FrancophonIA/ELRC3.0 huggingface dataset:
English: Used to draw medicinal solution from the vial into the syringe.
Danish: Anvendes til at trække medicinopløsningen op fra hætteglasset og ind i sprøjten.
English: Clean the vial rubber stopper with an alcohol wipe and allow it to dry.
Danish: Aftør hætteglassets gummiprop med en spritserviet, og lad den tørre.
English: TAKHZYRO may be self-administered or administered by a caregiver only after training on SC injection technique by a healthcare professional.
Danish: TAKHZYRO må kun administreres af patienten selv eller dennes omsorgsperson, hvis vedkommende er blevet oplært i korrekt subkutan injektionsteknik af en læge eller anden sundhedsperson.
English: TAKHZYRO contains sodium
Danish: TAKHZYRO indeholder natrium
English: • Use each vial of TAKHZYRO only once.
Danish: Brug kun hvert hætteglas med TAKHZYRO én gang.
English: Important: Do not remove the needle cap from the needle when attaching to the syringe.
Danish: Vigtigt: Fjern ikke kanylehætten fra kanylen, når du fastgør den på sprøjten.
English: Do not use any syringes, blunt-tip vial access needles and pointed-tip injection needles that appear damaged.
Danish: Anvend ikke sprøjter, overførselskanyler med stump spids og injektionskanyler med skarp spids, hvis de synes beskadigede.
English: 100% of the subjects on 300 mg q2wks or q4wks and 89% on 150 mg q4wks achieved at least a 50% reduction in HAE attack rate compared to the run-in period.
Danish: 100 % af de forsøgspersoner, der fik 300 mg hver 2. eller hver 4. uge, og 89 % af de forsøgspersoner, der fik 150 mg hver 4. uge, opnåede en reduktion på mindst 50 % i hyppigheden af HAE-anfald sammenlignet med indkøringsperioden.
English: a) Take the vial out of the refrigerator 15 minutes before use to allow it to reach room temperature (15°C to 25°C) before preparing an injection.
Danish: Trin 1: Klargør et hætteglas med TAKHZYRO a) Tag hætteglasset ud af køleskabet 15 minutter før brug så det får stuetemperatur (15 °C til 25 °C), før der gøres klar til en injektion.
English: Inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm (see section 4.2).
Danish: Injicér TAKHZYRO subkutant i abdomen, lår eller overarm (se pkt.
English: Transfer TAKHZYRO into syringe and switch to the pointed-tip injection needle 4.
Danish: Overfør TAKHZYRO til sprøjten, og skift over til injektionskanylen med den skarpe spids 4.
English: If you forget to use TAKHZYRO
Danish: Hvis du har glemt at bruge TAKHZYRO
English: d) Remove the vial from the packaging.
Danish: d) Tag hætteglasset ud af pakningen.
English: Rotation of the injection site is recommended.
Danish: Det anbefales at skifte injektionssted for hver injektion.
English: Using aseptic technique, withdraw the prescribed dose of TAKHZYRO from the vial into the syringe using an 18 gauge needle.
Danish: Udtag den ordinerede dosis TAKHZYRO fra hætteglasset ved hjælp af aseptisk teknik med 18 gaugekanylen.
English: If you stop using TAKHZYRO
Danish: Hvis du holder op med at bruge TAKHZYRO
English: • TAKHZYRO is for injection under the skin (‘subcutaneous injection').
Danish: TAKHZYRO er beregnet til injektion under huden (subkutan injektion).
English: MULTIPACK OUTER CARTON (INCLUDING BLUE-BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING YDRE ÆSKE (INKLUSIVE BLÅT FELT)
English: Release the skin fold and gently remove the needle.
Danish: Giv slip på hudfolden, og træk forsigtigt kanylen ud.
English: Accordingly, in a population pharmacokinetic analysis, renal impairment (estimated GFR: 60 to 89 ml/min/1.73 m
Danish: I overensstemmelse hermed havde nedsat nyrefunktion (estimeret GFR: 60 til 89 ml/min/1,73 m [mild, N=98] og 30 til 59 ml/min/1,73 m
English: • Talk to your doctor, pharmacist or nurse before using TAKHZYRO.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger TAKHZYRO.
English: Place all used syringes and needles in the sharps container.
Danish: Læg alle brugte sprøjter og kanyler i kanylebøtten.
English: Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger Brugsanvisning
English: • The active substance is lanadelumab.
Danish: Aktivt stof: lanadelumab.
English: Subjects were randomized into 1 of 4 parallel treatment arms, stratified by baseline attack rate, in a 3:2:2:2 ratio (placebo, lanadelumab 150 mg every 4 weeks [q4wks], lanadelumab 300 mg every 4 weeks [q4wks], or lanadelumab 300 mg every 2 weeks [q2wks] by SC injection) for the 26-week treatment period.
Danish: Forsøgspersonerne blev randomiseret til 1 af 4 parallelle behandlingsgrupper, der var stratificeret i henhold til anfaldshyppigheden ved baseline, i forholdet 3:2:2:2 (placebo, lanadelumab 150 mg hver 4. uge, lanadelumab 300 mg hver 4. uge eller lanadelumab 300 mg hver 2. uge ved subkutan injektion) i behandlingsperioden på 26 uger.
English: Lanadelumab inhibits active plasma kallikrein proteolytic activity.
Danish: Lanadelumab hæmmer det aktive plasmakallikreins proteolytiske aktivitet.
English: Exposures in the ePPND study were approximately 32-fold greater than that noted at 300 mg q2 wks based on AUC.
Danish: Eksponeringer i ePPND-studiet var ca. 32 gange højere end den eksponering, der blev observeret ved 300 mg hver 2. uge baseret på AUC.
English: b) Push the plunger down to inject air into the vial and hold the plunger down.
Danish: b) Tryk stemplet ned og injicér luft ind i hætteglasset.
English: Exposures in sexually mature cynomolgus monkeys in the fertility study were approximately 20-and 22-fold greater than that noted at 300 mg q2 wks based on Cmax and AUC, respectively.
Danish: Eksponeringen hos de kønsmodne cynomolgusaber i fertilitetsstudiet var ca. 20 og 22 gange højere end den eksponering, der blev observeret ved 300 mg hver 2. uge baseret på henholdsvis Cmax og AUC.
English: Each TAKHZYRO vial is intended for single use only (see section 6.6).
Danish: Hvert hætteglas med TAKHZYRO er kun beregnet til engangsbrug (se pkt.
English: Keep in the outer carton in order to protect from light.
Danish: Opbevar i den ydre karton for at beskytte mod lys.
English: The single and multiple dose pharmacokinetics of lanadelumab have been studied in patients with HAE.
Danish: Lanadelumabs farmakokinetik efter enkelte og gentagne doser er blevet undersøgt hos patienter med hereditært angioødem.
English: • One empty 3 ml syringe.
Danish: • En tom 3 ml sprøjte.
English: Inject TAKHZYRO
Danish: Injicér TAKHZYRO
English: Only use the syringes, blunt-tip vial access needles and pointed-tip injection needles one time.
Danish: Anvend kun sprøjterne, overførselskanylerne med stump spids og injektionskanylerne med skarp spids én gang.
English: No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med nedsat leverfunktion (se pkt.
English: Lanadelumab had no effect on male or female fertility in cynomolgus monkeys (see section 5.3).
Danish: Lanadelumab havde ingen virkning på fertiliteten hos han- og hun-cynomolgusaber (se pkt.
English: As a precautionary measure, it is preferable to avoid the use of lanadelumab during pregnancy.
Danish: For en sikkerheds skyld bør lanadelumab undgås under graviditeten.
English: c) Pull off the needle cap straight away from the syringe without touching the needle.
Danish: c) Træk kanylehætten lige af sprøjten uden at berøre kanylen.
English: MULTIPACK INNER CARTON (NO BLUE-BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING INDRE ÆSKE (INTET BLÅT FELT)
English: Exposures in cynomolgus monkeys following 6 months of administration were approximately 23-fold greater than that noted at 300 mg q2 wks based on AUC.
Danish: Eksponeringen hos cynomolgusaber efter 6 måneders administration var ca. 23 gange højere end den eksponering, der blev observeret med 300 mg hver 2. uge, baseret på AUC.
English: As a precautionary measure, it is preferable to avoid the use of lanadelumab during pregnancy and breast-feeding.
Danish: For en sikkerheds skyld bør lanadelumab undgås under graviditeten og amning.
English: Each vial contains 300 mg of lanadelumab in 2mL.
Danish: Hvert hætteglas indeholder 300 mg lanadelumab i 2 ml.
English: • Insert the needle into the fatty tissue in the tummy (abdomen), thigh or upper arm.
Danish: Indfør kanylen i mavens (abdomen), lårets eller overarmens fedtvæv.
English: • Allergic reactions including itching, discomfort and tingling of the tongue
Danish: Allergiske reaktioner, herunder kløe, ubehag og snurren i tungen Svimmelhed, mathed
English: No studies have been conducted in patients with hepatic impairment.
Danish: Der er ikke udført studier med patienter med nedsat leverfunktion.
English: EU/1/18/1340/002 EU/1/18/1340/003
Danish: EU/1/18/1340/002
English: How much TAKHZYRO to use
Danish: Så meget TAKHZYRO skal der bruges
English: • Empty 3 ml syringe
Danish: • Tom 3 ml sprøjte
English: c) Pull off the needle cap straight from the syringe without touching the needle.
Danish: c) Træk kanylehætten lige af sprøjten uden at berøre selve kanylen.
English: Fatigue/Mood score
Danish: Træthed-/humørscore
English: TAKHZYRO 300 mg solution for injection
Danish: TAKHZYRO 300 mg injektionsvæske, opløsning
English: 300 mg q2wks (N=27)
Danish: 300 mg hver 2. uge (N=27)
English: c) Slowly turn the vial upside down with needle and syringe attached.
Danish: c) Vend langsomt hætteglasset på hovedet med kanylen og sprøjten isat.
English: 300 mg q4wks (N=29)
Danish: 300 mg hver 4. uge (N=29)
English: 150mg q4wks (N=28)
Danish: 150 mg hver 4. uge (N=28)
English: TAKHZYRO total
Danish: TAKHZYRO i alt
English: Hypersensitivity reactions
Danish: Allergiske reaktioner
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ENHEDSPAKNING, ÆSKE
English: f) Place the 18 gauge blunt-tip vial access needle and the vial in a sharps container.
Danish: f) Bortskaf overførselskanylen med stump spids (18 gauge) i en kanyleboks.
English: Pharmacotherapeutic group: Other haematological agents, drugs used in hereditary angioedema, ATC code: B06AC05
Danish: Farmakoterapeutisk klassifikation: andre hæmatologiske midler, lægemidler til hereditært angioødem.
English: Hepatic impairment is not expected to affect exposure to lanadelumab.
Danish: Nedsat leverfunktion forventes ikke at påvirke eksponeringen for lanadelumab.
English: TAKHZYRO 300 mg
Danish: INFORMATION I BRAILLESKRIFT TAKHZYRO 300 mg
English: unscrew the syringe by holding the top of the needle and turning the syringe counter clockwise.
Danish: e) Uden at fjerne kanylen fra hætteglasset skal sprøjten skrues af ved at holde øverst på kanylen og dreje sprøjten mod uret.
English: Tell your doctor, pharmacist or nurse if you notice any of the following side effects.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: • face, eyelids, lips or tongue
Danish: Knogler, led, muskler og bindevæv Myalgi
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: TAKHZYRO 300 mg solution for injection lanadelumab
Danish: LÆGEMIDLETS NAVN TAKHZYRO 300 mg injektionsvæske, opløsning lanadelumab
English: Secondary endpoint - Number of HAE attacks requiring acute treatment from Day 0 to 182 LS Mean (95% CI) monthly attack rate b
Danish: Sekundært endepunkt - Antallet af HAE-anfald, der krævede akut behandling fra dag 0 til 182.
English: 150 mg q4wks
Danish: 150 mg hver 4. uge
English: One vial contains 300 mg of lanadelumab* in 2 mL solution.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et hætteglas indeholder 300 mg lanadelumab* i 2 ml opløsning.
English: Too much bradykinin leads to symptoms of HAE like swelling and pain on the,
Danish: For meget bradykinin fører til symptomer på HAE, såsom hævelse og smerter i hænder og fødder ansigt, øjenlåg, læber eller tunge strubehoved (larynx), som kan gøre det svært at trække vejret kønsorganer
English: Keeping a record
Danish: Før journal
English: The injection should be given subcutaneously.
Danish: Injektionen skal gives under huden (subkutant).
English: Functioning score
Danish: Funktionsscore
English: Do not recap the needle.
Danish: Sæt ikke hætten på kanylen igen.
English: Keep vial in the outer carton in order to protect from light.
Danish: Opbevar hætteglas i den ydre karton for at beskytte mod lys.
English: TAKHZYRO is provided in single-use vials as ready-to-use solution.
Danish: TAKHZYRO er en brugsklar opløsning, der udleveres i hætteglas til engangsbrug.
English: How to use TAKHZYRO
Danish: Sådan skal du bruge TAKHZYRO
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med TAKHZYRO Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Subcutaneous use Read the package leaflet before use For single use only
Danish: ADMINISTRATIONSMETODE Læs indlægssedlen inden brug
English: How to inject TAKHZYRO
Danish: Sådan injiceres TAKHZYRO
English: Hepatic impairment
Danish: Makulopapuløst udslæt
English: UNIT PACK CARTON
Danish: FREMSTILLERENS BATCHNUMMER Lot
English: • 18G vial access needle
Danish: • Overførselskanyle (18G)
English: g) Screw the 27 gauge ½-inch (0.4 x 13 mm)
Danish: • Injektionskanyle (27G x ½" (0,4 x 13 mm))
English: Aspartate aminotransferase increased Common *Hypersensitivity includes: pruritus, discomfort and tingling of tongue.
Danish: *Overfølsomhed omfatter: pruritus, ubehag og snurren i tungen.
English: 300 mg q4wks
Danish: 300 mg hver 4. uge
English: What you need to know before you use TAKHZYRO
Danish: Det skal du vide, før du begynder at bruge TAKHZYRO Brug ikke TAKHZYRO:
English: What you need to know before you use TAKHZYRO 3.
Danish: Det skal du vide, før du begynder at bruge TAKHZYRO Sådan skal du bruge TAKHZYRO Bivirkninger
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet.
English: Fear/Shame score
Danish: Angst-/skamscore
English: EU/1/18/1340/001 EU/1/18/1340/002 EU/1/18/1340/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1340/002
English: This pack also contains: 3 ml syringe 18 gauge access needle Injection needle
Danish: Denne pakning indeholder også: 3 ml sprøjte
English: pointed-tip injection needle to the syringe.
Danish: Sæt en overførselskanyle med stump spids på sprøjten 3.
English: Primary endpoint - Number of HAE attacks from Day 0 to 182 LS Mean (95% CI) monthly attack rate b
Danish: Primært endepunkt - Antallet af HAE-anfald fra dag 0 til 182.
English: Check with your doctor, pharmacist or nurse if you are not sure or have any further questions on the use of this medicine.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: • 18 gauge blunt tip vial access needle • 27 gauge ½ inch (0.4 x 13 mm) pointed tip administration (injection) needle.
Danish: • En injektionskanyle med skarp spids i størrelsen 27 gauge ½" (0,4 x 13 mm).
English: Prepare the vial of TAKHZYRO
Danish: Klargør et hætteglas med TAKHZYRO
English: wheezing, or a fast heart beat, tell your doctor, pharmacist or nurse immediately.
Danish: trykken for brystet, hivende vejrtrækning eller hurtige hjerteslag, skal du straks kontakte lægen,
English: If you use more TAKHZYRO than you should
Danish: Hvis du har brugt for meget TAKHZYRO
English: Administration steps
Danish: Administration
English: • One 27 gauge ½-inch (0.4 x 13 mm) pointed tip injection needle.
Danish: f) Anbring injektionskanylen med skarp spids (27 gauge ½" (0,4 x 13 mm)) og sprøjten i kanyleboksen.
English: No dose adjustment is required in patients with renal impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion (se pkt.
English: • Keep this leaflet.
Danish: Hold stemplet nede.
English: 20 October 2011
Danish: 20. oktober 2011
English: Background information
Danish: Baggrundsinformation
English: The final opinion was converted into a Decision by the European Commission on 20 October 2011.
Danish: Den endelige udtalelse blev den 20. oktober 2011 omdannet til en afgørelse truffet af EuropaKommissionen.
English: The Committee appointed Dr Bruno Urbain as rapporteur and Mrs Ruth Kearsley as co-rapporteur.
Danish: Udvalget udpegede Dr Bruno Urbain som rapportør og Ruth Kearsley som medrapportør.
English: The referral procedure started on 14 April 2010.
Danish: Indbringelsesproceduren blev indledt den 14. april 2010.
English: Oral explanations were given on 4 May 2011.
Danish: Der blev fremsat mundtlige redegørelser den 4. maj 2011.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended summary of product characteristics in Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De videnskabelige konklusioner findes i bilag II, og det ændrede produktresumé i bilag III.
English: Written explanations were provided by the marketing authorisation holders on 18 August 2010 and 8 February 2011.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 18. august 2010 og den 8. februar 2011.
English: Further to the resignation of Mrs Ruth Kearsley as CVMP member, Ms Helen Jukes was appointed to replace her and took over the co-rapporteurship.
Danish: Da Ruth Kearsley trådte tilbage som CVMP-medlem, blev Helen Jukes udpeget til at erstatte hende og overtog hvervet som medrapportør.
English: Prednisolone is an anti-inflammatory corticosteroid.
Danish: Prednisolon er et antiinflammatorisk kortikosteroid.
English: The product is intended for the treatment of bovine clinical mastitis in lactating cows.
Danish: Lægemidlet er beregnet til behandling af klinisk bovin mastitis hos diegivende køer.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the benefit/risk profile for Synulox Lactating Cow and associated names remains positive subject to
Danish: På baggrund af rapportørernes vurdering af de aktuelt tilgængelige data var CVMP af den opfattelse, at benefit/risk-profilen for Synulox Lactating Cow og relaterede navne fortsat er positiv som følge af
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Synulox Lactating Cow and associated names and differences between the summary of product characteristics (SPC) of the product as authorised in the Member States, the issue was referred on 26 March 2010 by Belgium and Denmark to the CVMP under Article 34(1) of Directive 2001/82/EC.
Danish: På grund af de divergerende nationale beslutninger truffet af medlemsstaterne vedrørende godkendelse af Synulox Lactating Cow og relaterede navne og divergenser mellem de nationalt godkendte produktresuméer i medlemsstaterne blev sagen den 26. marts 2010 indbragt for CVMP af Belgien og Denmark i henhold til artikel 34, stk. 1, i direktiv 2001/82/EF.
English: The reason for divergent national decisions regarding the authorisation of the products was mainly the justification of the combination of amoxicillin/clavulanic acid/prednisolone for the treatment of bovine mastitis.
Danish: Årsagen til de divergerende nationale beslutninger vedrørende lægemidlets godkendelse var primært begrundelsen for kombinationen af amoxicillin/clavulansyre/prednisolon til behandling af bovin mastitis.
English: Synulox Lactating Cow and associated names is a 3 g pale cream/buff coloured oily suspension presented in disposable intramammary syringes containing 200 mg amoxicillin as amoxicillin trihydrate, 50 mg clavulanic acid as potassium clavulanate and 10 mg prednisolone.
Danish: Synulox Lactating Cow og relaterede navne er en bleg cremefarvet/brungul 3 g suspension i intramammære engangssprøjter med 200 mg amoxicillin som amoxicillintrihydrat, 50 mg clavulansyre som kaliumclavulanat og 10 mg prednisolon.
English: variation of the marketing authorisations in accordance with the summary of product characteristics, and therefore adopted a positive opinion on 7 June 2011.
Danish: ændringen af markedsføringstilladelserne i overensstemmelse med produktresuméet, og CVMP vedtog således en positiv udtalelse den 7. juni 2011.
English: This combination is effective against β-lactamase producing organisms.
Danish: Denne kombination er effektiv over for betalaktamaseproducerende organismer.
English: International non-proprietary name (inn): amoxicillin trihydrate, potassium clavulanate, prednisolone
Danish: Internationalt fællesnavn (INN): amoxicillintrihydrat, kaliumclavulanat, prednisolon
English: The main sections of disharmony of the existing SPCs related to indications, posology and withdrawal periods.
Danish: De områder, der især er uenighed om i de eksisterende produktresuméer, vedrører indikationer, dosering og tilbageholdelsesperioder.
English: Clavulanic acid inactivates β-lactamases.
Danish: Clavulansyre inaktiverer betalactamaser.
English: Amoxicillin is a broad spectrum bactericidal β-lactam antibiotic.
Danish: Amoxicillin er et bredspektret betalactam antibiotikum med batericid virkning.
English: This summary was last updated in January 2012.
Danish: Dette sammendrag er sidst opdateret i januar 2012.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Acticam on 9 December 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Acticam den 9. december 2008.
English: Other information about Acticam:
Danish: Andre oplysninger om Acticam:
English: These side effects occur usually within the first week of treatment and are generally temporary.
Danish: Disse bivirkninger opstår som regel inden for den første uge af behandlingen og er generelt forbigående.
English: They disappear once treatment has stopped.
Danish: De forsvinder, så snart behandlingen afbrydes.
English: EPAR summary for the public
Danish: EPAR-sammendrag for offentligheden
English: Accidental self-injection may give rise to pain.
Danish: Utilsigtet selvinjektion kan forårsage smerter.
English: Acticam has been investigated in comparison with Metacam which is already authorised in the EU.
Danish: Acticam er blevet undersøgt og sammenlignet med Metacam, som allerede er tilladt i EU.
English: What is the risk associated with Acticam?
Danish: Hvilken risiko er der forbundet med Acticam?
English: People with known hypersensitivity (allergic) to meloxicam should avoid contact with the product.
Danish: Personer med kendt overfølsomhed (allergi) over for meloxicam skal undgå kontakt med lægemidlet.
English: As the prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces those responses.
Danish: Da prostaglandinerne er de stoffer, der udløser betændelse, smerter, ekssudation og feber, mindsker meloxicam disse reaktioner.
English: Why has Acticam been approved?
Danish: Hvorfor blev Acticam godkendt?
English: If the product is swallowed by a person, the advice of a doctor should be sought immediately.
Danish: Hvis en person indtager lægemidlet, bør der straks søges lægehjælp.
English: In case of accidental self-injection, medical advice should be sought immediately showing the package leaflet or the label to the physician.
Danish: I tilfælde af utilsigtet selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: Acticam should not be administered to pregnant or lactating animals as the safety of the product has not been established in these cases.
Danish: Acticam må ikke gives til drægtige eller lakterende dyr, da det ikke er fastslået, at lægemidlet er sikkert i disse tilfælde.
English: Acticam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Acticam indeholder meloxicam, som tilhører en lægemiddelgruppe, der kaldes ikke-steroide antiinflammatoriske lægemidler (NSAID'er).