FrancophonIA/ELRC3.0 huggingface dataset:
English: Paediatric population (bitherapy)
Slovenian: Pediatrična populacija (dvojna terapija)
English: One pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 50 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Slovenian: En napolnjen injekcijski peresnik vsebuje zadostno količino peginterferona alfa-2b za dajanje 50 mikrogramov v 0,5 ml peginterferona alfa-2b po rekonstituciji v skladu s priporočili.
English: ViraferonPeg 150 micrograms powder and solvent for injection peginterferon alfa-2b
Slovenian: ViraferonPeg 150 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
English: ViraferonPeg 150 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Slovenian: ViraferonPeg 150 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku peginterferon alfa-2b
English: ViraferonPeg 80 micrograms powder and solvent for injection peginterferon alfa-2b
Slovenian: ViraferonPeg 80 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
English: ViraferonPeg 50 micrograms powder and solvent for injection peginterferon alfa-2b
Slovenian: ViraferonPeg 50 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
English: ViraferonPeg 100 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Slovenian: ViraferonPeg 100 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku peginterferon alfa-2b
English: Sustained Virologic Response
Slovenian: Histološki odziv:
English: ViraferonPeg 100 micrograms powder and solvent for injection peginterferon alfa-2b
Slovenian: ViraferonPeg 100 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
English: ViraferonPeg 120 micrograms powder and solvent for injection peginterferon alfa-2b
Slovenian: ViraferonPeg 120 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
English: Mix
Slovenian: Mešanje
English: EU/1/00/132/015 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/028 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Slovenian: EU/1/00/132/028 (12 vial praška, 12 ampul vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
English: Powder and solvent for solution for injection in pre-filled pen 1 pen (CLEARCLICK), 1 injection needle and 2 cleansing swabs 4 pens (CLEARCLICK), 4 injection needles and 8 cleansing swabs 12 pens (CLEARCLICK), 12 injection needles and 24 cleansing swabs 100 micrograms/0.5 ml
Slovenian: prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku 1 peresnik (CLEARCLICK), 1 injekcijska igla in 2 čistilna tampona 4 peresniki (CLEARCLICK), 4 injekcijske igle in 8 čistilnih tamponov 12 peresnikov (CLEARCLICK), 12 injekcijskih igel in 24 čistilnih tamponov 100 mikrogramov/0,5 ml
English: Powder and solvent for solution for injection in pre-filled pen 1 pen (CLEARCLICK), 1 injection needle and 2 cleansing swabs 4 pens (CLEARCLICK), 4 injection needles and 8 cleansing swabs 12 pens (CLEARCLICK), 12 injection needles and 24 cleansing swabs 50 micrograms/0.5 ml
Slovenian: prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku 1 peresnik (CLEARCLICK), 1 injekcijska igla in 2 čistilna tampona 4 peresniki (CLEARCLICK), 4 injekcijske igle in 8 čistilnih tamponov 12 peresnikov (CLEARCLICK), 12 injekcijskih igel in 24 čistilnih tamponov 50 mikrogramov/0,5 ml
English: Conjunctival haemorrhage, eye pruritus, keratitis, vision blurred, photophobia Ear and labyrinth disorders
Slovenian: krvavitev v očesno veznico, pruritus očesa, keratitis, zamegljen vid, fotofobija Ušesne bolezni, vključno z motnjami labirinta Pogosti:
English: Powder and solvent for solution for injection in pre-filled pen 1 pen (CLEARCLICK), 1 injection needle and 2 cleansing swabs 4 pens (CLEARCLICK), 4 injection needles and 8 cleansing swabs 12 pens (CLEARCLICK), 12 injection needles and 24 cleansing swabs 120 micrograms/0.5 ml
Slovenian: prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku 1 peresnik (CLEARCLICK), 1 injekcijska igla in 2 čistilna tampona 4 peresniki (CLEARCLICK), 4 injekcijske igle in 8 čistilnih tamponov 12 peresnikov(CLEARCLICK), 12 injekcijskih igel in 24 čistilnih tamponov 120 mikrogramov/0,5 ml
English: Powder and solvent for solution for injection in pre-filled pen 1 pen (CLEARCLICK), 1 injection needle and 2 cleansing swabs 4 pens (CLEARCLICK), 4 injection needles and 8 cleansing swabs 12 pens (CLEARCLICK), 12 injection needles and 24 cleansing swabs 80 micrograms/0.5 ml
Slovenian: prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku 1 peresnik (CLEARCLICK), 1 injekcijska igla in 2 čistilna tampona 4 peresniki (CLEARCLICK), 4 injekcijske igle in 8 čistilnih tamponov 12 peresnikov (CLEARCLICK), 12 injekcijskih igel in 24 čistilnih tamponov 80 mikrogramov/0,5 ml
English: - changes in taste, diarrhoea, stomach upset, oral pain, - fainting, palpitations (pounding heart beat), rapid heart rate, flushing, nosebleed, - sores in mouth, scaling lips and clefts in the corners of the mouth, rash, redness of skin, itching,
Slovenian: - bolečine v želodcu, bruhanje, siljenje na bruhanje, driska, izguba apetita, hujšanje, suha usta, - izpadanje las, srbenje, suha koža, izpuščaj, draženje ali pordelost (in redko poškodbe kože) na mestu injiciranja, - zmanjšanje števila rdečih krvnih celic (ki lahko povzroči utrujenost, kratko sapo, omotico),
English: EU/1/00/132/010 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/027 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Slovenian: EU/1/00/132/027 (12 vial praška, 12 ampul vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
English: Powder
Slovenian: Trombociti
English: Discard the ViraferonPeg pre-filled pen (CLEARCLICK) with any solution that is left in it after you give yourself the injection.
Slovenian: Morebitno raztopino, ki po injiciranju zdravila še ostane v ViraferonPeg napolnjenem injekcijskem peresniku (CLEARCLICK), zavrzite.
English: EU/1/00/132/025 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/030 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Slovenian: EU/1/00/132/030 (12 vial praška, 12 ampul vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
English: Use in children 3 years of age and older and adolescents ViraferonPeg will be given in combination with ribavirin.The dose of ViraferonPeg is determined by a calculation accounting for both height and weight.
Slovenian: Uporaba pri otrocih, starih 3 leta ali več, in mladostnikih Zdravilo ViraferonPeg se uporablja v kombinaciji z ribavirinom.
English: EU/1/00/132/020 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/029 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Slovenian: EU/1/00/132/029 (12 vial praška, 12 ampul vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
English: Needle shield
Slovenian: Ščitnik igle
English: Injury and poisoning Uncommon:
Slovenian: pozitivna antitiroidna protitelesa Poškodbe in zastrupitve in zapleti pri posegih Občasni:
English: The PRAC adopted a recommendation on 6 July 2017 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Slovenian: Odbor PRAC je 6. julija 2017 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnavala skupina CMDh.
English: Having reviewed the PRAC recommendation, the CMDh agrees with the PRAC overall conclusions and grounds for recommendation.
Slovenian: Po pregledu priporočila odbora PRAC se je odbor CMDh strinjal s končnimi zaključki odbora PRAC in s podlago za priporočilo.
English: The PRAC noted that the lactose used in these products is produced in accordance with the European Pharmacopoeia (Ph.
Slovenian: Odbor PRAC je opozoril, da se laktoza, uporabljena v teh izdelkih, proizvaja v skladu z Evropsko farmakopejo (Ph.
English: In addition, it was noted that patients experiencing an allergic reaction may be more sensitive to exposure to a second allergen.
Slovenian: Poleg tega je bilo izpostavljeno, da so bolniki, ki imajo alergijsko reakcijo, bolj občutljivi za izpostavitev drugemu alergenu.
English: monograph, which does not exclude traces of milk proteins.
Slovenian: ), kar ne izključuje sledi mlečnih beljakovin.
English: • 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.
Slovenian: • 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.
English: A letter should also be disseminated to relevant HCPs to inform of the above mentioned risk and measures recommended to minimise it.
Slovenian: Treba je tudi poslati dopis zadevnim zdravstvenim delavcem in jih obvestiti o omenjenem tveganju in priporočenih ukrepih za zmanjšanje tveganja.
English: 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.
Slovenian: 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.
English: Further, anaphylactic reactions caused by traces of milk proteins in the product may be misinterpreted as lack of therapeutic effect in acute allergic conditions.
Slovenian: Poleg tega se lahko anafilaktične reakcije, ki jih povzročijo sledi mlečnih beljakovin v izdelku, napačno razumejo kot pomanjkanje terapevtskega učinka pri akutnih alergijskih stanjih.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: V prehodnem obdobju se izvaja zgornji pristop zmanjšanja tveganja v obliki sprememb povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The PRAC considered that methylprednisolone containing products formulated with lactose of bovine origin must not be used in patients allergic to cow's milk.
Slovenian: Odbor je menil, da se zdravila, ki vsebujejo metilprednizolon, pripravljena z laktozo govejega izvora, ne smejo uporabljati pri bolnikih, alergičnih na kravje mleko.
English: • 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).
Slovenian: • 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.)
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • 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.
Slovenian: • 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;
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • 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.
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: grade lactose for IV/IM use in acute allergic conditions.
Slovenian: uporabo pri akutnih alergijskih stanjih.
English: 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.
Slovenian: 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.)
English: • 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.
Slovenian: • 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;
English: The summary of products characteristics (SmPC) and patient leaflet (PL) should be amended accordingly.
Slovenian: Povzetek glavnih značilnosti zdravila in navodilo za uporabo zdravila je treba ustrezno spremeniti.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.