natgillin/translations-raw huggingface dataset:
ViraferonPeg 80 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen Hver fyldt pen (CLEARCLICK) tilberedes med den vedlagte solvens i tokammer-cylinderampullen (vand til injektionsvæsker) for indgift af op til 0,5 ml opløsning.
ViraferonPeg 80 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
ViraferonPeg 100 mikrogram - hætteglas med pulver
ViraferonPeg 100 micrograms - vial of powder
Ikke-detekterbar hcv-RNA ved behandlingsuge
HCV-RNA negative
EU/1/00/132/018 (4 hætteglas med pulver, 4 ampuller med solvens) EU/1/00/132/019 (4 hætteglas med pulver, 4 ampuller med solvens, 4 injektionssprøjter, 8 kanyler og 4 renseservietter)
EU/1/00/132/018 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/019 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Hvert hætteglas giver 100 mikrogram/0,5 ml opløsning, når det er rekonstitueret som anbefalet.
Each vial provides 100 micrograms/0.5 ml of solution when reconstituted as recommended.
ViraferonPeg 150 mikrogram pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder 150 mikrogram peginterferon alfa-2b målt på proteinbasis.
ViraferonPeg 150 micrograms powder and solvent for solution for injection Each vial contains 150 micrograms of peginterferon alfa-2b measured on a protein basis.
ViraferonPeg 50 mikrogram pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder 50 mikrogram peginterferon alfa-2b målt på proteinbasis.
ViraferonPeg 50 micrograms powder and solvent for solution for injection Each vial contains 50 micrograms of peginterferon alfa-2b measured on a protein basis.
ViraferonPeg 120 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen Hver fyldt pen (CLEARCLICK) tilberedes med den vedlagte solvens i tokammer-cylinderampullen (vand til injektionsvæsker) for indgift af op til 0,5 ml opløsning.
ViraferonPeg 120 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
Hver fyldt pen giver 50 mikrogram/0,5 ml peginterferon alfa-2b efter tilberedning som anbefalet.
Each pre-filled pen provides 50 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Hver fyldt pen giver 100 mikrogram/0,5 ml opløsning, når det er blandet som anbefalet.
Each pre-filled pen provides 100 micrograms/0.5 ml of solution when reconstituted as recommended.
ViraferonPeg 100 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen Hver fyldt pen indeholder 100 mikrogram peginterferon alfa-2b målt på proteinbasis.
ViraferonPeg 100 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 100 micrograms of peginterferon alfa-2b measured on a protein basis.
EU/1/00/132/023 (4 hætteglas med pulver, 4 ampuller med solvens) EU/1/00/132/024 (4 hætteglas med pulver, 4 ampuller med solvens, 4 injektionssprøjter, 8 kanyler og 4 renseservietter)
EU/1/00/132/023 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/024 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
ViraferonPeg 100 mikrogram pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder 100 mikrogram peginterferon alfa-2b målt på proteinbasis.
ViraferonPeg 100 micrograms powder and solvent for solution for injection Each vial contains 100 micrograms of peginterferon alfa-2b measured on a protein basis.
EU/1/00/132/021 (1 hætteglas med pulver, 1 ampul med solvens) EU/1/00/132/022 (1 hætteglas med pulver, 1 ampul med solvens, 1 injektionssprøjte, 2 kanyler og 1 renseserviet)
EU/1/00/132/021 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/022 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
EU/1/00/132/031 (1 pen, 1 kanyle og 2 renseservietter) EU/1/00/132/032 (4 penne, 4 kanyler og 8 renseservietter) EU/1/00/132/034 (12 penne, 12 kanyler og 24 renseservietter)
EU/1/00/132/031 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/132/032 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/132/034 (12 pens, 12 injection needles and 24 cleansing swabs)
Hver fyldt pen indeholder en tilstrækkelig mængde peginterferon alfa-2b til at give 120 mikrogram i 0,5 ml peginterferon alfa-2b ved tilberedning som anbefalet.
One pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 120 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Hæmoglobin
Dyspnoea
ViraferonPeg 50 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen ViraferonPeg 80 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen ViraferonPeg 100 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen ViraferonPeg 120 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen ViraferonPeg 150 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen
ViraferonPeg 50 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 80 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 100 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 120 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 150 micrograms powder and solvent for solution for injection in pre-filled pen
Hver fyldt pen indeholder en tilstrækkelig mængde peginterferon alfa-2b til at give 80 mikrogram i 0,5 ml peginterferon alfa-2b ved tilberedning som anbefalet.
One pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 80 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
EU/1/00/132/010 (6 hætteglas med pulver, 6 ampuller med solvens) EU/1/00/132/027 (12 hætteglas med pulver, 12 ampuller med solvens, 12 injektionssprøjter, 24 kanyler og 12 renseservietter)
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)
EU/1/00/132/015 (6 hætteglas med pulver, 6 ampuller med solvens) EU/1/00/132/028 (12 hætteglas med pulver, 12 ampuller med solvens, 12 injektionssprøjter, 24 kanyler og 12 renseservietter)
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)
EU/1/00/132/003 (4 hætteglas med pulver, 4 ampuller med solvens) EU/1/00/132/004 (4 hætteglas med pulver, 4 ampuller med solvens, 4 injektionssprøjter, 8 kanyler og 4 renseservietter)
EU/1/00/132/003 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/004 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Hvert hætteglas giver 80 mikrogram/0,5 ml peginterferon alfa-2b efter tilberedning som anbefalet.
Each vial provides 80 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
EU/1/00/132/025 (6 hætteglas med pulver, 6 ampuller med solvens) EU/1/00/132/030 (12 hætteglas med pulver, 12 ampuller med solvens, 12 injektionssprøjter, 24 kanyler og 12 renseservietter)
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)
EU/1/00/132/013 (4 hætteglas med pulver, 4 ampuller med solvens) EU/1/00/132/014 (4 hætteglas med pulver, 4 ampuller med solvens, 4 injektionssprøjter, 8 kanyler og 4 renseservietter)
EU/1/00/132/013 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/014 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
EU/1/00/132/005 (6 hætteglas med pulver, 6 ampuller med solvens) EU/1/00/132/026 (12 hætteglas med pulver, 12 ampuller med solvens, 12 injektionssprøjter, 24 kanyler og 12 renseservietter)
EU/1/00/132/005 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/026 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
ViraferonPeg-volumen, der skal indgives (ml)
Volume of ViraferonPeg to administer (ml)
Hver fyldt pen giver 100 mikrogram/0,5 ml peginterferon alfa-2b efter tilberedning som anbefalet.
Each pre-filled pen provides 100 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
ViraferonPeg 50 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen Hver fyldt pen (CLEARCLICK) tilberedes med den vedlagte solvens i tokammer-cylinderampullen (vand til injektionsvæsker) for indgift af op til 0,5 ml opløsning.
ViraferonPeg 50 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
Hver fyldt pen indeholder en tilstrækkelig mængde peginterferon alfa-2b til at give 100 mikrogram i 0,5 ml peginterferon alfa-2b ved tilberedning som anbefalet.
One pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 100 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
EU/1/00/132/001 (1 hætteglas med pulver, 1 ampul med solvens) EU/1/00/132/002 (1 hætteglas med pulver, 1 ampul med solvens, 1 injektionssprøjte, 2 kanyler og 1 renseserviet)
EU/1/00/132/001 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/002 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
3 observeret hos 4 % (88/194) af patienterne.
3 was observed in 4 %
Hvert hætteglas giver 120 mikrogram/0,5 ml peginterferon alfa-2b efter tilberedning som anbefalet.
Each vial provides 120 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Hver fyldt pen indeholder en tilstrækkelig mængde peginterferon alfa-2b til at give 50 mikrogram i 0,5 ml peginterferon alfa-2b ved tilberedning som anbefalet.
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.
P 1,5 ViraferonPeg 1,5 mikrogram/kg P 1,0 ViraferonPeg 1,0 mikrogram/kg
ViraferonPeg 1.0 microgram/kg
ViraferonPeg 100 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen Hver fyldt pen (CLEARCLICK) tilberedes med den vedlagte solvens i tokammer-cylinderampullen (vand til injektionsvæsker) for indgift af op til 0,5 ml opløsning.
ViraferonPeg 100 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
Hver fyldt pen indeholder en tilstrækkelig mængde peginterferon alfa-2b til at give 150 mikrogram i 0,5 ml peginterferon alfa-2b ved tilberedning som anbefalet.
One pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 150 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Karton 80 mikrogram pulver og solvens til injektionsvæske, opløsning
Carton 80 micrograms powder and solvent for solution for injection in pre-filled pen
Hvert hætteglas giver 150 mikrogram/0,5 ml peginterferon alfa-2b efter tilberedning som anbefalet.
Each vial provides 150 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
ViraferonPeg 80 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen peginterferon alfa-2b
ViraferonPeg 80 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
ViraferonPeg 120 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen peginterferon alfa-2b
ViraferonPeg 120 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
ViraferonPeg 50 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen peginterferon alfa-2b
ViraferonPeg 50 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Pulver og solvens til injektionsvæske, opløsning i fyldt pen 1 pen (CLEARCLICK), 1 kanyle og 2 renseservietter 4 penne (CLEARCLICK), 4 kanyler og 8 renseservietter 12 penne (CLEARCLICK), 12 kanyler og 24 renseservietter 100 mikrogram/0,5 ml
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
Trombocytter
Haemoglobin
Pulver og solvens til injektionsvæske, opløsning i fyldt pen 1 pen (CLEARCLICK), 1 kanyle og 2 renseservietter 4 penne (CLEARCLICK), 4 kanyler og 8 renseservietter 12 penne (CLEARCLICK), 12 kanyler og 24 renseservietter 120 mikrogram/0,5 ml
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
• kraftig blødning fra næse, gummer eller andre dele kroppen.
- pain in joints and muscles, muscle and bone pain.
Hvert hætteglas giver 100 mikrogram/0,5 ml peginterferon alfa-2b efter tilberedning som anbefalet.
Each vial provides 100 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
≥ 25 x 10 9/l, og < 50 x 10
9/l, and < 50 x 10
Hvert hætteglas giver 50 mikrogram/0,5 ml peginterferon alfa-2b efter tilberedning som anbefalet.
Each vial provides 50 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Pulver og solvens til injektionsvæske, opløsning i fyldt pen 1 pen (CLEARCLICK), 1 kanyle og 2 renseservietter 4 penne (CLEARCLICK), 4 kanyler og 8 renseservietter 12 penne (CLEARCLICK), 12 kanyler og 24 renseservietter 50 mikrogram/0,5 ml
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
Pulver og solvens til injektionsvæske, opløsning i fyldt pen 1 pen (CLEARCLICK), 1 kanyle og 2 renseservietter 4 penne (CLEARCLICK), 4 kanyler og 8 renseservietter 12 penne (CLEARCLICK), 12 kanyler og 24 renseservietter 80 mikrogram/0,5 ml
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
ViraferonPeg 150 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen peginterferon alfa-2b
ViraferonPeg 150 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
- 4 fyldte penne indeholdende pulver og solvens til injektionsvæske, opløsning, 4 kanyler (”Pushon Needle”), 8 renseservietter; - 12 fyldte penne indeholdende pulver og solvens til injektionsvæske, opløsning, 12 kanyler (”Push-on Needle”), 24 renseservietter.
8 cleansing swabs; - 12 pre-filled pens containing powder and solvent for solution for injection, 12 needles ("Push-On Needle"),
ViraferonPeg 100 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen peginterferon alfa-2b
ViraferonPeg 100 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
• Trombocytter
• Platelets
Penkrop
EXP
Hvis udløbsdatoen er overskredet, må du ikke bruge pennen.
Do not use if the expiration date has passed.
PRAC vedtog den 6. juli 2017 en anbefaling, der efterfølgende blev vurderet af CMDh i overensstemmelse med artikel 107k i direktiv 2001/83/EF.
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.
Der bør også formidles et brev til det relevante sundhedspersonale for at orientere om ovennævnte risiko og de anbefalede foranstaltninger til at minimere denne.
A letter should also be disseminated to relevant HCPs to inform of the above mentioned risk and measures recommended to minimise it.
Derudover blev det bemærket, at patienter, der oplever en allergisk reaktion, kan være mere sensitive over for eksponering for et andet allergen.
In addition, it was noted that patients experiencing an allergic reaction may be more sensitive to exposure to a second allergen.
I mellemtiden skal ovenfor nævnte risikominimering i form af ændringer af produktresuméet, mærkning og indlægsseddel implementeres.
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.
PRAC bemærkede, at skønsmæssige vurderinger af prævalensen af komælksallergi ved dobbeltblindet placebokontrolleret fødevareprovokation varierer mellem 0 % og 3 % og er højere hos børn end hos voksne.
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.
PRAC vurderede endvidere, at i de situationer, hvor disse lægemidler anvendes, giver sagens hastende karakter eller patienternes tilstand ikke altid mulighed for at gennemgå patienternes sygdomshistorie i detaljer, hvilket således potentielt begrænser effekten af rutinemæssige risikominimeringsforanstaltninger.
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.
Solu-Medro 40 mg pulver og solvens til injektionsvæske, opløsning, (herefter benævnt "SoluMedrol") indeholder methylprednisolon og, som et hjælpestof, laktosemonohydrat fra komælk.
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.
Den 21. november 2016 indledte den kroatiske konkurrencemyndighed derfor en indbringelsesprocedure i henhold til artikel 31 i direktiv 2001/83/EF som følge af en evaluering af lægemiddelovervågningsdata og anmodede PRAC om at vurdere ovenstående problemstillings betydning for benefit/risk-forholdet for alle lægemidler til intravenøs eller intramuskulær anvendelse, som indeholder laktose fra komælk, og som anvendes i behandlingen af akut allergi og anafylaktisk chok, og fremsætte en anbefaling om, hvorvidt de pågældende markedsføringstilladelser bør opretholdes, ændres, suspenderes eller tilbagekaldes.
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.
Under hensyntagen til omfanget og alvorligheden af de tilstande, hvor der anvendes lægemidler indeholdende methylprednisolon, samt nødvendigheden af hurtig administration, manglen på en sikker grænse for eksponering samt risikoen for befolkningen, har PRAC vurderet, at sporene af mælkeproteiner skal udtages fra disse lægemidler, der indeholder methylprednisolon, med henblik på helt at imødegå denne risiko.
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.
• PRAC konkluderer, at risikoen for alvorlige allergiske reaktioner bør minimeres ved at inkludere oplysninger om en kontraindikation i produktinformationen hos patienter, der er allergiske overfor komælk, og advarsler om at orientere sundhedspersonale og patienter om denne risiko.
• 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.
Fordelene ved lægemidler, der indeholder methylprednisolon, enten alene eller som hjælpebehandling i behandlingen af akutte allergiske reaktioner, er fastlagt som vist i retningslinjerne for behandling.
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.
Indehaverne af markedsføringstilladelse bør aftale behandlingsformen i overgangen til de laktosefri formuleringer med deres kompetente nationale myndigheder på tidspunktet for anvendelsen af de nye formuleringer.
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.
Derudover kan anafylaktiske reaktioner forårsaget af mælkeproteiner i lægemidlet fejlfortolkes som mangel på terapeutisk virkning ved akutte allergiske reaktioner.
Further, anaphylactic reactions caused by traces of milk proteins in the product may be misinterpreted as lack of therapeutic effect in acute allergic conditions.
• PRAC vurderede proceduren i henhold til artikel 31 i direktiv 2001/83/EF, som stammer fra lægemiddelovervågningsaktiviteter for lægemidler, der indeholder laktose fra kvæg, til intravenøs/intramuskulær (IV/UM) anvendelse ved akutte allergiske reaktioner (se bilag 1).
• 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).
Idet denne risiko alene gælder for visse styrker af lægemidler indeholdende methylprednisolon (dvs. dem, der er formuleret med laktose fra kvæg), og idet disse lægemidler hovedsageligt anvendes i katastrofesituationer, bør der også indsættes en advarsel om, at lægemidlet ikke må anvendes til patienter, der er allergiske over for komælk, på den ydre emballage og den indre enhed, for at forbedre identifikationen af lægemidlets fremtoning(er) og minimere risikoen yderligere.
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.