natgillin/translations-raw huggingface dataset:
Kontakt straks lægen hvis du oplever: • Øget puls, hjertebanken (palpitations), brystsmerter, strammende fornemmelse i brystet eller mere alvorlige lidelser som blodprop i hjertet eller hjerteanfald. • Vejrtrækningsproblemer eller hoste.
Tell your doctor immediately if you experience: • Faster heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness in your chest or more serious problems including heart attack and stroke • Shortness of breath, cough fever lasting 2 to 3 days and feeling less hungry.
Dette kunne være tegn på lungeproblemer. • Lettere tendens til blå mærker, længere blødningsperioder, tegn på blødninger (f. eks. blødning fra tandkødet), lilla mærker på huden, lettere tendens til at få infektioner, halsbetændelse, feber, træthedsfornemmelse, svimmel eller bleghed.
These could be signs of lung problems including inflammation • Bruising more easily, bleeding for longer than normal, any sign of bleeding (e.g. bleeding from the gums), purple spots, blotching on the skin or getting infections more easily than usual, sore throat and
Dette kan være tegn på blod - eller knoglemarvs problemer. • Alvorlig mavepine der strækker sig om til ryggen.
These can be signs of blood or bone marrow problems. • Severe stomach pain which may reach through to your back.
Dette kan være tegn på pancreatitis (betændelse i bugspytkirtlen). • Feber, kuldegysninger, træthed, mistet appetit, mavepine, kvalme, gullig hud eller øjne (jaundice).
This could be a sign of pancreatitis (inflammation of the pancreas) • Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice).
Kontakt straks lægen, hvis én af følgende bivirkninger bliver alvorlige eller varer længere end et par dage:
Please tell your doctor if any of the following gets serious or lasts longer than a few days.
34 • Hovedpine eller træthedsfornemmelse • Svimmelhed.
Common (affects less than 1 in 10 people) • Headache, feeling week or tired • Feeling dizzy.
Dette er mest sandsynligligt når du starter med at anvende TRITACE eller når dosis opjusteres. • Tør hoste eller bronkitis • Blodprøveresultater der viser højere sukkerindhold i blodet end normalt.
This is more likely to happen when you start taking TRITAZIDE or start taking a higher dose • Dry tickly cough or bronchitis • Blood test showing a higher amount of sugar than usual in your blood.
Hvis du har diabetes, kan det forværre din diabetes. • Blodprøveresultater der viser højere indhold af urinsyre eller fedtindhold end norrmalt i blodet • Ledsmerter og røde og hævede led
If you have diabetes, this may make your diabetes worse • Blood test showing a higher amount of uric acid or more fat than usual in your blood • Painful, red, and swollen joints
Hævede arme og ben.
Uncommon (affects less than 1 in 100 people) • Skin rash with or without raised area • Flushing, fainting, hypotension (abnormally low blood pressure), especially when you stand or sit up quickly • Balance problems (vertigo) • Itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia) • Loss or change in the way things taste • Sleep problems • Feeling depressed, anxious, more nervous or shaky than usual • Blocked nose, inflammation of your sinuses (sinusitis), shortness of breath • Inflammation of the gums (gingivitis), swollen mouth • Red, itchy, swollen or watery eyes • Ringing in your ears • Blurred vision • Hair loss • Chest pain • Pain in your muscles • Constipation, stomach or gut pain • Indigestion or feeling sick • Passing more water (urine) than usual over the day • Sweating more than usual or feeling thirsty • Loss or decrease of appetite (anorexia), feeling less hungry • Increased or irregular heartbeat • Swollen arms and legs.
Hvilket kan være et tegn på at kroppen tilbageholder mere vand end vanligt. • Feber • Nedsat libido hos mænd • Blodprøveresultater der viser et fald i antallet af røde blodlegemer, hvide blodlegemer, blodplader eller i haemaglobinmængden • Blodprøveresultater der viser ændring i lever, bugspytkirtel og nyrernes funktion • Blodprøveresultater der viser mindre kalium i blodet end normalt
This may be a sign of your body holding onto more water than usual • Fever • Sexual inability in men • Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets or in the amount of haemoglobin • Blood tests showing changes in the way your liver, pancreas or kidneys are working • Blood tests showing less potassium than usual in your blood.
Meget sjældne bivirkninger (forekommer hos færre end 1 ud af 10. 000 patienter) • Kvalme, diarré eller halsbrand • Rød hævet tunge eller mundtørhed • Blodprøverresultater der viser mere kalium i blodet end normalt
37 Very rare (affects less than 1 in 10,000 people) • Being sick, getting diarrhoea or heartburn • Red swollen tongue or dry mouth • Blood tests showing more potassium than usual in your blood.
Kontakt lægen hvis nogen af følgende bivirkninger bliver alvorlige eller hvis de varer længere end et par dage: • Koncentrationsbesvær • Hvide ” døde ” fingre og tæer (Raynaud’ s phenomen) • Forstørrelse af brysterne hos mænd • Blodpropper • Høreforstyrrelser
Please tell your doctor if any of the following gets serious or lasts longer than a few days. • Difficulty concentrating, feeling restless or confused • Fingers and toes changing colour when cold and then tingling or painful when you warm up.
35 • Tørre øjne • Fornemmelse af at ting ser gule ud • Dehydrering • Hævelser, smerter og rødmen i kinden (betændelse af spytkirtlerne) • Hævelse i tarmsystemet kaldet ” intestinal angiødem ” der medfører symptomer som smerter i maveregionen, opkast og diarré • Lysskyhed • Afskalningen eller Kraftig afstødning af hud, kløe, ujævn rødmen eller andre hudreaktioner såsom rødmen i ansigtet eller i panden • Hududslæt eller forekomst af blå mærker • Hudpletter og kolde hænder og fødder • Negle problemer (f. eks. at de løser sig fra neglebåndet) • Stivhed i bevægeapparatet eller besvær med at bevæge kæben (tetani) • Svage muskler der også kan krampe • Nedsat seksuel lyst hos mænd og kvinder • Blod i urinen.
This could be R aynaud's phenomenon • Breast enlargement in men • Blood clots • Disturbed hearing • Your eyes watering less than usual • Objects looking yellow • Dehydration • Swelling, pain and redness in your cheek (inflammation of a salivary gland) • A swelling in your gut called “intestinal angioedema” presenting with symptoms like abdominal pain, vomiting and diarrhoea • Being more sensitive to the sun than usual • Severe flaking or peeling of the skin, itchy, lumpy rash or other skin reactions such as red rash on your face or forehead • Skin rash or bruising • Blotches on your skin and cold extremities • Nail problems (e.g. loosening or separation of a nail from its bed) • Musculoskeletal rigidity or not being able to move your jaw (tetany) • Weakness or cramps in your muscles • Reduced sexual desire in men or women • Blood in your water (urine).
Dette kan være tegn på nyresygdom (interstitial nephritis) • Højere sukkerindhold i urinen end normalt • Forhøjet antal af visse hvide blodlegemer i blodet (pancytopenia) • Blodprøveresultater der viser en ændring i indholdet af salte som f. eks. natrium, kalcium, magnesium og klor i dit blod • Nedsat reaktionstid • Forstyrrelse af lugtesansen • Vejrtrækningsproblemer eller forværring af astma
This could be a sign of a kidney problem (interstitial nephritis) • More sugar than usual in your water (urine) • An increased number of certain white blood cells (eosinophilia) found during a blood test • Blood tests showing too few blood cells in your blood (pancytopenia) • Blood tests showing a change in the amount of salts such as sodium, calcium, magnesium and chloride in your blood • Slowed or impaired reactions • Change in the way things smell • Difficulty breathing or worsening of asthma
Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre eller du får bivirkninger, som ikke er nævny her.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
OPBEVARING
HOW TO STORE TRITAZIDE
TRITAZIDE indeholder
What TRITAZIDE contains
Udseende og pakningsstørrelser
38 What TRITAZIDE looks like and contents of the pack
[Udfyldes nationalt]
Tablets [To be completed nationally]
{Navn og adresse} {telefon} {fax} {e- mail}
{Name and address} {tel} {fax} {email}
Dette lægemiddeler godkendt i EEAs medlemslande under følgende navne:
This medicinal product is authorised in the Member States of the EEA under the following names:
36 Tritazide 2. 5 mg/ 12. 5 mg Tabletten, Tritazide 5 mg/ 25 mg Tabletten Hypren Plus 2. 5 mg/ 12. 5 mg Tabletten, Hypren Plus Forte 5 mg/ 25 mg Tabletten
Tritazide 2.5 mg/12.5 mg Tabletten, Tritazide 5 mg/25 mg Tabletten Hypren Plus 2.5 mg/12.5 mg Tabletten, Hypren Plus Forte 5 mg/25 mg Tabletten
Bulgarien Tritace 2. 5 Plus 2. 5 mg/ 12. 5 mg таблетки, Tritace 5 Plus 5 mg/ 25 mg таблетки
Tritace 2.5 Plus 2.5 mg/12.5 mg таблетки, Tritace 5 Plus 5 mg/25 mg таблетки
Ungarn:
39 Hungary:
37 Tritace 2. 5 Comb 2. 5 mg/ 12. 5 mg tabletki, Tritace 5 Comb 5 mg/ 25 mg tabletki
Tritace 2.5 Comb 2.5 mg/12.5 mg tabletki, Tritace 5 Comb 5 mg/25 mg tabletki
Slovakiet:
Slovak Republic:
38
40
EMEA/ 202985/ 2009
EMEA/ CHMP/ 204584/ 2009
Spørgsmål og svar vedrørende indbringelsesproceduren for Tritazide- tabletter indeholdende ramipril og hydrochlorothiazid 2, 5/ 12, 5 mg, 5/ 12, 5 mg, 5/ 25 mg
Questions and answers on the referral for Tritazide tablets containing ramipril and hydrochlorothiazide 2.5/ 12.5 mg, 5/ 12.5 mg, 5/ 25 mg
EMEA' s Udvalg for Humanmedicinske Lægemidler (CHMP) er af den opfattelse, at der er behov for at harmonisere ordinationsoplysningerne for Tritazide i Den Europæiske Union (EU) og Det Europæiske Økonomiske Samarbejdsområde (EØS).
The Agency’ s Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Tritazide in the European Union and the European Economic Area (EEA).
Vurderingen blev gennemført inden for rammerne af en indbringelsesprocedure i henhold til artikel 30 1.
The review was carried out under an ‘ Article 30’ referral 1.
Ramipril er en ACE- hæmmer (Angiotensin Converting Enzyme).
Ramipril is an angiotensin converting enzyme (ACE) inhibitor.
Tritazide har været godkendt i EU siden 1993, først i Tyskland dernæst i følgende lande:
Tritazide has been authorised in the EU since 1993, first in Germany and then in the following countries:
Østrig, Belgien, Bulgarien, Cypern, Den Tjekkiske Republik, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Luxembourg, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien, og Sverige.
Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden.
Tritazide findes muligvis også i EU og EØS under følgende andre handelsbetegnelser:
Tritazide can also be available in the EU and the EEA under other trade names:
Tritace Plus, Triatec Plus, Triatec Comp, Tritace Comp, Tritace Comb, Triatec Composto, Triatec Composto Forte, Cardace Comp, Cardace Plus, Cotriatec, Delix Plus, Ramilich Comp, Tritace HCT, Triatec HCT, Ramipril e Idrocloritiazide, Ramicor D, and Triatec Comp Mite, Hypren Plus, Hypren Plus Forte, Vesdil Plus, Ramipril HCT Zentiva, Unipril Diur og Idroquark.
Tritace Plus, Triatec Plus, Triatec Comp, Tritace Comp, Tritace Comb, Triatec Composto, Triatec Composto Forte, Cardace Comp, Cardace Plus, Cotriatec, Delix Plus, Ramilich Comp, Tritace HCT, Triatec HCT, Ramipril e Idrocloritiazide, Ramicor D, and Triatec Comp Mite, Hypren Plus, Hypren Plus Forte, Vesdil Plus, Ramipril HCT Zentiva, Unipril Diur, Idroquark..
Tritazide markedsføres af virksomheden Sanofi- aventis.
The company that markets Tritazide is Sanofi-aventis.
Det er blevet bestemt af den
This has led to divergences across member states on the way the medicine can be used, as seen in the differences observed in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed.
Reproduction is authorised provided the source is acknowledged. humanmedicinske koordineringsgruppe for gensidig anerkendelse og decentraliserede procedurer (CMD( h)), at Tritazide bør harmoniseres.
Reproduction is authorised provided the source is acknowledged.
Den 18. januar 2008 henviste Europa- Kommissionen sagen til Udvalget for Humanmedicinske Lægemidler med henblik på harmonisering af markedsføringstilladelserne for Tritazide i EU og EØS.
On 18 January 2008, the European Commission referred the matter to the Committee for Medicinal Products for Human Use (CHMP) in order to harmonise the marketing authorisations for Tritazide in the EU and the EEA.
CHMP bemærkede, at der var uoverensstemmelser i indikationens ordlyd i de forskellige lande, idet der blev anvendt både "essentiel hypertension", "arteriel hypertension" og "arteriel essentiel hypertension".
The CHMP noted inconsistencies in the wording of the indication across countries, with terms including ‘ essential hypertension’, ‘ arterial hypertension’ and ‘ arterial essential hypertension’ being used.
Kombinationen ramipril 2, 5 mg/ HCTZ 12, 5 mg medførte større fald i blodtrykket end behandling med individuelle komponenter, og kombinationen af 5 mg/ 25 mg havde en bedre terapeutisk effekt, end når dosis af ramipril blev fordoblet til 10 mg.
The combination ramipril 2.5 mg/ HCTZ 12.5 mg led to greater reduction in blood pressure than the treatment with individual components and the combination of 5 mg/ 25 mg produced a better therapeutic effect than doubling the ramipril dose to 10 mg.
I betragtning af at der ikke kan påvises nogen større problemer i forhold til sikkerhed, effekt og kliniske bivirkninger i forbindelse med kombinationen ramipril/ HCTZ hos patienter, der ikke responderer på HCTZ og ramipril alene, vedtog CHMP følgende to harmoniserede formuleringer af indikationer: • Behandling af hypertension • Denne fastdosiskombination er indiceret til patienter, hvis blodtryk ikke kan kontrolleres tilfredsstillende ved hjælp af ramipril eller hydrochlorothiazid alene.
Considering that no major concern can be established concerning the safety, efficacy and clinical adverse event of the ramipril/ HCTZ combination in non responders to HCTZ and ramipril alone, the CHMP adopted the following two harmonised wordings for indications: • Treatment of hypertension • This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or hydrochlorothiazide alone.
CHMP vedtog følgende harmoniserede formulering:
The CHMP adopted the harmonised wording:
4. 4) og blodtrykskontrol.
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
CHMP bemærkede, at nogle af kontraindikationerne i lokale produktresuméer (såsom akut hypertension og primær aldosteronisme) faktisk var ikke- indikationer.
The CHMP noted that some of the contraindications in local SPCs (such as acute hypertension or primary aldosteronism) were in fact non-indications.
6. 1). • Tidligere angioødem (hereditært, idiopatisk eller som følge af tidligere angioødem med ACE - hæmmere eller angiotensin II- receptorantagonister (AIIRA)).
The CHMP adopted the following harmonised wording: • Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin Converting Enzyme) inhibitors (see section 6.1) • History of angioedema (hereditary, idiopathic or due to previous angioedema wit ACE inhibitors or AIIRAs(Angiotensin II Receptor Antagonists)) • Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5) • Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney • 2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6) • Lactation (see section 4.6) Page 2/ 3 • Severe impairment of renal function with a creatinine clearance below 30 ml/ min in undialysed patients • Clinically relevant electrolyte disturbances which may worsen following treatment with TRITAZIDE (see section 4.4) • Severe impairment of liver function, hepatic encephalopathy
4. 4) • Svært nedsat leverfunktion, leverencefalopati.
4.4 Special warnings and special precautions for use
CHMP inkluderede i denne runde advarslen om primær hyperaldosteronisme og vedtog derfor den følgende harmoniserede formulering:
The CHMP included under this session the warning about primary hyperaldosteronism, therefore adopted the following harmonised wording:
Kombinationen af ramipril og hydrochlorothiazid udgør ikke et behandlingstilbud mod primær hyperaldosteronisme.
The combination ramipril + hydrochlorothiazide does not represent a treatment of choice for primary hyperaldosteronism.
Hvis ramipril og hydrochlorothiazid anvendes til en patient med primær hyperaldosteronisme, kræver det omhyggelig overvågning af kalium- plasma - niveauet.
If ramipril + hydrochlorothiazide is used in a patient with primary hyperaldosteronism, then careful monitoring of plasma potassium level is required.
4. 5 Interaktion
4.5 Interactions
CHMP godkendte den aktuelle liste over produkter, som interagerer eller kan interagere med Tritazide, herunder yderligere tekst, som underbygger lithiumtoksicitet.
This is in line with the recommendation of the CHMP’ s Pharmacovigilance Working Party on use of ACE inhibitors in pregnancy.
4. 6 Graviditet og amning
The European Commission issued a decision on 6 March 2009.
28. april 2008, 24. oktober 2008 18. december 2008
Dr Ian Hudson (UK) Prof János Borvendég (HU) 24 January 2008 28 April 2008, 24 October 2008 18 December 2008
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM( ER), STYRKE( R), INDGIVELSESVEJ( E), ANSØGER( E), INDEHAVER( E) AF MARKEDSFØRINGSTILLADELSE( R) I MEDLEMSSTATERNE
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATE
Loc Ai Conti 55051 Castelvecchio Pascoli, Barga (Lucca) - ITALIEN
Loc Ai Conti 55051 Castelvecchio Pascoli, Barga (Lucca) - ITALY
UMAN BIG 180 180 IE/ ml I. E. / ml Injektionslösung
UMAN BIG 180 180 IU/ ml I. E. / ml Injektionslösung
180 IE/ ml 540IE/ 3ml
180 IU/ ml 540IU/ 3ml
UMAN BIG 180 IE/ ml
UMAN BIG 180 IU/ ml
UMAN BIG 180 IE/ ml
180 IU/ ml
Umanbig 180 180 IE/ ml NE/ ml
Umanbig 180 NE/ ml
180 IE/ ml
180 IU/ ml
2 Medlemsstat EU/ EEA
2 Member State EU/ EEA
Umanbig 180 IU/ ml solution for injection
Umanbig 180
180 IE/ ml 540IE/ 3ml
180 IU/ ml
UMAN BIG er et plasmafremstillet lægemiddelpræparat af immunoglobuliner (hovedsagelig IgG) med et særligt højt indhold af antistoffer imod hepatitis B- overfladeantigen (HBsAg).
UMAN BIG is a plasma derived medicinal product preparation of immunoglobulins (mainly IgG) with a specifically high content of antibodies against the hepatitis B virus surface antigen (HBsAg).
UMAN BIG tilhører den farmakologiske klasse for immunsera og humanspecifikke immunoglobuliner til intramuskulær administration og indeholder 100- 180 g/ l plasmaproteiner, hvoraf mindst 90% repræsenterer immunoglobulin G (IgG).
UMAN BIG belongs to the pharmacological class of immune sera and human specific immunoglobulins for intramuscular administration and contains 100-180 g/ l of plasma proteins with at least 90% of them representing Immunoglobulin G (IgG).
Specifikke neutraliserende antistoffer imod hepatitis B- virus forekommer ved en koncentration på ikke mindre end 180 IE/ ml.
Specific neutralizing antibodies against the Hepatitis B virus are present at a concentration of not less than 180 IU/ ml.
UMAN BIG fremstilles på grundlag af store mængder humant plasma ved en konsolideret og valideret industriel proces, som sikrer overholdelse af kravene i Den Europæiske Farmakopé såvel som reproducerbarheden af de kvalitative egenskaber, og således konsistensen i den biologiske respons.
Eur. requirements, as well as reproducibility of quality characteristics, hence consistency of the biological response.
Ansøgningen om UMAN BIG 180 IE/ ml injektionsvæske blev indgivet via proceduren for gensidig anerkendelse og på baggrund af markedsføringstilladelsen udstedt af referencemedlemsstaten (Italien) den 2. juni 1979.
The application for UMAN BIG 180 IU/ ml solution for injection was submitted through the Mutual Recognition Procedure, on the basis of the marketing authorisation granted by the RMS (Italy) on the 2nd of June 1979.
Resultaterne af undersøgelsen kan derfor ikke ekstrapoleres til den tiltænkte population, og som følge heraf kendes mængden af beskyttende anti- HBs hos de patienter, præparatet er beregnet til, ikke, og det er ligeledes uvist, hvorvidt den anbefalede dosis i det grundlæggende produktresumé kan sikre et antistofniveau, der kan forebygge hepatitis B hos voksne patienter og hæmodialysepatienter såvel som hos nyfødte af mødre med hepatitis B- virus.
Therefore the results of the study can not be extrapolated to the population intended for use and consequently, the protective anti-HBs level in the population intended for use is not known and neither whether the recommended dose in the core SPC could guarantee an appropriate antibody level to prevent hepatitis B in adults and hemodialysed patients as well as newborns of a hepatitis B virus carrier-mother.
Ansøgeren forpligtede sig under RMS- proceduren til at foretage en observationsundersøgelse af nyfødte af mødre med hepatitis B- virus.
During the RMS procedure, the Applicant committed to carry out an observational study on newborns with mothers carrying the hepatitis B virus.
Sammendrag af rapporten fra BPWP og CHMP' s holdning:
Summary of the report from the BPWP and CHMP position:
Ansøgeren har angivet, at det eneste relevante effektmål for denne type produkt er niveauet af beskyttende anti- HBs i plasmaet, da det efter indførelsen af vaccine ikke længere er muligt at vurdere produktets effekt på baggrund af forekomsten af nye infektioner.
The Applicant stated that the only relevant measure of efficacy for this kind of product is the level of protective anti-HBs achieved in the plasma, since after the introduction of vaccination it is no longer feasible to assess the efficacy of the product on the basis of the incidence of new infections.
Ansøgeren påviste også, at det var umuligt at gennemføre kliniske
The Applicant also demonstrated the impossibility to perform any clinical study in any of the populations included in the indication, apart from newborns, after the introduction of the vaccination.
5 undersøgelser i nogen af de i indikationen angivne populationer, med undtagelse af nyfødte, efter indførelsen af vaccinen.
The Applicant submitted data from study PK KB-036, which evaluates the PK profile of Hepatitis B
Ansøgeren indsendte data fra undersøgelse PK KB- 036, som evaluerer den farmakokinetiske profil for hepatitis B- immunoglobuliner hos HBs- Ag- negative patienter, som har modtaget levertransplantation (OLT- patienter), med henblik på at understøtte produktets effekt.
5 immunoglobulins in HBs-Ag-Negative patients who have received liver transplantation (OLT patients) in order to support the efficacy of the product.
Ansøgeren forelagde bibliografiske data, der viste, at farmakokinetikken for UMAN BIG i den population, som den farmakokinetiske undersøgelse var foretaget på, kan lægges oven i raske frivillige forsøgspersoners, hvorfor populationen i undersøgelse KB- 036, selv om denne repræsenterede en bestemt undergruppe af patienter, ikke havde nogen indflydelse på resultaterne.
The Applicant provided bibliographic data showing that the pharmacokinetics of UMAN BIG in the population in which the PK study was carried out is super-imposable to that of healthy volunteers; therefore the population of study KB 036, although representing a specific subset of patients, did not influence the results obtained.