FrancophonIA/ELRC3.0 huggingface dataset:
English: Cmax: ↑ 49% (↑ 32 to ↑ 69)
Danish: AUC: ↑ 34% (↑ 18 til ↑ 53) Cmax: ↑ 49% (↑ 32 til ↑ 69) Efavirenz:
English: SUSTIVA 100 mg hard capsules efavirenz
Danish: SUSTIVA 100 mg hårde kapsler (efavirenz)
English: Co-administraion with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) because competition for CYP3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/or life-threatening adverse reactions [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
Danish: Samtidigt med terfenadin, astemizol, cisaprid, midazolam, triazolam, primozid, bepridil eller sekalealkaloider (fx. ergotamin, dihydroergotamin, ergonovin og methylergonovin) da konkurrence om CYP3A4 fra efavirenz kan resultere i hæmning af metaboliseringen.
English: Medicines that impact heart rhythm: - Medicines used to treat heart rhythm problems such as flecainide or metoprolol.
Danish: Lægemidler med indvirkning på hjerterytmen: - Lægemidler til behandling af problemer med hjerterytmen: fx flecainid eller metoprolol - Lægemidler til behandling af depression, fx imipramin, amitriptylin eller clomipramin.
English: Morning Cmin: ↑ 42% (↑ 9 to ↑ 86) b Evening Cmin: ↑ 24% (↑ 3 to ↑ 50) b Efavirenz:
Danish: 86)b Cmin aften: ↑ 24% (↑ 3 til ↑ 50)b
English: Treatment Regimend n
Danish: Behandlingsregimed
English: Breast-feeding should be discontinued during treatment with SUSTIVA.
Danish: Amning skal ophøre under behandling med efavirenz.
English: Antifungals
Danish: Antimykotika
English: Liver disease
Danish: Leversygdom
English: AUC: ↔ 19%* Cmax: ↔ 8%
Danish: AUC: ↔ 19%*
English: The capsule shell contains: gelatine, sodium laurilsulfate, yellow iron oxide (E172), titanium dioxide (E171) and silicon dioxide.
Danish: Kapselskallen indeholder: Gelatine, natriumlaurilsulfat, gul jernoxid (E172), titandioxid (E171) og siliciumdioxid (E551).
English: The median increase from baseline in CD4+ count at 48 weeks of therapy was 238 cells/mm3 and the median increase in
Danish: Den mediane stigning i CD4+ tal ved uge 48 fra baseline var 215 celler/mm
English: Proguanil: AUC: ↓ 43% (↓ 7 to ↓ 65)
Danish: AUC: ↓ 43% (↓ 7 til ↓ 65) Cmax: ↔
English: AUC or Cmax values.
Danish: yoghurt eller modermælkserstatning.
English: Integrase strand transfer inhibitor
Danish: Plasma hiv-RNA
English: Cmin: ↓ 37% (↓ 17 to ↓ 52) Efavirenz:
Danish: Cmax: ↓ 17% (↓ 6 til ↓ 26) Cmin: ↓ 50% (↓ 40 til ↓ 59) Efavirenz:
English: No data are available to make a dose recommendation.
Danish: Data er ikke tilgængelige mhp.
English: uncommon hepatitis acute rare hepatic failure‡,*
Danish: Vaskulære sygdomme Ikke almindelig
English: Voriconazole: AUC: ↓ 77%
Danish: AUC: ↓ 77%
English: Cmin: ↓ 32% (↓ 15 to ↓ 46) (CYP3A4 and CYP2B6 induction)
Danish: AUC: ↓ 26% (↓ 15 til ↓ 36) Cmax: ↓ 20% (↓ 11 til ↓ 28) Cmin: ↓ 32% (↓ 15 til ↓ 46) (CYP3A4- og CYP2B6induktion)
English: Capsule shell: Gelatine, Sodium laurilsulfate, Yellow iron oxide (E172), Titanium dioxide (E171), Silicon dioxide (E551)
Danish: Kapselkerne: Natriumlaurilsulfat, Lactosemonohydrat, Magnesiumstearat, Natriumstivelsesglycollat Kapselskal: Gelatine, Natriumlaurilsulfat, Gul jernoxid (E172), Titandioxid (E171), Siliciumdioxid (E551)
English: Telaprevir (relative to 750 mg q8h): AUC: ↓ 18% (↓ 8 to ↓ 27) Cmax: ↓ 14% (↓ 3 to ↓ 24)
Danish: AUC: ↓ 18% (↓ 8 til ↓ 27) Cmax: ↓ 14% (↓ 3 til ↓ 24) Cmin: ↓ 25% (↓ 14 til ↓ 34) Efavirenz:
English: Indigo carmine (E132)
Danish: Gul jernoxid (E172) Carnaubavoks
English: Cmax: ↓ 76% (↓ 63 to ↓ 79)
Danish: AUC: ↓ 69% (↓ 62 til ↓ 73) Cmax: ↓ 76% (↓ 63 til ↓ 79) Simvastatinsyre:
English: Morning Cmax: ↑ 24% (↑ 12 to ↑ 38) Evening Cmax: ↔
Danish: AUC aften: ↔ Cmax morgen: ↑ 24% (↑ 12 til ↑
English: NNRTIs/Efavirenz
Danish: NNRTIer/efavirenz
English: Cmax: ↑ 14% (↑ 4 to ↑ 26)
Danish: AUC: ↑ 21% (↑ 10 til ↑ 34) Cmax: ↑ 14% (↑ 4 til ↑ 26) Cmin: ↑ 25% (↑ 7 til ↑ 46)b
English: AUC: ↑ 21% (↑ 10 to ↑ 34)
Danish: Cmin aften: ↑ 24% (↑ 3 til ↑ 50)b
English: These are used to treat conditions where the body's defence system against disease is not working properly.
Danish: De anvendes til at behandle tilstande, hvor kroppens forsvarssystem mod sygdomme ikke fungerer korrekt.
English: Use in children of more than 2 years old
Danish: Brug til børn over 2 år
English: In particular, tell your doctor if you have:
Danish: Du skal især fortælle det til din læge, hvis du har:
English: Patients with pre-existing risk factors
Danish: Patienter med allerede eksisterende risikofaktorer
English: Tell your doctor immediately.
Danish: Kontakt straks din læge.
English: Frequencies have been evaluated according to the following convention:
Danish: Hyppighederne er blevet evalueret i henhold til følgende konvention:
English: Certain side effects may occur more frequently:
Danish: Visse bivirkninger kan forekomme hyppigere:
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af shock skal medicinsk standardbehandling for shock implementeres.
English: Allergic reactions are rare.
Danish: Allergiske reaktioner er sjældne.
English: Produced from the plasma of human donors.
Danish: Fremstillet af plasma fra humane donorer.
English: There are five groups:
Danish: Der er fem grupper:
English: ● Coombs test positive
Danish: • positiv Coombs test
English: - very common (>1/10) - common (>1/100 to <1/10) - uncommon (>1/1,000 to <1/100) - rare (>1/10,000 to <1/1,000) - very rare (<1/10,000) - not known (cannot be estimated from the available data)
Danish: - Meget almindelig (>1/10) - Almindelig (>1/100 til <1/10) - Ikke almindelig (>1/1000 til <1/100) - Sjælden (>1/10.000 til <1/1000) - Meget sjælden (<1/10.000) - Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: It is worth considering that these 2 subjects contributed to the higher frequency of infusions with reactions in this group.
Danish: Det er værd at tage med i betragtning, at disse 2 forsøgspersoner bidrog til den større hyppighed af infusioner med reaktioner i denne gruppe.
English: You must not be given a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: In case of measles, the period is up to 1 year.
Danish: I tilfælde af mæslinger er perioden op til 1 år.
English: ● general physical health deterioration
Danish: ● almen forringelse af det fysiske helbred
English: Interference with serological testing
Danish: Interferens med serologisk testning
English: This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 1,5 % af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden for biologiske lægemidler skal det administrerede produkts navn og batchnummer tydeligt registreres.
English: You will be watched carefully until an hour after the infusion to detect potential side effects.
Danish: Du vil blive nøje overvåget i en time efter infusionen for at opdage eventuelle bivirkninger.
English: - If you have fructose intolerance, a quite rare genetic condition where the enzyme for breaking down fructose is not produced.
Danish: - Hvis du har fructoseintolerans, en ret sjælden genetisk tilstand, hvor enzymet til nedbrydning af fructose ikke produceres.
English: There are two groups:
Danish: Der er to grupper:
English: IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Danish: IgG- og IgG-komplekser nedbrydes i cellerne i det reticuloendoteliale system.
English: Discontinuation of IVIg treatment has resulted in remission of AMS within several days without sequelae.
Danish: Seponering af IVIg-behandlingen har resulteret i remission af AMS i løbet af adskillige dage uden sequelae.
English: Single dose toxicity studies were carried out in rats and mice.
Danish: Der er udført enkeltdosis-toksicitetsforsøg på rotter og mus.
English: • Guillain Barré syndrome, where the immune system damages the nerves and hinders them from working properly.
Danish: • Guillain-Barrés syndrom, hvor immunsystemet beskadiger nerverne og forhindrer dem i at fungere korrekt.
English: Effects on blood tests
Danish: Indvirkning på blodprøver
English: However, depending on the required dose, the patient may receive more than 1 vial.
Danish: Afhængigt af den påkrævede dosis kan patienten imidlertid få mere end 1 hætteglas.
English: In rare and isolated cases, the following side effects have been reported with immunoglobulin preparations.
Danish: I sjældne og isolerede tilfælde er følgende bivirkninger blevet indberettet for immunglobulinpræparater.
English: It is usually prepared from pooled plasma from not fewer than 1000 donors.
Danish: Det fremstilles normalt ud fra plasma poolet af mindst 1000 donorer.
English: TRALI is a potentially life-threatening condition requiring immediate intensive-care-unit management.
Danish: TRALI er en potentielt livstruende tilstand, der kræver øjeblikkelig intensiv behandling.
English: The treatment can be repeated if relapse occurs.
Danish: Behandlingen kan gentages i tilfælde af tilbagefald.
English: Your doctor will consider your risk factors and take measures such as to decrease the rate of infusion or to stop the treatment.
Danish: Lægen vil overveje dine risikofaktorer og tage forholdsregler, såsom nedsættelse af infusionshastigheden eller ophør af behandlingen.
English: This half-life may vary from patient to patient, in particular in primary immunodeficiency.
Danish: Halveringstiden kan variere fra patient til patient, især ved primær immundefekt.
English: Symptoms of TRALI typically develop during or within 6 hours of a transfusion, often within 1 - 2 hours.
Danish: Symptomer på TRALI opstår typisk under eller inden for 6 timer efter en transfusion, ofte inden for 1-2 timer.
English: Effects of the product on the immune system of the newborn have not been studied.
Danish: Lægemidlets virkning på den nyfødtes immunsystem er ikke blevet undersøgt.
English: One ml contains:
Danish: 1 ml indeholder:
English: This typically occurs within hours or days after IVIg administration and resolves spontaneously within 7 to 14 days.
Danish: Dette opstod typisk i løbet af timer eller dage efter administration af IVIg og fortog sig spontant i løbet af 7 til 14 dage.
English: The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Danish: Virkningsmekanismen ved andre indikationer end substitutionsterapi er ikke fuldt belyst, men omfatter immunmodulerende virkning.
English: Infusion rates during the initial infusions should be slow.
Danish: Infusionshastighederne under de initiale infusioner skal være langsomme.
English: All other patients should be observed for at least 20 minutes after administration
Danish: Alle andre patienter bør observeres i mindst 20 minutter efter infusion.
English: Patients exhibiting such signs and symptoms should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis.
Danish: Patienter, der udviser sådanne tegn og symptomer, skal gennemgå en grundig neurologisk undersøgelse, herunder CSF-undersøgelser, for at udelukke andre årsager til meningitis.
English: Seek medical care with no delay if any of the following side effects happen during or after the infusion:
Danish: Søg lægehjælp uden forsinkelse, hvis du oplever en eller flere af disse bivirkninger under eller efter infusionen:
English: Cyanosis was reported in one child but not in adults.
Danish: Cyanose blev rapporteret hos ét barn, men ikke hos voksne.
English: Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Danish: Patienter skal overvåges nøje og følges tæt for symptomer under hele infusionsperioden.
English: It may be self-administered if you have been fully trained by hospital staff.
Danish: Du kan gøre det selv, hvis du er blevet grundigt instrueret fra hospitalets side.
English: These include:
Danish: Disse forholdsregler omfatter:
English: • (rarely) transient cutaneous reactions (including cutaneous lupus erythematosus - frequency unknown)
Danish: • (sjældent) forbigående kutane reaktioner (herunder kutan lupus erythematosus - hyppighed ukendt)
English: The dose and dose regimen is dependent on the indication.
Danish: Dosis og dosisregime afhænger af indikationen.
English: • Effects on vaccines: Flebogamma DIF may reduce the effectiveness of certain types of vaccines (live attenuated virus vaccines).
Danish: • Indvirkning på vacciner: Flebogamma DIF kan svække virkningen af visse typer vacciner (levende svækkede virusvacciner).
English: It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3 - 5 days equilibrium is reached between the intra- and extravascular compartments.
Danish: Det fordeler sig relativt hurtigt mellem plasma og ekstravaskulær væske, og efter 3-5 dage opnås ligevægt mellem det intra- og det ekstravaskulære rum.
English: Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.
Danish: Tilstrækkelige doser af dette lægemiddel kan bringe unormalt lave niveauer af immunglobulin G tilbage til normalt niveau.
English: Patients should receive concomitant treatment with acetylsalicylic acid.
Danish: Patienterne skal samtidig behandles med acetylsalicylsyre.
English: This medicine belongs to the group of medicines called intravenous immunoglobulins.
Danish: Dette lægemiddel tilhører gruppen af lægemidler kaldet intravenøse immunglobuliner.
English: The safety results for 29 paediatric patients (those ≤ 17 years old) included in the PID studies were evaluated.
Danish: Sikkerhedsresultaterne for 29 pædiatriske patienter (≤ 17 år), der var inkluderet i PID-studierne, blev evalueret.
English: Hypersensitivity reactions are rare.
Danish: Overfølsomhedsreaktioner er sjældne.
English: Frequency per patient
Danish: Hyppighed pr. patient
English: SPECIAL STORAGE CONDITIONS Do not store above 30 ºC.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30 ºC.
English: Tell your doctor or pharmacist immediately and follow his/her instructions.
Danish: Underret straks din læge eller apoteket, og følg deres anvisninger.
English: No differences of the pharmacokinetic properties are expected in the paediatric population.
Danish: Der forventes ingen forskelle i de farmakokinetiske egenskaber hos den pædiatriske population.
English: Immunoglobulins are excreted into human milk.
Danish: Immunglobuliner udskilles i human mælk.
English: The syndrome usually begins within several hours to 2 days following IVIg treatment.
Danish: Syndromet opstår sædvanligvis inden for adskillige timer til 2 dage efter IVIg-behandling.
English: Instructions for handling and disposal
Danish: Regler for håndtering og bortskaffelse
English: A transient decrease in neutrophil count and/or episodes of neutropenia, sometimes severe, have been reported after treatment with IVIgs.
Danish: Et forbigående fald i neutrofiltal og/eller episoder med neutropeni, i nogle tilfælde svære, er blevet rapporteret efter behandling med IVIg'er.
English: The dose recommendations are summarised in the following table: Indication
Danish: Dosisanbefalingerne er opsummeret i nedenstående tabel: Indikation
English: The dose that you will be given will depend on your illness and body weight and will be worked out by your doctor (please see section “Instructions for healthcare professionals” given at the end of this leaflet).
Danish: Den dosis, som du skal have, afhænger af din sygdom og kropsvægt og vil blive fastsat af lægen (se punktet "Oplysninger til læger og sundhedspersonale" sidst i indlægssedlen).
English: The following information is intended for healthcare professionals only (see section 3 for further information):
Danish: Nedenstående oplysninger er til læger og sundhedspersonale (se punkt 3 for at få yderligere oplysninger):
English: Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Danish: Substitutionsterapi bør kun påbegyndes og administreres under supervision af en læge med erfaring i behandling af immundefekter.
English: To reduce the rate of bacterial infections, it may be necessary to increase the dosage and aim for higher trough levels.
Danish: For at reducere bakterieinfektionshyppigheden kan det være nødvendigt at øge doseringen og sigte mod højere dalkoncentrationer.
English: • if you are having Flebogamma DIF for the first time, or it has been switched from an alternative human normal immunoglobulin (IVIg) product, or it is a long time since your last infusion (e.g. several weeks).
Danish: • hvis du får Flebogamma DIF for første gang, eller der er skiftet til dette fra et andet humant normalt immunglobulin (IVIg)-produkt, eller der er gået lang tid siden din sidste infusion (fx flere uger).
English: Flebogamma DIF does not contain sucrose, maltose or glucose.
Danish: Flebogamma DIF indeholder ikke saccharose, maltose eller glucose.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, nor with any other IVIg products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler eller med andre IVIg-præparater.
English: • cases of increased serum creatinine level and/or occurrence of acute renal failure
Danish: • tilfælde af forhøjede serumkreatininniveauer og/eller forekomst af akut nyresvigt
English: MedDRA System Organ Class (SOC)
Danish: MedDRA-systemorganklasse (SOC)
English: IVIg products have been shown to cross the placenta, increasingly during the third trimester.
Danish: IVIg-præparater er vist at krydse placenta, i stigende grad under tredje trimester.
English: • Cases of temporary reduction in the number of the red cells in the blood (reversible haemolytic anaemia/haemolysis).
Danish: • Midlertidigt fald i antallet af røde blodlegemer i blodet (reversibel hæmolytisk anæmi/hæmolyse).
English: In patients receiving IVIg, there have been some reports of acute non-cardiogenic pulmonary oedema [Transfusion Related Acute Lung Injury (TRALI)].
Danish: Hos patienter, der har fået IVIg, har der været nogle rapporter om akut ikke-kardiogen lungeødem [transfusionsrelateret akut lungeskade (TRALI)].
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Danish: Standardforholdsreglerne til forebyggelse af infektioner, der skyldes brug af lægemidler fremstillet af humant blod eller plasma, omfatter udvælgelse af donorer, screening af de enkelte donationer og plasmapools for specifikke infektionsmarkører samt inkludering af effektive trin til inaktivering/eliminering af vira i fremstillingsproceduren.
English: If you get more Flebogamma DIF than you should, your body may take on too much fluid.
Danish: Hvis du får mere Flebogamma DIF end du skal, kan din krop få tilført for meget væske.
English: Please consult your doctor should you have increased side effects.
Danish: Kontakt lægen, hvis du oplever en øget forekomst af bivirkninger.
English: Guillain Barré syndrome
Danish: Guillain-Barrés syndrom
English: Interferences with determination of blood glucose levels are not expected.
Danish: Der forventes ikke interferens med måling af blodglucose.
English: Date of latest renewal: 24 April 2017
Danish: Dato for første markedsføringstilladelse: 23. august 2007 Dato for seneste fornyelse: 24. april 2017
English: Flebogamma DIF contains human normal immunoglobulin, highly purified protein extracted from human plasma (part of the blood of donors).
Danish: Flebogamma DIF indeholder humant normalt immunglobulin, højoprenset, protein, der er ekstraheret fra humant plasma (en del af blodet fra donorer).
English: Assessment of vital signs in clinical trials of the paediatric population did not indicate any pattern of clinically relevant changes.
Danish: Vurdering af vitale tegn i kliniske studier hos den pædiatriske population indikerede ikke noget mønster for klinisk relevante forskelle.
English: The product should be brought at room temperature (no more than 30 ºC) before use.
Danish: Produktet bør have stuetemperatur (maksimalt 30 ºC) før brug.
English: If you have a renal disease and you are receiving Flebogamma DIF for the first time, you may suffer a problem in your kidneys.
Danish: Hvis du har en nyresygdom, og du får Flebogramma DIF for første gang, kan du få problemer med dine nyrer.
English: This also applies to unknown or emerging viruses and other pathogens.
Danish: Dette gælder også nye eller hidtil ukendte vira og andre patogener.
English: The product is also used in patients at high risk of bleeding or prior to surgery to correct the platelet count.
Danish: Produktet anvendes også til patienter med høj risiko for blødning eller før en operation for at korrigere antallet af blodplader.
English: Flebogamma DIF is isotonic, with an osmolality from 240 to 370 mOsm/kg.
Danish: Flebogamma DIF er isotonisk, med osmolalitet fra 240 til 370 mOsm/kg.
English: Multifocal motor neuropathy (MMN)
Danish: Multifokal motorisk neuropati (MMN)
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Danish: Nedenstående tabel er sammenfattet i henhold til MedDRAs systemorganklasser (SOC og foretrukken betegnelse).
English: Renal parameters should be assessed prior to infusion of IVIg, particularly in patients judged to have a potential increased risk for developing acute renal failure, and again at appropriate intervals.
Danish: Nyreparametrene skal vurderes før infusion af IVIg, især hos patienter, der bedømmes til at have en muligt forhøjet risiko for at udvikle akut nyresvigt, og igen med passende intervaller.
English: • (rarely) a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration
Danish: • (sjældent) et pludseligt blodtryksfald og i isolerede tilfælde anafylaktisk shock, selv når patienten ikke har vist overfølsomhed ved tidligere administration
English: Radiculopathy, Syncope
Danish: Radikulopati, synkope
English: Neutropenia/Leukopenia
Danish: Neutropeni/leukopeni
English: Please tell your doctor if you have any other condition and/or illness, as control is required in patients with pre-existing risk factors for thrombotic events (formation of blood clots inside your blood).
Danish: Fortæl det til din læge, hvis du lider af andre tilstande og/eller sygdomme, da kontrol er nødvendig hos patienter med risikofaktorer for trombotiske hændelser (dannelse af blodpropper i blodet).
English: In case of inadvertent administration and suspicion of fructose intolerance the infusion has to be stopped immediately, normal glycaemia has to be re-established and organ function has to be stabilized by means of intensive care.
Danish: I tilfælde af uagtsom anvendelse eller mistanke om fructoseintolerans skal infusionen omgående stoppes, normal glykæmi genoprettes og organfunktionen stabiliseres ved hjælp af intensiv pleje.
English: As the dosage for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned conditions, the dosage in children is not considered to be different to that of adults.
Danish: Da doseringen for hver indikation gives efter kropsvægt og justeres efter det kliniske resultat af de ovennævnte tilstande, betragtes doseringen til børn ikke som anderledes end doseringen til voksne.
English: The treatment required depends on the nature and severity of the adverse reaction.
Danish: Den påkrævede behandling afhænger af arten og sværhedsgraden af bivirkningen.