter nepoznavanja varnega praga izpostavljenosti in ogrožene populacije, je odbor menil, da je treba sledi mlečnih beljakovin umakniti iz zdravil, ki vsebujejo metilprednizolon, da bi v celoti odpravili to tveganje.
The PRAC further noted that all milk proteins are potential allergens, that the dose of milk proteins sufficient to induce allergic symptoms can vary widely from individual to individual and that trace amounts were detected in analyses of methylprednisolone-containing products that triggered allergic reactions in patients allergic to cow's milk. 
Odbor je upošteval tudi, da so vse mlečne beljakovine potencialni alergeni, da se lahko odmerek mlečnih beljakovin, ki zadošča za sprožitev alergijskih simptomov, zelo razlikuje od osebe do osebe in da so bili pri analizah zdravil, ki vsebujejo metilprednizolon, zaznani sledovi alergenov, ki so povzročili alergične reakcije pri bolnikih, ki so alergični na kravje mleko.
• The PRAC concludes that the risk of serious allergic reactions should be minimised through inclusion in the product information of a contraindication in patients allergic to cow's milk and warnings to inform health care professionals and patients of this risk. 
• odbor meni, da je treba tveganje resnih alergijskih reakcij zmanjšati z vključitvijo kontraindikacije glede bolnikov, ki so alergični na kravje mleko, in opozoril, da se o tem tveganju obvesti zdravstvene delavce in bolnike;
In this regard, the PRAC recommends as a condition to the marketing authorisations that the current formulations shall be replaced with formulations free from cow's milk proteins, within the agreed timeframe. 
V zvezi s tem odbor kot pogoj za dovoljenja za promet priporoča, da se trenutne formulacije zamenjajo s formulacijami brez beljakovin iz kravjega mleka v dogovorjenem časovnem okviru.
As this risk only applies to certain strengths of methylprednisolonecontaining products (i.e. those formulated with lactose of bovine origin) and as these products are mainly used in emergency settings, a warning that the product must not be used in patients allergic to cow's milk should also be implemented on the outer packaging and immediate unit to improve the identification of the products' presentation(s) concerned and further minimise the risk. 
Ker to tveganje velja le za nekatere jakosti zdravil, ki vsebujejo metilprednizolon (tj. tiste, ki so pripravljene z laktozo govejega izvora) in ker se ta zdravila večinoma uporabljajo v nujnih primerih, je treba uvesti opozorilo, da se zdravilo ne sme uporabljati pri bolnikih, alergičnih na kravje mleko, na zunanjo in stično ovojnino zaradi izboljšanja prepoznavnosti zadevnih oblik zdravila in dodatnega zmanjšanja tveganja.
The PRAC noted that estimates of prevalence of cow's milk allergy on double blind placebo controlled oral food challenge varies from 0% to 3% and is higher in children than adults. 
Odbor PRAC je upošteval ocene pogostnosti alergije na kravje mleko od 0 % do 3 % iz dvojno slepe, s placebom kontrolirane provokacije s peroralnim vnosom, pri čemer je pogostnost višja pri otrocih kot pri odraslih.
The scope of this procedure is limited to medicinal products for intravenous or intramuscular administration, containing lactose derived from bovine milk, used in the treatment of acute allergy and anaphylactic shock, thereinafter referred to as acute allergic conditions. 
Področje tega postopka je omejeno na zdravila za intravensko ali intramuskularno uporabo, ki vsebujejo laktozo, pridobljeno iz kravjega mleka, ki se uporablja pri zdravljenju akutne alergije in anafilaktičnega šoka, v nadaljnjem besedilu akutnih alergijskih stanj.
This review was initiated further to reports of serious allergic reactions in patients allergic to cow's milk treated with these products for acute allergic conditions. 
Ta pregled je bil sprožen zaradi poročil o resnih alergijskih reakcijah pri bolnikih, ki so alergični na kravje mleko in so bili zdravljeni s temi zdravili zaradi akutnih alergijskih stanj.
• The PRAC notes that data currently available does not allow establishing a safe threshold for milk proteins in lactose of bovine origin used as excipient in methylprednisolonecontaining products for IV/IM use in acute allergic conditions. 
• odbor ugotavlja, da trenutno razpoložljivi podatki ne omogočajo določitve varnega praga mlečnih beljakovin v laktozi govejega izvora, ki se uporablja kot pomožna snov v zdravilih, ki vsebujejo metilprednizolon in se uporabljajo za i.v./i.m.
The PRAC concluded that the benefit-risk balance of methylprednisolone-containing products formulated with lactose of bovine origin for intravenous/intramuscular (IV/IM) use in acute allergic conditions remains favourable, provided the MAHs replace the current formulations with formulations free from cow's milk proteins and submit for assessment the corresponding documentation to the relevant National Competent Authorities by end of June 2019 and provided the agreed changes to the product information are implemented in the interim. 
uporabo pri akutnih alergijskih stanjih, ugodno, če imetniki dovoljenj za promet z zdravili zamenjajo sedanje formulacije s formulacijami brez beljakovin iz kravjega mleka in do konca junija 2019 v oceno nacionalnim pristojnim organom predložijo ustrezno dokumentacijo ter v vmesnem času uvedejo dogovorjene spremembe informacij o zdravilu.
It was noted that in the European Union member states (EU MS), Norway and Iceland, at start of the procedure, medicinal products formulated with lactose of bovine origin and authorised for IV/IM use in acute allergic conditions, and therefore concerned by this procedure, were limited to certain strengths of methylprednisolone-containing products. 
Ugotovljeno je bilo, da so v državah članicah Evropske unije (EU), na Norveškem in Islandiji na začetku postopka bile odobrene le nekatere jakosti zdravil z laktozo govejega izvora za i.v./i.m.
grade lactose for IV/IM use in acute allergic conditions. 
uporabo pri akutnih alergijskih stanjih.
In view of the above, the Croatian national competent authority (NCA) HALMED considered that the risk of serious allergic reactions in patients allergic to cow's milk treated for acute allergic conditions with intravenous/intramuscular (IV/IM) medicinal products containing as excipient lactose from bovine origin should be reviewed. 
Glede na navedeno je hrvaški nacionalni pristojni organ HALMED menil, da je treba pregledati tveganje resnih alergijskih reakcij pri bolnikih, alergičnih na kravje mleko, zdravljenih zaradi akutnih alergijskih stanj z intravenskimi/intramuskularnimi (i.v./i.m.)
• The PRAC reviewed the totality of the data provided by the marketing authorisation holders, in relation to the risk of serious allergic reactions in patients allergic to cow's milk treated for acute allergic conditions with methylprednisolone-containing products formulated with lactose of bovine origin, as well as data available in Eudravigilance and the literature. 
• odbor je pregledal vse podatke, ki so jih predložili imetniki dovoljenj za promet v zvezi s tveganjem resnih alergijskih reakcij pri bolnikih, ki so alergični na kravje mleko in so zdravljeni zaradi akutnih alergijskih stanj z zdravili, ki vsebujejo metilprednizolon in so pripravljeni z laktozo govejega izvora, ter podatke, ki so na voljo v zbirki Eudravigilance in literaturi;
The summary of products characteristics (SmPC) and patient leaflet (PL) should be amended accordingly. 
Povzetek glavnih značilnosti zdravila in navodilo za uporabo zdravila je treba ustrezno spremeniti.
When considering all the data submitted by the marketing authorisation holders (MAHs), in relation to the risk of serious allergic reactions in patients allergic to cow's milk treated for acute allergic conditions with methylprednisolone-containing products formulated with lactose of bovine origin, as well as data available in Eudravigilance and the literature, the PRAC was of the view that medicinal products containing lactose of bovine origin for IV/IM use in acute allergic conditions are associated with a risk of serious allergic reactions in patients allergic to cow's milk. 
Pri obravnavi vseh podatkov, ki so jih predložili imetniki dovoljenj za promet z zdravilom v zvezi s tveganjem resnih alergijskih reakcij pri bolnikih, ki so alergični na kravje mleko in so bili zdravljeni zaradi akutnih alergijskih stanj z zdravili, ki vsebujejo metilprednizolon, formuliran z laktozo govejega izvora, ter podatkov, ki so na voljo v zbirki Eudravigilance in literaturi, je odbor PRAC menil, da so zdravila, ki vsebujejo laktozo govejega izvora za i.v./i.m.
To that effect, the PRAC recommends as a condition to the marketing authorisations that the MAHs shall replace the current formulations with formulations free from cow's milk proteins, within an agreed timeframe. 
V ta namen je odbor kot pogoj za dovoljenja za promet priporočil, da imetniki dovoljenj za promet z zdravili v dogovorjenem časovnem okviru nadomestijo sedanje formulacije s formulacijami brez beljakovin iz kravjega mleka.
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for medicinal products containing lactose of bovine origin for intravenous/intramuscular (IV/IM) use in acute allergic conditions. 
Odbor zato priporoča spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo laktozo govejega izvora, za intravensko/intramuskularno (i.v./i.m.)
Serious cases of allergic reactions have been reported in patients allergic to cow's milk administered Solu-Medrol for acute allergic conditions, including cases reporting a positive skin prick test for Solu-Medrol, a skin test for immunoglobulin E mediated allergic response. 
Poročali so o hudih primerih alergijskih reakcij pri bolnikih, ki so alergični na kravje mleko in so prejeli zdravilo Solu-Medrol za akutna alergijska stanja, vključno s primeri pozitivnega kožnega vbodnega testa za Solu-Medrol, kožnega testa za alergijski odziv, ki ga posreduje imunoglobulin E. Ker se zdravilo Solu-Medrol uporablja za akutno alergijsko stanje, se morebitna anafilaktična reakcija, ki jo lahko povzročijo sledovi mlečnih beljakovin v izdelku, lahko napačno razlaga kot pomanjkanje terapevtskega učinka, kar odloži ustrezno oskrbo bolnika.
• The PRAC considers that, in patients allergic to cow's milk, a risk of serious allergic reactions, including anaphylactic reactions, is associated to IV/IM treatment of acute allergic conditions with methylprednisolone-containing products formulated with lactose of bovine origin. 
• odbor meni, da je pri bolnikih, alergičnih na kravje mleko, tveganje resnih alergijskih reakcij, vključno z anafilaktičnimi reakcijami, povezano z i.v./i.m.
Therefore the CMDh recommends the variation to the terms of the marketing authorisations for medicinal products containing lactose of bovine origin for IV/IM use in acute allergic conditions. 
Zato odbor CMDh priporoča spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo laktozo govejega izvora, za intravensko/intramuskularno (i.v./i.m.)
In view of the above, the Committee considers that the benefit-risk balance of medicinal products containing lactose of bovine origin for intravenous/intramuscular (IV/IM) use in acute allergic conditions remains favourable subject to the agreed condition to the marketing authorisations, and taking into account the agreed amendments to the product information. 
uporabo pri akutnih alergijskih stanjih, ostane ugodno, če se izpolni dogovorjeni pogoj za dovoljenje za promet in se uvedejo dogovorjene spremembe informacij o zdravilu.
Thus, data currently available does not allow establishing a safe IV/IM intake threshold for patients allergic to cow's milk and the risk of serious allergic reactions in these patients applies to all products formulated with Ph. Eur. 
vnos pri bolnikih, alergičnih na kravje mleko, obstaja tveganje resnih alergijskih reakcij pri teh bolnikih v primeru uporabe zdravil, pripravljenih z laktozo Ph. Eur.
The CMDh, as a consequence, considers that the benefit-risk balance of medicinal products containing lactose of bovine origin for IV/IM use in acute allergic conditions remains favourable subject to the amendments to the product information and to the condition described above. 
uporabo pri akutnih alergijskih stanjih, še naprej ugodno, če se upoštevajo spremembe informacij o zdravilu in pogoj, opisan zgoraj.
Methylprednisolone-containing products formulated with lactose of bovine origin are authorised for IV/IM use in a range of different indications across EU MSs, including in relation to acute allergic conditions. 
Zdravila, ki vsebujejo metilprednizolon, pripravljena z laktozo govejega izvora, so odobrena za i.v./i.m.
It is also approved in Norway and Iceland. 
Odobren je tudi na Norveškem in v Islandiji.
The Member States' competent authorities will continue to keep the product under regular review. 
Pristojni organi držav članic bodo zdravilo še naprej redno nadzorovali.
The Rapporteur and Co-Rapporteur appointed were Dr Julia Dunne and Dr Ingemar Persson, respectively. 
Poročevalec oz. soporočevalec sta bila dr. Julia Dunne oz. dr. Ingemar Persson.
The final opinion was converted into a Decision by the European Commission on 03.09.2007. 
Končno mnenje je Evropska komisija dne 03.09.2007 spremenila v odločbo.
SUMMARY INFORMATION ON REFERRAL OPINION PURSUANT TO ARTICLE 31 OF COUNCIL DIRECTIVE 2001/83/EC, AS AMENDED, FOR 
POVZETEK MNENJA, SPREJETEGA V OKVIRU POSTOPKA NAPOTITVE V SKLADU S ČLENOM 31 DIREKTIVE SVETA 2001/83/ES, KAKOR JE BILA SPREMENJENA, ZA
International Non-Proprietary Name (INN): bicalutamide 
Mednarodno nelastniško ime (INN): bikalutamid
To address this concern, a new epidemiological study will be performed, as part of an agreed Risk Management Plan. 
Za razjasnitev tega pomisleka bo v okviru dogovorjenega načrta za obvladovanje tveganj izvedena nova epidemiološka raziskava.
* Note: The information given in this document and Annexes reflect only the CHMP Opinion dated 24 May 2007. 
* Opomba: Informacije, podane v tem dokumentu in dodatkih, odražajo le mnenje CHMP z dne 24. maja 2007.
Oral explanations were given on 22 May 2007. 
Ustna pojasnila so bila podana 22. maja 2007.
The referral procedure started on 27 July 2006. 
Postopek obravnave se je začel 27. julija 2006.
On 27 July 2006, Belgium presented a referral to the EMEA under Article 31 of Directive 2001/83, as amended. 
Belgija je 27. julija 2006 EMEA posredovala napotitev v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena.
Written explanations were provided by the Marketing Authorisation Holders on 20 October 2006, 22 March 2007 and on 15 May 2007. 
Imetniki dovoljenj za promet z zdravilom so podali pisna pojasnila 20. oktobra 2006, 22. marca 2007 in 15. maja 2007.
London, 16 August 2007 EMEA/378451/2007 
London, 16. avgust 2007 EMEA/378451/2007
The 4 issues raised in the referral concerned the analyses of the Early Prostate Cancer Programme (EPC): 
Štiri vprašanja, izpostavljena v napotitvi, so se nanašala na analizo programa v zvezi z zgodnjo fazo raka prostate (Early Prostate Cancer Programme - EPC):
Bicalutamide 150 mg is marketed in the EU following national and Mutual Recognition application procedures. 
Bikalutamid 150 mg se v EU trži na podlagi nacionalnih postopkov in postopka medsebojnega priznavanja.
Its authorised indications include the treatment of patients with locally advanced prostate cancer, as an immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy. 
Odobrene indikacije vključujejo zdravljenje bolnikov z lokalno napredovalim rakom prostate, in sicer kot takojšnje samostojno zdravljenje ali kot dodatek pri zdravljenju z radikalno prostatektomijo ali radioterapijo.
- the lack of an overall survival benefit versus adverse events in ‘locally advanced prostate cancer'; - statistical concerns regarding multiplicity; - the standard of care for the placebo group in the relevant studies; - the number of deaths due to cardiac failure. 
- odsotnost celokupne koristi zaradi podaljšanja preživetja v primerjavi z neželenimi učinki pri lokalno napredovalem raku prostate; - statistični pomisleki v zvezi z multipliciteto; - standardno zdravljenje v skupini s placebom v zadevnih raziskavah; - število smrti zaradi srčne odpovedi.
Bicalutamide 150 mg-containing medicinal products (See Annex 1) 
zdravila, ki vsebujejo 150 mg bikalutamida (glejte Dodatek I)
Locally advanced prostate cancer refers to larger tumours or tumours with spread to lymph nodes, but not involving spread to other organs. 
Lokalno napredovali rak predstavlja večje tumorje ali tumorje s širitvijo na bezgavke, vendar ne vključuje širitve na druge organe.
Bicalutamide is an oral anti-androgen used in the management of prostate cancer. 
Bikalutamid je peroralni antiandrogen, ki se uporablja pri zdravljenju raka prostate.
In view of the available data, the CHMP concluded that a potential association between the use of bicalutamide 150 mg and heart failure cannot be ruled out and therefore considered that the need to further study cardiovascular morbidity and mortality remains. 
Z ozirom na razpoložljive podatke je CHMP zaključil, da potencialne povezave med uporabo bikalutamida 150 mg in srčno odpovedjo ni mogoče izključiti ter da posledično obstaja potreba po nadaljnjem preučevanju kardiovaskularne obolevnosti in smrtnosti.