FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains dolutegravir sodium equivalent to 10 mg dolutegravir.
Danish: Hver filmovertrukken tablet indeholder dolutegravirnatrium svarende til 10 mg dolutegravir.
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with nevirapine.
Danish: Den anbefalede dosis af dolutegravir til voksne er 50 mg to gange daglig, når det administreres samtidigt med nevirapin.
English: Dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% C24 ↓ 38% (induction of UGT1A1 and CYP3A enzymes)
Danish: Dolutegravir  AUC  22 % Cmax  11 % C24  38 % (induktion af UGT1A1 og CYP3A-enzymer)
English: Tivicay 10 mg film-coated tablets are white, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘10' on the other side.
Danish: Tivicay 10 mg filmovertrukne tabletter er hvide, runde, bikonvekse tabletter mærket med 'SV 572' på den ene side og '10' på den anden.
English: Dolutegravir ↔ AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (induction of UGT1A1 and CYP3A enzymes)
Danish: Dolutegravir  AUC  5 % Cmax  16 % Cτ  30 % (induktion af UGT1A1 og CYP3A-enzymer)
English: Tivicay 10 mg film-coated tablets
Danish: Tivicay 10 mg filmovertrukne tabletter
English: Tivicay 50 mg film-coated tablets are yellow, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘50' on the other side.
Danish: Tivicay 50 mg filmovertrukne tabletter er gule, runde, bikonvekse filmovertrukne tabletter mærket med koden 'SV 572' på den ene side og '50' på den anden.
English: Each film-coated tablet contains dolutegravir sodium equivalent to 25 mg dolutegravir.
Danish: Hver filmovertrukken tablet indeholder dolutegravirnatrium svarende til 25 mg dolutegravir.
English: Yellow, round, biconvex tablets approximately 9 mm in diameter debossed with ‘SV 572' on one side and ‘50' on the other side.
Danish: Gule, runde, bikonvekse tabletter med en diameter på ca. 9 mm præget med 'SV 572' på den ene side og '50' på den anden.
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid Tivicay nøjagtigt efter lægens anvisning.
English: White, round, biconvex tablets approximately 6 mm in diameter debossed with ‘SV 572' on one side and ‘10' on the other side.
Danish: Hvide, runde, bikonvekse tabletter med en diameter på ca. 6 mm præget med 'SV 572' på den ene side og '10' på den anden.
English: Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir.
Danish: Hver filmovertrukken tablet indeholder dolutegravirnatrium svarende til 50 mg dolutegravir.
English: Don't stop unless your doctor advises you to.
Danish: Du må ikke stoppe med at tage Tivicay, medmindre lægen foreskriver det.
English: Dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76% (induction of UGT1A1 and CYP3A enzymes)
Danish: Dolutegravir  AUC  59 % Cmax  47 % Cτ  76 % (induktion af UGT1A1 og CYP3A-enzymer)
English: In SPRING-2, four patients in the RAL-arm failed with major NRTI mutations and one with raltegravir resistance; in SINGLE, six patients in the EFV/TDF/FTC-arm failed with mutations associated with NNRTI resistance, and one developed a major NRTI mutation.
Danish: I SPRING-2, udviklede fire patienter i RAL-gruppen alvorlige NRTI-mutationer og en resistens over for raltegravir.
English: In patients infected with HIV-1 without resistance to the integrase class, the recommended dose of dolutegravir in children (6 to less than 12 years of age and weighing at least 15 kg) is determined according to the weight of the child.
Danish: Den anbefalede dosis af dolutegravir til børn (fra 6 år op til 12 år, som vejer mindst 15 kg), der er inficeret med hiv 1 uden resistens over for integrasehæmmere, bestemmes i henhold til barnets vægt.
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with efavirenz.
Danish: Den anbefalede dosis af dolutegravir til voksne er 50 mg to gange daglig, når det administreres samtidigt med efavirenz.
English: By BL HIV-1 RNA
Danish: Antivirale midler mod hiv-1
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 25mg film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON 25 mg filmovertrukne tabletter
English: VO Population (HIV-1 RNA <50 c/mL, Snapshot algorithm)
Danish: Tabel 8 Respons efter baseline-resistens, VIKING-3, VO-population (hiv-1-RNA < 50 kopier/ml, snapshot-algoritme)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 10mg film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON 10 mg filmovertrukne tabletter
English: Dolutegravir ↔ Methadone ↔ AUC ↓ 2% Cmax ↔ 0% Cτ ↓ 1%
Danish: Dolutegravir  Methadon  AUC  2 % Cmax  0 % C  1 %
English: Dolutegravir did not affect male or female fertility in rats at doses up to 1000 mg/kg/day, the highest dose tested (24 times the 50 mg twice daily human clinical exposure based on AUC).
Danish: 1.000 mg/kg/dag var den højeste dosis, der blev afprøvet (24 gange den humane kliniske eksponering ved 50 mg to gange daglig baseret på AUC).
English: Do not take an antacid during the 6 hours before you take Tivicay, or for at least 2 hours after you take it. (See also Section 3).
Danish: Tag ikke et antacida, i 6 timer før du tager Tivicay, eller i mindst 2 timer efter at du har taget Tivicay.
English: Tivicay 50 mg film-coated tablets
Danish: Tivicay 50 mg filmovertrukne tabletter
English: Tivicay 25 mg film-coated tablets
Danish: Tivicay 25 mg filmovertrukne tabletter
English: Tivicay 25 mg film-coated tablets are pale yellow, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘25' on the other side.
Danish: Tivicay 25 mg filmovertrukne tabletter er svagt gule, runde, bikonvekse tabletter mærket med 'SV 572' på den ene side og '25' på den anden.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 50mg film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON 50 mg filmovertrukne tabletter
English: Subjects were enrolled with a screening plasma HIV-1 RNA of 1000
Danish: Forsøgspersoner blev indskrevet med et screeningsplasma hiv-1 RNA på 1000 kopier/ml til ≤ 50.000 kopier/ml.
English: NAME OF THE MEDICINAL PRODUCT Tivicay 10 mg tablets dolutegravir
Danish: Tivicay 10 mg tabletter dolutegravir
English: Pale yellow, round, biconvex tablets approximately 7 mm in diameter debossed with ‘SV 572' on one side and ‘25' on the other side.
Danish: Svagt gule, runde, bikonvekse tabletter med en diameter på ca. 7 mm præget med 'SV 572' på den ene side og '25' på den anden.
English: Dolutegravir ↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49% (induction of UGT1A1 and CYP3A enzymes)
Danish: Dolutegravir  AUC  35 % Cmax  24 % Cτ  49 % (induktion af UGT1A1 og CYP3A-enzymer)
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓72% (induction of UGT1A1 and CYP3A enzymes)
Danish: Dolutegravir  AUC  54 % Cmax  43 % Cτ 72 % (induktion af UGT1A1 og CYP3A-enzymer)
English: NAME OF THE MEDICINAL PRODUCT Tivicay 25 mg tablets dolutegravir
Danish: Tivicay 25 mg tabletter dolutegravir
English: Total
Danish: Sjælden
English: Etravirine ↔
Danish: SPRING-2
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains dolutegravir sodium equivalent to 10 mg dolutegravir
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder dolutegravirnatrium svarende til 10 mg dolutegravir
English: Possible side effects
Danish: Sjældne bivirkninger
English: In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in children.
Danish: Der er utilstrækkelige data til at anbefale en dosis af dolutegravir til børn med resistens over for integrasehæmmere.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 25 mg film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET TIL BEHOLDER 25 mg filmovertrukne tabletter
English: Very common Headache Common Dizziness
Danish: Hovedpine Almindelig Svimmelhed Mave-tarm-kanalen Meget almindelig
English: • muscle pain
Danish: • mavepine
English: NAME OF THE MEDICINAL PRODUCT Tivicay 50 mg tablets dolutegravir
Danish: Tivicay 50 mg tabletter dolutegravir
English: Clade C
Danish: Vistor hf.
English: Rare side effects These may affect up to 1 in 1000 people:
Danish: Kan forekomme hos op til 1 ud af 1.000 personer:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains dolutegravir sodium equivalent to 25 mg dolutegravir
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder dolutegravirnatrium svarende til 25 mg dolutegravir.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 10 mg film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET TIL BEHOLDER 10 mg filmovertrukne tabletter
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 50 mg film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET TIL BEHOLDER 50 mg filmovertrukne tabletter
English: → If you think any of these apply to you, tell your doctor.
Danish:  Fortæl lægen, hvis du tror, at noget af ovenstående gælder for dig.
English: What Tivicay looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in adolescents.
Danish: Der er utilstrækkelige data til at anbefale en dosis af dolutegravir til unge med resistens over for integrasehæmmere.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder dolutegravirnatrium svarende til 50 mg dolutegravir.
English: NAME OF THE MEDICINAL PRODUCT Tivicay 25 mg film-coated tablets dolutegravir
Danish: Tivicay 25 mg filmovertrukne tabletter dolutegravir
English: Table 1 Paediatric dose recommendations Body weight (kg)
Danish: Tabel 1 Pædiatriske dosisanbefalinger
English: NAME OF THE MEDICINAL PRODUCT Tivicay 10 mg film-coated tablets dolutegravir
Danish: Tivicay 10 mg filmovertrukne tabletter dolutegravir
English: What Tivicay is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: NAME OF THE MEDICINAL PRODUCT Tivicay 50 mg film-coated tablets dolutegravir
Danish: Tivicay 50 mg filmovertrukne tabletter dolutegravir
English: In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in children and adolescents.
Danish: Der er ikke tilstrækkelige data til at anbefale en dosis af dolutegravir til børn og unge ved tilstedeværelse af resistens over for integrasehæmmere.
English: If you take more Tivicay than you should
Danish: Hvis du har taget for meget Tivicay
English: Uncommon Hypersensitivity (see section 4.4) Uncommon Immune Reconstitution Syndrome (see section 4.4)** Psychiatric disorders Common Insomnia Common Abnormal dreams
Danish: Almindelig Insomni Almindelig Unormale drømme Almindelig Depression Almindelig Angst Ikke almindelig
English: • feeling sick (nausea).
Danish: Overfølsomhed (se pkt.
English: AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
Danish: Cmax  33 % C  73 %
English: If you take too many tablets of Tivicay, contact your doctor or pharmacist for advice.
Danish: Kontakt lægen eller apoteket, hvis du har taget mere Tivicay, end der står i denne information, eller mere end lægen har foreskrevet.
English: blister (PVC/PVDC/alu) 50 x 1 tablets (unit dose)
Danish: MF (EU)-nummer
English: In the meantime, the applicant withdrew the application in the Netherlands.
Danish: I mellemtiden trak ansøgeren sin ansøgning tilbage i Nederlandene.
English: • The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as potential serious risk to public health.
Danish: • Udvalget behandlede samtlige data indsendt af ansøgeren i forbindelse med de indsigelser, der var rejse som potentiel alvorlig risiko for folkesundheden.
English: The decentralised procedure PT/H/1256/001/DC started on 04 June 2014.
Danish: Den decentrale procedure PT/H/1256/001/DC blev indledt den 4. juni 2014.
English: The application was submitted to the reference Member State (RMS): Portugal and the concerned Member States (CMS): Germany, Netherlands and United Kingdom.
Danish: Ansøgningen blev fremsendt til referencemedlemsstaten, Portugal, og de berørte medlemsstater, Tyskland, Nederlandene og Det Forenede Kongerige.
English: Day 60 of the CMDh procedure was on 29 March 2018 and as no agreement could be reached the procedure was referred to the CHMP.
Danish: Dag 60 i CMDh-proceduren var den 29. marts 2018, og da der ikke kunne opnås enighed, blev proceduren indbragt for CHMP.
English: The CMDh 60 day procedure was initiated on 29 January 2018.
Danish: CMDh's 60-dages procedure blev indledt den 29. januar 2018.
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC.
Danish: • Udvalget behandlede indbringelsen i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF.
English: The reference medicinal product (Taxol) has a complex formulation for which it is known that the micellar formulation affects the pharmacokinetic profile of paclitaxel after intravenous administration.
Danish: Referencelægemidlet (Taxol) har en kompleks formulering, for hvilken det er kendt, at den micellære formulering påvirker paclitaxels farmakokinetiske profil efter intravenøs administration.
English: Therefore, the Committee recommends the refusal of the marketing authorisation of Paclitaxel Hetero in the reference and concerned Member States.
Danish: Udvalget anbefaler derfor afslag på ansøgningen om markedsføringstilladelse for Paclitaxel Hetero i referencemedlemsstaten og de berørte medlemsstater.
English: An application was submitted under the decentralised procedure for Paclitaxel Hetero, 6 mg/mL, concentrate for solution for infusion on 15 May 2014.
Danish: Der blev den 15. maj 2014 indsendt en ansøgning i henhold til den decentrale procedure for Paclitaxel Hetero, 6 mg/ml, koncentrat til infusionsvæske, opløsning.
English: The applicant submitted a study report with results of the direct comparison of micelles' characteristics of Paclitaxel Hetero and Taxol and another publication containing data on the free drug fraction of Taxol in human plasma.
Danish: Ansøgeren forelagde en studierapport med resultaterne af den direkte sammenligning af micellernes egenskaber i Paclitaxel Hetero og Taxol og en anden publikation indeholdende data om den frie fraktion af Taxol i humant plasma.
English: The CHMP considered that it is essential in order to waive the bioequivalence study requirement to establish that the generic medicinal product and the reference medicinal product have the same behaviour in plasma and ultimately in vivo, i.e. a direct comparison of the free fraction between the two medicinal products should be considered in line with the “Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems” (EMA/CHMP/QWP/799402/2011
Danish: CHMP fandt, at det for at give dispensation fra kravet om bioækvivalensundersøgelse er afgørende at fastslå, at det generiske lægemiddel og referencelægemidlet har samme virkemåde i plasma og ultimativt in vivo, dvs. en direkte sammenligning af den frie fraktion mellem de to lægemidler bør tages i betragtning i overensstemmelse med "Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems" (EMA/CHMP/QWP/799402/2011).
English: The Netherlands raised objections on the fact that the indirect comparison data on which the applicant based its claim for equivalence was not considered robust nor was convincing enough to support a biowaiver, and this was regarded to be a potential serious risk to public health.
Danish: Nederlandene gjorde indsigelse på baggrund af, at de indirekte sammenligningsdata, hvorpå ansøgeren baserede sit krav om ækvivalens, ikke blev anset for at være solide eller tilstrækkeligt overbevisende til at støtte dispensation fra bioækvivalensundersøgelse, og dette blev anset for at udgøre en potentiel alvorlig risiko for folkesundheden.
English: On 29 March 2018 Portugal therefore triggered a referral under Article 29(4) of Directive 2001/83/EC.
Danish: Den 29. marts 2018 indledte Portugal derfor en indbringelse i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF.
English: However, the additional data provided were not robust enough to establish equivalence between Paclitaxel Hetero and the EU reference medicinal product.
Danish: De supplerende data var imidlertid ikke tilstrækkeligt solide til dokumentere ækvivalens mellem Paclitaxel Hetero og EU-referencelægemidlet.
English: While there may be occasions where an indirect comparison may be acceptable to support a biowaiver, having assessed the literature provided, the CHMP concluded that the data was not sufficiently robust nor convincing enough to replace the need for a head-to-head comparison using identical methods and performed at the same time for test and reference product, and therefore should be understood as supportive only.
Danish: Selv om der kan være tilfælde, hvor en indirekte sammenligning kan accepteres som støtte for en dispensation fra bioækvivalensundersøgelse, konkluderede CHMP efter at have vurderet den forelagte litteratur, at dataene ikke var tilstrækkeligt solide eller overbevisende til at erstatte behovet for en direkte sammenligning ved hjælp af identiske metoder og udført på samme tidspunkt for test- og referencelægemidlet, og derfor kun bør ses som underbyggende.
English: In such case, in principle a biowaiver of in vivo bioequivalence study is only possible when there are adequate in vitro data to demonstrate similarity between generic and reference medicinal product.
Danish: I dette tilfælde er det i princippet kun muligt at give dispensation fra in vivo-bioækvivalensundersøgelsen, hvis der findes tilstrækkelige in vitro-data til at påvise lighed mellem det generiske lægemiddel og referencelægemidlet.
English: The CHMP considered, as a consequence, that the benefit-risk balance of Paclitaxel Hetero is not favourable.
Danish: CHMP fandt som følge heraf, at benefit/risk-forholdet for Paclitaxel Hetero ikke er positivt.
English: The Committee, as a consequence, considers that the benefit-risk balance of Paclitaxel Hetero is not favourable.
Danish: finder udvalget følgelig, at benefit/risk-forholdet for Paclitaxel Hetero ikke er positivt.
English: On day 210, major issues on bioequivalence, raised by the Netherlands, remained unresolved; hence the procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), under Article 29, paragraph 1 of Directive 2001/83/EC, by Portugal on 02 November 2017.
Danish: Proceduren blev derfor den 2. november 2017 af Portugal indbragt for koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh) i henhold til artikel 29, stk. 1, i direktiv 2001/83/EF.
English: • The Committee considered that the data available was insufficient to establish equivalence between Paclitaxel Hetero and the EU reference medicinal product.
Danish: • Udvalget fandt, at de tilgængelige data var utilstrækkelige til at fastslå ækvivalens mellem
English: This may be repeated up to six times.
Danish: Dette kan gentages op til seks gange.
English: Tell your doctor as soon as possible.
Danish: Fortæl det til lægen så hurtigt som muligt.
English: • Wash your hands before you begin.
Danish: • Vask hænder, før du begynder.
English: Do not apply further force.
Danish: Undgå at anvende yderligere kraft.
English: A higher than proportional increase in exposure was observed.
Danish: Der blev observeret en mere end proportional stigning i eksponeringen.
English: Thus, no valid estimation of the absolute bioavailability could be done.
Danish: Der kunne således ikke foretages et gyldigt skøn af den absolutte biotilgængelighed.
English: 1160 Vienna
Danish: 1160 Wien
English: not known
Danish: ikke kendt
English: These elevations were mostly transient and occurred during the first treatment year.
Danish: Disse stigninger var for det meste forbigående og optrådte i det første år af behandlingen.
English: Duration of PV (months)*
Danish: PV-varighed (måneder)*
English: After first use
Danish: Efter første brug
English: • Immunosuppressed transplant recipients
Danish: • Immunsupprimerede transplantationsmodtagere
English: Effects on fertility was not assessed.
Danish: Virkninger på fertiliteten blev ikke undersøgt.
English: Presence of splenomegaly
Danish: Tilstedeværelse af splenomegali
English: Instead, get a new pen.
Danish: Tag i stedet en ny pen.
English: Benzyl alcohol may cause allergic reactions.
Danish: Benzylalkohol kan give allergiske reaktioner.
English: Your doctor will tell you the dose you need.
Danish: Din læge vil fortælle dig, hvilken dosis du har brug for.
English: You will see the figures in the window change, and you will hear clicks when the button moves.
Danish: Du vil kunne se, at tallene i vinduet skifter, og du vil høre et klik, når trykknappen bevæges.
English: Empty pens must never be reused and must be properly discarded.
Danish: Tomme penne må aldrig genbruges og skal kasseres på korrekt vis.
English: Your doctor will usually check your vision before starting your treatment.
Danish: Din læge vil normalt undersøge dit syn, før du starter behandlingen.
English: Do not use the pen if it appears damaged.
Danish: Brug ikke pennen, hvis den er beskadiget.
English: • Pre-existing thyroid disease unless it can be controlled with conventional treatment
Danish: • Forud eksisterende thyroideasygdom medmindre den kan kontrolleres med konventionel behandling
English: Interferons are produced by your immune system to block the growth of cancer cells.
Danish: Interferoner produceres af dit immunsystem for at blokere kræftcellernes vækst.
English: You should inject the dose as soon as you remember.
Danish: Du skal injicere dosen, så snart du husker det.
English: It will need a certain time to reach your individual optimal dose of Besremi.
Danish: Det vil tage noget tid, før du opnår din individuelle optimale dosis Besremi.
English: Do not stop using Besremi before you have talked to your doctor.
Danish: Du må ikke stoppe med at bruge Besremi, før du har talt med din læge.
English: Do not give this medicine to children and adolescents because no information is available on the use of Besremi in this age group.
Danish: Dette lægemiddel må ikke gives til børn og unge, fordi der ikke findes oplysninger om brugen af Besremi til denne aldersgruppe.
English: Since Besremi is a solution, it does not require resuspension before use.
Danish: Eftersom Besremi er en opløsning, kræves der ikke resuspension før anvendelse.
English: • Note: The blue protective sleeve locks automatically and the now visible red locking indicator covers the needle for your protection.
Danish: • Bemærk: Den blå beskyttelsesmuffe låser automatisk, og den nu synlige røde låseindikator dækker kanylen for din egen sikkerheds skyld.
English: This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Danish: Dette skyldes, at store mængder benzylalkohol kan ophobe sig i din krop og give bivirkninger (kaldet "metabolisk acidose").
English: You will need the following supplies for your injection:
Danish: Du skal bruge følgende udstyr til injektionen:
English: - if you take telbivudine (a medicine used to treat hepatitis B infection).
Danish: - hvis du tager telbivudin (et lægemiddel, der anvendes til behandling af hepatitis B infektion).
English: The dose at which stabilisation of the haematological parameters is achieved should be maintained in a two week administration interval for at least 1.5 years.
Danish: Dosen, hvor der opnås stabilisering af de hæmatologiske parametre, skal opretholdes med et administrationsinterval på to uger i mindst 1,5 år.
English: Always use a new needle for each injection.
Danish: Brug altid en ny kanyle til hver injektion.