FrancophonIA/ELRC3.0 huggingface dataset:
English: Vascular disorders hypotension, thrombophlebitis, phlebitis flushing
Danish: Vaskulære sygdomme ypotension, tromboflebitis, flebitis hedeture
English: Your doctor may want to check your kidneys before you take this medicine, and may perform regular blood tests during treatment.
Danish: I så tilfælde skal du g ikke nogen former for yrefunktion, inden du e lægemiddel, og kan tage regelmæssige blodprøver under behandlingen.
English: Your doctor or other healthcare professional will give you this medicine through an infusion (a drip for 30 minutes) into one of your veins.
Danish: hedsfaglig person vil give dig dette lægemiddel som infusion (et drop i behandles for, din nge på 12 år og derover dosis indgives i en
English: INHERENTLY RESISTANT ORGANISMS Aerobic Gram-positive micro-organisms Corynebacterium jeikeium Aerobic Gram-negative micro-organisms Legionella species
Danish: Serratia-a ORGANISMER MED ERHVERVET RESISTENS Aerobe grampositive mikroorganismer Corynebacterium jeikeium Aerobe gramnegative mikroorganismer Legionella-arter Stenotrophomonas maltophilia+,$
English: Pregnancy There are no or a limited amount of data from the use of Tazocin in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af piperacillin / tazobactam til gr avide kvinder.
English: In circumstances where co-administration is recomended, TAZOCIN is compatible for simultaneous co-administration via Y-site infusion only with the following aminoglycosides under the following conditions:
Danish: I de tilfælde, hvo administration er anbefalet, er TAZOCIN ku elig med samtidig tration via fusion minogl und elser:
English: Neutropenic children with fever suspected to be due to bacterial infections*
Danish: Neutropeniske børn m kg legemsvægt/hver 6. time ed feber, der mistænkes for at være forårsaget af bakterieinfektioner*
English: The reconstituted solutions may be further diluted to the desired volume (e.g. 50 ml to 150 ml) with one of the following compatible solvents: 0.9% (9 mg/ml) sodium chloride solution for injection Glucose 5%
Danish: 0,9 % (9 mg/ml) natriumchlorid-injektionsvæske, opløsning Sterilt vand til injektionsvæsker Glucose med et af følgende forligelige solvenser: 0,9 % (9 mg/ml) natriumchlorid-injektionsvæske, opløsning Glucose 5 %
English: Peritoneal dialysis removes approximately 6% and 21% of the piperacillin and tazobactam doses, respectively, with up to 18% of the tazobactam dose removed as the tazobactam metabolite.
Danish: Peritonealdialyse fjerner henholdsvis ca. 6 % og 21 % af tazobactam-dose
English: The population mean (SE) for piperacillin volume of distribution is 0.243 (0.011) l/kg and is independent of age.
Danish: Populationsgennemsnittet (SE) for piperacillins fordelingsvolumen er 0 er uafhængig af alder.
English: Dextran 6% in 0.9% sodium chloride
Danish: Dextran 6 % i 0,9 % na Ringer-laktat-in Hartmanns op
English: Rare side effects: (abnormal) decrease of red blood cells or blood pigment / haemoglobin, (abnormal) decrease of red blood cells due to premature breakdown (degradation) (haemolytic anaemia), small spot bruising (purpura), bleeding of the nose (epistaxis) and bleeding time prolonged, (abnormal) increase of a specific type of white blood cells (eosinophilia) severe allergic reaction (anaphylactic/anaphylactoid reaction, including shock) flushed red skin a certain form of infection of the colon (pseudomembranous colitis), abdominal pain inflammation of the liver (hepatitis), increase of a blood pigments breakdown product (bilirubin), increase of certain enzymes in the blood (blood alkaline phosphatase increased, gammaglutamyltransferase increased)
Danish: (unormalt) fald i antallet af røde blodlegemer eller blodpigment/hæmoglobin, (unormalt) fald i antallet af røde blodlegemer på grund af for tidlig nedbrydning (degradation) (hæmolytisk anæmi), små pletvise blå mærker (purpura), næseblødning (epistaxis) og øget blødningstid, (unormal) stigning i antallet af en bestemt type hvide blodlegemer (eosinofili) svær allergisk reaktion (anafylaktisk/anafylaktoid reaktion, herunder shock) rødme en vis form for infektion af tyktarmen (pseudomembranøs colitis), mavesmerter leverbetændelse (hepatitis), øget mængde af et blodpigments nedbrydningsprodukt (bilirubin), øget antal af visse enzymer i blodet (øget basisk fosfatase i blodet, øget gamma-glutamyltransferase) hudreaktioner med rødme og dannelse af hudlæsioner (eksantem, erythema multiforme), hudreaktioner med blæredannelse (bulløs dermatitis)
English: 70 ml Type I glass vial with a bromo-butyl rubber stopper and flip-off seal.
Danish: 6.5 Emballagetype og pakningsstørrelser 30 ml type I-hætteglas med brombutylgummipr 70 ml type I-hætteglas med brombutylgummiprop og flip-off-forsegling.
English: Uncommon side effects: thrush (abnormal) decrease in white blood cells (leukopenia, neutropenia) and platelets (thrombocytopenia) allergic reaction headache, sleeplessness low blood pressure, inflammation of the veins (felt as tenderness or redness in the affected area) jaundice (yellow staining of the skin or whites of the eyes), inflammation of the mucous lining of the mouth, constipation, indigestion, stomach upset increase of certain enzymes in the blood (alanine aminotransferase increased, aspartate aminotransferase increased) itching, nettle rash increase of muscle metabolism product in the blood (blood creatinine increased) fever, injection site reaction yeast infection (candidal superinfection)
Danish: Ikke almindelige bivirkninger: trøske (unormalt) (trombocytopeni) allergisk reaktion hovedpine, søvnløshed lavt blodtr gulsot (gulfarvning af huden eller det hvide omkring øjnene), slimhindebet forstoppelse, fordøjelsesbesvær, mavebesvær øget mængde af visse enzymer i blodet (øget alaninaminotransferase, øget kløe, nældefeber et mængde af muskelmetabolismeprodukter i blodet (øget blo øg feber, reaktion på injektionsstedet gærinfektion (candidiasis-superinfektion)
English: How to store TAZOCIN Further information
Danish: [Udfyldes nationalt] Du kan finde yderligere information om TAZOCIN på h
English: Hepatic impairment
Danish: væske, opløsning
English: 6.3 Shelf life
Danish: 6.6 Regler f
English: Very rare side effects: severe decrease of granular white blood cells (agranulocytosis), severe decrease of red blood cells, white blood cells and platelets (pancytopenia) prolonged time for blood clot formation (prolonged partial thromboplastin time, prothrombin time prolonged), abnormal lab test (positive direct Coombs), increase of platelets (thrombocythaemia) decrease of potassium in the blood (hypokalaemia), decrease of blood sugar (glucose), decrease of the blood protein albumin, decrease of blood total protein detachment of the top layer of the skin all over the body (toxic epidermal necrolysis), serious bodywide allergic reaction with skin and mucous lining rashes and various skin eruptions (StevensJohnson Syndrome) blood urea nitrogen increased
Danish: Meget sjældne bivirkninger: svært fald i antallet af den del af de hvide blodlegemer, der hedder g svært fald i antallet af røde blodlegemer, hvide blodlegemer og blodplade øget tid til blodstørkning (øget partiel tromboplastintid, øg laboratorieprøver (positiv direkte Coombs-test), øget antal blodplader (tr fald i kaliumniveauet i blodet (hypokaliæmi), fald i niveauet af blodsukk af blodprote mængde afskalning af det øverste lag hu allergisk reaktion over hele kroppen med kløe i hud og slimhinder og forskel (Stev
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains: 2 g piperacillin (as sodium salt) and 0.25 g tazobactam (as sodium salt).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder: 2 g piperacillin (som natriumsalt) og 0,25 g tazobactam (som natriumsalt).
English: For frequency of these reactions, refer to the information below.
Danish: Hvis du bemærker noget af det ovenstående, skal du strak nedenunder for hyppigheden af disse bivirkninger.
English: A fertility study in rats showed no effect on fertility and mating after intraperitoneal administration of tazobactam or the combination piperacillin / tazobactam (see section 5.3).
Danish: I et fertilitetsstudie hos rotter blev der ikke påvist nogen virkning på fertilitet og parri intraperitoneal admi
English: Musculoskeletal and connective tissue disorders arthralgia, myalgia
Danish: devæv artralgi, myalgi
English: Therefore, enzymatic urinary glucose measurement is required under Tazocin therapy.
Danish: Det er derfor nødvendigt at anvende enzymatiske måling
English: 0.9% (9 mg/ml) sodium chloride solution for injection
Danish: 0,9 % (9 mg/ml) natriumchlorid-injektionsvæske, opløsning Glucose 5 %
English: The solution should only be used if the solution is clear and free from particles.
Danish: Opløsningen må kun bruge indeholder partikler.
English: Piperacillin, tazobactam, and desethyl piperacillin are also secreted into the bile.
Danish: Piperacillin, tazobac udskilles også i galden.
English: Each vial of Tazocin 4 g / 0.5 g contains 11.16 mmol (256 mg) of sodium.
Danish: Hvert hætteglas med Tazocin 4 g/0,5 g indeholder 11,16 mmol (256 mg) natrium.
English: In this case, you should inform your doctor or other healthcare professional immediately.
Danish: I så tilfælde bør du med det samme sige det ti sundhedsfaglig person.
English: The serious side effects of Tazocin are: -swelling of the face, lips, tongue or other parts of the body -shortness of breath, wheezing or trouble breathing -severe rash, itching or hives on the skin -yellowing of the eyes or skin -damage to blood cells (the signs include: being breathless when you do not expect it, red or brown urine, nosebleeds and bruising)
Danish: TAZOCINs alvorlige bivirkninger er -hævelse af ansigt, læb -stakåndethed, hvæsen eller vejrtrækningsbesvær -alvorligt udslæt, kl -gulfarvning af øjne eller hud -beskadigede blodlegemer (tegn herpå o
English: Hepatobiliary disorders alanine aminotransferase increased, aspartate aminotransferase increased hepatitis, blood bilirubin increased, blood alkaline phosphatase increased, gammaglutamyltransferase increased
Danish: hepatitis, øget blo øge glutamyltransferase galde dbilirubin, t basisk fatase i blodet,
English: SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM Aerobic Gram-positive micro-organisms
Danish: Inddeling af relevante arter i forhold til piperacillin-/tazobactamfølsomhed ARTER, HVOR ERHVERVET RESISTENS KAN VÆRE ET PROBLEM Aerobe grampositive mikroorganismer Enterococcus faecium$,+
English: Dose per weight and treatment frequency
Danish: Dosis pr. kg legemsvægt og
English: Because of chemical instability, TAZOCIN should not be used with solutions containing only sodium bicarbonate.
Danish: På grund af kemisk ustabilitet bør TAZOCIN ikke anvende
English: Tazocin may be used in the management of neutropenic children with fever suspected to be due to a bacterial infection.
Danish: Tazocin kan anvendes til behandling af neutropeniske børn med feber, der mistænkes at være forårsaget af eh gttagelse af officielle retningslinjer for korrekt anvendelse af antibakterielle midler.
English: Volume of solvent* to be added to vial 2 g / 0.25 g (2 g piperacillin and 0.25 g tacobactam) 10 ml 4 g / 0.50 g (4 g piperacillin and 0.5 g tacobactam)
Danish: 2 g/0,25 g (2 g piperacillin og 0,25 g tazobactam) 10 ml 4 g/0,50 g (4 g piperacillin og 0,5 g tazobactam) 20 ml
English: TAZOCIN may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).
Danish: TAZOCIN anve ndtarmsbetændelse, peritonitis (infektion af væsken i mavens organer og de at behandle bakterieinfektioner hos pati t antal hvide blodlegemer (nedsat modstandsdygtighed over for infektioner).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains piperacillin (as sodium salt) equivalent to 2 g and tazobactam (as sodium salt) equivalent to 0.25 g.
Danish: ITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas indeholder piperacillin (som natriumsalt) svarende til 2 g og tazobactam (som natriumsalt)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at 2-8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.
Danish: Hvis den ikke bruges straks, er brugsopbevaringstider og -forhold før brug brugerens ansvar og påvirket.
English: medicines to thin your blood or to treat blood clots (e.g. heparin, warfarin or aspirin).
Danish: Dette kan øge den tid, det tager f tazobactam at forlade lægemidler, der fortynder dit blod, eller som anvendes til at behandle blodprop warfarin eller aspiri lægemidler, der får have et generelt bedøvelsesmiddel.
English: Providencia ssp.
Danish: ngangsbrug.
English: 5.2 Pharmacokinetic properties
Danish: 5.1 Farmak
English: Piperacillin appears to slightly reduce the clearance of tazobactam.
Danish: tam. Piperacillin synes patienter ved nedsat kreatininclearance.
English: 0.9% sodium chloride or 5% glucose
Danish: 0,7 - 3,32 nat riumchlorid eller % glucose
English: 5 x 1 vial with powder for solution for infusion.
Danish: 5 x 1 hætteglas med pulver til infusionsvæske, opløsning.
English: Each vial contains piperacillin (as sodium salt) equivalent to 4 g and tazobactam (as sodium salt) equivalent to 0.5 g.
Danish: Hvert hætteglas indeholder piperacillin (som natriumsalt) svarende til 4 g og tazobactam (som natriumsalt) svarende til 0,5 g.
English: Tell your doctor if you have kidney problems.
Danish: lægemidler, der i hvis du har nyreproblemer.
English: 4.7 Effects on ability to drive and use machines
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene 4.8 Bivirkninger
English: Groupings of relevant species according to piperacillin / tazobactam susceptibility COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive micro-organisms Enterococcus faecalis Listeria monocytogenes Staphylococcus aureus, methicillin-susceptible£
Danish: Enterococcus faecalis Listeria monocytogenes Staphylococcus aureus, methicillinfølsom£
English: Renal and urinary disorders blood creatinine increased renal failure, tubulointerstitial nephritis blood urea increased
Danish: blodkreatinin tubulointerstitiel nefritis get blodurea
English: Use in children aged below 2 years
Danish: Brug hos børn under 2 år Tazocins sik
English: Route of administration
Danish: ÅDE OG ADMINISTRATIONSVEJ(E)
English: 12 x 1 vial with powder for solution for infusion.
Danish: 12 x 1 hætteglas med pulver til infusionsvæske, opløsning.
English: Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics, Tazocin and the aminoglycoside are recommended for separate administration.
Danish: På grund af in vitro-inaktiveringen af aminoglykosidet forårsaget af betalaktam-antibiotika anbefales det bør rekonstitueres og ret.
English: Piperacillin is excreted rapidly as unchanged substance, with 68% of the administered dose appearing in the urine.
Danish: Piperacillin og tazobactam elimineres gennem nyrerne via glomerulær filtration og Piperacillin udskilles hurtigt i uforandret form, og 68 % af den administrerede dosis g Tazobactam og dets m tubulær sekretion.
English: POSSIBLE SIDE EFFECTS
Danish: Sjældne bivirkninger:
English: Each vial contains: 4 g piperacillin (as sodium salt) and 0.5 g tazobactam (as sodium salt).
Danish: Hvert hætteglas indeholder: 4 g piperacillin (som natriumsalt) og 0,5 g tazobactam (som natriumsalt).
English: WHAT TAZOCIN IS AND WHAT IT IS USED FOR
Danish: er, der er toksiske for
English: Piperacillin, either alone or with tazobactam, did not significantly alter the pharmacokinetics of tobramycin in subjects with normal renal function and with mild or moderate renal impairment.
Danish: De højeste signifikant amycins farmakokinetik hos forsøgspersoner med normal nyrefunktion og med mildt til moderat refunktion.
English: Each vial contains 4 g piperacillin (as sodium salt) and 0.5 g tazobactam (as sodium salt).
Danish: Hvert hætteglas indeholder 4 g piperaci llin (som natriumsalt) og 0,5 g tazobactam (som natriumsalt).
English: if you are suffering from diarrhoea before, or if you develop diarrhoea during or after your treatment.
Danish: hvis du har diarré før, eller hvis du får diarré med det samme sige det til lægen eller en anden sundhedsfaglig person.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and dilution.
Danish: travenøs anvendelse efter rekonstituering og fo
English: Co-administration of TAZOCIN with aminoglycosides Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics, TAZOCIN and the aminoglycoside are recommended for separate administration.
Danish: Samtidig indgift af TAZOCIN og aminoglykosider det forårsaget af betalaktam-antibiotika a at indgive TA fortyndes sep ykosidet separat.
English: What TAZOCIN is and what it is used for Before you use TAZOCIN How to use TAZOCIN Possible side effects
Danish: Oversigt over indlægs Virkning og anv Sådan skal du bruge TAZOCIN Opbevaring
English: 10 x 1 vial with powder for solution for infusion.
Danish: 10 x 1 hætteglas med pulver til infusionsvæske, opløsning.
English: Each vial of Tazocin 2 g / 0.25 g contains 5.58 mmol (128 mg) of sodium.
Danish: Hvert hætteglas med Tazocin 2 g/0,25 g indeholder 5,58 mmol (1
English: The usual dose for children with abdominal infections is 100 mg / 12.5 mg / kg of body weight of piperacillin / tazobactam given every 8 hours into one of your veins (directly into the blood stream).
Danish: Børn på 2-12 år vanlige dosis for børn med maveinfektioner er 100 mg/12,5 mg piperacillin / tazobactam pr. kg i blodbanen).
English: If you have any further questions, ask your doctor or pharmacist.
Danish: Spørg lægen eller på apoteket, hvis der er mere, du vil vide.
English: Reconstituted solution in vial
Danish: Rekonstitueret opløsning i hætteglas
English: Adults and adolescents aged 12 years or older
Danish: Voksne og unge
English: Tazobactam and its metabolite are eliminated primarily by renal excretion, with 80% of the administered dose appearing as unchanged substance and the remainder as the single metabolite.
Danish: etabolit elimineres primært gennem renal ekskretion, og 80 % af den administrerede tam og desetylpiperacillin re doser af piperacillin / tazobactam hos raske forsøgspersoner varierede kke påvirket af .
English: The mixing of beta-lactam antibiotics with an aminoglycoside in vitro can result in substantial inactivation of the aminoglycoside.
Danish: Blanding af betala væsentlig inaktivering af aminoglykosidet.
English: Treatment
Danish: FARMACE
English: TAZOCIN is used in children aged 2-12 years to treat infections of the abdomen such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs), and gallbladder (biliary) infections.
Danish: Tazobactam kan forebygge, at visse resistente bakterier tazobactam gives sammen, bliver tioner, herunder infektioner i vendes til at behandle bakterieinfektioner hos patienter med lavt antal hvide blodlegemer (nedsat modstandsdygtighed over for infe ndes til børn i alderen 2-12 år til at behandle infektioner i maven såsom bli res membraner) samt betændelse i galdeblæren.
English: The piperacillin clearance estimate is 80% of this value for paediatric patients 2-9 months of age.
Danish: Estimatet for piperacillinclearance er 80 % af denne værdi for pædiatriske patienter på ,243 (0,011) l/kg og ldsvis 32 % og 55 forandringer i
English: Race
Danish: Ringe
English: TAZOCIN and the aminoglycoside should be reconstituted and diluted separately when concomitant therapy with aminoglycosides is indicated.
Danish: TAZOCIN og a behandling med am glykoside oglykoside indiceret.
English: General disorders and administration site conditions pyrexia,
Danish: Almene symptomer og reaktioner på pyreksi, reaktion på injektionsstedet kulderystelser administrationsstedet
English: Each vial of Tazocin 2 g / 0.25 g contains 5.58 mmol (128 mg) of sodium and Tazocin 4 g / 0.5 g contains 11.16 mmol (256 mg) of sodium.
Danish: g/0,25 g indeholder 5,58 mmol (128 mg) natrium, og Tazocin 4 g/0,5 g os patienter, der er på
English: Renal impairment
Danish: rsion på tidspunktet
English: 1 vial with powder for solution for infusion.
Danish: 1 hætteglas med pulver til infusionsvæske, opløsning.
English: History of acute severe allergic reaction to any other beta-lactam active substances (e.g. cephalosporin, monobactam or carbapenem).
Danish: cefalosporin, monobaktam eller carbapenem).
English: Gastrointestinal disorders diarrhoea, vomiting, nausea jaundice, stomatitis, constipation, dyspepsia pseudomembranous colitis, abdominal pain
Danish: Mave -tarmkanale n diarré, opkastn kvalme t,
English: 80 mg Piperacillin / 10 mg Tazobactam per kg body weight / every 6 hours
Danish: Indikatio doseringsshyppighed 80 mg piperacillin / 10 mg tazobactam pr.
English: CARTON AND VIALS
Danish: ÆSKE OG HÆTTEGLAS
English: Gram-negative and
Danish: 4.2 og
English: Infections
Danish: Bivirkninger
English: Treatment frequency
Danish: ZO fortyndingsvolumen
English: 2 g / 0.25 g (2 g piperacillin and 0.25 g tacobactam)
Danish: 2 g/0,25 g 4 g/0,5 g natriumchlorid eller 5 % glucose
English: See section 6.2 for incompatibilities.
Danish: 6.2 vedrørende uf Ikke anvendte Kun til e
English: Piperacillin / tazobactam is not recommended for use in children below the age of 2 years due to insufficient data on safety and effectiveness.
Danish: til børn under 2 år, da der ikke findes tilstrækkelige data om sikkerhed ler en anden sundhedsfaglig person, hvis du bruger anden medicin eller har gemidler kan or piperacillin og din krop.
English: 4 g / 0.5 g (4 g piperacillin and 0.5 g tacobactam) 20 ml
Danish: 2 g/0,25 g (2 g piperacillin og 0,25 g tazobactam) 10 ml 4 g/0,5 g (4 g piperacillin og 0,5 g tazobactam) 20 ml
English: Altogether 30 female partners participated in the study.
Danish: I alt deltog 30 kvindelige partnere i studiet.
English: Thus, the carcinogenic risk is unknown.
Danish: Derfor er den karcinogene risiko ikke kendt.
English: Treatment in this group can therefore not be recommended.
Danish: Behandling af denne gruppe kan derfor ikke anbefales.
English: Patients were however followed up to 36 weeks.
Danish: Patienterne blev imidlertid fulgt i op til 36 uger.
English: **Note: 22 subjects were excluded from this analysis.
Danish: **Bemærk: 22 personer blev ekskluderet fra denne analyse.
English: Date of first authorisation: 28 February 2011 Date of latest renewal: 18 January 2016
Danish: Dato for første markedsføringstilladelse: 28. februar 2011 Dato for seneste fornyelse: 18. januar 2016
English: <1/100), and not known: cannot be estimated from the available data.
Danish: <1/100) og ikke kendt: kan ikke estimeres ud fra forhåndenværende data.
English: In Studies 1 and 2, the co-primary endpoints were:
Danish: I studie 1 og 2 var de to primære endepunkter:
English: Frequency of side effects not known
Danish: Hyppighed af bivirkninger ikke kendt
English: No overall differences in safety or effectiveness were observed between elderly and younger patients.
Danish: Der er generelt ikke set nogen forskelle i sikkerhed og virkning mellem ældre og yngre patienter.
English: No formal studies on elimination have been performed.
Danish: Der er ikke udført formelle eliminationsstudier.
English: Before you are given this medicine, make sure your doctor knows:
Danish: Før De får denne medicin, skal De være sikker på, at Deres læge ved:
English: As this medicine is administered to you by your doctor it is very unlikely that you will be given an incorrect dose.
Danish: Da dette lægemiddel indgives af Deres læge, er det meget usandsynligt, at De skulle få en ukorrekt dosis.
English: 3 months prior to completion c Higher scores represent worse symptoms
Danish: 3 måneder før studiets gennemførelse c Højere scorer afspejler værre symptomer
English: Follow-up Interval (days)
Danish: Opfølgningsinterval (dage)
English: No new safety signals were identified during the 5 year follow-up period.
Danish: Der blev ikke identificeret nogen nye sikkerhedssignaler i løbet af de 5 års opfølgningsperiode.