FrancophonIA/ELRC3.0 huggingface dataset:
English: Nasalspray, suspension
Danish: Næsespray, suspension
English: Be sure to tell your doctor immediately if you are breast-feeding.
Danish: Fortæl det straks til lægen, hvis du ammer.
English: - the therapeutic equivalence of Budesonide Sandoz to the originator in adults has been established and
Danish: - Budesonid Sandoz' terapeutiske ækvivalens med originalpræparatet er blevet dokumenteret ved behandling af voksne, og
English: • the treatment and prevention of the symptoms of allergies like hay fever (eg caused by grass pollen)
Danish: • Behandling og forebyggelse af allergisymptomer, såsom høfeber (for eksempel forårsaget af græspollen).
English: Situations which may potentially trigger acute adrenal crisis include trauma, infection, surgery or any rapid reduction in dosage.
Danish: Dette kan f. eks. være traume (kvæstelse), infektion, operation eller en hurtig dosisnedsættelse,.
English: • if you have a bacterial or fungal infection of your nose: You should use Budesonide nasal spray if you were prescribed treatment for the infection as well
Danish: • Hvis du har en bakterie- eller svampeinfektion i næsen: Du kan bruge budesonid næsespray,
English: Rare: growth suppression in children (see section 4.4), Very rare: adrenal supression
Danish: Sjælden: Væksthæmning hos børn (se pkt.
English: Budesonide nasal spray is not recommended in patients with epistaxis and in patients, with herpetic infection of oral, nasal or ophthalmic region.
Danish: Budesonid næsespray frarådes til patienter med epistaxis og hos patienter med herpesinfektion i mund-, næse- eller øjenregionen.
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg på apoteket, hvordan du skal aflevere medicinrester.
English: White homogeneous suspension
Danish: Hvid, ensartet suspension.
English: Pharmacotherapeutic group: Decongestants and other nasal preparations for topical use, Corticosteroids,
Danish: Farmakoterapeutisk klassifikation: Midler mod tilstoppelse og andre nasale midler til lokal anvendelse, kortikosteroider.
English: Concomitant therapy may sometimes be necessary to treat the symptoms affecting the eye caused by the allergy.
Danish: I nogle tilfælde kan det være nødvendigt med anden samtidig behandling af øjensymptomer.
English: Common: local symptoms like nasal mucosa irritation, slight haemorrhagic secretion, epistaxis (immediately after application)
Danish: Luftveje, thorax og mediastinum Almindelig: Lokale symptomer såsom slimhindeirritation, let blodig sekretion, epistaxis (umiddelbart efter administration)
English: Corticosteroids are a group of medicines which help fight inflammation.
Danish: Kortikosteroider tilhører en gruppe lægemidler, der virker mod inflammation (kroppens reaktion på cellebeskadigelse).
English: Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses.
Danish: Der kan opstå systemiske virkninger ved nasale kortikosteroider, særligt ved høje doser.
English: Treatment and prevention of signs and symptoms of seasonal and perennial allergic rhinitis Treatment of signs and symptoms of nasal polyps
Danish: Behandling og forebyggelse af tegn og symptomer på sæsonbetinget og vedvarende allergisk rhinitis.
English: After cleaning the nozzle must be primed (filled with medicine) again before use.
Danish: Efter rengøring skal næsespidsen igen klargøres (fyldes med medicin) inden anvendelse.
English: Figure 2.
Danish: Tegning 2.
English: - 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: Sjælden (≥1/10.000 og <1/1.000) Meget sjælden (<10.000)
English: Duration of treatment:
Danish: Behandlingsvarighed
English: Before using Budesonide nasal spray suspension for the first time you must prime the nozzle (i.e. fill it with medicine).
Danish: Inden budesonid næsespray, suspension anvendes første gang, skal pumpen (næsespidsen) klargøres (dvs. fyldes med medicin).
English: Figure 1.
Danish: Tegning 1.
English: Once the effect is achieved, the lowest dose which relieves your symptoms should be used.
Danish: Når virkningen er opnået, skal du anvende den laveste dosis, der kan lindre dine symptomer.
English: In the therapeutic equivalence study, systemic exposure was determined indirectly by measurement of 12-h free cortisol in the urine, correcting for creatinine excretion.
Danish: I den undersøgelse, der havde til formål at undersøge den terapeutiske ækvivalens, blev systemisk eksponering bestemt indirekte ved måling af frit kortisol i 12
English: Budesonide in not metabolised locally in the nasal mucosa.
Danish: Budesonid metaboliseres ikke lokalt i næsens slimhinde.
English: Figure 3.
Danish: Tegning 3.
English: Budesonide Nasal Spray is intended for nasal use.
Danish: Budesonid næsespray er beregnet til anvendelse i næsen.
English: Marketing Authorisation Holder
Danish: Indehaver af markedsføringstill adelse
English: Afterwards, the lowest dose should be chosen that keeps the patient just without symptoms.
Danish: Herefter skal den laveste dosis, hvormed patienten er symptomfri, vælges.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines without a prescription.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: Always use Budesonide Nasal Spray exactly as your doctor has told you.
Danish: Brug altid Budesonid næsespray nøjagtigt efter lægens anvisning.
English: Store the bottle in an upright position.
Danish: Opbevar flasken stående.
English: • if you have any ulcers in your nose
Danish: • Hvis du har sår i næsen.
English: Administration of doses higher than recommended (see section 4.2) for a longer period (over months) may result in suppression of hypothalamic-pituitaryadrenal axis.
Danish: 4.2) i længere tid (månedsvis) kan resultere i suppression af hypothalamus-hypofyse-binyrebark-aksen.
English: Consideration of potential systemic effects may be needed in severe impairment of hepatic function.
Danish: I tilfælde af alvorligt nedsat leverfunktion kan det være nødvendigt at tage eventuelle systemiske virkninger i betragtning.
English: the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Budesonide Sandoz and associated names (see Annex I).
Danish: har CHMP anbefalet udstedelse af markedsføringstilladelse for Budesonid Sandoz og tilknyttede navne (se bilag I).
English: Budesonide Aqua 64 micrograms Nasal Spray
Danish: Budesonide Aqua 64 micrograms Nasal Spray mikrogram/dosis mikrogram/dosis
English: Spray into the other nostril in the same way.
Danish: Gentag fremgangsmåden i det andet næsebor.
English: However, if you have been using more 8 [Nationally completed name] 32 micrograms/dose nasal spray, suspension] sprays a day for more than a month consult your doctor immediately.
Danish: Hvis du har brugt mere end 8 pust [Navn udfyldes nationalt], 32 mikrogram/dosis om dagen i mere end en måned, skal du dog straks kontakte lægen.
English: Nasal polyps Adults, adolescents (12 years of age and older) and children older than 6 years of age: The recommended starting dose of Budesonide nasal spray is a total of 8 [Nationally completed name] 32 micrograms/dose nasal spray, suspension] sprays (256 micrograms) each day.
Danish: Næsepolypper Voksne, unge (12 år eller derover) og børn 6 år eller derover: Den anbefalede startdosis budesonid næsespray er i alt 8 pust (256 mikrogram) [Navn udfyldes nationalt], 32 mikrogram/dosis, hver dag.
English: Cleaning your Budesonide nasal spray suspension You should clean the plastic nozzle of Budesonide nasal spray suspension regularly, and at any time the spray of medicine is not coming out as it should.
Danish: Rengøring af budesonid næsespray Plastiknæsespidsen på budesonid næsespray, suspension bør rengøres regelmæssigt og hver gang, lægemidlet ikke kommer ud, som det skal.
English: Rare side effects (fewer than 1 patient in every 1.000 and more than 1 patient in every 10.000 patients treated): These may occur after using this medicine for a long time:
Danish: Sjældne bivirkninger (forekommer hos mellem 1 og 10 ud af 10.000 behandlede) Følgende bivirkninger kan opstå efter langvarig brug af dette lægemiddel:
English: Common side effects (fewer than 1 patient in every 10 and more than 1 patient in every 100 patients treated) These may occur immediately after using this medicine:
Danish: Almindelige bivirkninger (forekommer hos mellem 1 og ud af 100 behandlede) Disse kan opstå umiddelbart efter du har brugt lægemidlet:
English: Budesonide nasal spray is not recommended in patients with nasal ulcerations, in cases of recent surgery or nasal trauma until it is fully recovered.
Danish: Budesonid næsespray frarådes til patienter med ulcerationer i næsen samt i tilfælde af nylig operation eller næseskade, der endnu ikke er helet.
English: BUDESONIDE SANDOZ 64 µg/dose, suspension pour pulvérisation nasale
Danish: BUDESONIDE SANDOZ 64 µg/dose, suspension pour pulvérisation nasale mikrogram/dosis
English: • slightly bloody discharge from your nose
Danish: • Let blodigt næsepuds.
English: Nasal spray, suspension.
Danish: Næsespray, suspension.
English: The Applicant stated that the only difference with the originator product is an additional 0.01% of ascorbic acid, a well-characterised chemical substance and a well-established excipient in locally applied products, with no reported adverse effects.
Danish: Ascorbinsyre er et velbeskrevet kemisk stof og et veletableret hjælpestof i lokalt anvendte produkter, uden rapporterede bivirkninger.
English: Take special care with Budesonide Nasal Spray
Danish: Vær ekstra forsigtig med at bruge budesonid næsespray
English: • adrenal supression.
Danish: • Hudirritation.
English: Remove the protective cap.
Danish: Tag hætten af.
English: This leaflet was last approved in. [To be completed nationally]
Danish: Denne indlægsseddel blev senest godkendt { MM/ÅÅÅÅ } [Udfyldes nationalt]
English: • Rinse the nozzle thoroughly, dry it and then replace onto the top of the bottle.
Danish: • Næsespidsen skylles med rigeligt vand og aftørres og sættes på flasken igen.
English: During the procedure it was concluded that therapeutic equivalence to the reference product was demonstrated in adults, the safety in adults was therefore considered proven and no PK data was required.
Danish: Sikkerheden ved behandling af voksne blev derfor betragtet som påvist, og der var ikke behov for farmakokinetiske data.
English: The delivered (metered) dose of 0.05 ml nasal spray, suspension contains 64 micrograms of budesonide.
Danish: Den afgivne (afmålte) dosis à 0,05 ml næsespray, suspension indeholder 64 mikrogram budesonid.
English: However if you have been using more than 4 [Nationally completed name] 64 micrograms/dose nasal spray, suspension] sprays a day for more than a month consult your doctor immediately.
Danish: Hvis du har brugt mere end 4 pust budesonid næsespray, 64 mikrogram/dosis om dagen i mere end en måned, skal du dog straks kontakte lægen.
English: Budesonide Sandoz and associated names (see Annex I) 64 µg nasal spray suspension 2 actuations into each nostril once daily in the morning or 1 actuation into each nostril in the morning and in the evening
Danish: Budesonide Sandoz og tilhørende navne (Se bilag I) 64 mikrogram/dosis næsespray, suspension 2 pust i hvert næsebor en gang dagligt om morgenen eller 1 pust i hvert næsebor om morgenen og om aftenen.
English: How to use Budesonide nasal spray).
Danish: 3 "Sådan skal du bruge Budesonid næsespray").
English: The combination should be avoided as there are no dose recommendations for the combination, but if not possible the time interval between the administrations of the two drugs should be as long as possible.
Danish: Hvis dette ikke er muligt, skal indgift af de to lægemidler adskilles af så lang tid som muligt.
English: − Rinse the nozzle thoroughly, dry it and then replace onto the top of the bottle.
Danish: − Næsespidsen skylles med rigeligt vand og aftørres og sættes på flasken igen.
English: The recommended starting dose of Budesonide nasal spray is a total of 4 [Nationally completed name] 64 micrograms/dose nasal spray, suspension] sprays (256 micrograms) each day.
Danish: Den anbefalede startdosis budesonid næsespray er i alt 4 pust (256 mikrogram) [Navn udfyldes nationalt], 64 mikrogram/dosis, hver dag.
English: • twice daily by applying 1 spray into each nostril in the morning and 1 spray into each nostril in the evening.
Danish: • To gange dagligt med 1 pust i hvert næsebor om morgenen og 1 pust i hvert næsebor om aftenen.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Budesonide Sandoz and associated names (see Annex I) 32 µg nasal spray suspension Budesonide Sandoz and associated names (see Annex I) 64 µg nasal spray suspension [See Annex I - To be completed nationally] Budesonide
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Budesonide Sandoz og tilhørende navne (Se bilag I) 32 mikrogram/dosis næsespray, suspension Budesonide Sandoz og tilhørende navne (Se bilag I) 64 mikrogram/dosis nasal spray, suspension [Se bilag I - Udfyldes nationalt] Budesonid
English: • nose bleed
Danish: • Næseblod.
English: Very rare: ulcerations of nasal mucosa, perforation of nasal septum
Danish: Meget sjælden: Ulcerationer i næseslimhinden og perforation af næseskillevæggen.
English: • twice daily by applying 2 sprays into each nostril in the morning and 2 sprays into each nostril in the evening.
Danish: • To gange dagligt med 2 pust i hvert næsebor om morgenen og 2 pust i hvert næsebor om aftenen.
English: Budesonide Sandoz and associated names (see Annex I) 32 µg nasal spray suspension 4 actuations into each nostril once daily in the morning or 2 actuations into each nostril in the morning and in the evening.
Danish: Budesonide Sandoz og tilhørende navne (Se bilag I) 32 mikrogram/dosis næsespray, suspension 4 pust i hvert næsebor en gang dagligt om morgenen eller, 2 pust i hvert næsebor om morgenen og om aftenen.
English: Breast-feeding mothers should not use Budesonide nasal spray.
Danish: Amning Hvis du ammer, må du ikke bruge budesonid næsespray.
English: Whereas
Danish: eller
English: HOW TO USE Budesonide Nasal Spray
Danish: SÅDAN SKAL DU BRUGE BUDESONID NÆSESPRAY
English: Important information about some of the ingredients of Budesonide Nasal Spray suspension Potassium sorbate is an ingredient of Budesonide Nasal Spray.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i budesonid næsespray Budesonid næsespray indeholder kaliumsorbat, der kan forårsage hud- eller slimhindeirritation (f.eks. kontaktallergi).
English: The delivered (metered) dose of 0.05 ml nasal spray, suspension contains 32 micrograms of budesonide.
Danish: En 0,05 ml dosis (1 spray) af næsespray, suspension indeholder 32 mikrogram budesonid.
English: What Budesonide Nasal Spray is and what it is used for Before you use Budesonide Nasal Spray How to use Budesonide Nasal Spray Possible side effects
Danish: Det skal du vide, før du begynder at bruge budesonid næsespray Sådan skal du bruge budesonid næsespray Bivirkninger
English: • if you suffer frome nosebleeds
Danish: • Hvis du ofte har næseblod.
English: Budesonide Sandoz and associated names (see Annex I) 32 µg nasal spray suspension Budesonide Sandoz and associated names (see Annex I) 64 µg nasal spray suspension [See Annex I - To be completed nationally] Budesonide
Danish: Budesonide Sandoz og tilhørende navne (Se bilag I) 32 mikrogram/dosis næsespray, suspension Budesonide Sandoz og tilhørende navne (Se bilag I) 64 mikrogram/dosis næsespray, suspension [Se bilag I - Udfyldes nationalt]
English: Budesonide Sandoz 64 microgram/dosis, neusspray, suspensie
Danish: Budesonide Sandoz 64 microgram/dosis, neusspray, suspensie mikrogram/dosis mikrogram/dosis
English: You are unlikely to experience any medical problems.
Danish: Det er usandsynligt, at det vil give dig bivirkninger.
English: Uncommon side effects (fewer than 1 patient in every 100 and more than 1 patient in every 1.000 patients treated):
Danish: Ikke almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 1.000 behandlede)
English: What Budesonide Nasal Spray Suspension looks like and contents of the pack Budesonide Nasal Spray looks like a white homogeneous suspension
Danish: Budesonid næsespray er en hvid, ensartet suspension.
English: Wipe the nozzle with a clean tissue and replace the protective cap. 6.
Danish: Rengør pumpen (næsespidsen) med en ren klud og sæt hætten på.
English: Tafen Aqua 64 µg nosní spray
Danish: Tafen Aqua 64 µg nosní spray mikrogram/dosis mikrogram/dosis
English: Budesonide has a high systemic clearance (appr. 1.2 L/min) and the half-life in plasma following an intravenous dose is on average appr. 4 hours.
Danish: ), og halveringstiden i plasma efter en intravenøs dosis er i gennemsnit ca. 4 timer.
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Se Bilag 1 - Udfyldes nationalt] MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes nationalt]
English: • once daily by applying 4 sprays into each nostril in the morning or
Danish: • En gang dagligt med 4 pust i hvert næsebor om morgenen.
English: NAME OF THE MEDICINAL PRODUCT Budesonide Sandoz and associated names (see Annex I) 32 µg nasal spray suspension Budesonide Sandoz and associated names (see Annex I) 64 µg nasal spray suspension [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Budesonide Sandoz og tilhørende navne (Se bilag I) 32 mikrogram/dosis næsespray, suspension Budesonide Sandoz og tilhørende navne (Se bilag I) 64 mikrogram/dosis næsespray, suspension [Se bilag I - Udfyldes nationalt]
English: BEFORE YOU USE Budesonide Nasal Spray
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT BRUGE BUDESONID NÆSESPRAY
English: • itching
Danish: • Kløe.
English: Rare: osteoporosis (with longterm treatment)
Danish: Knogler, led, muskler og bindevæv Sjælden: Osteoporose (ved langtidsbehandling).
English: Budesonid Sandoz 32 mcg/dose 64 mcg/dose
Danish: Budesonid Sandoz 32 mikrogram/dosis mikrogram/dosis
English: • a hole in the cartilage dividing your nostrils
Danish: • Hul i næseskillevæggen.
English: Desonix
Danish: Budesonid
English: PHARMACEUTICAL FORM Nasal spray, suspension.
Danish: Rengøring af budesonid næsespray, suspension
English: • once daily by applying 2 sprays into each nostril in the morning or
Danish: • En gang dagligt med 2 pust i hvert næsebor om morgenen.
English: If you forget to use your medicine on time, use it as soon as possible, then go back to your regular dosing schedule.
Danish: Hvis du har glemt at bruge budesonid næsespray Hvis du har glemt at bruge budesonid næsespray til tiden, skal du bruge den, så snart du kommer i tanker om det, og derefter følge doseringen som sædvanligt.
English: Using more than the recommended 4 [Nationally completed name] 64 micrograms/dose nasal spray, suspension] sprays of this medicine each day will not make this medicine work any better.
Danish: Du får ikke bedre virkning af lægemidlet ved at anvende mere end de anbefalede 4 pust af [Navn udfyldes nationalt], 64 mikrogram/dosis.
English: Disodium edetate
Danish: • Udslæt.
English: Raiffeisenstraße 11
Danish: Raiffeisenstraße 11 83607 Holzkirchen
English: Each 0.05 ml dose (one spray) of this nasal spray, suspension, contains 32 micrograms of budesonide Each 0.05 ml dose (one spray) of this nasal spray, suspension, contains 64 micrograms of budesonide
Danish: En 0,05 ml dosis (1 spray) af næsespray, suspension indeholder 64 mikrogram budesonid.
English: • irritation of the skin
Danish: • Sårdannelse i næsen.
English: Using more than the recommended 8 [Nationally completed name] 32 micrograms/dose nasal spray, suspension] sprays of this medicine each day will not make this medicine work any better.
Danish: Du får ikke bedre virkning af lægemidlet ved at anvende mere end de anbefalede 8 pust [Navn udfyldes nationalt], 32 mikrogram/dosis.
English: EXP
Danish: PRODUKTRESUME
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: 0.9 ml intravenous use syringe (glass) with needle safety guard with needle safety guard
Danish: kanylebeskytt else fyldt sprøjte (glas) med kanylebeskytt else
English: Solution for injection in Subcutaneous or pre-filled
Danish: Subkutan eller intravenøs fyldt sprøjte (glas) med injektionssprøjte anvendelse.
English: Your doctor will review your treatment.
Danish: Så vil lægen revurdere din behandling.
English: Adopted at the 1-4 October 2018 PRAC
Danish: Vedtaget på PRAC's møde 1.-4. oktober 2018
English: Not known (frequency cannot be estimated from the available data)
Danish: Ikke kendt (kan ikke beregnes ud fra tilgængelige data)
English: Fertility, pregnancy and lactation
Danish: Fertilitet, graviditet og amning
English: 3 Chlormadinone, estradiol; chlormadinone acetate, ethinylestradiol ; conjugated estrogens, medrogestone ; conjugated estrogens, medroxyprogesterone acetate; conjugated estrogens, norgestrel; cyproterone, ethinylestradiol; cyproterone acetate, estradiol valerate; desogestrel; desogestrel ,ethinylestradiol; dienogest, estradiol; dienogest, ethinylestradiol; drospirenone, estradiol; drospirenone, ethinylestradiol; estradiol, estriol, levonorgestrel; estradiol, gestodene; estradiol, levonorgestrel; estradiol, medroxyprogesterone acetate; estradiol, nomegestrol acetate; estradiol, norethisterone; estradiol, norgestimate; estradiol (17-beta), progesterone; estradiol (17-beta), trimegestone; estradiol valerate, norgestrel; ethinylestradiol, etonogestrel; ethinylestradiol, etynodiol; ethinylestradiol, gestodene; ethinylestradiol, gestodene; ethinylestradiol, levonorgestrel; ethinylestradiol, lynestrenol; ethinylestradiol, norethisterone; ethinylestradiol, norgestimate; ethinylestradiol, norgestrel; levonorgestrel, ethinylestradiol; ethinylestradiol; levonorgestrel; medroxyprogesterone; mestranol, norethisterone; nomegestrol; nomegestrol acetate, estradiol; norelgestromin, ethinyl estradiol; norethisterone
Danish: 3 Chlormadinon, estradiol; chlormadinonacetat, ethinylestradiol ; konjugerede østrogener, medrogeston ; konjugerede østrogener, medroxyprogesteronacetat;konjugerede østrogener, norgestrel; cyproteron, ethinylestradiol; cyproteronacetat, estradiolvalerat; desogestrel; desogestrel ,ethinylestradiol; dienogest, estradiol; dienogest, ethinylestradiol; drospirenon, estradiol; drospirenon, ethinylestradiol; estradiol, estriol, levonorgestrel; estradiol, gestoden; estradiol, levonorgestrel; estradiol, medroxyprogesteronacetat; estradiol, nomegestrolacetat; estradiol, norethisteron; estradiol, norgestimat; estradiol (17-beta), progesteron; estradiol (17-beta), trimegeston; estradiolvalerat, norgestrel; ethinylestradiol, etonogestrel; ethinylestradiol, etynodiol; ethinylestradiol, gestoden; ethinylestradiol, gestoden; ethinylestradiol, levonorgestrel; ethinylestradiol, lynestrenol; ethinylestradiol, norethisteron; ethinylestradiol, norgestimat; ethinylestradiol, norgestrel; levonorgestrel, ethinylestradiol; ethinylestradiol; levonorgestrel; medroxyprogesteron; mestranol, norethisteron; nomegestrol; nomegestrolacetat, estradiol; norelgestromin, ethinyl estradiol; norethisteron
English: Tell your doctor immediately if you become pregnant or are planning to become pregnant.
Danish: Fortæl det straks til lægen, hvis du er gravid eller planlægger at blive gravid.
English: Depression can be serious and may sometimes lead to suicidal thoughts.
Danish: Depression kan være alvorligt og kan nogle gange føre til selvmordstanker.
English: Do not discontinue {product name} without consulting your doctor, as this may harm you and your unborn child.
Danish: Du må ikke ophøre med at tage {produktnavn} uden først at tale med lægen, da det kan være skadeligt for dig og dit ufødte barn.