natgillin/translations-raw huggingface dataset:
Metabolisme og ernæring Meget sjælden Reduktion af vitamin B12-absorption og laktatacidose* Nervesystemet Almindelig 
Decrease of vitamin B12 absorption and lactic acidosis*
Derfor forventes den metaboliske clearance for vildagliptin ikke at blive påvirket af samtidig administration af præparater, der er CYP 450-hæmmere og/eller -induktorer. 
Vildagliptin is not metabolised by CYP 450 enzymes to any quantifiable extent, and accordingly the metabolic clearance of vildagliptin is not anticipated to be affected by comedications that are CYP 450 inhibitors and/or inducers.
Mørkegul, oval, filmovertrukket tablet med skrå kant, præget med ”NVR” på den ene side og ”FLO” på den anden side. 
Dark yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “FLO” on the other side.
Zomarist 50 mg/850 mg filmovertrukne tabletter 
Zomarist 50 mg/850 mg film-coated tablets
KARTON FOR ENHEDSPAKNING 
FOLDING BOX FOR UNIT PACK
Zomarist 50 mg/850 mg filmovertrukne tabletter Zomarist 50 mg/1000 mg filmovertrukne tabletter 
Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets
For at undgå at du får lavt blodsukker [hypoglykæmi], vil din læge måske nedsætte din dosis af sulfonylurinstoffet, når du tager det sammen med Zomarist. 
Your doctor may want to reduce your dose of the sulphonylurea when you take it together with Zomarist in order to avoid low blood glucose (hypoglycaemia).
Er du i tvivl, så spørg lægen eller på apotekspersonalet. 
- If you have any further questions, ask your doctor, pharmacist or nurse.
Zomarist 50 mg/1000 mg filmovertrukne tabletter vildagliptin/metforminhydrochlorid 
Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
- Enhver type af akut metabolisk acidose (såsom laktatacidose, diabetisk ketoacidose) - Diabetisk præ-koma - Svær nyreinsufficiens (GFR < 30 ml/min) (se pkt. 
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) Diabetic pre-coma Severe renal failure (GFR < 30 ml/min) (see section 4.4) Acute conditions with the potential to alter renal function, such as: dehydration, severe infection, shock, intravascular administration of iodinated contrast agents (see section 4.4).
- Hver Zomarist 50 mg/850 mg filmovertrukket tablet indeholder 50 mg vildagliptin og 850 mg metforminhydrochlorid (svarende til 660 mg metformin). 
- Each Zomarist 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
Zomarist bør ikke anvendes til børn og unge under 18 år. 
Zomarist is not recommended for use in children and adolescents (< 18 years).
- Øvrige indholdsstoffer: Hydroxypropylcellulose, magnesiumstearat, hypromellose, titandioxid 
- The other ingredients are: Hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 4000 and talc.
- Hver Zomarist 50 mg/1000 mg filmovertrukket tablet indeholder 50 mg vildagliptin og 1000 mg metforminhydrochlorid (svarende til 780 mg metformin). 
- Each Zomarist 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Mave-tarm-kanalen Ikke kendt 
Hepatobiliary disorders Not known
Laktatacidose er kendetegnet ved acidotisk dyspnø, mavesmerter, muskelkramper, asteni og hypotermi efterfulgt af koma. 
Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma In case of suspected symptoms, the patient should stop taking metformin and seek immediate medical attention.
Zomarist 50 mg/850 mg filmovertrukne tabletter vildagliptin/metforminhydrochlorid 
Zomarist 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Zomarist 50 mg/850 mg filmovertrukne tabletter Zomarist 50 mg/1000 mg filmovertrukne tabletter vildagliptin/metforminhydrochlorid 
Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Sådan skal du tage Zomarist 
How to take Zomarist
Knogler, led, muskler og bindevæv Ikke kendt 
Musculoskeletal and connective tissue disorders Not known
Hver tablet indeholder 50 mg vildagliptin og 850 mg metforminhydrochlorid (svarende til 660 mg metformin). 
Each tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
Hver tablet indeholder 50 mg vildagliptin og 1000 mg metforminhydrochlorid (svarende til 780 mg metformin). 
Each tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Kvalme, gastroøsofageal reflukssygdom Ikke almindelig Diarré, flatulens 
Nausea, gastro-oesophageal reflux disease
Hver filmovertrukket tablet indeholder 50 mg vildagliptin og 1000 mg metforminhydrochlorid (svarende til 780 mg af metformin). 
Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin).
Hver filmovertrukket tablet indeholder 50 mg vildagliptin og 850 mg metforminhydrochlorid (svarende til 660 mg af metformin). 
Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin).
Tag pakningen og denne indlægsseddel med, hvis det er nødvendigt at gå til lægen eller på hospitalet. 
If you have to go to a doctor or hospital, take the pack and this leaflet with you.
EU/1/08/483/007 10 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/008 30 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/009 60 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/010 120 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/011 180 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/012 360 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/025 10 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/026 30 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/027 60 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/028 120 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/029 180 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/030 360 filmovertrukne tabletter (PCTFE/PVC/Alu) 
EU/1/08/483/007 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/008 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/009 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/010 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/011 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/012 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/025 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/026 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/027 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/028 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/029 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/030 360 film-coated tablets (PCTFE/PVC/Alu)
Lever og galdeveje Ikke kendt 
Gastrointestinal disorders Not known
EU/1/08/483/001 10 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/002 30 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/003 60 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/004 120 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/005 180 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/006 360 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/019 10 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/020 30 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/021 60 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/022 120 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/023 180 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/024 360 filmovertrukne tabletter (PCTFE/PVC/Alu) 
EU/1/08/483/001 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/002 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/003 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/004 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/005 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/006 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/019 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/020 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/021 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/022 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/023 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/024 360 film-coated tablets (PCTFE/PVC/Alu)
EU/1/08/483/016 120 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/017 180 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/018 360 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/034 120 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/035 180 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/036 360 filmovertrukne tabletter (PCTFE/PVC/Alu) 
EU/1/08/483/016 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/017 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/018 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/034 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/035 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/036 360 film-coated tablets (PCTFE/PVC/Alu)
Laktatacidose 
Dizziness
EU/1/08/483/013 120 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/014 180 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/015 360 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/08/483/031 120 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/032 180 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/08/483/033 360 filmovertrukne tabletter (PCTFE/PVC/Alu) 
EU/1/08/483/013 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/014 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/015 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/031 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/032 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/033 360 film-coated tablets (PCTFE/PVC/Alu)
Det skal du vide, før du begynder at tage Zomarist Sådan skal du tage Zomarist Bivirkninger 
What Zomarist is and what it is used for What you need to know before you take Zomarist How to take Zomarist
Din læge kan også ordinere en lavere dosis, hvis du tager anden medicin kaldet sulfonylurinstof mod din diabetes. 
Also if you are taking an anti-diabetic medicine known as a sulphonylurea your doctor may prescribe a lower dose.
Monitorering af leverenzymer 
Liver enzyme monitoring
- Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne anført i pkt 6.1. 
For the full list of excipients, see section 6.1.
Behandling 
Asthenia
Mave-tarm-kanalen Almindelig 
Vascular disorders Uncommon
Startdosis af Zomarist bør gives som 50 mg vildagliptin to gange dagligt (i alt 100 mg dagligt) samt den dosis metformin, som allerede administreres. 
- For patients inadequately controlled at their maximal tolerated dose of metformin monotherapy: The starting dose of Zomarist should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
Det afhænger af din sygdom, hvor mange Zomaristtabletter du skal tage. 
The amount of Zomarist that people have to take varies depending on their condition.
Hovedpine, kulderystelser 
Headache, chills
Svimmelhed Ikke almindelig Træthed Mave-tarm-kanalen Almindelig 
Constipation Musculoskeletal and connective tissue disorders Uncommon
Metformin udskilles gennem nyrerne. 
Metformin is eliminated by renal excretion.
De kan få brug for at læse den igen. 
You may need to read it again
De to drøftede emner var følgende: 
The two issues discussed were as follows:
{Navn og adresse} <{tlf}> <{fax>} <{email}> 
{Name and address} <{tel}> <{fax}> <{e-mail}>
Behandlingen bør være symptomatisk. 
Treatment should be symptomatic.
• Hvis De bliver gravid 
• If you become pregnant
Som følge heraf skulle disse 7 prøver ikke være blevet medtaget i den endelige beregning. 
Consequently, these 7 samples should have been excluded from the final calculation.
Denne reduktion var vedvarende indtil forsøgets afslutning ved 24. uge. 
This reduction remained until the conclusion of the study at week 24.
- KLIM/PD/11/USA-forsøget: 
- KLIM/PD/11/USA study:
Dette betyder, at doserne af E2 og NETA er reduceret med henholdsvis 50 % og 80 %. 
This means that the doses of E2 and NETA are decreased by 50% and 80%, respectively.
Der var ingen forskelle i risici mellem forskellige administrationsveje. 
There was no evidence of a difference in risk between the different routes of administration.
Forhold som kræver overvågning 
Conditions which need supervision
Henvisningen under artikel 29, stk. 4, i Kommissionens forordning (EF) nr. 83/2001 blev oplyst til CHMP den 3. marts 2008, da Tyskland og Frankrig ikke anså ansøgningen for at være acceptabel. 
The referral under article 29(4) of directive 2001/83/EC was notified to the CHMP on March 3rd, 2008 as Germany and France did not consider the application acceptable.
Der blev den 19. marts 2008 udarbejdet en liste over spørgsmål vedrørende de emner, der skulle drøftes under denne procedure. 
A list of questions highlighting the issues to be discussed during this procedure was finalised on the 19th of March, 2008.
Kontakt Deres læge snarest muligt: 
But contact your doctor as soon as possible:
Brug af Activelle sammen med mad og drikke Tabletterne kan tages sammen med eller uden mad og drikke. 
Using Activelle with food and drink The tablets can be taken with or without food and drink.
Deres læge vil fortælle Dem, hvornår De kan starte på behandlingen igen. 
Your doctor will tell you when you can start treatment again.
Erfaring med behandling af kvinder over 65 år er begrænset. 
The experience of treating women older than 65 years is limited.
Frie eller biologisk aktive hormonkoncentrationer er uforandrede. 
Free or biological active hormone concentrations are unchanged.
I alle tilfælde bør der foretages en nøje vurdering af fordele og risici mindst en gang om året, og HRT bør kun fortsættes, så længe fordelen opvejer risikoen. 
In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder: 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains:
Farmakokinetikken hos ældre er ikke undersøgt. 
The pharmacokinetics in the elderly has not been studied.
A-1010 Vienna Østrig 
A-1010 Vienna Austria
Medicinsk undersøgelse/opfølgning 
Medical examination/follow-up
• Systemisk lupus erythematose 
• Systemic lupus erythematosus
Drej ugedagsskiven hver dag 
Move the dial every day
En ny kombination burde ikke inducere en højere frekvens af hyperplasi, når der sammenlignes med de for nylig godkendte kombinationer. 
A new combination should not induce a higher frequency of hyperplasia as compared to the recently authorised combinations.
HRT kan øge denne risiko yderligere. 
HRT may add to this risk.
B-1070 Brussel Belgien 
B-1070 Brussel Belgium
Der findes ikke afgørende beviser for forbedring af den kognitive funktion. 
There is no conclusive evidence for improvement of cognitive function.
Amenorrhoea (ingen blødning eller pletblødning) er observeret hos 89% kvinder i den 6. behandlingsmåned. 
Amenorrhoea (no bleeding or spotting) was seen in 89% of the women in month 6 of treatment.
Halveringstiden for 17β-østradiol er ca. 15 timer. 
The half-life of 17β-estradiol is about 15 hours.
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF ACTIVELLE OG TILKNYTTEDE NAVNE (SE BILAG I) 
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ACTIVELLE AND ASSOCIATED NAMES (SEE ANNEX I)
Forekomsten af sådanne tilfælde er mere sandsynlig i det første år af HRT-behandlingen end senere. 
The occurrence of such an event is more likely in the first year of HRT than later.
NET bindes til SHBG (36%) og til albumin (61%). 
NET binds to SHBG (36%) and to albumin (61%).
Resumé af CHMP's udtalelse 
Summary of CHMP's Opinion
Hvis nogen af følgende tilstande er til stede, er forekommet for nylig og/eller er blevet forværret under graviditet eller tidligere hormonbehandling, skal patienten overvåges nøje. 
If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
Den viste hyppighed skal tolkes i lyset af dette: 
The presented frequencies should be interpreted in that light:
Riverside Business Park Boulevard International BE-1070 Brussels Belgien 
Riverside Business Park Boulevard International BE-1070 Brussels Belgium
Husk at De kun skal tage en tablet en gang om dagen. 
Remember to take only one tablet once a day.
Lægen vil forklare virkningen af at stoppe hormonbehandlingen og diskutere andre behandlingsmuligheder med Dem. 
Your doctor will explain the effects of stopping treatment and discuss other possibilities with you.
Activelle kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger. 
Like all medicines, Activelle can have side effects, although not everybody gets them.
For at man kan opdage eventuelle knuder i brystet så tidligt som muligt, er det vigtigt, at De undersøger Deres bryster regelmæssigt for ændringer, og at De diskuterer eventuelle ændringer med lægen. 
To be able to detect a breast tumour as early as possible, it is important to regularly check your breasts for any changes and to discuss any changes with your doctor.
Det kan være skadeligt for andre, selvom de har de samme symptomer, som De har. 
It may harm them, even if their symptoms are the same as yours
Årsager til øjeblikkelig ophør af behandlingen 
Reasons for immediate withdrawal of therapy
Det er beregnet til administration én gang dagligt til postmenopausale kvinder med en intakt uterus. 
It is intended for once daily administration to postmenopausal women with an intact uterus.
• Hvis De har epilepsi eller astma 
• If you have epilepsy or asthma
FrieT4 og T3 koncentrationer er uforandrede. 
Free T4 and free T3 concentrations are unaltered.
Det vides ikke, hvorvidt disse resultater også gælder kvinder, som er under 65 år, når de starter behandlingen, eller kvinder der tager andre HRTpræparater. 
It is not known whether these results also applies to women younger than 65 years when starting the treatment or to women taking other HRT preparations.
Tag altid Activelle nøjagtigt efter lægens anvisning. 
Always take Activelle exactly as your doctor has told you.
Se indlægsseddel for yderligere oplysninger. 
See leaflet for further information.
Vip næste tablet ud. 
Tip out the next tablet.
Hormonbehandlingen bør ikke genoptages, før kvinden igen er helt mobil. 
Treatment should not be restarted until the woman is completely mobilised.
Depression eller forværret depression 
Depression or depression aggravated
Lindring af menopausale symptomer opnås i løbet af de første få ugers behandling. 
Relief of menopausal symptoms is achieved during the first few weeks of treatment.
Blødning og/eller pletblødning forekom hos 11-15% af kvinderne i de første 6 behandlingsmåneder. 
Bleeding and/or spotting appeared in 11 to 15% of the women during the first six months of treatment.
Klassen "forstyrret proliferativ", der bruges i forsøget KLIM/PD/7/USA, er ikke ordentligt defineret og normalt ikke anerkendt. 
The class “disordered proliferative” used in study KLIM/PD/7/USA is not well defined and not usually recognized.
Det skal bemærkes, at stikprøvestørrelsen var meget lille (22 til 29 kvinder), og at der ikke er opstillet nogen 95 %konfidensintervaller for incidensen af hyperplasi. 
It should be noted that sample size was very small (22 to 29 women), and no 95% confidence intervals for the incidence of hyperplasia are stated.
Tal med Deres læge, hvis Deres gener ikke er blevet mindre efter tre måneders behandling. 
Talk to your doctor if your symptoms are not better after three months of treatment.
Meget almindelige bivirkninger - Vaginalblødning. 
Very common side effects • Vaginal bleeding.
(Særnavn) Navn 
(Invented) Name Strength
Undersøgelser inklusive mammografi bør foretages i henhold til gældende screening-praksis, men tilpasset den enkeltes behov. 
Investigations, including mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
Novo Nordisk Pharmaceutique S.A. 30 Rue De Valmy FR-92936 Paris La Defence Cedex Frankrig 
Novo Nordisk Pharmaceutique S.A. 30 Rue De Valmy FR-92936 Paris La Defence Cedex France
Activelle ordineres til kvinder, som ikke har fået fjernet deres livmoder, og som ikke har haft menstruation i over et år. 
Activelle is prescribed for women who have not had their womb removed, and whose periods stopped more than a year ago.
Kvinder bør lære, hvilke slags forandringer i brysterne, som skal rapporteres til lægen eller sygeplejersken (Se afsnittet om ”Brystcancer” nedenfor). 
Women should be advised what changes in their breasts should be reported to their doctor or nurse (see section below “Breast cancer”).
Hvis patienten glemmer at tage en tablet, skal den glemte tablet tages snarest muligt inden for de næste 12 timer. 
If the patient has forgotten to take a tablet, the tablet should be taken as soon as possible within the next twelve hours.
- Procentdelen af proliferativt endometrium (71 %) var højere, hvorimod procentdelen af atrofisk endometrium var lavere (19 %) end forventet i forbindelse med en kontinuert kombination. 
- The proportion of proliferative endometrium (71%) was higher, on the contrary the proportion of atrophic endometrium was lower (19%) than expected for a continuous combination.
Kontakt Deres læge snarest muligt. 
See a doctor as soon as possible.
De kan først dreje den gennemsigtige skive, når De har fjernet tabletten i åbningen. 
You can only turn the transparent dial after the tablet in the opening has been removed.
Hvis der opstår nogle af følgende tilstande, skal De stoppe med at tage Activelle low og straks kontakte Deres læge: 
If you are experiencing any of the following conditions below, stop taking Activelle, and contact your doctor immediately:
Hvis De har nært familiemedlem (mor, søster, mormor eller farmor), som har lidt af alvorlig sygdom, som for eksempel blodprop eller brystkræft, har De muligvis også en øget risiko. 
If you have any close relative (mother, sister, maternal or paternal grandmother), who has suffered from serious illness, e.g. blood clot or breast cancer, you might also be at increased risk.
Grundet den store forskel mellem dyrearter og mellem dyr og mennesker, er forudsigeligheden af effekten på mennesker på baggrund af prækliniske resultater kun af begrænset værdi. 
Due to the large differences between animal species and between animals and humans preclinical results are of limited value for predicting the effect on humans.
Efter oral administration af en Activelle tablet bliver norethisteronacetat hurtigt optaget og omdannet til norethisteron (NET). 
After oral administration of an Activelle tablet, norethisterone acetate is rapidly absorbed and transformed to norethisterone (NET).
MWS-studiet estimerede ud fra den kendte forekomst af brystcancer i industrialiserede lande, at: 
The MWS has estimated, from the known average incidence of breast cancer in developed countries, that:
Ikke-kliniske data baseret på konventioenelle studier pharmakologisk sikkerhed, genotoksicitet og karcinogen potentiale udviser ingen specielle humane risici udover hvad, der allerede er diskuteret i andre dele af produktresuméet. 
Non-clinical data based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential reveal no special hazard for humans apart from those already discussed in other sections of the summary of product characteristics.
Der er ingen bevis for, at hormonbehandling forbedrer evnen til at huske, tænke, lære og vurdere (kognitiv funktion). 
There is no evidence that HRT improves processes of remembering, learning and judging (cognitive function).
Den svarer til abnormt endometrium, og sondringen fra hyperplastisk er ikke entydig. 
It corresponds to abnormal endometrium and distinction from hyperplasia is not so clear.