FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use three separate 1 mg blisters in place of one 3 mg blister, as this will give you a much higher insulin dose (see “How to take EXUBERA” for further advice).
Danish: De må ikke anvende 3 separate blistere à 1 mg i stedet for 1 blister à 3 mg, da dette vil give en meget højere insulindosis (se yderligere informationer i afsnittet ”Hvordan De tager
English: Each unit dose blister contains 1 mg insulin human.
Danish: Hver enkeltdosisblister indeholder 1 mg humant insulin.
English: Inhaled human insulin, like fast-acting insulin analogues, has a more rapid onset of glucose lowering activity compared to subcutaneously administered soluble human insulin.
Danish: Ligesom hurtigtvirkende insulin-analoger har inhaleret humant insulin en hurtigere indsættende glucosesænkende virkning sammenlignet med subkutant indgivet opløseligt humant insulin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton/Unit dose blisters (30, 60, 90, 180 and 270)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton/ Enkeltdosisblister (30, 60, 90, 180 og 270)
English: Respiratory
Danish: Brystsmerter
English: Each unit dose blister contains 3 mg insulin human.
Danish: Hver enkeltdosisblister indeholder 3 mg humant insulin.
English: There is no experience with EXUBERA in patients with pneumonia.
Danish: Der er ingen erfaring med EXUBERA til patienter med infektion i de nedre luftveje (lungebetændelse).
English: See
Danish: Hvordan
English: For further details on how to use the insulin inhaler refer to the instructions for use (IFU).
Danish: Yderligere information vedrørende brugen af insulininhalatoren findes i brugsanvisningen.
English: The effect of renal impairment on the absorption of inhaled human insulin has not been studied (see section 4.2).
Danish: Det er ikke undersøgt, hvorvidt absorption af inhaleret humant insulin påvirkes ved nedsat nyrefunktion (se pkt.
English: The tray is sealed in a foil laminate pouch with a desiccant.
Danish: Bakken er forseglet i en plastikfoliepose med et tørremiddel.
English: 6.4 Special precautions for storage Store below 30
Danish: 6.4 Særlige opbevaringsforhold
English: In type 2 subjects, resolution of small treatment group differences (0.039L favouring comparator) occurred within 6 weeks of EXUBERA cessation following 2 years of therapy (Figure 3).
Danish: Hos type 2 diabetikere forsvandt de små forskelle imellem behandlingsgrupperne (0,039 l til fordel for sammenligningsprodukt) inden for 6 uger efter ophør med EXUBERA efter 2 års behandling (figur 3).
English: In type 1 subjects, resolution of small treatment group differences (0.010L favouring comparator) occurred within 2 weeks of EXUBERA cessation following 12 weeks of therapy.
Danish: Hos type 1 diabetikere forsvandt de små forskelle imellem behandlingsgrupperne (0,010 l til fordel for sammenligningsprodukt) inden for 2 uger efter ophør med EXUBERA efter 12 ugers behandling.
English: If the 3 mg blister is temporarily unavailable, two 1 mg blisters should be substituted and blood
Danish: Hvis blistere à 3 mg midlertidigt ikke er tilgængelige, skal disse erstattes med 2 blistere à 1 mg, og
English: Fasting plasma glucose levels were significantly lower in patients treated with regimens including EXUBERA compared with those treated with subcutaneously administered fast-acting human insulin only regimens.
Danish: Fastende plasmaglucoseniveauer er signifikant lavere hos patienter, der behandles med EXUBERA end hos dem, der kun behandles med subkutant indgivet hurtigtvirkende humant insulin.
English: Hepatic impairment
Danish: Produktiv hoste Halsirritation
English: Inhaled human insulin has a faster onset of activity than subcutaneously administered fast-acting human insulin.
Danish: Inhaleret humant insulin virker hurtigere end subkutant indgivet hurtigtvirkende humant insulin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton/Unit dose blisters (60, 90, 180, 270)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton/Enkeltdosisblister (60, 90, 180, 270)
English: One percent of patients discontinued EXUBERA
Danish: 1% af patienterne seponerede EXUBERA-behandling på grund af hoste.
English: Hold the insulin blister by the tab with printed side up with the notch pointed towards the
Danish: Indsætning af insulinblister Hold insulinblisteren i flappen med den trykte side opad.
English: Your doctor will prescribe your starting pre-meal dose of EXUBERA based on your body weight.
Danish: På baggrund af Deres vægt vil Deres læge udskrive den startdosis af EXUBERA, som skal tages før et måltid.
English: Hold the new IRU so the top is facing you.
Danish: Sørg for at holde den nye insulinfrigivelsesenhed med toppen ind mod Dem selv.
English: HOW TO TAKE EXUBERA
Danish: SÅDAN SKAL DE BRUGE EXUBERA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton/Unit dose blisters (60, 90, 270)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton/Enkeltdosisblister (60, 90, 270)
English: The 1 mg blister is printed with green ink and has one raised dot on the protruding end of each The 3 mg blister is printed with blue ink and has three raised dots on the protruding end of each
Danish: Blisteren med 3 mg er trykt med blåt blæk og har 3 hævede prikker på den ende af blisteren, der stikker blisteren er indsat, så De kan sikre Dem, at den
English: 4.5 Interaction with other medicinal products and other forms of interaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion En række stoffer påvirker glucosemetabolismen, og justering af insulindosis kan være nødvendig.
English: Slowly and deeply breathe in the insulin cloud
Danish: Sug insulinskyen langsomt ind gennem munden i en dyb indånding.
English: Push the base
Danish: Skub hoveddelen tilbage i
English: Decline in pulmonary function
Danish: Nedsat nyrefunktion
English: In subjects with diabetes and in subjects without diabetes, no apparent differences in absorption of inhaled human insulin were observed between men and women.
Danish: Der er ikke set nogen umiddelbare forskelle i absorptionen af inhaleret humant insulin mellem mandlige og kvindelige forsøgspersoner med og uden diabetes.
English: Patients in a clinical trial for type 2 diabetes, who used a regimen of EXUBERA in combination with long- or intermediate-acting insulin, had similar changes in HbA1c compared with patients treated
Danish: I et klinisk forsøg på type 2 diabetes patienter, som fik EXUBERA i kombination med langtids- eller middellangtidsvirkende insulin ses lignende fald i HbA1c sammenlignet med de patienter der kun
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG ¾ Indehaveren af markedsføringstilladelsen skal implementere en national undervisningsplan,
English: Please see the end of this section for important further information about hypoglycaemia and its treatment.
Danish: De kan finde vigtige informationer vedrørende hypoglykæmi og behandlingen heraf sidst i dette afsnit.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på fremstilleren af det biologisk aktive stof Pfizer Manufacturing Frankfurt GmbH & Co.
English: It is important to follow your doctor's instructions exactly.
Danish: Det er vigtigt, at De nøje
English: For use only with the insulin inhaler.
Danish: EXUBERA enkeltdosisblistere må kun anvendes sammen med insulininhalatoren.
English: Therefore three 1 mg unit dose blisters should not be substituted for one 3 mg unit dose blister (see sections 2, 4.4 and 5.2).
Danish: Derfor bør 3 enkeltdosisblistere à 1 mg ikke erstattes af 1 enkeltdosisblister à 3 mg (se pkt.
English: In older subjects with type 2 diabetes, inhaled human insulin was absorbed more rapidly than subcutaneously administered fast-acting human insulin.
Danish: Inhaleret humant insulin absorberes hurtigere hos ældre forsøgspersoner med type 2 diabetes end subkutant administreret hurtigtvirkende humant insulin.
English: If you notice a change in your breathing while taking EXUBERA inform your doctor.
Danish: Hvis De mærker ændringer i Deres vejrtrækning, mens De er i behandling med
English: • A kit containing 90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU) Additional insulin inhaler, insulin release units and chamber packages are available.
Danish: Karton med 90 x 1 PVC/aluminium perforeret enkeltdosisblister (3 poser), 1 insulininhalator, 1 reservekammer og 6 ekstra insulinfrigivelsesenheder
English: The IRU must be changed after accidental exposure to extremely moist conditions, e.g. steamy bathroom.
Danish: Insulinfrigivelsesenheden skal udskiftes efter at denne ved et uheld har været udsat for fugtige omgivelser, f.eks.
English: Three 1 mg unit dose blisters should not be substituted for one 3mg blister (see section 2, “Take special care with EXUBERA”, section 3, “How to take EXUBERA” and section 6
Danish: At tage 3 separate blistere à 1 mg giver mere insulin i lungerne end 1 enkelt blister à 3 mg. 3 blistere à 1 mg må derfor ikke erstatte 1 blister à 3 mg (se afsnit 2, ” Vær særlig forsigtig med at anvende EXUBERA”, afsnit 3 ”Hvordan De tager EXUBERA” og afsnit 6 ”Yderligere oplysninger”).
English: (If the new IRU does not drop into place or fits tightly, remove
Danish: Pres ikke denne ind, den skal nemt insulinfrigivelsesenhed ikke kan sættes på plads eller sidder stramt, fjern da denne og prøv igen).
English: • Cardboard box containing 180 x 1 PVC/Aluminium perforated unit dose blisters (6 pouches)
Danish: • Karton med 180 x 1 PVC/aluminium perforeret enkeltdosisblister (6 poser)
English: Caution should be exercised with concomitant use of
Danish: Forsigtighed tilrådes, hvis EXUBERA-behandling anvendes samtidigt med disse lægemidler.
English: Comparator INH Washout
Danish: GmbH & Co.
English: A 3 mg blister of EXUBERA gives you about the same insulin dose as 8 IU of subcutaneously injected fast-acting insulin human.
Danish: 1 blister à 3 mg EXUBERA giver Dem ca. samme mængde insulin som 8 IE subkutant injiceret hurtigtvirkende humant insulin.
English: Mistakes in dosage
Danish: SÅDAN TAGES DOSIS
English: A 1 mg blister of EXUBERA gives you about the same insulin dose as 3 IU of subcutaneously injected fast-acting insulin human.
Danish: 1 blister à 1 mg EXUBERA giver Dem ca. samme mængde insulin som 3 IE subkutant injiceret hurtigtvirkende humant insulin.
English: • Cardboard box containing 270 x 1 PVC/Aluminium perforated unit dose blisters (9 pouches)
Danish: • Karton med 270 x 1 PVC/aluminium perforeret enkeltdosisblister (9 poser)
English: For instructions on how to look after your insulin inhaler see “Instructions for Use” at the end of the package leaflet.
Danish: Yderligere information vedrørende håndtering og brug af insulininhalatoren findes i brugsanvisningen som findes i sidste del af denne indlægsseddel.
English: A 1 mg unit dose blister is approximately equal to 3 IU of fast-acting subcutaneous insulin and a 3 mg unit dose blister is approximately equal to 8 IU of fast-acting subcutaneous insulin.
Danish: 1 blister à 1 mg EXUBERA giver Dem ca. samme mængde insulin som 3 IE subkutant injiceret hurtigtvirkende humant insulin, og 1 blister à 3 mg giver Dem ca. samme mængde insulin som 8 IE subkutant injiceret hurtigtvirkende humant insulin.
English: NAME OF THE MEDICINAL PRODUCT EXUBERA 1 mg inhalation powder pre-dispensed.
Danish: LÆGEMIDLETS NAVN EXUBERA 1 mg inhalationspulver, afdelt.
English: NAME OF THE MEDICINAL PRODUCT EXUBERA 3 mg inhalation powder pre-dispensed.
Danish: LÆGEMIDLETS NAVN EXUBERA 3 mg inhalationspulver, afdelt.
English: The intra-subject variability of glucose lowering activity of inhaled human insulin was generally comparable to that of subcutaneously administered fast-acting human insulin in subjects with type 1
Danish: Den intraindividuelle variation af den glucosesænkende virkning af inhaleret humant insulin er generelt sammenlignelig med subkutant indgivet hurtigtvirkende humant insulin givet til forsøgspersoner med type 1 og type 2 diabetes mellitus.
English: Bioavailability of inhaled human insulin relative to subcutaneously administered fast-acting human insulin was comparable to those in younger
Danish: Biotilgængeligheden af inhaleret humant insulin i forhold til subkutant administreret hurtigtvirkende humant insulin er sammenlignelig med biotilgængeligheden hos yngre voksne forsøgspersoner med type 2 diabetes.
English: Do not wipe the blister slot
Danish: De må ikke synke indholdet af blisteren.
English: Table 1 above presents the approximate IU dose of fast-acting human insulin for initial, pre-meal EXUBERA doses in mg.
Danish: Tabel 1 ovenfor viser vejledende dosis i IE af hurtigtvirkende humant insulin for
English: Chest Pain
Danish: Hosten er
English: You should avoid taking EXUBERA in moist conditions e.g. a bathroom following a steamy shower as this will usually give you a lower insulin dose than you need (see package leaflet
Danish: Skub hoveddelen tilbage dampende bad, da dette sædvanligvis vil give Dem mindre insulin end De har behov for (se yderligere oplysninger i separat indlægsseddel for blistere).
English: A 3 mg blister of inhaled insulin is approximately equivalent to 8 IU of subcutaneously injected fast-acting human insulin.
Danish: 1 blister à 3 mg inhaleret insulin svarer ca. til injektion af 8 IE subkutant hurtigtvirkende humant insulin.
English: If your blood sugar is too high (hyperglycaemia) Your blood sugar level may be too high, if for example: - you have not taken enough insulin, or if it has become less effective, e.g. through incorrect storage, - you are doing less physical exercise, you are under stress (emotional distress, excitement), or if you have an injury, operation, feverish illness or certain other diseases, - you are taking or have taken certain other medicines (see section 2, “Taking other medicines”).
Danish: - får mindre motion eller er stresset (følelsesmæssigt ude af balance, opstemthed), eller hvis De har fået en læsion, er blevet opereret, har en febersygdom, eller har visse andre sygdomme, - tager eller har taget visse andre lægemidler (se punkt 2, "Indtagelse af andre lægemidler").
English: A 1 mg blister of inhaled insulin is approximately equivalent to 3 IU of subcutaneously injected fastacting human insulin.
Danish: 1 blister à 1 mg inhaleret insulin svarer ca. til 3 IE subkutant injiceret hurtigtvirkende humant insulin.
English: 2 years.
Danish: 6.3 Opbevaringstid 2 år.
English: Infections and Infestations
Danish: 4.6 Graviditet og amning
English: • Cardboard box containing 30 x 1 PVC/Aluminium perforated unit dose blisters (1 pouch)
Danish: • Karton med 30 x 1 PVC/aluminium perforeret enkeltdosisblister (1 pose)
English: Three 1 mg blisters should not be substituted for one 3 mg blister (see section 2, “Take special care with EXUBERA” and section 3, “How to take EXUBERA”).
Danish: At tage 3 separate blistere à 1 mg giver mere insulin i lungerne end 1 enkelt blister à 3 mg. 3 blistere à 1 mg må derfor ikke erstatte 1 blister à 3 mg (se afsnit 2, ” Vær særlig forsigtig med at anvende EXUBERA” og afsnit 3 ”Hvordan De tager EXUBERA”).
English: Insulin Inhaler Instructions for Use
Danish: Brugsanvisning for insulininhalator
English: • Cardboard box containing 60 x 1 PVC/Aluminium perforated unit dose blisters (2 pouches)
Danish: • Karton med 60 x 1 PVC/aluminium perforeret enkeltdosisblister (2 poser)
English: • Cardboard box containing 90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches)
Danish: • Karton med 90 x 1 PVC/aluminium perforeret enkeltdosisblister (3 poser)
English: NAME OF THE MEDICINAL PRODUCT EXUBERA 3 mg inhalation powder pre-dispensed Insulin human
Danish: LÆGEMIDLETS NAVN EXUBERA 3 mg inhalationspulver, afdelt
English: BEFORE YOU TAKE EXUBERA
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT BRUGE EXUBERA
English: • A pack containing 180 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (6 pouches) and 2 spare Insulin Release Units (IRU)
Danish: • Karton med 180 x 1 à 3 mg PVC/aluminium perforeret enkeltdosisblister (6 poser) og 2 ekstra
English: • A kit containing 90 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU)
Danish: • 1 kit med 90 x 1 PVC/aluminium perforeret enkeltdosisblister (3 poser), 1 insulininhalator, 1
English: NAME OF THE MEDICINAL PRODUCT EXUBERA 1 mg inhalation powder pre-dispensed Insulin human
Danish: LÆGEMIDLETS NAVN EXUBERA 1 mg inhalationspulver, afdelt
English: The exposure of human insulin following administration of three 1 mg blisters is significantly greater than that following a single 3 mg blister.
Danish: Eksponeringen for humant insulin efter indgift af 3 blistere à 1 mg er betydeligt større end den efter 1 enkelt blister à 3 mg. Blistere à 3 mg kan derfor ikke erstattes med 3 blistere à 1 mg (se pkt.
English: If you need dose titrations of less than 1 mg it is
Danish: Hvis De har behov for en dosis, der er lavere end 1 mg, anbefales det ikke, at De anvender EXUBERA.
English: • Cardboard box containing 90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches) and
Danish: • Karton med 90 x 1 PVC/aluminium perforeret enkeltdosisblister (3 poser) og 2 ekstra
English: • Cardboard box containing 60 x 1 PVC/Aluminium perforated unit dose blisters (2 pouches) and
Danish: • Karton med 60 x 1 PVC/aluminium perforeret enkeltdosisblister (2 poser) og 2 ekstra
English: • A pack containing 270 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Release Units (IRU)
Danish: • Karton med 270 x 1 à 3 mg PVC/aluminium perforeret enkeltdosisblister (9 poser) og 6 ekstra
English: • A pack containing 270 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Release Units (IRU)
Danish: • Karton med 270 x 1 à 1 mg PVC/aluminium perforeret enkeltdosisblister (9 poser) og 6 ekstra
English: If you need another blister(s) as part of your
Danish: Hvis De har behov for endnu en blister eller flere til
English: Figure 1.
Danish: Fig. 1.
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret EXUBERA til Dem personligt.
English: In a study in healthy subjects, systemic exposure (AUC and Cmax) of inhaled human insulin
Danish: Insulin human (INH) Sammenligningsprodukt Insulin human udvaskning
English: • A pack containing 60 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Release Units (IRU)
Danish: • Karton med 60 x 1 à 3 mg PVC/aluminium perforeret enkeltdosisblister (2 poser) og 2 ekstra
English: • A pack containing 60 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Release Units (IRU)
Danish: • Karton med 60 x 1 à 1 mg PVC/aluminium perforeret enkeltdosisblister (2 poser) og 2 ekstra
English: In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar.
Danish: Hvis De indtager mere mad og kontrollerer blodsukkeret, kan det almindeligvis forebygge udvikling af hypoglykæmi.
English: • If you feel hypoglycaemia (low blood sugar) coming on. See the information at the end of section 4 “Possible side effects” of this leaflet for further advice.
Danish: Yderligere information med råd findes i slutningen af punkt 4 ”Hvilke mulige bivirkninger EXUBERA har” i denne indlægsseddel.
English: Cough
Danish: Hoste
English: please tell your doctor or pharmacist.
Danish: - Spørg lægen eller på apoteket, hvis der er mere, De vil vide.
English: --1 Live non-pathogenic Escherichia coli O8:K87* (F4ac):.......................1.3x108 to 9.0x108 CFU** Live non-pathogenic Escherichia coli O141:K94* (F18ac): ...............2.8x108 to 3.0x109 CFU**
Danish: --1 Levende, ikke-patogene Escherichia coli O8:K87* (F4ac):.......................1.3x108 til 9.0x108 CFU** Levende, ikke-patogene Escherichia coli O141:K94* (F18ac): ...............2.8x108 til 3.0x109 CFU**
English: * not attenuated ** CFU - colony forming units
Danish: * ikke svækket ** CFU = kolonidannende enheder
English: EU (MA) Number Invented name
Danish: EU-nummer (markedsføringst illadelsesnumme r)
English: Withdrawal period
Danish: Tilbageholdelsesti d
English: Packaging Content (concentration)
Danish: Navn Styrke Lægemiddelform Indgivelsesvej Emballage Indhold (Koncentration)
English: Route of Administration
Danish: 1 hætteglas
English: Powder: 100 mg Solvent: 3 ml
Danish: Pulver: 100 mg Solvens: 3 ml
English: EU/1/18/1278/001 Carmustine Obvius 100 mg Powder and solvent for solution for infusion
Danish: EU/1/18/1278/001 Carmustine Obvius
English: Intravenous use Powder: vial (glass) Solvent: ampoule (glass)
Danish: Pulver: hætteglas (glas) Solvens: ampul (glas)
English: - 3 years.
Danish: 3 år.
English: See instructions below.
Danish: Se vejledningen nedenfor.
English: Slovenská republika Servier Slovensko spol.
Danish: Servier Slovensko spol.
English: You should not leave more than 24 hours before you drink it.
Danish: De må ikke lade opslæmningen stå længere end 24 timer, før De drikker den.
English: These potentially life-threatening skin rashes are often accompanied by flu-like symptoms.
Danish: Disse potentielt livstruende hududslæt er ofte ledsaget af influenzalignende symptomer.
English: Disturbances in consciousness Memory loss
Danish: Bevidsthedsforstyrrelser Hukommelsestab
English: Therefore, in view of available data regarding the PASS final study report, the PRAC considered that changes to the conditions of the marketing authorization were warranted.
Danish: På baggrund af de tilgængelige data vedrørende den endelige PASS-studierapport vurderede PRAC derfor, at ændringerne af betingelserne for markedsføringstilladelsen var berettigede.
English: The CHMP is of the opinion that the terms of the marketing authorisation of the medicinal product mentioned above should be varied.
Danish: CHMP mener, at betingelserne for markedsføringstilladelsen for det lægemiddel, der er nævnt ovenfor, bør ændres.
English: If tests are positive for one or both alleles, OSSEOR should not be started.
Danish: Hvis resultaterne er positive for en eller begge alleler, bør OSSEOR ikke initieres.
English: - if you have severe kidney disease.
Danish: - hvis De lider af en alvorlig nyresygdom.
English: Adverse reactions are listed below using the following convention : very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Bivirkninger er angivet nedenfor i henhold til følgende konvention: meget almindelig (≥ 1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥ 1/1.000 til <1/100), sjælden (≥ 1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: However, absence of these alleles upon genotyping does not exclude that SJS/TEN can still occur.
Danish: Hvis der efter genotypebestemmelse ikke findes alleler, kan det dog ikke udelukkes, at der kan forekomme SJS/TEN.
English: However, it is recommended to drink the suspension immediately after preparation (see section 3).
Danish: Det anbefales dog at drikke suspensionen umiddelbart efter tilberedning (se punkt 3).
English: The PASS final study report submitted by the MAH complies with their obligation to perform a PASS to evaluate risk of serious cardiac disorders as imposed during the Article 20 procedure EMA/112925/2014.
Danish: Med indsendelse af den endelige PASS-studierapport har indehaveren af markedsføringstilladelsen opfyldt sin forpligtelse til at gennemføre et PASS-studie for at undersøge risikoen for alvorlige hjertesygdomme, som pålagt i henhold til artikel 20 under proceduren EMA/112925/2014.
English: Table 1: Incidence of patients with vertebral fracture and relative risk reduction Study
Danish: Tabel 1: Incidens af patienter med vertebralfrakturer og relativ risikoreduktion