FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies that evaluated reactogenicity in adults aged 18 years and above who received two 0.5 ml doses of Pandemrix (H1N1)v, higher rates of general solicited symptoms (such as fatigue, headache, arthralgia, myalgia, shivering, sweating and fever) were observed after the second dose compared to the first dose.
Icelandic: Í klínískum rannsóknum þar sem lagt var mat á hversu miklum aukaverkunum Pandemrix (H1N1)v getur valdið hjá fullorðnum 18 ára og eldri sem fengu tvo 0,5 ml skammta, var tíðni flestra almennra einkenna sem sérstaklega var leitað eftir (solicited symptoms) (s.s. þreytu, höfuðverks, liðverkja, vöðvaverkja, skjálfta, svitamyndunar og hita) hærri eftir seinni skammtinn en eftir fyrri skammtinn.
English: Day 21 N=22
Icelandic: Dagur 21 N=22
English: Total enrolled subjects N=60
Icelandic: Heildarfjöldi einstaklinga N=60
English: neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
Icelandic: Taugakvillar svo sem heila- og mænubólga (bólgur í miðtaugakerfi), taugabólga og tegund lömunar sem kallast Guillain-Barré-heilkenni
English: Day 42 N=17
Icelandic: Dagur 42 N=17
English: Day 42 N=22
Icelandic: Dagur 42 N=22
English: Pandemrix can be given at the same time as seasonal influenza vaccines that do not contain an adjuvant.
Icelandic: á sama tíma og bóluefni gegn árstíðabundinni inflúensu, sem ekki innihalda ónæmisglæði.
English: • if you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate.
Icelandic: ef þú hefur fengið skyndileg lífshættuleg ofnæmisviðbrögð við einhverju innihaldsefni þessa bóluefnis (talin upp í kafla 6) eða við einhverjum af eftirtöldum efnum sem geta verið til staðar í snefilmagni: eggja- og kjúklingapróteinum, eggjahvítu, formaldehýði, gentamisínsúlfati (sýklalyf) eða natríumdeoxýkólati.
English: Day 21 N=17
Icelandic: Dagur 21 N=17
English: Day 42 N=18
Icelandic: Dagur 42 N=18
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 25 VIALS OF EMULSION (ADJUVANT)
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM PAKKI MEÐ 25 HETTUGLÖSUM MEÐ FLEYTI (ÓNÆMISGLÆÐIR)
English: Month 12 N=7
Icelandic: 12. mánuður N=7
English: Day 21 N=18
Icelandic: Dagur 21 N=18
English: GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkustraße 40, D-01069 Dresden Germany
Icelandic: KG Zirkustraße 40, D-01069 Dresden Þýskaland
English: Total enrolled subjects N=40
Icelandic: Heildarfjöldi einstaklinga N=40
English: Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Icelandic: Bóluefni gegn inflúensu (H1N1)v (klofin veiruögn, deydd, ónæmisglætt)
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6), to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
Icelandic: ef þú hefur fengið ofnæmisviðbrögð önnur en skyndileg lífshættuleg ofnæmisviðbrögð við einhverjum af innihaldsefnum þessa bóluefnis (talin upp í kafla 6), tíómersali, eggja- og kjúklingapróteini, eggjahvítu, formaldehýði, gentamisínsúlfati (sýklalyf) eða natríumdeoxýkólati.
English: Injection site reactions (such as inflammation, mass, ecchymosis)
Icelandic: Einkenni frá meltingarvegi (svo sem niðurgangur, uppköst, kviðverkir, ógleði)
English: 2percentage of vaccinees who, if initially seronegative reach an antibody titre ≥32 1/DIL after vaccination or, if initially seropositive reach an antibody titre ≥ 4-fold the pre-vaccination antibody titre
Icelandic: 2hlutfall bólusettra sem voru sermisneikvæðir í upphafi og náðu mótefnatítra ≥32 1/DIL eftir bólusetningu eða, sem voru sermisjákvæðir í upphafi og náðu mótefnatítra sem var ≥ fjórfaldur mótefnatítri fyrir bólusetningu.
English: Total enrolled subjects N=25
Icelandic: Heildarfjöldi einstaklinga N=25
English: Month N=16
Icelandic: 6. mánuður N=16
English: Total enrolled subjects N=67 [95% CI]
Icelandic: Heildarfjöldi einstaklinga N=67 [95% CI]
English: In a clinical study that evaluated reactogenicity in children aged 6 to 35 months who received either two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) (21 days apart) of Pandemrix (H1N1)v there was an increase in injection site reactions and general symptoms after the second dose compared to the first dose particularly in rates of axillary fever (>38°C).
Icelandic: Í klínískri rannsókn þar sem lagt var mat á hversu miklum aukaverkunum Pandemrix (H1N1)v getur valdið, hjá börnum á aldrinum 6 til 35 mánaða sem fengu annaðhvort tvo 0,25 ml skammta (hálfan fullorðinsskammt) eða tvo 0,5 ml skammta (fullorðinsskammt) (með 21 dags millibili), kom fram aukin tíðni viðbragða á stungustað og almennra einkenna eftir seinni skammtinn, borið saman við fyrri skammtinn, einkum tíðni hita í handarkrika (> 38°C).
English: Month 6 N=13
Icelandic: 6. mánuður N=13
English: What Pandemrix looks like and contents of the pack
Icelandic: Lýsing á útliti Pandemrix og pakkningastærðir
English: Redness Swelling Shivering Sweating Fever >38°C Fever >39°C Diarrhoea
Icelandic: Svitamyndun Hiti >38°C Hiti >39°C
English: Month 6 N=15
Icelandic: 6. mánuður N=15
English: • Feeling sick, diarrhoea, vomiting, stomach pain
Icelandic: Herslismyndun og hiti á stungustað, flensulík veikindi, lasleiki
English: Immune response to A/California/7/2009 (H1N1)v-like 24-35 months
Icelandic: Ónæmissvörun við A/California/7/2009 (H1N1)v-líkum stofni 24-35 mánaða
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
Icelandic: 1hlutfall ónæmissvörunar: hlutfall einstaklinga með títra hemagglútínínhindrunar (HI) ≥ 1:40;
English: A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms** * propagated in eggs ** haemagglutinin
Icelandic: A/California/07/2009 (H1N1) afleiddur stofn notaður NYMC X-179A 3,75 míkróg** * ræktuð í eggjum ** hemagglútínín (HA)
English: Immune response to A/California/7/2009 (H1N1)v-like 12-23 months
Icelandic: Ónæmissvörun við A/California/7/2009 (H1N1)v-líkum stofni 12-23 mánaða4
English: After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 25°C.
Icelandic: Eftir blöndun skal nota bóluefnið innan 24 klst. og geyma við lægri hita en 25°C.
English: Month 6 after 1 dose of 0.5 ml
Icelandic: Mánuður 6 eftir einn 0,5 ml skammt
English: If they persist, CONSULT YOUR DOCTOR.
Icelandic: LEITIÐ RÁÐA HJÁ LÆKNINUM ef þær hverfa ekki.
English: Febrile convulsions
Icelandic: Flensulík einkenni
English: Total enrolled subjects N=24
Icelandic: Heildarfjöldi einstaklinga N=24
English: Total subjects4 N=28 [95% CI]
Icelandic: Heildarfjöldi einstaklinga4 N=28 [95% CI]
English: What Pandemrix contains
Icelandic: Pandemrix inniheldur
English: Data obtained on the administration of a non-adjuvanted seasonal influenza vaccine (Fluarix, as above) three weeks before a dose of Pandemrix (H1N1)v in healthy adults over 60 years of age, did not suggest any significant interference in the immune response to Pandemrix (H1N1)v. Therefore the data indicate that Pandemrix may be administered three weeks after the administration of non-adjuvanted seasonal influenza vaccines.
Icelandic: Upplýsingar sem fengust við gjöf bóluefnis gegn árstíðabundinni inflúensu, án ónæmisglæðis (Fluarix, sbr. hér á undan), þremur vikum fyrir gjöf Pandemrix (H1N1)v hjá heilbrigðum einstaklingum eldri en 60 ára, bentu ekki til neinna marktækra truflana á ónæmissvörun við Pandemrix (H1N1)v.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 50 VIALS OF SUSPENSION (ANTIGEN)
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM PAKKI MEÐ 50 HETTUGLÖSUM MEÐ DREIFU (MÓTEFNAVAKI)
English: NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Pandemrix
Icelandic: Dreifa með mótefnavaka fyrir Pandemrix Bóluefni gegn inflúensu
English: GlaxoSmithKline Lietuva UAB Tel: +370 5 264 90 00 info.lt@gsk.com
Icelandic: +370 5 264 90 00 info.lt@gsk.com
English: Full dose (D-Pan-H1N1-010)
Icelandic: Heill skammtur (D-Pan-H1N1-010)
English: Month 12 after 1 dose of 0.5 ml
Icelandic: Mánuður 12 eftir einn 0,5 ml skammt
English: Neuralgia
Icelandic: Taugakerfi
English: Split influenza virus inactivated, containing antigen equivalent to: A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms* AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80 * haemagglutinin
Icelandic: A/California/07/2009 (H1N1) afleiddur stofn notaður NYMC X-179A 3,75 míkróg* AS03-ónæmisglæði sem samanstendur af skvaleni, DL-α-tókóferóli og pólýsorbati 80 * hemagglútínín
English: 1antigenically similar to A/California/7/2009 (H1N1)v-like
Icelandic: 1mótefnavaki svipaður mótefnavaka A/California/7/2009 (H1N1)v-líks stofns
English: 2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold increase in titre;
Icelandic: 2hlutfall mótefnasvörunar: hlutfall einstaklinga sem voru annaðhvort sermisneikvæðir fyrir bólusetningu og hafa verndandi ónæmistítra sem er ≥ 1:40 eftir bólusetningu, eða sem voru sermisjákvæðir fyrir bólusetningu og hafa títra sem hefur fjórfaldast; 3mótefnasvörunarstuðull: hlutfall meðaltalsmótefnastyrks (geometric mean titre (GMT)) eftir og fyrir bólusetningu.
English: Musculoskeletal and connective tissue disorders
Icelandic: Liðverkir Vöðvaverkir Þreyta
English: There are no data with Pandemrix using the subcutaneous route.
Icelandic: Engin gögn eru fyrirliggjandi varðandi gjöf Pandemrix undir húð.
English: Total enrolled subjects N=15
Icelandic: Heildarfjöldi einstaklinga N=15
English: • A hard lump and warmth at the injection site
Icelandic: Harður hnútur eða hiti á stungustað
English: Adult dose5 (D-Pan-H1N1-010)
Icelandic: Fullorðinsskammtur5 (D-Pan-H1N1-010)
English: Seronegative subjects prior to vaccination N=48 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=48 [95% CI]
English: Total subjects4 N=51 [95% CI]
Icelandic: Heildarfjöldi einstaklinga 4 N=51 [95% CI]
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1
Icelandic: Ónæmissvörun við A/Netherlands/602/9 (H1N1)v-líkum stofni1
English: - Phenotypic characterization of hypocretin and influenza-specific T cells after stimulation with hypocretin or influenza peptides.
Icelandic: - Gera svipgerðargreiningu á hýpókretín- og inflúensusértækum T-frumum eftir örvun með hýpókretíneða inflúensupeptíðum.
English: Pandemrix suspension and emulsion for emulsion for injection Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Icelandic: Pandemrix dreifa og fleyti fyrir stungulyf, fleyti Bóluefni gegn inflúensu (H1N1)v (klofin veiruögn, deydd, ónæmisglætt)
English: A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms** per 0.5 ml dose *propagated in eggs **expressed in microgram haemagglutinin
Icelandic: A/California/07/2009 (H1N1) afleiddur stofn notaður NYMC X-179A 3,75 míkrógrömm** í hverjum 0,5 ml skammti
English: • Itching, rash
Icelandic: Náladofi, sundl
English: Adult dose (D-Pan-H1N1-010)
Icelandic: Fullorðinsskammtur (D-Pan-H1N1-010)
English: The neutralising antibody responses in subjects >60 years were as follows: Serum neutralising antibody
Icelandic: Svörun hlutleysandi mótefna hjá einstaklingum >60 ára var eftirfarandi:
English: In clinical studies that evaluated the reactogenicity in children 10 to 17 years of age who received either two 0.5 ml doses (adult dose) or two 0.25 ml doses (half adult dose) (21 days apart) of Pandemrix (H1N1)v, the per-dose frequency of the following adverse reactions was as shown in the table:
Icelandic: Í klínískum rannsóknum þar sem lagt var mat á hversu miklum aukaverkunum Pandemrix (H1N1)v getur valdið, hjá börnum á aldrinum 10 til 17 ára sem fengu annaðhvort tvo 0,5 ml skammta (fullorðinsskammt) eða tvo 0,25 ml skammta (hálfan fullorðinsskammt) (með 21 dags millibili), var tíðni eftirfarandi aukaverkana fyrir hvern skammt eins og fram kemur í töflunni:
English: Drowsiness
Icelandic: Niðurgangur
English: Seronegative subjects prior to vaccination N=37 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=37 [95% CI]
English: Total enrolled subjects2 N=2 [95% CI]
Icelandic: Heildarfjöldi einstaklinga2 N=2 [95% CI]
English: Seronegative subjects prior to vaccination N=29 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=29 [95% CI]
English: antibody
Icelandic: Líffæraflokkur
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 12-23 months
Icelandic: Ónæmissvörun við A/Netherlands/602/9 (H1N1)v-líkum stofni1 12-23 mánaða
English: Seronegative subjects prior to vaccination N=16 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=16 [95% CI]
English: Your doctor will normally recommend a different vaccine (annual trivalent/quadrivalent influenza vaccine) instead of Pandemrix, but if the trivalent/quadrivalent vaccines are not available Pandemrix may still be an option if you need protection against A(H1N1)v influenza (see Take special care with Pandemrix).
Icelandic: Ef þrígildu/fjórgildu bóluefnin eru ekki fáanleg getur Pandemrix samt verið valkostur ef þú þarft vörn gegn A(H1N1)v-inflúensu (sjá „Varnaðarorð og varúðarreglur“).
English: Total enrolled subjects N=51 [95% CI]
Icelandic: Heildar-fjöldi einstaklinga N=51 [95% CI]
English: Seronegative subjects prior to vaccination N=42 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=42 [95% CI]
English: Seronegative subjects prior to vaccination N=26 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=26 [95% CI]
English: Seronegative subjects prior to vaccination N=1 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=1 [95% CI]
English: Immune response to A/California/7/2009 (H1N1)v-like 6-9 years
Icelandic: Ónæmissvörun við A/California/7/2009 (H1N1)v-líkum stofni 6-9 ára
English: Seronegative subjects prior to vaccination N=19 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=19 [95% CI]
English: Seronegative subjects prior to vaccinatio n N=15 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=15 [95% CI]
English: • The minimal data elements to be transmitted in individual case safety reports in order to facilitate the evaluation and the identification of the vaccine administered to each subject, including the invented name, the vaccine manufacturer and the batch number.
Icelandic: Lágmarksupplýsingar sem koma þurfa fram í einstökum aukaverkanatilkynningum, til að auðvelda mat og auðkenningu á því bóluefni sem gefið var hjá hverjum einstaklingi, þ. á m.
English: Seronegative subjects prior to vaccination N=32 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=32 [95% CI]
English: In clinical studies that evaluated reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) (21 days apart) of Pandemrix (H1N1)v, the per-dose frequency of the following adverse reactions was as shown in the table:
Icelandic: Í klínískum rannsóknum þar sem lagt var mat á hversu miklum aukaverkunum Pandemrix (H1N1)v getur valdið, hjá börnum á aldrinum 3 til 5 ára og 6 til 9 ára sem fengu annaðhvort tvo 0,25 ml skammta (hálfan fullorðinsskammt) eða tvo 0,5 ml skammta (fullorðinsskammt) (með 21 dags millibili), var tíðni eftirtalinna aukaverkana fyrir hvern skammt eins og fram kemur í töflunni:
English: България ГлаксоСмитКлайн ЕООД
Icelandic: ГлаксоСмитКлайн ЕООД Тел.:
English: Seronegative subjects prior to vaccination N=36 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=36 [95% CI]
English: NA NA NA NA 21.5% 20.6% 42.1% 45.6%
Icelandic: NA NA NA NA 21,5% 20,6% 42,1% 45,6% NA= not available = liggur ekki fyrir
English: Month 12 after 2 doses of 0.5 ml
Icelandic: Mánuður 12 eftir tvo 0,5 ml skammta
English: How Pandemrix works
Icelandic: Hvernig verkar Pandemrix
English: GMT.
Icelandic: Ltd
English: • Increased sweating
Icelandic: Aukin svitamyndun •
English: Seronegative subjects prior to vaccination N=7 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=7 [95% CI]
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Icelandic: 1hlutfall ónæmissvörunar: hlutfall einstaklinga með títra hemagglútínínhindrunar (HI) ≥ 1:40
English: Pandemrix contains thiomersal
Icelandic: Pandemrix má gefa
English: Total subjects5 [95% CI]
Icelandic: Heildarfjöldi einstaklinga5 [95% CI]
English: Total enrolled subjects N=52 [95% CI]
Icelandic: Heildarfjöldi einstaklinga N=52 [95% CI]
English: Twelve months after the first dose, the seroprotection rate was as follows: anti-HA antibody
Icelandic: Tólf mánuðum eftir fyrri skammt var hlutfall ónæmissvörunar eftirfarandi:
English: Total enrolled subjects N=3 [95% CI]
Icelandic: Heildarfjöldi einstaklinga N=3 [95% CI]
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 3-5 years
Icelandic: Ónæmissvörun við A/Netherlands/602/9 (H1N1)v-líkum stofni1 3-5 ára
English: Total enrolled subjects N=41 [95% CI]
Icelandic: Heildarfjöldi einstaklinga N=41 [95% CI]
English: • Short-term sleepiness following vaccination
Icelandic: Skammvinn syfja eftir bólusetningu
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 6-11 months
Icelandic: Ónæmissvörun við A/Netherlands/602/9 (H1N1)v-líkum stofni1 6-11 mánaða
English: NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Pandemrix Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Icelandic: Dreifa fyrir Pandemrix stungulyf, fleyti Bóluefni gegn inflúensu (H1N1)v (klofin veiruögn, deydd, ónæmisglætt)
English: Month 6 after 2 doses of 0.5 ml
Icelandic: Mánuður 6 eftir tvo 0,5 ml skammta
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 6-9 years
Icelandic: Ónæmissvörun við A/Netherlands/602/9 (H1N1)v-líkum stofni1 6-9 ára
English: Pain
Icelandic: Bólga
English: Octoxynol 10
Icelandic: Oktoxýnól 10
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for Pandemrix
Icelandic: Fleyti með ónæmisglæði fyrir Pandemrix i.m.
English: Vaccine Response
Icelandic: Lyfjagjöf
English: Emulsion vial:
Icelandic: Fylgiseðill:
English: • Redness and itching at the injection site
Icelandic: Roði og kláði á stungustað
English: Suspension and emulsion for emulsion for injection.
Icelandic: Dreifa og fleyti fyrir stungulyf, fleyti.
English: Irritability
Icelandic: Taugaverkir
English: tection rate1 55.0%
Icelandic: 5.1 Lyfhrif
English: Adults, including the elderly
Icelandic: Fullorðnir, þ.m.t. aldraðir
English: Uncommon Lymphadenopathy
Icelandic: B. FYLGISEÐILL
English: anti-HA
Icelandic: HA-mótefni
English: Month N=22
Icelandic: Fullorðinsskammtur mánuður N=22
English: In two clinical studies in which children aged 3 to 9 years old received two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) of Pandemrix, the anti-HA antibody responses 21 days after the first and the second dose were as follows:
Icelandic: Í 2 klínískum rannsóknum fengu börn á aldrinum 3 til 9 ára tvo 0,25 ml skammta (hálfan fullorðinsskammt) eða tvo 0,5 ml skammta (fullorðinsskammt) af Pandemrix.
English: Medical attention may be needed.
Icelandic: Þörf gæti verið á læknishjálp.
English: - You can use Brimica Genuair anytime before or after food or drink.
Icelandic: - Nota má Brimica Genuair hvenær sem er fyrir eða eftir neyslu matar eða drykkjar.
English: [arrow] Tear here
Icelandic: [ör] Rífið hér
English: If the control window still does not change to red, you may have forgotten to release the orange button before inhaling, or you may not have inhaled strongly enough.
Icelandic: Ef stjórnglugginn breytist ekki enn í rauðan gætir þú hafa gleymt að sleppa appelsínugula hnappinum fyrir innöndun, eða þú hefur ekki andað nógu kröftuglega að þér.
English: Further information regarding these two substances is provided below.
Icelandic: Frekari upplýsingar um þessi tvö efni má finna hér á eftir.
English: - The effects of Brimica Genuair last for 12 hours; therefore, you should try to use Brimica Genuair at the same time each morning and evening as this will ensure that there is always enough medicine in your body to help you breathe more easily throughout the day and night.
Icelandic: - Verkun Brimica Genuair varir í 12 klukkustundir, því skaltu reyna að nota Brimica Genuair alltaf á sama tíma á hverjum morgni og hverju kvöldi því það tryggir að ávallt sé nægt lyf í líkamanum til að auðvelda þér öndun allan daginn og alla nóttina.
English: In case such effects occur, treatment may need to be discontinued.
Icelandic: Ef slík áhrif koma fram gæti þurft að stöðva meðferð.
English: Менарини България” EООД тел.
Icelandic: Менарини България” EООД
English: This medicine should not be used for the treatment of asthma.
Icelandic: Lyfið skal ekki nota til meðferðar á astma.
English: Children and adolescents Brimica Genuair is not for use in children or adolescents below 18 years of age.
Icelandic: Brimica Genuair er ekki ætlað börnum eða unglingum undir 18 ára aldri.
English: A video demonstration on how to use the Genuair inhaler is also available on www.genuair.com and through the code below.
Icelandic: Sýnikennsla á myndbandi um hvernig nota á Genuair innöndunartækið er einnig fáanleg á www.genuair.com og með kóðanum hér fyrir neðan.
English: The plasma protein binding of formoterol is 61% to 64% (34% primarily to albumin).
Icelandic: Próteinbinding formóteróls í plasma er 61% til 64% (34% fyrst og fremst við albúmín).
English: If you want to stop treatment, first talk to your doctor, as your symptoms may worsen.
Icelandic: Ef þú vilt hætta meðferðinni skaltu fyrst hafa samband við lækninn þar sem einkennin geta versnað.
English: To be used within 60 days of opening the bag.
Icelandic: Notið innan 60 daga frá því að pokinn er opnaður.
English: The medicine must be used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.
Icelandic: Nota verður lyfið alla daga, tvisvar á dag, en ekki aðeins þegar öndunarerfiðleikar eða önnur einkenni sjúkdómsins koma fram.
English: No dose adjustments are necessary in these patients.
Icelandic: Ekki er þörf á aðlögun skammta hjá þessum sjúklingum.
English: *As the primary endpoint did not achieve statistical significance, all p-values for secondary endpoints are tested at a nominal significance level of 0.05, and no formal statistical inference can be drawn.
Icelandic: *Þar sem aðalendapunkturinn náði ekki tölfræðilegri marktækni, eru öll p-gildi fyrir aðra endapunkta prófaðir við málamynda marktæknigildi 0,05, og ekki er hægt að draga formlegar tölfræðilegar ályktanir.
English: - The recommended dose is one inhalation in the morning and one inhalation in the evening.
Icelandic: - Ráðlagður skammtur er ein innöndun að morgni til og ein innöndun að kvöldi til.
English: Cytochrome P450 isoenzymes CYP2D6, CYP2C19, CYP2C9 and CYP2A6 are involved in the O-demethylation of formoterol.
Icelandic: Cýtókróm P450 ísóensímin CYP2D6, CYP2C19, CYP2C9 og CYP2A6 taka þátt í O-afmetýleringu formóteróls.
English: • Each time you load a dose by pressing the orange button, the dose indicator moves by a small amount towards the next number (50, 40, 30, 20, 10, or 0).
Icelandic: Í hvert skipti sem þú hleður skammti með því að þrýsta á appelsínugula hnappinn færist skammtavísirinn örlítið í átt að næstu tölu (50, 40, 30, 20, 10, eða 0).
English: EU/1/14/963/001 1 inhaler with 60 doses EU/1/14/963/002 3 inhalers each with 60 doses EU/1/14/963/003 1 inhaler with 30 doses
Icelandic: EU/1/14/963/001 1 innöndunartæki með 60 skömmtum EU/1/14/963/002 3 innöndunartæki með 60 skömmtum hvert EU/1/14/963/003 1 innöndunartæki með 30 skömmtum
English: It is important to instruct the patients to read the Instructions for Use in the Package Leaflet.
Icelandic: Mikilvægt er að leiðbeina sjúklingum um að lesa Notkunarleiðbeiningarnar í fylgiseðlinum.