FrancophonIA/ELRC3.0 huggingface dataset:
English: It has been demonstrated in clinical studies that daptomycin is not effective in the treatment of pneumonia.
Danish: Kliniske studier har vist, at daptomycin ikke har effekt på pneumoni.
English: Stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours if stored under refrigeration at 2°C-8°C.
Danish: Stabilitet af den fortyndede opløsning i infusionspose er fastsat til 12 timer ved 25°C eller 24 timer ved opbevaring i køleskab ved 2°C-8°C.
English: After a single 6 mg/kg dose of daptomycin, the clearance and elimination half-life of daptomycin in children 13-24 months of age were similar to children 2-6 years of age who received a single 4-10 mg/kg dose.
Danish: Efter en enkelt 6 mg/kg dosis daptomycin var clearance og eliminationshalveringstid for daptomycin hos børn i alderen 13-24 måneder sammenlignelig med dem hos børn i alderen 2-6 år, som fik en enkelt 4-10 mg/kg dosis.
English: Creatine phosphokinase (CPK) levels must be measured at baseline and at regular intervals (at least weekly) during treatment (see section 4.4).
Danish: Kreatinkinase (CK)-niveauet skal monitoreres ved baseline og med regelmæssige mellemrum (mindst en gang om ugen) under behandlingen (se pkt.
English: Slowly remove the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle that is 21 gauge or smaller in diameter.
Danish: Træk langsomt den rekonstituerede væske (50 mg daptomycin/ml) op af hætteglasset med en steril kanyle, der har en diameter på 21G eller mindre.
English: Fungal infections, urinary tract infection, candida infection Uncommon: Fungaemia Not known*: Clostridium difficile-associated diarrhoea**
Danish: Svampeinfektion, urinvejsinfektion, candidainfektion Ikke almindelig: Fungæmi Ikke kendt*:
English: Effects on peripheral nerves were observed at higher doses than those associated with skeletal muscle effects in adult rats and dogs, and were primarily related to plasma Cmax.
Danish: Der blev observeret påvirkning af perifere nerver ved doser, der var større end dem, der blev associeret med påvirkning af skeletmuskulatur, hos voksne rotter og hunde.
English: - cSSTI with concurrent SAB: daptomycin 6 mg/kg is administered once every 24 hours.
Danish: - cSSTI med samtidigSAB: daptomycin 6 mg/kg administreres en gang i døgnet.
English: - That daptomycin susceptibility testing needs Ca in the testing medium and testing methods with mediums providing consistent Ca concentrations are recommended.
Danish: - At antibiotisk følsomhedsbestemmelse for daptomycin kræver calcium i testmediet, og testmetoder med passende Ca-koncentration i mediet anbefales.
English: Daptomycin Hospira should only be reconstituted with sodium chloride 9 mg/ml (0.9%).
Danish: Daptomycin Hospira må kun rekonstitueres med natriumchlorid 9 mg/ml (0,9%).
English: Due to limited clinical experience (see table and footnotes below) daptomycin should only be used in adult patients with any degree of renal impairment (CrCl <80 ml/min) when it is considered that the expected clinical benefit outweighs the potential risk.
Danish: Da der er begrænset klinisk erfaring (se tabel og fodnoter nedenfor) bør daptomycin kun anvendes til voksne patienter med nedsat nyrefunktion af enhver grad (kreatininclearance <80 ml/min.
English: The safety and efficacy of daptomycin in children and adolescents aged below 18 years with RIE due to Staphylococcus aureus have not been established.
Danish: Daptomycins sikkerhed og virkning hos børn og unge under 18 år med højresidig infektiøs endocarditis (RIE) som følge af Staphylococcus aureus er ikke klarlagt.
English: The dosage regimen for daptomycin in paediatric patients with renal impairment has not been established.
Danish: Doseringsregimet for daptomycin hos pædiatriske patienter med nedsat nyrefunktion er ikke fastlagt.
English: Driving and using machines Daptomycin Hospira has no known effects on the ability to drive or use machines.
Danish: Daptomycin Hospira har ingen kendt indvirkning på evnen til at føre motorkøretøj eller betjene maskiner.
English: Creatine phosphokinase and myopathy Increases in plasma creatine phosphokinase (CPK; MM isoenzyme) levels associated with muscular pains and/or weakness and cases of myositis, myoglobinaemia and rhabdomyolysis have been reported during therapy with daptomycin (see also sections 4.5, 4.8 and 5.3).
Danish: Kreatinkinase og myopati Der er blevet rapporteret forøget kreatinkinase i plasma (CK, MM isoenzym) forbundet med muskelsmerter og/eller -svækkelse og om tilfælde af myositis, myoglobinæmi og rabdomyolyse under behandlingen med daptomycin (se også pkt.
English: Gastrointestinal and abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, bloating and distension
Danish: Gastrointestinale og abdominale smerter, kvalme,opkastning, obstipation, diarré, flatulens oppustethed og udspiling Ikke almindelig: Dyspepsi, glossitis
English: Daptomycin Hospira is administered intravenously in 0.9 % sodium chloride (see section 6.6).
Danish: Daptomycin Hospira administreres intravenøst i 0,9% natriumchlorid (se pkt.
English: Paediatric patients (1 to 17 years of age) The recommended dosage regimens for paediatric patients based on age and indication are shown below.
Danish: De anbefalede doseringsregimer for pædiatriske patienter baseret på alder og indikation er vist nedenfor.
English: In adults, daptomycin may be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes.
Danish: Hos voksne kan daptomycin administreres intravenøst som infusion over 30 minutter eller som injektion over 2 minutter.
English: Uncommon: Decreased appetite, hyperglycaemia, electrolyte imbalance
Danish: Metabolisme og ernæring Ikke almindelig: Nedsat appetit, hyperglykæmi, forstyrrelser i elektrolytbalancen
English: What you need to know before you are given Daptomycin Hospira
Danish: Det skal du vide, før du begynder at få Daptomycin Hospira
English: If you are allergic to daptomycin or to sodium hydroxide or to any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få Daptomycin Hospira: - hvis du er allergisk over for daptomycin eller et af de øvrige indholdsstoffer (angivet i afsnit
English: Methicillin-susceptible Staphylococcus aureus (MSSA) Methicillin-resistant Staphylococcus aureus (MRSA) Streptococcus pyogenes a
Danish: Methicillin-følsom Staphylococcus aureus (MSSA) Methicillin-resistent Staphylococcus aureus (MRSA) Streptococcus pyogenes
English: - Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
Danish: 4.4 og 5.1): - Voksne og pædiatriske (i alderen 1-17 år) patienter med komplicerede hud- og bløddelsinfektioner (cSSTI).
English: 7-11 years (N=19)
Danish: 7-11 år (N=19)
English: 350 mg presentation:
Danish: 350 mg tilberedning:
English: 6 mg/kg once daily
Danish: 6 mg/kg en gang dagligt
English: In adults, daptomycin Hospira may be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes.
Danish: Hos voksne kan Daptomycin Hospira administreres intravenøst som infusion over 30 minutter eller som injektion over 2 minutter.
English: 500 mg presentation:
Danish: 500 mg tilberedning:
English: Unlike in adults, daptomycin should not be administered by injection over a 2-minute period in paediatric patients.
Danish: Til forskel fra hos voksne må daptomycin ikke administreres som en 2minutters injektion til pædiatriske patienter.
English: 12-17 years (N=13)
Danish: 12-17 år (N=13)
English: Reconstituted solutions of Daptomycin Hospira range in colour from yellow to light brown.
Danish: Rekonstituerede opløsninger af Daptomycin Hospira har en gul til lys brun farve.
English: Not known*: Acute generalised exanthematous pustulosis
Danish: Akut generaliseret eksantematøs pustulose
English: Based on these study results, both methods of daptomycin administration, the 2-minute intravenous injection and the 30-minute intravenous infusion,
Danish: Resultater fra disse studier viste, at begge metoder til administration af daptomycin, 2-minutters intravenøs injektion og 30 minutters intravenøs infusion, havde sammenlignelig sikkerheds- og tolerabilitetsprofil.
English: Microbiological Success rate in Paedatric SAB n/N (%)
Danish: Mikrobiologisk succesrate hos pædiatriske patienter med SAB n/N (%)
English: To prepare Daptomycin Hospira for intravenous injection, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute lyophilised Daptomycin Hospira.
Danish: Ved fremstilling af Daptomycin Hospira til intravenøs injektion skal følgende instruktioner følges: Der skal anvendes aseptisk teknik, når lyofiliseret Daptomycin Hospira rekonstitueres.
English: No clinical data on pregnancies are available for daptomycin.
Danish: Der foreligger ikke kliniske data om daptomycin under graviditet.
English: Your doctor will perform blood tests to monitor the health of your muscles both before you start treatment and frequently during treatment with Daptomycin Hospira.
Danish: Din læge vil tage blodprøver, før du start behandlingen og jævnligt under behandlingen med Daptomycin Hospira for at kontrollere, om dine muskler tager skade af behandlingen.
English: For example, patients with any degree of renal impairment (creatinine clearance <80 ml/min; see also section 4.2), including those on haemodialysis or CAPD, and patients taking other medicinal products known to be associated with myopathy (e.g. HMG-CoA reductase inhibitors, fibrates and ciclosporin).
Danish: 4.2), inklusive patienter i hæmodialyse eller CAPD, og patienter, som bruger andre lægemidler, der vides at være forbundet med myopati (f.eks. HMG-CoA reduktasehæmmere, fibrater og ciclosporin).
English: After a single 4 mg/kg dose of daptomycin, total clearance of daptomycin in children 7-11 years of age with Gram-positive infection was higher than in adolescents, whereas elimination half-life was shorter.
Danish: Efter en enkelt 4 mg/kg dosis daptomycin var total-clearance for daptomycin hos børn i alderen 7-11 år med grampositiv infektion højere end den hos unge, hvorimod eliminationshalveringstiden var kortere.
English: To prepare Daptomycin Hospira for intravenous infusion, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute lyophilised Daptomycin Hospira.
Danish: Ved fremstilling af Daptomycin Hospira til intravenøs infusion skal følgende instruktioner følges: Der skal anvendes aseptisk teknik, når lyofiliseret Daptomycin Hospira rekonstitueres.
English: A Phase 4 study (DAP-PEDS-07-03) was conducted to assess safety, efficacy, and pharmacokinetics of daptomycin in paediatric patients (1 to 17 years old, inclusive) with cSSTI caused by Gram-positive pathogens.
Danish: Et fase 4-studie (DAP-PEDS-07-03) blev udført for at vurdere daptomycins sikkerhed, virkning og farmakokinetik hos pædiatriske patienter (1-17 år, inklusive) med cSSTI forårsaget af grampositive patogener.
English: The efficacy of daptomycin in patients with prosthetic valve infections or with left-sided infective endocarditis due to Staphylococcus aureus has not been demonstrated.
Danish: Hos patienter med prostetiske hjerteklapinfektion eller venstresidigt infektiøs endocarditis som følge af Staphylococcus aureus er effekten af daptomycin ikke blevet vist.
English: 4 mg/kg once daily
Danish: 4 mg/kg en gang dagligt
English: It is mixed with a solvent to form a liquid before it is administered.
Danish: Før brug blandes det med et opløsningsmiddel, så der dannes en væske.
English: Your doctor may need to change the dose of Daptomycin Hospira (see section 3 of this leaflet).
Danish: Daptomycin Hospira (se afsnit 3 i denne indlægsseddel).
English: Chemical and physical stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours at 2°C - 8°C.
Danish: Kemisk og fysisk stabilitet af den fortyndede opløsning i infusionspose er fastsat til 12 timer ved 25°C eller 24 timer ved 2°C-8°C.
English: After reconstitution: Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours at 2°C - 8°C.
Danish: Efter rekonstitution: Der er påvist kemisk og fysisk stabilitet under brug af den rekonstituerede opløsning i hætteglasset i 12 timer ved 25°C og i op til 48 timer ved 2°C-8°C.
English: In paediatric patients aged 1 to 6 years, Daptomycin Hospira is given by intravenous infusion over a 60-minute period (see section 6.6).
Danish: Hos pædiatriske patienter i alderen 1-6 år indgives Daptomycin Hospira som intravenøs infusion over 60 minutter (se pkt.
English: An adjustment of daptomycin dose interval is needed for adult patients whose creatinine clearance is <30 ml/min (see sections 4.2 and 5.2).
Danish: Justering af dosisinterval af Daptomycin Hospira er nødvendig hos voksne patienter, hvis kreatininclearance er <30 ml/min.
English: Serious side effects with frequency not known (frequency cannot be estimated from the available data) A rare but potentially serious lung disorder called eosinophilic pneumonia has been reported in patients given daptomycin, mostly after more than 2 weeks of treatment.
Danish: En sjælden, men muligvis alvorlig lungesygdom, der hedder eosinofil pneumoni, er blevet indberettet fra patienter i behandling med Daptomycin Hospira, for det meste efter mere end 2 ugers behandling.
English: Replace needle with a new needle for the intravenous injection.
Danish: Erstat kanylen med en ny kanyle til den intravenøse injektion.
English: Eosinophilic pneumonia has been reported in patients receiving daptomycin (see section 4.8).
Danish: Der er rapporteret om eosinofil pneumoni hos patienter i behandling med daptomycin (se pkt.
English: Table 2 Mean (Standard Deviation) of Daptomycin Pharmacokinetics in Paediatric cSSTI Patients (1 to 17 Years of Age) in Study DAP-PEDS-07-03
Danish: Tabel 2 Den gennemsnitlige (standardafvigelse) farmakokinetik for daptomycin hos pædiatriske patienter med cSSTI (1 til 17 år) i studiet DAP-PEDS-07-03
English: Table 3 Mean (Standard Deviation) of Daptomycin Pharmacokinetics in Paediatric SAB Patients (1 to 17 Years of Age) in Study DAP-PEDBAC-11-02
Danish: Tabel 3 Den gennemsnitlige (standardafvigelse) farmakokinetik for daptomycin hos pædiatriske patienter med SAB (1-17 år) i studiet DAP-PEDBAC-11-02
English: - CPK should be measured more frequently (e.g. every 2-3 days at least during the first two weeks of treatment) in patients who are at higher risk of developing myopathy.
Danish: • CK bør måles hyppigere (f.eks. hver 2.-3. dag i minimum de første to uger af behandlingen) hos patienter, som harøget risiko for at udvikle myopati, f.eks. patienter med alle grader af nedsat nyrefunktion (kreatininclearance <80 ml/min; se også pkt.
English: Replace needle with a new needle for the intravenous infusion.
Danish: Erstat kanylen med en ny kanyle til den intravenøse infusion.
English: How to store Daptomycin Hospira
Danish: Sådan får du Daptomycin Hospira
English: Your doctor will check the condition of your lungs and decide whether or not you should continue Daptomycin Hospira treatment.
Danish: Din læge vil kontrollere dine lunder og vurdere, om du skal fortsætte behandlingen med Daptomycin Hospira.
English: What Daptomycin Hospira looks like and contents of the pack Daptomycin Hospira powder for solution for injection/infusion is supplied as a light yellow to light brown lyophilised cake or powder in a glass vial.
Danish: Daptomycin Hospira pulver til injektions-/infusionsvæske, opløsning, leveres som en lysegul til lysebrun lyofiliseret masse eller pulver i et hætteglas.
English: Powder for solution for injection/infusion 1 vial
Danish: Pulver til injektions-/infusionsvæske, opløsning 1 hætteglas
English: Daptomycin is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Danish: Daptomycin Hospira er indiceret til behandling af følgende infektioner (se pkt.
English: Therefore caution should be exercised if Daptomycin Hospira is given to such patients.
Danish: Hvis Daptomycin Hospira administreres til sådanne patienter, bør der derfor udvises forsigtighed.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 1 HÆTTEGLAS
English: Daptomycin Hospira vials are for single-use only.
Danish: Hætteglas med Daptomycin Hospira er kun til engangsbrug.
English: Tell your doctor or nurse straight away if you experience any of the following symptoms: - Chest pain or tightness, - Rash with blistering, sometimes affecting the mouth and genitals, - Swelling around throat, - Rapid or weak pulse, - Wheezing, - Fever, - Shivering or trembling, - Hot flushes, - Dizziness, - Fainting, - Metallic taste.
Danish: Fortæl det straks til en læge eller sundhedspersonalet, hvis du oplever nogle af følgende symptomer: - Brystsmerter eller brystet snører sig sammen - Udslæt med blæredannelse, som nogle gange kan være i munden og omkring kønsdelene - Hævelse omkring halsen - Hurtig eller svag puls - Hvæsende vejrtrækning - Feber - Kulderystelser eller skælven
English: In paediatric patients under 7 years old receiving a 9-12 mg/kg dose, daptomycin should be administered over 60 minutes (see sections 4.2 and 5.2).
Danish: Hos pædiatriske patienter under 7 år, der skal have en dosis på 9-12 mg/kg, skal daptomycin administreres over 60 minutter (se pkt.
English: The reconstituted and diluted solution should then be infused intravenously over 30 or 60 minutes.
Danish: Den rekonstituerede og fortyndede opløsning skal gives som intravenøs infusion over 30 eller 60 minutter.
English: After a single 4 mg/kg dose of daptomycin, total clearance normalised by weight and elimination half-life of daptomycin in adolescents (12-17 years of age) with Gram-positive infection were similar to adults.
Danish: Efter en enkelt 4 mg/kg dosis daptomycin var total-clearance normaliseret efter vægt og eliminationshalveringstid for daptomycin hos unge (12-17 år) med grampositiv infektion sammenlignelig med den hos voksne.
English: A light yellow to light brown lyophilised cake or powder.
Danish: En lysegul til lysebrun, frysetørret masse eller pulver.
English: Fungal infections, urinary tract infection, candida infection, anaemia, anxiety, insomnia, dizziness, headache, hypertension, hypotension, gastrointestinal and abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, bloating and distension, liver function tests abnormal (increased alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP)), rash, pruritus, limb pain, serum creatine phosphokinase (CPK) increased, infusion site reactions, pyrexia, asthenia.
Danish: De hyppigste rapporterede bivirkninger (almindelig hyppighed (≥ 1/100 til < 1/10)) er: Svampeinfektion, urinvejsinfektion, candida-infektion, anæmi, angst, insomni, svimmelhed, hovedpine, hypertension, hypotension, gastrointestinale og abdominale smerter, kvalme, opkastning, obstipation, diarré, flatulens, oppustethed og distension, unormale leverfunktionstest (øget alaninaminotransferase (ALAT), aspartat-aminotransferase (ASAT) og basisk fosfatase (ALP)), udslæt, pruritus, ekstremitetssmerter, forhøjet serumkreatinkinase (CK), reaktioner ved infusionsstedet, pyreksi, asteni.
English: - The other ingredientsaresodium hydroxideand citric acid.
Danish: - Øvrige indholdsstoffer: natriumhydroxid og citronsyre.
English: Clinical Success in Paedatric cSSTI Daptomycin n/N (%)
Danish: Klinisk succes hos pædiatriske patienter med cSSTI Daptomycin n/N (%)
English: Chemical and physical in-use stability on the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours if stored under refrigeration (2°C-8°C).
Danish: Der er påvist kemisk og fysisk stabilitet under brug af den rekonstituerede opløsning i hætteglas i 12 timer ved 25°C og i op til 48 timer ved opbevaring i køleskab (2°C-8°C).
English: In paediatric patients aged 7 to 17 years, Daptomycin Hospira is given by intravenous infusion over a 30-minute period (see section 6.6).
Danish: Hos pædiatriske patienter i alderen 7-17 år indgives Daptomycin Hospira som intravenøs infusion over 30 minutter (se pkt.
English: Common: may affect up to 1 in 10 people - Fungal infections such as thrush, - Urinary tract infection, - Decreased number of red blood cells (anaemia), - Dizziness, anxiety, difficulty in sleeping, - Headache, - Fever, weakness (asthenia), - High or low blood pressure, - Constipation, abdominal pain, - Diarrhoea, feeling sick (nausea) or being sick (vomiting), - Flatulence, - Abdominal swelling or bloating, - Skin rash or itching, - Pain, itchiness or redness at the site of infusion, - Pain in arms or legs, - Blood testing showing higher levels of liver enzymes or creatine phosphokinase (CPK).
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter) - Svampeinfektioner, som f.eks. trøske (gråhvide belægninger på mundslimhinden) - Urinvejsinfektion - Nedsat antal røde blodlegemer (blodmangel) - Svimmelhed, angst, søvnbesvær - Hovedpine - Feber, svaghed (asteni) - Forhøjet eller lavt blodtryk - Forstoppelse, mavesmerter - Diarré, kvalme eller opkastning - Luft i maven - Udspilet eller oppustet mave - Hududslæt eller kløe - Smerter, kløe eller rødme på infusionsstedet - Smerter i arme eller ben - Blodprøver, der viser forhøjede værdier af leverenzymer eller kreatinkinase (CK)
English: Uncommon: Fatigue, pain * Based on post-marketing reports.
Danish: * Baseret på post-marketing rapporter.
English: The safety and efficacy of daptomycin was evaluated in paediatric patients aged 1 to 17 years (Study DAP-PEDS-07-03) with cSSTI caused by Gram positive pathogens.
Danish: Daptomycins sikkerhed og virkning blev evalueret hos pædiatriske patienter i alderen 1-17 år med cSSTI forårsaget af grampositive patogener (studie DAP-PEDS-07-03).
English: However, daptomycin can cross the placenta in pregnant rats (see section 5.2).
Danish: Hos drægtige rotter kan daptomycin dog passerer placenta (se pkt.
English: The reconstituted solution should then be injected intravenously slowly over 2 minutes as directed in section 4.2.
Danish: Den rekonstituerede opløsning skal injiceres intravenøst langsomt over 2 minutter som anført i pkt.
English: • Age group 4 (n=45): 1 to < 2 years treated with daptomycin dosed at 10 mg/kg or SOC.
Danish: • Aldersgruppe 4 (n=45): 1 til < 2 år blev behandlet med daptomycindoser på 10 mg/kg eller SOC.
English: Infusion site reactions, pyrexia, asthenia
Danish: Reaktioner ved infusionsstedet, pyreksi, asteni Ikke almindelig: Træthed, smerter
English: Paediatric patients 7 to 17 years old should receive daptomycin infused over 30 minutes.
Danish: Pædiatriske patienter i alderen 7 til 17 år skal have administreret daptomycin som en infusion over 30 minutter.
English: Available in packs containing 1 vial or 5 vials.
Danish: Fås i pakninger med 1 eller 5 hætteglas.
English: Posology
Danish: Dosisanbefaling
English: Uncommon: may affect up to 1 in 100 people - Blood disorders (e.g. increased number of small blood particles called platelets, which may increase the tendency for blood clotting, or higher levels of certain types of white blood cells), - Decreased appetite, - Tingling or numbness of the hands or feet, taste disturbance,
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter) - Blodsygdomme (f.eks. forhøjet antal blodlegemer, kaldet blodplader, som kan øge tendensen til at blodet klumper sammen eller øgede niveauer af visse typer af hvide blodceller) - Nedsat appetit - Prikkende eller følelsesløs fornemmelse i hænder eller fødder, smagsforstyrrelser - Rysten - Forandringer i hjerterytmen, hedeture - Fordøjelsesbesvær (dyspepsi), betændelse af tungen - Kløende hududslæt - Muskelsmerter, muskelkramper eller muskelsvaghed, betændelse i musklerne (myositis),