FrancophonIA/ELRC3.0 huggingface dataset:
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
Danish: 2procent af de vaccinerede, som initialt var seronegative og opnåede en antistoftiter ≥ 32 1/dil efter vaccination, eller som initialt var seropositive og opnåede en antistoftiter ≥ 4 gange antistoftiteren før vaccination.
English: Children and adolescents aged 10-17 years Dosing may be in accordance with the recommendations for adults.
Danish: Doseringen kan være i overensstemmelse med anbefalingerne for voksne.
English: Adverse reactions reported are listed per dose according to the following frequency: Very common (≥1/10)
Danish: De rapporterede bivirkninger pr. dosis er opstillet i henhold til følgende frekvenser:
English: After 1 dose of 0.5 ml
Danish: Efter 1 dosis af 0,5 ml
English: • Generally feeling unwell
Danish: • generel utilpashed
English: • Flu-like symptoms
Danish: • influenzalignende symptomer.
English: How Pandemrix works
Danish: Sådan virker Pandemrix
English: The vaccine contains 5 micrograms thiomersal
Danish: Hjælpestof, som behandleren skal være opmærksom på Vaccinen indeholder 5 mikrogram thiomersal.
English: Total enrolled subjects N=66
Danish: Inkluderede personer i alt n = 66
English: • A hard lump and warmth at the injection site
Danish: • hårdhed og varmefølelse, hvor indsprøjtningen blev givet
English: A/California/07/2009 (H1N1) derived strain used NYMC X-179A I.M.
Danish: A/California/07/2009 (H1N1) afledt fra NYMC X-179A-stamme i.m.
English: This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Danish: Adjuvansen består af squalen (10,69 mg), DL-α-tocopherol (11,86 mg) og polysorbat 80 (4,86 mg).
English: Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Danish: Influenzavaccine (H1N1)v (split virion, inaktiveret, adjuveret)
English: How to store Pandemrix
Danish: Sådan får du Pandemrix
English: anti-HA antibody Immune response to A/California/7/2009 (H1N1)v-like >80 years Month 12 after 2 doses of 0.5 ml
Danish: Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme > 80 år 12 måneder efter 2 doser af 0,5 ml
English: Adult dose
Danish: Voksendosis
English: Please consult the Product Information of Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted).
Danish: Se produktinformationen for Pandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret).
English: Immune response to A/California/7/2009 (H1N1)v-like Half dose (D-Pan-H1N1-023)
Danish: Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme halv dosis (D-Pan-H1N1-023)
English: Post dose 2
Danish: Efter 2. dosis
English: After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 25°C.
Danish: Efter sammenblandingen, skal den færdige vaccine anvendes inden for 24 timer, og den må ikke opbevares over 25 °C.
English: Vasculitis with transient renal involvement 1frequency based on estimated attributable risk from epidemiological studies in several European countries (see section 4.4) 2Reported in patients with narcolepsy and as a temporary event following vaccination
Danish: Meget sjælden Vaskulitis med forbigående nyrepåvirkning 1 Hyppighed baseret på estimeret risiko ud fra epidemiologiske studier i flere europæiske lande (se pkt.
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.
Danish: • hvis du tidligere har haft en pludselig, livstruende overfølsomhedsreaktion (allergisk reaktion) over for et eller flere af indholdsstofferne i denne vaccine (angivet i punkt 6), eller over for nogle af følgende stoffer, som kan være til stede i meget små mængder: ægge- og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat (antibiotikum) eller natriumdeoxycholat.
English: Pandemrix suspension and emulsion for emulsion for injection Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Danish: Pandemrix suspension og emulsion til injektionsvæske, emulsion Influenzavaccine (H1N1)v (split virion, inaktiveret, adjuveret)
English: If you have any further questions on the use of this vaccine, ask your doctor or nurse.
Danish: Spørg lægen eller sygeplejersken, hvis du har yderligere spørgsmål til anvendelsen af denne vaccine.
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
Danish: seroprotektionsrate: andelen af personer med hæmagglutinationshæmningstiter (HI-titer) ≥ 1:40.
English: Total enrolled subjects N=59
Danish: Inkluderede personer i alt n = 59
English: Post dose 1
Danish: Efter 1. dosis
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:
Danish: I to kliniske studier, hvor børn i alderen 3-9 år fik to doser 0,25 ml (halv voksendosis) eller to doser 0,5 ml (voksendosis) Pandemrix, var anti-HA-antistofresponset 21 dage efter henholdsvis første og anden dosis følgende:
English: Transient thrombocytopenia
Danish: Forbigående trombocytopeni
English: One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
Danish: En pakke indeholder: - en pakke med 50 hætteglas (type I-glas), hver indeholdende 2,5 ml suspension og forsynet med prop (butylgummi) - to pakker med 25 hætteglas (type I-glas), hver indeholdende 2,5 ml emulsion og forsynet med prop (butylgummi).
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 After 2 doses of 0.5 ml
Danish: Immunrespons mod A/Netherlands/602/9 (H1N1)v-lignende stamme 1 Efter 2 doser af 0,5 ml
English: Total enrolled subjects N=24
Danish: Inkluderede personer i alt n = 24
English: Full dose (D-Pan-H1N1-010)
Danish: fuld dosis (D-Pan-H1N1-010)
English: Half adult dose4
Danish: Inkluderede personer i alt4
English: N=60 N=56 N=53 N=52 N=65 N=63 N=57 N=57
Danish: Efter 2. dosis n = 34 n = 32 n = 33 n = 31 n = 16 n = 17 n = 15 n = 16
English: Very rare (<1/10,000)
Danish: Meget almindelig (≥ 1/10)
English: GSK Services Sp. z o.o Tel.: + 48 (22) 576 9000
Danish: Tel.: + 48 (22) 576 9000
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.
Danish: • hvis du har haft en overfølsomhedsreaktion, som ikke var livstruende, over for et eller flere af indholdsstofferne i denne vaccine (angivet i punkt 6), thiomersal, ægge- og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat (antibiotikum) eller natriumdeoxycholat
English: Children from the age of 10 years onwards
Danish: Børn i alderen 10 år og derover
English: Clinical trials Blood and lymphatic system disorders
Danish: Blod og lymfesystem Ikke almindelig Lymfadenopati Psykiske forstyrrelser
English: Month 6 N=22
Danish: Måned 6 n = 22
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
Danish: Tidligere anafylaktisk (dvs. livstruende) reaktion over for et eller flere af indholdsstofferne eller over for spor af reststoffer (ægge- og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat og natriumdeoxycholat) i denne vaccine.
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;
Danish: seroprotektionsrate: andelen af personer med hæmagglutinationshæmningstiter (HI-titer) ≥ 1:40. serokonverteringsrate: andelen af personer, som enten var seronegative før vaccination og opnåede en beskyttende post-vaccinationstiter på ≥ 1:40, eller som var seropositive før vaccination og opnåede en firdobbelt stigning i titer.
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
Danish: A/California/07/2009 (H1N1) afledt fra NYMC X-179A-stamme 3,75 mikrogram** pr. 0,5 ml dosis
English: Month 12 N=31
Danish: Måned 12 n = 31
English: Day 21 N=22
Danish: Dag 21 n = 22
English: • Aching muscles, joint pain
Danish: • ømme muskler, ledsmerter.
English: Month 12 N=28
Danish: Måned 12 n = 28
English: If a second dose is administered there should be an interval of at least three weeks between the first and second dose.
Danish: Hvis der skal gives yderligere en dosis, skal denne gives mindst tre uger efter den første vaccination.
English: Day 42 N=22
Danish: Dag 42 n = 22
English: NA NA NA NA 27.7% 20.6% 35.1% 49.1%
Danish: Feber > 38 °C 10,0 % 14,3 % 5,7 % 32,6 % 4,6 % 6,4 % 1,8 % 12,3 % Feber > 39 °C 1,7 % 5,4 % 0,0 % 3,8 % 0,0 % 3,2 % 0,0 % 1,8 % Diarré
English: Half adult dose (D-Pan-H1N1-023)
Danish: Halv voksendosis (D-Pan-H1N1-023)
English: Day 42 N=17
Danish: Dag 42 n = 17
English: Vaccine Response
Danish: Vaskulære sygdomme
English: Month 12 N=7
Danish: Måned 12 n = 7
English: Day 21 N=17
Danish: Dag 21 n = 17
English: Month 12 N=5
Danish: Måned 12 n = 5
English: 1antigenically similar to A/California/7/2009 (H1N1)v-like
Danish: 1antigen svarende til A/California/7/2009 (H1N1)v-lignende stamme.
English: Total enrolled subjects N=40
Danish: Inkluderede personer i alt n = 40
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelige: kan forekomme hos op til 1ud af 100 personer
English: Month 6 N=17
Danish: Måned 6 n = 17
English: Month 6 N=18
Danish: Måned 6 n = 18
English: • Generalised skin reactions including facial swelling and urticaria (hives)
Danish: • reaktioner i huden, f.eks. hævelse af ansigt og nældefeber (udslæt)
English: Total enrolled subjects N=60
Danish: Inkluderede personer i alt n = 60
English: Immune response to A/California/7/2009 (H1N1)v-like >80 years
Danish: Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme > 80 år
English: Seronegative subjects prior to vaccination [95% CI]
Danish: Seronegative personer før vaccination [95 % CI]
English: Day 21 N=18
Danish: Dag 21 n = 18
English: Day 42 N=18
Danish: Dag 42 n = 18
English: Month 6 N=15
Danish: Måned 6 n = 15
English: Adult dose5 (D-Pan-H1N1-010)
Danish: Voksendosis5 (D-Pan-H1N1-010)
English: Redness Swelling Fever (>38°C) axillary
Danish: Hævelse Aksillær feber (> 38 °C) Aksillær feber (> 39 °C) Døsighed Irritabilitet Appetitmangel
English: Total enrolled subjects N=67 [95% CI]
Danish: Inkluderede personer i alt n = 67 [95 % CI]
English: Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Indhold: AS03-adjuvans bestående af squalen (10,69 mg), DL-α-tocopherol (11,86 mg) og polysorbat 80 (4,86 mg)
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:
Danish: I kliniske studier, hvor reaktogeniciteten blev evalueret hos børn i alderen 3-5 år og 6-9 år, som havde fået enten to doser 0,25 ml (halv voksendosis) eller to doser 0,5 ml (voksendosis) Pandemrix (H1N1)v (med 21 dages mellemrum), var hyppigheden pr. dosis af nedennævnte bivirkninger som anført i tabellen:
English: • Dizziness
Danish: • svimmelhed
English: Month 12 after 2 doses of 0.5 ml
Danish: 12 måneder efter 2 doser af 0,5 ml
English: Month 12 N=14
Danish: Måned 12 n = 14
English: • Pain and swelling at the injection site
Danish: • smerter og hævelse, hvor indsprøjtningen blev givet
English: Immune response to A/California/7/2009 (H1N1)v-like 12-23 months
Danish: Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme 12-23 måneder
English: Month 6 N=13
Danish: Måned 6 n = 13
English: Seroconversio n rate2
Danish: Sero konverterings -rate2
English: - If you have any further questions, ask your doctor or nurse.
Danish: Hvis noget af ovenstående gælder for dig, SKAL DU FORTÆLLE DET TIL LÆGEN ELLER SYGEPLEJERSKEN.
English: Seronegative subjects prior to vaccination N=35
Danish: Seronegative personer før vaccination n = 15
English: Month 6 after 2 doses of 0.5 ml
Danish: 6 måneder efter 2 doser af 0,5 ml
English: Immune response to A/California/7/2009 (H1N1)v-like 24-35 months
Danish: Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme 24-35 måneder
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 Half dose
Danish: Immunrespons mod A/Netherlands/602/9 (H1N1)v-lignende stamme 1 Halv dosis
English: NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Pandemrix Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Danish: Suspension til Pandemrix injektionsvæske, emulsion Influenzavaccine (H1N1)v (split virion, inaktiveret, adjuveret)
English: NAME OF THE MEDICINAL PRODUCT Pandemrix suspension and emulsion for emulsion for injection.
Danish: Pandemrix suspension og emulsion til injektionsvæske, emulsion.
English: In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
Danish: Det er ikke sikkert, at du skal vaccineres, eller måske skal vaccinationen udsættes.
English: • Sleeplessness
Danish: • søvnighed
English: Month 12 N=13
Danish: Måned 12 n = 13
English: Seronegative subjects prior to vaccination N=48 [95% CI]
Danish: Seronegative personer før vaccination n = 48 [95 % CI]
English: Month 6 after 1 dose of 0.5 ml
Danish: 6 måneder efter 1 dosis af 0,5 ml
English: Month 12 after 1 dose of 0.5 ml
Danish: 12 måneder efter 1 dosis af 0,5 ml
English: Seronegative subjects prior to vaccination N=43
Danish: Seronegative personer før vaccination n = 42
English: N=34 N = 32 N=30
Danish: Efter 2. dosis n = 34 n = 32
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).
Danish: Lægen vil normalt anbefale en anden vaccine (årlig trivalent/tetravalent sæsoninfluenzavaccine) i stedet for Pandemrix.
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 12-23 months
Danish: Immunrespons mod A/Netherlands/602/9 (H1N1)v-lignende stamme 1 12-23 måneder
English: Total enrolled subjects2 N=2 [95% CI]
Danish: Inkluderede personer i alt2 n = 2 [95 % CI]
English: INFORMATION IN BRAILLE
Danish: Se information i pkt.
English: Drowsiness
Danish: • træthed
English: Total enrolled subjects N=40 [95% CI]
Danish: Inkluderede personer i alt n = 40 [95 % CI]
English: Total enrolled subjects N=41 [95% CI]
Danish: Inkluderede personer i alt n = 41 [95 % CI]
English: Seroconversio n factor3
Danish: Sero konverte ringsfaktor3
English: Seronegative subjects prior to vaccination N=26 [95% CI]
Danish: Seronegative personer før vaccination n = 26 [95 % CI]
English: Seronegative subjects prior to vaccination N=29 [95% CI]
Danish: Seronegative personer før vaccination n = 29 [95 % CI]
English: Seronegative subjects prior to vaccination N=1 [95% CI]
Danish: Seronegative personer før vaccination n = 1 [95 % CI]
English: Seronegative subjects prior to vaccination N=37 [95% CI]
Danish: Seronegative personer før vaccination n = 37 [95 % CI]
English: Seronegative subjects prior to vaccination N=19 [95% CI]
Danish: Seronegative personer før vaccination n = 19 [95 % CI]
English: Seronegative subjects prior to vaccination N=36 [95% CI]
Danish: Seronegative personer før vaccinatio n n = 36 [95 % CI]
English: Serum neutrali-sing antibody
Danish: Serumneutraliserende antistof
English: • Redness and itching at the injection site
Danish: • rødme og kløe, hvor indsprøjtningen blev givet
English: Adult dose (D-Pan-H1N1-010)
Danish: Voksendosis (D-Pan-H1N1-010)
English: Total enrolled subjects N=52 [95% CI]
Danish: Inkluderede personer i alt n = 52 [95 % CI]
English: Seronegative subjects prior to vaccination N=32 [95% CI]
Danish: Seronegative personer før vaccination n = 32 [95 % CI]
English: Post dose N=32
Danish: Efter 2. dosis n = 33
English: Seronegative subjects prior to vaccination N=3 [95% CI]
Danish: Seronegative personer før vaccination n = 3 [95 % CI]
English: Seronegative subjects prior to vaccination N=15 [95% CI]
Danish: Seronegative personer før vaccination n = 15 [95 % CI]
English: Total enrolled subjects N=3 [95% CI]
Danish: Inkluderede personer i alt n = 3 [95 % CI]
English: Seronegative subjects prior to vaccination N=32
Danish: Seronegative personer før vaccination n = 16
English: Seronegative subjects prior to vaccination N=7 [95% CI]
Danish: Seronegative personer før vaccination n = 7 [95 % CI]
English: Total enrolled subjects N=51 [95% CI]
Danish: Inkluderede personer i alt n = 51 [95 % CI]
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 6-11 months
Danish: Immunrespons mod A/Netherlands/602/9 (H1N1)v-lignende stamme 1 6-11 måneder
English: Immune response to A/California/7/2009 (H1N1)v-like 6-9 years
Danish: Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme 6-9 år
English: GMT.
Danish: Amning
English: Loss of appetite
Danish: Appetitmangel
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 3-5 years
Danish: Immunrespons mod A/Netherlands/602/9 (H1N1)v-lignende stamme 1 3-5 år
English: Total subjects4 N=28 [95% CI]
Danish: Inkluderede personer i alt n = 28 [95 % CI]
English: Total subjects4 N=30 [95% CI]
Danish: Inkluderede personer i alt n = 30 [95 % CI]
English: Total enrolled subjects N=5 [95% CI]
Danish: Inkluderede personer i alt n = 5 [95 % CI]
English: 24-35 months
Danish: Børn 6-35 måneder
English: However, if this cannot be avoided, the vaccines should be injected into separate limbs.
Danish: Hvis samtidig vaccination med andre vacciner er nødvendigt, gives vaccinerne i hver sin arm. Du skal være opmærksom på, at bivirkningerne kan blive kraftigere.
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 6-9 years
Danish: Immunrespons mod A/Netherlands/602/9 (H1N1)v-lignende stamme 1 6-9 år
English: Month N=24
Danish: Måned 12 n = 24
English: Total subjects4 N=55 [95% CI]
Danish: Inkluderede personer i alt n = 55 [95 % CI]
English: A.
Danish: (AESI).
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:
Danish: I kliniske studier, hvor reaktogeniciteten blev evalueret hos børn i alderen 10-17 år, som havde fået enten to doser 0,5 ml (voksendosis) eller to doser 0,25 ml (halv voksendosis) Pandemrix (H1N1)v
English: hard lump (mass)
Danish: Mave-tarm-kanalen
English: Total subjects4 N=51 [95% CI]
Danish: Inkluderede personer i alt n = 51 [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).
Danish: I et klinisk studie, hvor reaktogeniciteten blev vurderet hos børn i alderen 6-35 måneder, som fik enten to doser 0,25 ml (halv voksendosis) eller to doser 0,5 ml (voksendosis) Pandemrix (H1N1)v (med 21
English: Month N=16
Danish: Måned 6 n = 16
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 Twelve months after the first dose, the seroprotection rate was as follows:
Danish: Seroprotektionsraten tolv måneder efter første dosis var følgende:
English: Further changes to the product information will contribute to better inform the healthcare professionals and women on the risk
Danish: Yderligere ændring af produktinformationen vil bidrage til bedre oplysning af sundhedspersoner og kvinder om risikoen for tromboemboli,
English: These are combined with varying doses of ethinylestradiol
Danish: Disse stoffer kombineres med forskellige doser ethinylestradiol (EE) eller med estradiol (E2).
English: Considering that risk factors for VTE change over time the PRAC noted that an individual's risk should
Danish: Da risikofaktorerne for venøs tromboemboli ændrer sig med tiden, bemærkede PRAC, at en persons individuelle risiko bør revurderes med jævne mellemrum.
English: In addition the PRAC imposed a post-authorisation safety study in order to better characterise the relative risk of thromboembolic events due to chlormadinone compared to the levonorgestrel
Danish: Derudover påbød PRAC en sikkerhedsundersøgelse efter markedsføringstilladelse til bedre karakterisering af den relative risiko for tromboemboliske hændelser med chlormadinon i forhold til produkter indeholdende levonorgestrel.
English: The PRAC confirmed the known risk of thromboembolism of combined hormonal contraceptive containing medicinal products, and recommended clear labelling of symptoms of thromboembolic events, as well as the risk
Danish: PRAC fastslog den kendte risiko for tromboemboli ved lægemidler indeholdende kombinerede hormonale kontraceptiva og anbefalede tydelig mærkning med symptomerne på og risikofaktorerne for tromboemboliske hændelser,
English: • The PRAC considered that further data are required for the combined hormonal contraceptives containing chlormadinone and imposed the conduct of a post authorisation safety study (PASS) to evaluate the relative risk of thromboembolic events due to these products compared to the
Danish: • PRAC fandt behov for flere data om kombinerede hormonale kontraceptiva indeholdende chlormadinon og påbød en sikkerhedsundersøgelse efter markedsføringsgodkendelse (PASS) til vurdering af den relative risiko for tromboemboliske hændelser betinget af disse produkter i forhold til produkter indeholdende levonorgestrel,
English: • For CHCs containing chlormadinone, dienogest and nomegestrol, the available data are insufficient to know how the risk compares with the other CHCs.
Danish: • For kombinerede hormonale kontraceptiva indeholdende chlormadinon, dienogest og nomegestrol er de foreliggende data utilstrækkelige til at bestemme risikoen i forhold til de
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products Evra, Ioa and Zoely in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation
Danish: konkluderede PRAC, at benefit/risk-forholdet fortsat er positivt for lægemidlerne Evra, Ioa og Zoely i indikationen antikonception under forudsætning af de vedtagne kontraindikationer, advarsler og andre ændringer i produktinformationen samt supplerende risikominimeringsforanstaltninger.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for the combined hormonal contraceptives containing medicinal products.
Danish: • udvalget fulgte proceduren i overensstemmelse med artikel 31 i direktiv 2001/83/EF for
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from
Danish: Videnskabelige konklusioner og begrundelse for ændring af betingelserne for markedsføringstilladelserne samt detaljeret redegørelse for afvigelserne fra anbefalingen fra PRAC (Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for