FrancophonIA/ELRC3.0 huggingface dataset:
English: Viraferon, 1 million IU/ml powder and solvent for solution for injection Interferon alfa-2b
Danish: Viraferon 1 million IE/ml pulver og solvens til injektionsvæske, opløsning Interferon alfa-2b
English: NAME OF THE MEDICINAL PRODUCT Viraferon 3 million IU/ml powder and solvent for solution for injection interferon alfa-2b
Danish: LÆGEMIDLETS NAVN Viraferon 3 millioner IE/ml pulver og solvens til injektionsvæske interferon alfa-2b
English: MARKETING AUTHORISATION NUMBERS EU/1/99/128/004
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/99/128/004
English: MARKETING AUTHORISATION NUMBERS EU/1/99/128/006
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/99/128/006
English: One vial of powder contains 1 million IU of interferon alfa-2b produced in E.coli by recombinant DNA technology.
Danish: Et hætteglas med pulver indeholder 1 Million IE interferon alfa-2b produceret i E. coli ved rekombinant DNA-teknologi.
English: 0.5 ml of solution (corresponding to 5 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) Pack sizes of 1
Danish: 0,5 ml opløsning (svarende til 5 MIE) i et hætteglas (type I glas), med en prop (halobutylgummi) i et aftageligt segl (aluminium) med en hætte (polypropylen).
English: Before you use Viraferon How to use Viraferon Possible side effects How to store Viraferon 6.
Danish: Det skal De vide, før De begynder at bruge Viraferon 3.
English: One ml of solution contains 10 million IU of interferon alfa-2b
Danish: En ml opløsning indeholder 10 millioner UI interferon alfa-2b
English: One vial of powder contains 3 million IU of interferon alfa-2b produced in E.coli by recombinant DNA technology.
Danish: Et hætteglas med pulver indeholder 3 Millioner IE interferon alfa-2b produceret i E. coli ved rekombinant DNA-teknologi.
English: Reconstitution of Viraferon, powder for solution for injection, for parenteral administration: Viraferon is supplied as a powder at strengths of 10 million IU/ml for single-dose use.
Danish: Færdigtilberedning af Viraferon, pulver til injektionsvæske, opløsning til parenteral indgift: Viraferon leveres som et pulver i styrker på 10 millioner IE/ml til éndosisbrug.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One cartridge contains 60 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 1.2 ml.
Danish: En cylinderampul indeholder 60 millioner IE rekombinant interferon alfa-2b, produceret i E. coli ved rekombinant DNA-teknologi i 1,2 ml.
English: Viraferon, 10 million IU/ml solution for injection Interferon alfa-2b
Danish: Viraferon 10 millioner IE/ml injektionsvæske, opløsning Interferon alfa-2b
English: Reconstitution of Viraferon, powder for solution for injection, for parenteral administration: Viraferon is supplied as a powder at strengths of 3 million IU/ml for single-dose use.
Danish: Færdigtilberedning af Viraferon, pulver til injektionsvæske, opløsning til parenteral indgift: Viraferon leveres som et pulver i styrker på 3 millioner IE/ml til éndosisbrug.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Viraferon 10 million IU/ml powder for injection interferon alfa-2b
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Viraferon 10 millioner IE/ml pulver til injektionsvæske interferon alfa - 2b s.c.
English: EU/1/99/128/016 12 single dose vials
Danish: EU/1/99/128/016 12 éndosis hætteglas
English: One vial of powder contains 10 million IU of interferon alfa-2b produced in E.coli by recombinant DNA technology.
Danish: Et hætteglas med pulver indeholder 10 Millioner IE interferon alfa-2b produceret i E. coli ved rekombinant DNA-teknologi.
English: Push button scale
Danish: Trykknapsskala
English: Viraferon, 3 million IU/ml powder and solvent for solution for injection Interferon alfa-2b
Danish: Viraferon 3 millioner IE/ml pulver og solvens til injektionsvæske, opløsning Interferon alfa-2b
English: One ml of solution contains 6 million IU of interferon alfa-2b.
Danish: En ml opløsning indeholder 6 millioner IE interferon alfa-2b.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Viraferon 18 million IU/3 ml solution for injection interferon alfa-2b
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Viraferon 18 millioner IE/3 ml injektionsvæske interferon alfa - 2b s.c.
English: 24 mg of powder (corresponding to 3 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml of water for injections in an ampoule (type I glass) Pack sizes of 6
Danish: 24 mg pulver (svarende til 3 MIE) i et hætteglas (type I glas), med en prop (butylgummi) i et aftageligt segl (aluminium) med en hætte (polypropylen) og 1 ml vand til injektionsvæsker i en ampul (type I glas).
English: MARKETING AUTHORISATION NUMBERS EU/1/99/128/002
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/99/128/002
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Viraferon 25 million IU/2.5 ml solution for injection interferon alfa-2b
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Viraferon 25 millioner IE/2,5 ml injektionsvæske interferon alfa - 2b s.c.
English: Viraferon, 10 million IU/ml powder and solvent for solution for injection Interferon alfa-2b
Danish: Viraferon 10 millioner IE/ml pulver og solvens til injektionsvæske, opløsning Interferon alfa-2b
English: 24 mg of powder (corresponding to 5 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) Pack sizes of 6
Danish: 24 mg pulver (svarende til 5 MIE) i et hætteglas (type I glas), med en prop (butylgummi) i et aftageligt segl (aluminium) med en hætte (polypropylen) og 1 ml vand til injektionsvæsker i en ampul (type I glas).
English: Remove the protective cap from the Viraferon vial.
Danish: Fjern beskyttelsesklappen fra kanylen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/128/029 1 pen
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/128/031 1 pen
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/128/004 1 vial of powder EU/1/99/128/005 6 vials of powder
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/128/004 1 hætteglas med pulver
English: MARKETING AUTHORISATION NUMBER EU/1/99/128/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/99/128/001
English: The active substance is recombinant interferon alfa-2b, 60 million IU/pen The other ingredients are disodium phosphate anhydrous, Sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections.
Danish: Aktivt stof: Rekombinant interferon alfa-2b, 60 millioner IE/pen Øvrige indholdsstoffer er dinatriumphosphat vandfri, natriumdihydrogenphosphatmonohydrat, natriumedetat, natriumchlorid, m-cresol, polysorbat 80 og vand til injektionsvæsker.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/128/002 1 vial of powder EU/1/99/128/003 6 vials of powder
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/128/002 1 hætteglas med pulver
English: The active substance is recombinant interferon alfa-2b, 30 million IU/pen The other ingredients are disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections.
Danish: Aktivt stof: Rekombinant interferon alfa-2b, 30 millioner IE/pen Øvrige indholdsstoffer er dinatriumphosphat vandfri, natriumdihydrogenphosphatmonohydrat, natriumedetat, natriumchlorid, m-cresol, polysorbat 80 og vand til injektionsvæsker.
English: Gastrointestinal disorders
Danish: Anoreksi Hypertriglyceridæmi
English: The active substance is recombinant interferon alfa-2b, 18 million IU in a multiple dose vial The other ingredients are disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections.
Danish: Aktivt stof: Rekombinant interferon alfa-2b, 18 millioner IE i et flerdosis hætteglas Øvrige indholdsstoffer er dinatriumphosphat vandfri, natriumdihydrogenphosphatmonohydrat, natriumedetat, natriumchlorid, m-cresol, polysorbat 80 og vand til injektionsvæsker.
English: Children 3 years of age or older and adolescents: Interferon alfa-2b 3 MIU/m is administered subcutaneously 3 times a week (every other day) in combination with ribavirin capsules or oral solution administered orally in two divided doses daily with food (morning and evening).
Danish: 3 gange om ugen (hver anden dag) i kombination med ribavirin kapsler eller oral opløsning indgivet oralt fordelt på to daglige doser til et måltid (morgen og aften).
English: The active substance is recombinant interferon alfa-2b, 18 million IU/pen The other ingredients are disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections.
Danish: Aktivt stof: Rekombinant interferon alfa-2b, 18 millioner IE/pen Øvrige indholdsstoffer er dinatriumphosphat vandfri, natriumdihydrogenphosphatmonohydrat, natriumedetat, natriumchlorid, m-cresol, polysorbat 80 og vand til injektionsvæsker.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Viraferon 3 million IU/0.5 ml solution for injection interferon alfa-2b
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Viraferon 3 millioner IE/0,5 ml injektionsvæske interferon alfa - 2b s.c.
English: The active substance is recombinant interferon alfa-2b, 25 million IU in a multiple dose vial The other ingredients are disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections.
Danish: Aktivt stof: Rekombinant interferon alfa-2b, 25 millioner IE i et flerdosis hætteglas Øvrige indholdsstoffer er dinatriumphosphat vandfri, natriumdihydrogenphosphatmonohydrat, natriumedetat, natriumchlorid, m-cresol, polysorbat 80 og vand til injektionsvæsker.
English: 10 million IU/ml powder and solvent for solution for injection 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 6 vials of powder and 6 ampoules of solvent
Danish: 10 millioner IE/ml pulver og solvens til injektionsvæske 1 hætteglas med pulver, 1 ampul med solvens, 1 injektionssprøjte, 2 kanyler og 1 renseserviet 6 hætteglas med pulver og 6 ampuller med solvens 10 hætteglas med pulver, 10 ampuller med solvens, 10 injektionssprøjter, 20 kanyler og 10 renseservietter
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Viraferon 5 million IU/0.5 ml solution for injection interferon alfa-2b
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Viraferon 5 millioner IE/0,5 ml injektionsvæske interferon alfa - 2b s.c.
English: EU/1/99/128/020 12 single dose vials
Danish: EU/1/99/128/020 12 éndosis hætteglas
English: EU/1/99/128/012 12 single dose vials
Danish: EU/1/99/128/012 12 éndosis hætteglas
English: 24 mg of powder (corresponding to 10 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) with 1 injection syringe, 2 injection needles and 1 cleansing swab.
Danish: 24 mg pulver (svarende til 10 MIE) i et hætteglas (type I glas), med en prop (butylgummi) i et aftageligt segl (aluminium) med en hætte (polypropylen) og 1 ml vand til injektionsvæsker i en ampul (type I glas) med 1 injektionssprøjte, 2 kanyler og 1 renseserviet.
English: 24 mg of powder (corresponding to 5 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) with 1 injection syringe, 2 injection needles and 1 cleansing swab.
Danish: 24 mg pulver (svarende til 5 MIE) i et hætteglas (type I glas), med en prop (butylgummi) i et aftageligt segl (aluminium) med en hætte (polypropylen) og 1 ml vand til injektionsvæsker i en ampul (type I glas) med 1 injektionssprøjte, 2 kanyler og 1 renseserviet.
English: 24 mg of powder (corresponding to 3 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml of water for injections in an ampoule (type I glass) with 1 injection syringe, 2 injection needles and 1 cleansing swab.
Danish: 24 mg pulver (svarende til 3 MIE) i et hætteglas (type I glas), med en prop (butylgummi) i et aftageligt segl (aluminium) med en hætte (polypropylen) og 1 ml vand til injektionsvæsker i en ampul (type I glas) med 1 injektionssprøjte, 2 kanyler og 1 renseserviet.
English: The active substance is recombinant interferon alfa-2b, 3 million IU in a single dose vial The other ingredients are disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections.
Danish: Aktivt stof: Rekombinant interferon alfa-2b, 3 millioner IE i et éndosis hætteglas Øvrige indholdsstoffer er dinatriumphosphat vandfri, natriumdihydrogenphosphatmonohydrat, natriumedetat, natriumchlorid, m-cresol, polysorbat 80 og vand til injektionsvæsker.
English: The active substance is recombinant interferon alfa-2b, 10 million IU in a single dose vial The other ingredients are disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections.
Danish: Aktivt stof: Rekombinant interferon alfa-2b, 10 millioner IE i et éndosis hætteglas Øvrige indholdsstoffer er dinatriumphosphat vandfri, natriumdihydrogenphosphatmonohydrat, natriumedetat, natriumchlorid, m-cresol, polysorbat 80 og vand til injektionsvæsker.
English: The active substance is recombinant interferon alfa-2b, 5 million IU in a single dose vial The other ingredients are disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections.
Danish: Aktivt stof: Rekombinant interferon alfa-2b, 5 millioner IE i et éndosis hætteglas Øvrige indholdsstoffer er dinatriumphosphat vandfri, natriumdihydrogenphosphatmonohydrat, natriumedetat, natriumchlorid, m-cresol, polysorbat 80 og vand til injektionsvæsker.
English: One ml of solution contains 10 million IU of interferon alfa-2b.
Danish: En ml opløsning indeholder 10 millioner IE interferon alfa-2b.
English: Injection site pain Injection site necrosis, face oedema
Danish: Nekrose på injektionsstedet, ansigtsødem
English: Check that Viraferon, solution for injection, is clear and colourless in appearance prior to use.
Danish: Når De er parat til at tage Deres indsprøjtning, klargøres Deres pen således: Kontroller, at Viraferon injektionsvæske, opløsning, ser klar ud før anvendelse.
English: §, asthenia, irritability, chest pain, malaise
Danish: §, influenzalignende symptomer§, asteni, irritabilitet, brystsmerte, utilpashed Smerte på injektionsstedet
English: 24 mg of powder (corresponding to 1 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) with 1 injection syringe, 2 injection needles and 1 cleansing swab.
Danish: 24 mg pulver (svarende til 1 MIE) i et hætteglas (type I glas), med en prop (butylgummi) i et aftageligt segl (aluminium) med en hætte (polypropylen) og 1 ml vand til injektionsvæsker i en ampul (type I glas) med 1 injektionssprøjte, 2 kanyler og 1 renseserviet.
English: Your doctor will advise you further.
Danish: Din læge vil rådgive dig yderligere.
English: The higher the dose, the higher the risks but all doses carry a risk.
Danish: Jo højere dosis, desto højere risici, men alle doser indebærer en risiko.
English: Pharmacist must ensure that
Danish: Apotekspersonalet skal sikre, at
English: Key messages:
Danish: De vigtigste budskaber:
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan senere opdateres af medlemsstaternes kompetente myndigheder, i samarbejde med referencemedlemsstaten, hvor det er relevant, i overensstemmelse med de fastsatte procedurer i kapitel 4, afsnit III af direktiv 2001/83/EC.
English: Please choose and read the situations which apply to you from the situations described below:
Danish: Find og læs om de situationer, der gælder for dig ud fra de situationer, der er beskrevet nedenfor:
English: This compares to 2 to 3 babies in every 100 born to women who don't have epilepsy.
Danish: Dette kan sammenlignes med 2 til 3 børn ud af 100 født af kvinder, der ikke har epilepsi.
English: It may harm them, even if their symptoms seem the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.
English: Educational materials
Danish: Uddannelsesmaterialer
English: • the patient has received the patient guide.
Danish: • patienten har modtaget patientvejledningen.
English: • Use the lowest effective dose and divide the daily dose of valproate into several small doses to be taken throughout the day.
Danish: • Anvende den laveste effektive dosis og opdele den daglige dosis af valproat i flere små doser, der skal tages i løbet af dagen.
English: • It is estimated that up to 30-40% of preschool children whose mothers took valproate during pregnancy may have problems with early childhood development.
Danish: • Det anslås, at op til 30-40% af førskolebørn, hvis mødre tog valproat under graviditeten, kan få problemer med den tidlige udvikling i barndommen.
English: [Quick Response (QR) code: A QR code should be included in the packaging material and/or the package leaflet, and its location should take into account the overall readability.]
Danish: [Quick Response (QR) kode: En QR-kode skal medtages i pakningsmaterialet og / eller indlægssedlen, og dens placering skal tage hensyn til den samlede læsbarhed]
English: If a woman plans a pregnancy
Danish: Hvis en kvinde planlægger graviditet
English: Your doctor will discuss this with you but you must also follow the advice in section 2 of this leaflet.
Danish: Din læge vil gennemgå dette med dig, men du skal også følge vejledningen i punkt 2 i denne indlægsseddel.
English: • the potential for pregnancy is assessed for all female patients.
Danish: • muligheden for graviditet skal vurderes for alle kvindelige patienter.
English: Children affected can be slow to walk and talk , intellectually less able than other children, and have difficulty with language and memory.
Danish: Berørte børn kan være langsomme til at gå og tale, have lavere intelligens end andre børn, og have problemer med sprog og hukommelse.
English: • It can cause serious birth defects and can affect the way in which the child develops as it grows.
Danish: • Det kan forårsage alvorlige fosterskader og kan påvirke måden, som barnet udvikler sig på efterhånden som det vokser.
English: <Invented name> is contraindicated in the following situations:
Danish: <Særnavn> er kontraindiceret i følgende situationer:
English: Your specialist can put several actions in place so that your pregnancy goes as smoothly as possible and any risks to you and your unborn child are reduced as much as possible.
Danish: Din specialist kan sætte flere tiltag i gang, så din graviditet går så glat som muligt, og eventuelle risici for dig og dit ufødte barn reduceres så meget som muligt.
English: These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Danish: Disse ændringer til de relevante afsnit af produktresuméet og indlægssedlen er resultatet af Referralproceduren.
English: The daily dose should be divided into at least two single doses (see section 4.6).
Danish: Den daglige dosis bør opdeles i mindst to enkeltdoser (se pkt.
English: Pregnant women
Danish: Gravide kvinder
English: These conditions also concern women who are not currently sexually active unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy.
Danish: Disse betingelser vedrører også kvinder, der ikke aktuelt er seksuelt aktive, medmindre den ordinerende læge mener, at der er tungtvejende grunde til at indikere, at der ikke er nogen risiko for graviditet.
English: Conditions of Pregnancy Prevention Programme: The prescriber must ensure that
Danish: Betingelser for præventionsprogram: Den ordinerende læge skal sikre, at
English: • Valproate carries a risk if taken during pregnancy.
Danish: • Valproat indebærer en risiko, hvis det tages under graviditet.
English: Teratogenicity and Developmental Effects
Danish: Teratogenicitet og effekt på udvikling
English: At least one effective method of contraception (preferably a user independent form such as an intra-uterine device or implant) or two complementary forms of contraception including a barrier method should be used.
Danish: Mindst én effektiv præventionsmetode (helst en brugeruafhængig form såsom spiral eller p-stav) eller to komplementære former for prævention, herunder en barrieremetode, bør anvendes.
English: Because valproate has been used for many years we know that in women who take valproate around 10 babies in every 100 will have birth defects.
Danish: Fordi valproat er blevet anvendt i mange år ved vi, at hos kvinder, der tager valproat, vil omkring 10 børn ud af 100 have fosterskader.
English: <Invented name> , <INN> can seriously harm an unborn child when taken during pregnancy.
Danish: <Særnavn>, <INN> kan skade et ufødt barn alvorligt, når det tages under graviditeten.
English: Your doctor will advise you further (see below under “Pregnancy, breast-feeding and fertility - Important advice for women”).
Danish: Din læge vil rådgive dig yderligere (se nedenfor under ” Graviditet, amning og frugtbarhed - Vigtig information til kvinder”).
English: Even if she has amenorrhea she must follow all the advice on effective contraception.
Danish: Selv hvis hun har amenorré, skal hun følge alle råd om effektiv prævention.
English: Treatment of epilepsy
Danish: Behandling af epilepsi
English: Important advice for women
Danish: Vigtig information til kvinder
English: In the exceptional circumstances when <Invented name> is the only available treatment option during pregnancy, you will be monitored very closely both for the management of your underlying condition and to check how your unborn child is developing.
Danish: I de ganske særlige tilfælde, hvor <Særnavn> er den eneste tilgængelige behandlingsmulighed under graviditet, vil du blive overvåget meget tæt både for at styre din underliggende sygdom og for at kontrollere, hvordan dit ufødte barn udvikler sig.
English: Pregnancy planning.
Danish: Planlægning af graviditet.
English: <Invented name> is contraindicated in the following situations: Treatment of epilepsy
Danish: <Særnavn> er kontraindiceret i følgende situationer: Behandling af epilepsi
English: By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Ved at indrapportere bivirkninger kan <De> <du> hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: • the patient card is provided with every valproate dispensing and that the patients understand its content.
Danish: • patientkortet udleveres med hver dispensering af valproat, og at patienterne forstår dets indhold.
English: I AM TAKING <invented name> AND PLANNING TO HAVE A BABY
Danish: JEG TAGER <SÆRNAVN> OG PLANLÆGGER AT FÅ ET BARN
English: I AM STARTING TREATMENT WITH <invented name>
Danish: JEG BEGYNDER BEHANDLING MED <SÆRNAVN>
English: Annex III Amendments to relevant sections of the Product Information
Danish: Ændringer i relevante afsnit af produktinformationen
English: If this is the first time you have been prescribed <Invented name> your doctor will have explained the risks to an unborn child if you become pregnant.
Danish: Hvis det er første gang, du har fået ordineret <Særnavn> vil din læge have forklaret risikoen for et ufødt barn, hvis du bliver gravid.