natgillin/translations-raw huggingface dataset:
Cerebrovaskulær blødning, cerebrovaskulær iskæmi,
Cerebrovascular haemorrhage, cerbrovascular ischaemia, seizure, impaired consciousness, encephalopathy, neuropathy, polyneuropathy
alg kramper, bevidsthedsforstyrrelse, encephalopati, neuropati, polyneuropati Ikke kendt:
Eye disorders
s Øjne Meget almindelig:
Very common:
til Almindelig:
184 Common:
t retinal arterie - eller veneobstruktion§, optisk neuritis,
Retinal haemorrhages§, retinopathies (including macular oedema), retinal artery or vein obstruction§, optic neuritis, papilloedema, loss of visual acuity or visual field, cotton- wool spots§
is Almindelig:
ed Common:
tor Hjerte Almindelig:
s Common:
Palpitation, tachycardi Cardiomyopati
Palpitation, tachycardia
Myocardieinfarkt, hjerteiskæmi Arytmi ere
Cardiomyopathy Myocardial infarction, cardiac ischaemia Arrhythmia
Meget almindelig:
ra Respiratory, thoracic and mediastinal disorders Very common:
Dyspnø *, hoste * ng
Dyspnoea*, coughing*
Epistaxis, respiratorisk forstyrrelse, forstoppet næse, rhinorrhea, hoste uden slim Lungeinfiltrationer§, lungebetændelse§
Epistaxis, respiratory disorder, nasal congestion, rhinorrhea, cough nonproductive
læ
Very rarely:
Mave- tarmkanalen Meget almindelig:
Nausea/ vomiting, abdominal pain, diarrhoea, stomatitis, dyspepsia
ke
Stomatitis ulcerative, right upper quadrant pain, glossitis, no
Kvalme/ opkastning, mavesmerte, diarré, stomatitis, dyspepsi Ulcerativ stomatitis, smerte i øvre højre kvadrant, glossitis,
gingivitis, constipation, loose stools
tandkødsbetændelse, forstoppelse, løs afføring Meget sjælden:
Very rarely:
Lever og galdeveje
uc
Meget almindelig: dle
Very common:
Almindelig:
Common: lp
Psoriasis (ny eller forværret) §, maculopapulært udslæt, erytematøst udslæt, eksem, erytem, hudlidelser
Alopecia, pruritus*, skin dry*, rash*, sweating increased Psoriasis (new or aggravated)§, rash maculopapular, rash
Meget sjælden: mi
erythematous, eczema, erythema, skin disorder Very rarely:
Stevens Johnson syndrom, toksisk epidermal nekrolyse,
Stevens Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
erytem multiforme Knogler, led, muskler og bindevæv Myalgi, arthralgi, smerter i bevægeapparatet ge
Musculoskeletal and connective tissue disorders i
Læ
Renal and urinary disorders Me
Arthritis Rhabdomyolyse, myositis, benkramper, rygsmerte
Arthritis Rhabdomyolysis, myositis, leg cramps, back pain
Nyrer og urinveje Almindelig:
Common:
181 menstruationsforstyrrelser, vaginale lidelser
Amenorrhea, breast pain, dysmenorrhea, menorrhagia, menstrual disorder, vaginal disorder
Meget almindelig:
185 Very common:
alg injektionsstedet *, træthed, stivhed, feber§, influenzalignende symptomer§, asteni, irritabilitet, brystsmerte, utilpashed Almindelig:
Injection site inflammation, injection site reaction*, fatigue, rigors, fever§, flu-like symptoms§, asthenia, irritability, chest pain, malaise
Smerte på injektionsstedet
Common:
t ere Disse bivirkninger er også rapporteret med Viraferon alene.
s These undesirable effects have also been reported with Viraferon alone.
Kardiovaskulære (CV) bivirkninger, specielt arytmi, syntes for det meste at være indbyrdes forbundet med
Cardiomyopathy, that may
Kardiomyopati, som kan være reversibel efter seponering af interferon alfa, er blevet rapporteret sjældent hos patienter uden
uth be reversible upon discontinuation of interferon alpha, has been reported rarely in patients without prior evidence of cardiac disease (see section 4.4).
4. 4).
ra A wide variety of autoimmune and immune-mediated disorders have been reported with alpha interferons including thyroid disorders, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies
Mange forskellige autoimmune og immunmedierede sygdomme er blevet rapporteret med alfa -
ge (see also section 4.4).
Forøgelse i serum ng
Clinically significant laboratory abnormalities, most frequently occurring at doses greater than 10 million IU lon daily, include reduction in granulocyte and white blood cell counts; decreases in haemoglobin level and platelet count; increases in alkaline phosphatase, LDH, serum creatinine and serum urea nitrogen levels.
ALAT/ ASAT (SGPT/ SGOT) - koncentrationer er blevet observeret som en abnormitet hos nogle non - hepatitis personer samt hos nogle patienter med kronisk hepatitis B samtidig med udskillelse af viral læ
Increase in serum ALT/ AST (SGPT/ SGOT) levels have been noted as an abnormality in some non-hepatitis subjects and also in some patients with chronic hepatitis B coincident with clearance of viral DNAp. no
4. 4. ke
Children and adolescents – Chronic Hepatitis C uc
Generelt svarede bivirkningsprofilen i den begrænsede undersøgte pædiatriske population til den profil, der er observeret hos voksne, selvom der er en specifik pædiatrisk bekymring te
In general, the adverse event profile in the limited paediatric population studied was similar to that observed in adults, although there is a paediatric specific concern regarding growth inhibition as decrease in rod
vedrørende væksthæmning, da en procentvis formindsket højde (gennemsnitlig procentvis nedgang i væksthastighed på 9%) og vægt (gennemsnitlig procentvis nedgang på 13%) blev observeret under behandling (se pkt.
height (mean percentile decrease of growth velocity of 9%) and weight (mean percentile decrease of 13%) percentile were observed during treatment (see section 4.4).
Derudover blev selvmordstanker eller - forsøg rapporteret hyppigere dle
Furthermore, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6 month lp
sammenlignet med voksne patienter (2, 4% mod 1%) under behandling og i den 6 måneder lange opfølgningsperiode efter behandling.
follow-up after treatment.
Derudover mi
As in adult patients, children and adolescents also experienced other psychiatric adverse events (e. g., depression, emotional lability, and somnolence) (see section 4.4).
forekom lidelser på injektionsstedet, feber, anoreksi, opkastning og emotionel labilitet hyppigere hos børn og unge sammenlignet med voksne patienter.
In addition, injection site disorders, fever, anorexia, vomiting, and emotional lability occurred more frequently in children and na
Læ
Dose modifications were required in 30% of patients, most commonly for anaemia and neutropaenia. i dic
Bivirkningerne er listet efter hyppighed under overskrifterne indenfor systemorganklasserne.
The adverse reactions listed in Table 2 are based on experience from paediatric clinical trials.
Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter faldende alvorlighed.
Me
Bivirkninger rapporteret som værende meget almindelige eller almindelige i kliniske undersøgelser hos børn Meget almindelig (≥1/ 10) - Almindelig (≥1/ 100, < 1/ 10) Systemorganklasser
Table 2 Adverse reactions very commonly and commonly reported in paediatric clinical trials Very common (≥ 1/ 10) - Common (≥ 1/ 100, < 1/ 10) System Organ Class Infection and infestations
alg Infektioner og parasitære sygdomme Meget almindelig:
Very common:
Svampeinfektion, bakteriel infektion, pulmonal infektion, otitis media, tand absces, herpes simplex, urinvejsinfektion, vaginitis,
Viral infection, pharyngitis Fungal infection, bacterial infection, pulmonary infection, otitis
til gastroenteritis Benigne, maligne og uspecificerede tumorer (inkl.
186 media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Meget almindelig:
ed disorders Very common:
is Almindelig:
Common:
Det endokrine system
Anaemia, neutropaenia Thrombocytopaenia, lymphadenopathy
Thrombocytopeni, lymphadenopati
s Endocrine disorders
tor Meget almindelig:
ori Very common:
au Metabolisme og ernæring Meget almindelig:
uth Metabolism and nutrition disorders Very common:
Anoreksi Hypertriglyceridæmi§, hyperurikæmi, øget appetit ere
Anorexia Hypertriglyceridemia§, hyperuricemia, increased appetite
Depression, emotionel ustabilitet, søvnløshed Selvmordstanker, aggressiv reaktion, forvirring, adfærdsforstyrrelser, agitation, søvngængeri, angst, nervøsitet, søvnforstyrrelser, unormale drømme, apati ng
Depression, emotional lability, insomnia Suicidal ideation, aggressive reaction, confusion, behaviour
Meget almindelig:
ge disorder, agitation, somnambulism, anxiety, nervousness, sleep disorder, abnormal dreaming, apathy Nervous system disorders§ lon Very common:
r ik
Raynaud’ s disease, flushing, pallor t
Raynauds syndrome, rødmen, bleghed
Respiratory, thoracic and uc
Luftveje, thorax og mediastinum Almindelig:
mediastinal disorders Common:
Mave- tarmkanalen Meget almindelig: dle
irritation, rhinorrhea, sneezing Gastrointestinal disorders Very common:
Mundsår, ulcerativ stomatitis, stomatitis, smerte i øvre højre kvadrant, dyspepsi, glossitis, gastroøsofageal refluks, rektale forstyrrelser, gastrointestinale forstyrrelser, forstoppelse, løs afføring, tandpine, tandproblemer
quadrant pain, dyspepsia, glossitis, gastroesophogeal reflux, rectal disorder, gastrointestinal disorder, constipation, loose stools, na
Lever og galdeveje Almindelig: ge
toothache, tooth disorder Hepatobiliary disorders Common:
Hud og subkutane væv Meget almindelig:
disorders Very common:
Alopeci, udslæt Fotosensitivitets reaktioner, makulopapulært udslæt, eksem, akne,
Alopecia, rash Photosensitivity reaction, maculopapular rash, eczema, acne, skin
hudlidelse, neglelidelse, pigmentforandringer, pruritus, tør hud, erythem, blå mærker, øget svedtendens Knogler, led, muskler og bindevæv Meget almindelig:
Renal and urinary disorders
alg Almindelig:
187 breast disorders Common:
til administartionsstedet Meget almindelig:
ed Very common:
t ere irritabilitet Almindelig:
Common:
Meget almindelig:
ori Very common:
4. 4
Common:
au 4. 9 Overdosering
4.9 Overdose
Der er ingen meddelelser om tilfælde af overdosering, der har medført akutte kliniske symptomer. ere Som for ethvert farmakologisk aktivt stof er symptomatisk behandling med hyppig monitorering af vitale tegn og tæt observation af patienten dog indiceret. ng
However, as for any pharmacologically active compound, symptomatic treatment with frequent monitoring of vital signs and close
FARMAKOLOGISKE EGENSKABER læ
PHARMACOLOGICAL PROPERTIES
5. 1 Farmakodynamiske egenskaber
5.1 Pharmacodynamic properties no
L03A B05 ke
L03A B05 t
Viraferon er en steril, stabil, formulering af højt oprenset interferon alfa- 2b produceret ved rekombinant r ik
Viraferon is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA uc
Det fås fra en klon af E. coli, som huser et genetisk fremstillet plasmid, hybridiseret med et interferon alfa- 2b gen fra humane leukocytter. te
It is obtained from a clone of E. coli, which harbours a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes. rod
Internationale enheder fastsættes ved at sammenligne aktiviteten af rekombinant interferon alfa- 2b med aktiviteten af den internationale referencestandard af human leukocyt interferon fastsat af dle
International Units are determined by comparison of the activity of the lp
verdenssundhedsorganisationen WHO.
recombinant interferon alfa-2b with the activity of the international reference preparation of human leukocyte interferon established by the World Health Organisation. na
De mi
The interferons are a family of small protein molecules with molecular weights of approximately 15,000 to 21,000 daltons.
produceres og udskilles af celler som respons på virale infektioner eller forskellige syntetiske og biologiske substanser.
They are produced and secreted by cells in response to viral infections or various synthetic and biological inducers.
Disse tre ge
Three major classes of interferons have been identified: alpha, beta and gamma. i dic
hovedklasser er i sig selv ikke homogene og kan indeholde forskellige molekyletyper af interferon.
These three main classes are themselves not homogeneous and may contain several different molecular species of interferon.
Viraferon er blevet klassificeret som rekombinant interferon alfa- 2b.
Viraferon has been classified as recombinant interferon alfa-2b.
184 visse abearter, såsom rhesus aber, modtagelige for farmakodynamisk stimulation ved udsættelse for human type 1 interferoner.
However, certain monkey species, eg, rhesus monkeys, are susceptible to pharmacodynamic stimulation upon exposure to human type 1 interferons.
Resultaterne af adskillige undersøgelser antyder, at når interferon er bundet til cellemembranen starter en
188 The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
s immunmodulerende aktiviteter som øgning af den fagocytære aktivitet af makrofager og øgning af den specifikke cytotoksicitet af lymfocytter på målcellerne.
It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virus-infected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
Nogle eller alle af disse aktiviteter kan være
Any or all of these activities may contribute to interferon's therapeutic effects.
Skønt den nøjagtige
s ori Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
is antivirale virkningsmekanisme af rekombinant alfa- 2b er ukendt, synes det at ændre værtscellemetabolismen.
Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism.
tor dannede virioner ude af stand til at forlade cellen.
This action inhibits viral replication or if replication occurs, the progeny virions are unable to leave the cell.
Kronisk hepatitis B:
uth Chronic hepatitis B:
au Nuværende kliniske erfaringer med patienter, som forbliver i interferon alfa- 2b behandling i 4 til 6 måneder, viser, at behandlingen kan give elimination af serum HBV- DNA.
ra therapy can produce clearance of serum HBV-DNA.
Hos voksne patienter med nedsættelse af HbeAg og HBV- DNA er set en ere signifikant reduktion i morbiditet og mortalitet.
In adult patients with loss of HBeAg and HBV-DNA, a significant reduction in morbidity and mortality has been observed.
Interferon alfa- 2b (6 MIE/ m2 3 gange om ugen i 6 måneder) er blevet givet til børn med kronisk aktiv hepatitis B.
ge Interferon alfa-2b (6 MIU/ m2 3 times a week for 6 months) has been given to children with chronic active hepatitis B.
Herudover fik børn behandlet ng
Because of a methodological flaw, efficacy could not be demonstrated.
med interferon alfa- 2b en nedsat væksthastighed og nogle tilfælde af depression sås.
Moreover children treated lon with interferon alfa-2b experienced a reduced rate of growth and some cases of depression were observed.
Kronisk hepatitis C: læ
Chronic hepatitis C:
Hos voksne patienter, som modtager interferon i kombination med ribavirin, er den opnåede vedvarende respons rate 47%.
47%.
Bedre effekt er blevet demonstreret med kombinationen af pegyleret interferon med ribavirin (vedvarende respons rate 61% opnået i en undersøgelse udført hos naive ke
Superior efficacy has been demonstrated with the combination of pegylated interferon with ribavirin (sustained response rate of 61% achieved in a study performed in naïve patients with a ribavirin dose > 10.6 mg/ kg, p < 0.01). t uc
Viraferon alene eller i kombination med ribavirin er blevet undersøgt r ik
Viraferon alone or in combination with ribavirin has been studied in 4 randomised Phase III clinical trials in 2,552 interferon-naïve patients with chronic hepatitis C.
Effekt blev defineret som vedvarende virologisk respons 6 måneder efter afsluttet te
Efficacy was defined as sustained virologic response, rod
behandling.
6 months after the end of treatment.
Patienter, der kunne indgå i disse undersøgelser, havde kronisk hepatitis C bekræftet ved en positiv HCV- RNA polymerasekædereaktions assay (PCR) (> 100 kopier/ ml), en leverbiopsi i overensstemmelse med en histologisk diagnose med kronisk hepatitis uden anden årsag til den dle
Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 100 copies/ ml), a liver biopsy consistent with a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT. lp
Viraferon blev indgivet i en dosis på 3 MIE 3 gange om ugen som monoterapi eller i kombination med mi
Viraferon was administered at a dose of 3 MIU 3 times a week as monotherapy or in combination with na
ribavirin.
ribavirin.
Vedvarende virologiske responsrater for behandlingsgrupper behandlet i et år med Viraferon ge
Sustained virologic response rates for treatment groups treated for one year with Viraferon alone or in i dic
alene eller i kombination med ribavirin (fra to undersøgelser) er vist i Tabel 3.
combination with ribavirin (from two studies) are shown in Table 3.
Samtidig indgift af Viraferon med ribavirin øgede effekten af Viraferon til mindst det dobbelte ved Læ
Co-administration of Viraferon with ribavirin increased the efficacy of Viraferon by at least two fold for the treatment of chronic heptatitis C in naïve patients.
behandling af kronisk heptatitis C hos naive patienter.
factors which are known to affect response rates.
Den relative gavn af kombinationsbehandling med Viraferon + ribavirin er særlig
The relative benefit of combination therapy with Viraferon + ribavirin is particularly significant in the most difficult to treat subgroup of patients (genotype 1 and high virus load) (Table 3).
alg fik Viraferon i kombination med ribavirin og fik ≥ 80% af deres behandling, et højere vedvarende respons 6 måneder efter 1 års behandling end dem, der anvendte < 80% af deres behandling (56% mod 32% i undersøgelse C/ I98- 580).
32% in trial C/ I98-580).
t ere
ed
Alle genotyper
s All Genotypes
is tor Genotype 1
ori Genotype 1
au Genotype 1 ≤ 2 millioner kopier/ ml Genotype 1
uth Genotype 1 ≤ 2 million
ng
3%
I/ R Viraferon (3 MIE 3 gange om ugen) + ribavirin (1. 000/ 1. 200 mg/ dag)
I Viraferon (3 MIU 3 times a week) I/ R Viraferon (3 MIU 3 times a week) + ribavirin (1,000/ 1,200 mg/ day) no
I begge ke
Overall, in both studies, patients who received Viraferon plus ribavirin, were less likely to respond than patients who received pegylated t
undersøgelser var patienter, der fik Viraferon plus ribavirin overordnet mindre tilbøjelige til at respondere end patienter, der fik pegyleret interferon alfa- 2b med ribavirin.
interferon alfa-2b with ribavirin.
Respons på behandlingen i r ik
The response to treatment in both of these trials is presented in Table 4. uc
Patienterne blev randomiseret til enten at få pegyleret interferon alfa 2b (1, 5 µg/ kg/ uge) plus ribavirin (800 mg/ dag) eller Viraferon (3 MIE TIW) plus te
Patients were randomized to receive either pegylated interferon alfa-2b (1.5 µg/ kg/ week) plus ribavirin (800 mg/ day) or Viraferon (3 MIU TIW) rod
ribavirin (800 mg/ dag) i 48 uger med en opfølgningsperiode på 6 måneder.
plus ribavirin (800 mg/ day) for 48 weeks with a follow-up period of 6 months.
Undersøgelse 2 (P02080) var en randomiseret enkeltcenterundersøgelse, der inkluderede 95 tidligere ubehandlede voksne dle
Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Patienterne blev randomiseret til at få enten pegyleret interferon alfa- 2b (100 eller 150 µg / uge baseret på vægt) plus ribavirin (800 - 1. 200 mg/ dag baseret på vægt) eller Viraferon (3 MIE TIW) plus ribavirin (800- 1. 200 mg/ dag baseret på vægt).
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load na
Behandlingsvarigheden var 48 uger med en opfølgningsperiode på 6 måneder med mi
< 800,000 IU/ ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period. i
undtagelse af de patienter, der var inficeret med genotype 2 og 3 og viral load < 800. 000 IE/ ml (Amplicor), som blev behandlet i 24 uger med en opfølgningsperiode på 6 måneder. ge Læ
Sustained virological response based on genotype after Viraferon in combination with
186 Tabel 4
dic
0, 017
190 All Genotype 1, 4
Grundet manglende resultater fra 187 børn med alvorlig sygdomsprogression, samt muligheden for bivirkninger, bør forholdet mellem fordele og ulemper af kombinationen ribavirin og interferon alfa- 2b overvejes nøje i denne population (se pkt.
the potential for undesirable effects, the benefit/ risk of the combination of ribavirin and interferon alfa-2b dic
ere Genotype 1 (n=92)
191 Genotype 1 (n=92)
Natriumchlorid, M- cresol, Polysorbat 80, dle
M-cresol, Polysorbate 80, Water for injections q. s. rod
15 måneder
15 months i dic
Fysisk- kemisk stabilitet under brug er vist i 27 dage ved 2°C - 8°C.
Chemical and physical in-use stability has been demonstrated for 27 days at 2ºC – 8ºC.
Fra et mikrobiologisk synspunkt kan produktet når det er åbnet opbevares i maksimalt 27 dage ved 2°C - 8°C.
From a microbiological point of view, once opened, the product may be stored for a maximum of 27 days at 2ºC – 8ºC.
Andre opbevaringstider og betingelser under brugen sker på brugers ansvar.
Me
189 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
Pakningsstørrelse á 1, 2 eller 8.
6.5 Nature and contents of container
t ere Ikke alle pakningsstørrelser er nødvendigvis markedsført.
193 1.2 ml of solution (corresponding to 18 MIU) in a pen made of a cartridge (type I glass) sealed at one end with an cap (aluminium) containing a liner (bromobutyl rubber) and at the other end by a plunger (bromobutyl rubber) with 12 injection needles and12 cleansing swabs Pack sizes of 1, 2 or 8 Not all pack sizes may be marketed.
Pennen er designet til at afgive sit indhold af 18 millioner IE i doser fra 1, 5 til 6 millioner IE.
ed The pen is designed to deliver its contents of 18 million IU in doses ranging from 1.5 to 6 million IU.
is 6. 6 Regler for destruktion
s 6.6 Special precautions for disposal
tor Ikke alle formuleringer og styrker er hensigtsmæssige for visse indikationer.
ori Not all dosage forms and strengths are appropriate for some indications.
au Viraferon injektionsvæske, opløsning, flerdosispen injiceres subkutant efter at en kanyle er påsat og den ordinerede dosis er indstillet. ere Pennen fjernes fra køleskabet cirka 30 minutter før indgift, for at tillade injektionsvæsken at få stuetemperatur (ikke mere end 25°C). ng
uth Viraferon, solution for injection, multidose pen is injected subcutaneously after attaching an injection needle and dialing the prescribed dose.
Detaljerede instruktioner til brug af præparatet følger med indlægsseddelen (se” Hvordan injicerer De selv Viraferon ”). læ
ra Remove the pen from the refrigerator approximately 30 minutes before administration to allow the injectable solution to reach room temperature (not more than 25°C).
Hver pen er beregnet til at kunne anvendes i højst fire uger og skal så bortskaffes.
ge Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “ How to self inject Viraferon”). lon Each pen is intended for a maximum four-week use period and must then be discarded.
Maksimalt 48 timers (to dages) udsættelse for 25°C er tilladt i den fire ugers ke
A maximum of 48 hours (two days) of exposure to 25°C is no
periode for at tage højde for tilfældige forsinkelser med at lægge pennen tilbage i køleskabet.
permitted over the four-week use period to cover accidental delays in returning the pen to the refrigerator.
renseservietter, der er tilbage efter sidste dosis er udtaget af pennen, skal smides ud på en passende og sikker måde. te
Instruct the patient that any extra needles and swabs that remain after the final dose has been taken from the pen, must be discarded appropriately and safely. t uc
Opløsningen skal være klar og farveløs. dle
The solution should be clear and colourless. rod