FrancophonIA/ELRC3.0 huggingface dataset:
English: Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effects), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Danish: Øget antal hvide blodlegemer (eosinofili), for få blodplader (trombocytopeni), alvorlige allergiske reaktioner (anafylaktisk reaktion), overfølsomhedsreaktioner (såsom udslæt, kløe, vejrtrækningsbesvær, hvæsende åndedræt, hævelser i ansigtet og lavt blodtryk), lave blodsukkerniveauer (hos diabetespatienter), nervøsitet, søvnighed nedsat syn, hurtig hjerterytme (puls), mundtørhed, maveuro, smagsforstyrrelser, unormal leverfunktion (japanske patienter har større sandsynlighed for at få denne bivirkning), eksem (en hudlidelse), rødmen, nældefeber, alvorligt medicinudløst udslæt, ledsmerter, smerter i arme og ben, senesmerter, influenzalignende symptomer, hæmaglobinmangel, forhøjet urinsyre, kreatinin, leverenzymer og kreatininkinase.
English: The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4).
Danish: I første trimester kan behandling med angiotensin II-receptorantagonister ikke anbefales (se pkt.
English: The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia dizziness, increase in serum creatinine, and acute renal failure have also been reported.
Danish: Bradykardi, svimmelhed, øget serumkreatinin og akut nyresvigt er også set.
English: What Telmisartan Teva is and what it is used for What you need t know before you take Telmisartan Teva How to take Telmisartan Teva Possible side effects
Danish: Det skal du vide, før du begynder at tage Telmisartan Teva Sådan skal du tage Telmisartan Teva Bivirkninger
English: White to off white, oval shaped tablet; one side of the tablet is debossed with the number "93".
Danish: Hvide til råhvide, ovale tabletter, hvor den ene side af tabletten er præget med tallet "93".
English: ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events.
Danish: De var 55 år eller ældre og havde en anamnese med koronararteriesygdom, apopleksi, transitorisk cerebral iskæmi (TCI), perifer arteriel sygdom eller diabetes mellitus type 2 med en organpåvirkning (f.eks. retinopati, venstre ventrikel hypertrofi, makro- eller mikroalbuminuri).
English: • Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
Danish: • Medicin, som kan forhøje blodets indhold af kalium, såsom kaliumholdige saltsubstitutter, kaliumbesparende medicin (visse typer diuretika eller vanddrivende tabletter), ACE-hæmmere, angiotensin II-receptorantagonister, non-steroid antiinflammatorisk medicin (NSAID'er som aspirin og ibuprofen), heparin, lægemidler der undertrykker immunsystemet (som cyclosporin og tacrolimus) og antibiotika indeholdende trimethoprim.
English: If concomitant use is indicated because of documented hypokalaemia, they should be used with caution and with frequent monitoring of serum potassium.
Danish: Der bør udvises forsigtighed og hyppigt udføres monitorering af serumkalium, hvis en sådan samtidig behandling er nødvendig på grund af dokumenteret hypokaliæmi.
English: Limited experience is available in patients with severe renal impairment or haemodialysis.
Danish: Der er utilstrækkelige data for patienter med svært nedsat nyrefunktion og for patienter, som er i hæmodialyse.
English: The use of angiotensin II receptor antagonists is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Danish: I andet og tredje trimester er behandling med angiotensin II-receptorantagonister kontraindiceret (se pkt.
English: Telmisartan Teva 80 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Danish: Telmisartan Teva 80 mg tabletter er hvide til råhvide, ovale tabletter, hvor den ene side af tabletten er præget med tallet "93".
English: Tel: +353 51 321740
Danish: Teva Pharmaceuticals Ireland Tel: +353 51 321740
English: Telmisartan Teva 40 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Danish: Telmisartan Teva 40 mg tabletter er hvide til råhvide, ovale tabletter, hvor den ene side af tabletten er præget med tallet "93".
English: Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for perforated blisters.
Danish: Pakningsstørrelser a 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablet med perforerede blistere.
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Danish: Patienterne skal indtage tilstrækkeligt med væske, og den behandlende læge bør være opmærksom på nødvendigheden af at monitorere nyrefunktionen.
English: Telmisartan Teva 20 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Danish: Telmisartan Teva 20 mg tabletter er hvide til råhvide, ovale tabletter, hvor den ene side af tabletten er præget med tallet "93".
English: Each tablet contains 21.4 mg sorbitol (E420) For the full list of excipients, see section 6.1.
Danish: En tablet indeholder 20 mg telmisartan Hjælpestoffer, som behandleren skal være opmærksom på: En tablet indeholder 21,4 mg sorbitol (E420) Alle hjælpestoffer er anført under pkt.
English: Each Telmisartan Teva tablet contains 20 mg telmisartan.
Danish: En Telmisartan Teva tablet indeholder 20 mg telmisartan.
English: Each Telmisartan Teva tablet contains 40 mg telmisartan.
Danish: En Telmisartan Teva tablet indeholder 40 mg telmisartan.
English: INFORMATION IN BRAILLE Telmisartan Teva 40 mg
Danish: Telmisartan Teva 40 mg
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release TEVA Pharmaceutical Works Private Limited Company HU-4042 Debrecen
Danish: TEVA Pharmaceutical Works Private Limited Company HU-4042 Debrecen
English: Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium,
Danish: • Medicin, som kan forhøje blodets indhold af kalium, såsom kaliumholdige saltsubstitutter,
English: Vascular disorders Uncommon:
Danish: Vaskulære sygdomme Ikke almindelig:
English: INFORMATION IN BRAILLE Telmisartan Teva 80 mg
Danish: Telmisartan Teva 80 mg
English: Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5 % CI 0.90 - 1.08), p (non-inferiority) = 0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.
Danish: Mht. det prædefinerede sekundære endepunkt (reduktion af kardiovaskulær død, ikke-letalt myokardieinfarkt og ikke-letal apopleksi) - som var identisk med det primære endepunkt i HOPE-studiet (The Heart Outcomes Prevention Evaluation Study) − blev telmisartan fundet ligeværdig med ramipril [0,99 (97,5% CI 0,90-1,08, p (non-inferioritet) = 0,0004)].
English: Each Telmisartan Teva tablet contains 80 mg telmisartan.
Danish: En Telmisartan Teva tablet indeholder 80 mg telmisartan.
English: Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Patienter, som planlægger graviditet, bør skifte til en alternativ antihypertensiv behandling, der er sikker at anvende for gravide, medmindre fortsat behandling med angiotensin II-receptorantagonist er påkrævet.
English: Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for peelable perforated blisters.
Danish: Pakningsstørrelser a 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablet med blistere med aftrækkeligt folie.
English: Each tablet contains 85.6 mg sorbitol (E420) For the full list of excipients, see section 6.1.
Danish: En tablet indeholder 80 mg telmisartan Hjælpestoffer, som behandleren skal være opmærksom på: En tablet indeholder 85,6 mg sorbitol (E420) Alle hjælpestoffer er anført under pkt.
English: Each tablet contains 42.8 mg sorbitol (E420) For the full list of excipients, see section 6.1.
Danish: En tablet indeholder 40 mg telmisartan Hjælpestoffer, som behandleren skal være opmærksom på: En tablet indeholder 42,8 mg sorbitol (E420) Alle hjælpestoffer er anført under pkt.
English: Some patients may already benefit at a daily dose of 20 mg.
Danish: Hos nogle patienter kan blodtrykket kontrolleres tilfredsstillende med blot 20 mg én gang daglig.
English: How to store Telmisartan Teva Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger Telmisartan Teva indeholder:
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Teva 20 mg tablets
Danish: Indlægsseddel: Information til brugeren Telmisartan Teva 20 mg tabletter
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Teva 40 mg tablets
Danish: Indlægsseddel: Information til brugeren Telmisartan Teva 40 mg tabletter
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Teva 80 mg tablets
Danish: Indlægsseddel: Information til brugeren Telmisartan Teva 80 mg tabletter
English: PHARMACEUTICAL PARTICULARS
Danish: LÆGEMIDLETS NAVN
English: Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Danish: Lægemidler, der kan udløse hyperkaliæmi, er kaliumholdige saltsubstitutter, kaliumbesparende diuretika, ACE-hæmmere, angiotensin II-receptorantagonister, non-steroide antiinflammatoriske lægemidler (NSAID'er, herunder selektive COX-2-hæmmere), heparin, immunosuppressiva (cyclosporin eller tacrolimus) og trimethoprim.
English: Alternatively, telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure lowering effect with telmisartan.
Danish: Alternativt kan telmisartan anvendes i kombination med et diuretikum af thiazidgruppen, såsom hydrochlorthiazid.
English: Cases of interstitial lung disease have been reported from post-marketing experience in temporal association with the intake of telmisartan.
Danish: Efter markedsføring er der set tilfælde af interstitiel lungesygdom hos patienter i behandling med telmisartan uden at der dog er fastslået en årsagssammenhæng.
English: When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy, such as Telmisartan Teva.
Danish: Man bør være opmærksom på, at der ved antihypertensiv behandling, som for eksempel med Telmisartan Teva, lejlighedsvis kan forekomme svimmelhed eller døsighed.
English: • Periodic Safety Update Reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR)
English: INFORMATION IN BRAILLE Telmisartan Teva 20 mg
Danish: Telmisartan Teva 20 mg
English: Posology
Danish: Telmisartan
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Danish: Samtidig behandling med angiotensin II-receptorantagonister og stoffer, der hæmmer cyclooxygenasen kan medføre en yderligere svækkelse af nyrefunktionen hos nogle patienter, der allerede har nedsat nyrefunktion (såsom dehydrerede patienter eller ældre patienter).
English: potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal antiinflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Danish: Lægemidler, der kan udløse hyperkaliæmi: Kaliumholdige saltsubstitutter, kaliumbesparende diuretika, ACE-hæmmere, angiotensin II-receptorantagonister, non-steroide anti-inflammatoriske lægemidler (NSAID'er herunder selektive COX-2-hæmmere), heparin, immunosuppressiva (cyclosporin eller tacrolimus) og trimethoprim.
English: These changes, also a class effect of angiotensin converting enzyme inhibitors and other angiotensin II receptor antagonists, do not appear to have clinical significance.
Danish: Disse fund synes ikke at være af signifikant klinisk betydning og anses også for at være klasseeffekter ved ACE-hæmmere og andre angiotensin II-receptorantagonister.
English: or have salt deficiency due to diuretic therapy (‘water tablets'), low-salt diet, diarrhoea, or vomiting.
Danish: For lavt blodtryk (hypotension), som kan forekomme, hvis du er dehydreret (overdrevent tab af kropsvæske) eller er i saltunderskud efter anvendelse af vanddrivende medicin, er på saltfattig kost, har diarré eller ved opkastning.
English: Read the package leaflet for further information
Danish: Læs flere oplysninger i indlægssedlen.
English: The manufacturer is:
Danish: Fremstiller:
English: EU/1/09/610/041 14x1 tablets EU/1/09/610/042 28x1 tablets EU/1/09/610/043 30x1 tablets EU/1/09/610/044 40x1 tablets EU/1/09/610/045 56x1 tablets EU/1/09/610/046 60x1 tablets EU/1/09/610/047 84x1 tablets EU/1/09/610/048 90x1 tablets EU/1/09/610/049 98x1 tablets EU/1/09/610/050
Danish: EU/1/09/610/041 14x1 tablet EU/1/09/610/042 28x1 tablet EU/1/09/610/043 30x1 tablet EU/1/09/610/044 40x1 tablet EU/1/09/610/045 56x1 tablet EU/1/09/610/046 60x1 tablet EU/1/09/610/047 84x1 tablet EU/1/09/610/048 90x1 tablet EU/1/09/610/049 98x1 tablet EU/1/09/610/050 100x1 tablet EU/1/09/610/061 30 tabletter
English: EU/1/09/610/031 14x1 tablets EU/1/09/610/032 28x1 tablets EU/1/09/610/033 30x1 tablets EU/1/09/610/034 40x1 tablets EU/1/09/610/035 56x1 tablets EU/1/09/610/036 60x1 tablets EU/1/09/610/037 84x1 tablets EU/1/09/610/038 90x1 tablets EU/1/09/610/039 98x1 tablets EU/1/09/610/040 100x1 tablets
Danish: EU/1/09/610/031 14x1 tablet EU/1/09/610/032 28x1 tablet EU/1/09/610/033 30x1 tablet EU/1/09/610/034 40x1 tablet EU/1/09/610/035 56x1 tablet EU/1/09/610/036 60x1 tablet EU/1/09/610/037 84x1 tablet EU/1/09/610/038 90x1 tablet EU/1/09/610/039 98x1 tablet EU/1/09/610/040 100x1 tablet
English: In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations was observed.
Danish: Plasmakoncentrationer er set dobbelt så høje hos patienter med let til moderat og svært nedsat nyrefunktion.
English: EU/1/09/610/051 14x1 tablets EU/1/09/610/052 28x1 tablets EU/1/09/610/053 30x1 tablets EU/1/09/610/054 40x1 tablets EU/1/09/610/055 56x1 tablets EU/1/09/610/056 60x1 tablets EU/1/09/610/057 84x1 tablets EU/1/09/610/058 90x1 tablets EU/1/09/610/059 98x1 tablets EU/1/09/610/060
Danish: EU/1/09/610/051 14x1 tablet EU/1/09/610/052 28x1 tablet EU/1/09/610/053 30x1 tablet EU/1/09/610/054 40x1 tablet EU/1/09/610/055 56x1 tablet EU/1/09/610/056 60x1 tablet EU/1/09/610/057 84x1 tablet EU/1/09/610/058 90x1 tablet EU/1/09/610/059 98x1 tablet EU/1/09/610/060 100x1 tablet EU/1/09/610/062 30 tabletter
English: EU/1/09/610/011 14x1 tablets EU/1/09/610/012 28x1 tablets EU/1/09/610/013 30x1 tablets EU/1/09/610/014 40x1 tablets EU/1/09/610/015 56x1 tablets EU/1/09/610/016 60x1 tablets EU/1/09/610/017 84x1 tablets EU/1/09/610/018 90x1 tablets EU/1/09/610/019 98x1 tablets EU/1/09/610/020 100x1 tablets
Danish: EU/1/09/610/011 14x1 tablet EU/1/09/610/012 28x1 tablet EU/1/09/610/013 30x1 tablet EU/1/09/610/014 40x1 tablet EU/1/09/610/015 56x1 tablet EU/1/09/610/016 60x1 tablet EU/1/09/610/017 84x1 tablet EU/1/09/610/018 90x1 tablet EU/1/09/610/019 98x1 tablet EU/1/09/610/020 100x1 tablet
English: At the beginning of the preventive therapy with Micardis 80 mg, blood pressure should be frequently monitored.
Danish: I den første periode af behandlingen skal blodtrykket kontrolleres regelmæssigt.
English: EU/1/09/610/001 14x1 tablets EU/1/09/610/002 28x1 tablets EU/1/09/610/003 30x1 tablets EU/1/09/610/004 40x1 tablets EU/1/09/610/005 56x1 tablets EU/1/09/610/006 60x1 tablets EU/1/09/610/007 84x1 tablets EU/1/09/610/008 90x1 tablets EU/1/09/610/009 98x1 tablets EU/1/09/610/010 100x1 tablets
Danish: EU/1/09/610/001 14x1 tablet EU/1/09/610/002 28x1 tablet EU/1/09/610/003 30x1 tablet EU/1/09/610/004 40x1 tablet EU/1/09/610/005 56x1 tablet EU/1/09/610/006 60x1 tablet EU/1/09/610/007 84x1 tablet EU/1/09/610/008 90x1 tablet EU/1/09/610/009 98x1 tablet EU/1/09/610/010 100x1 tablet
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder
Danish: Hvis du vil have yderligere oplysninger om Telmisartan Teva, skal du henvende dig til den lokale repræsentant:
English: A.
Danish: SN:
English: Package leaflet: Information for the user
Danish: INFORMATION VEDRØRENDE ANVENDELSEN
English: General disorders and administration site conditions Uncommon:
Danish: Infektiøse og parasitære sygdomme Ikke almindelig:
English: Concomitant use not recommended
Danish: Nedenstående kombinationer frarådes.
English: Pliva Hrvatska d.o.o Tel: + 385 1 37 20 000
Danish: Tel: + 385 1 37 20 000
English: However, a causal relationship has not been established.
Danish: Det kan dog ikke udelukkes, at der er en lille risiko.
English: You may need to read it again.
Danish: Du kan have brug for at læse den igen senere.
English: 36 months
Danish: 36 måneder
English: Other trials gave similar or higher results.
Danish: Andre studier viste lignende eller bedre resultater.
English: Very rare (<1/10,000)
Danish: Meget sjældne (<1/10.000)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION October 23
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN 23 oktober 2000
English: Do not use after the expiry date stated on the label.
Danish: Må ikke anvendes efter udløbsdatoen, som er anført på etiketten.
English: Antipyretic treatment should be initiated according to local guidelines.
Danish: Antipyretisk behandling bør indledes i overensstemmelse med lokale retningslinjer.
English: * As lower confidence limit (p = 0.95).
Danish: * Som nedre konfidensgrænse (p = 0,95).
English: As with other vaccines your child may have some side effects.
Danish: Som med andre vacciner kan dit barn muligvis opleve nogle bivirkninger.
English: Possible side effects 5.
Danish: Mulige bivirkninger 5.
English: Official batch release: in accordance with Article 114 Directive 2001/83/EEC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: Officiel batchfrigivelse: i overensstemmelse med artikel 114 i Rådets direktiv 2001/83/EØF vil den officielle batchfrigivelse blive foretaget af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: These reactions were mostly moderate and transient.
Danish: Disse reaktioner var for det meste moderate og forbigående.
English: Using other vaccines
Danish: Anvendelse sammen med andre vacciner
English: Evaluation of pharmacokinetic properties is not required for vaccines.
Danish: Vurdering af farmakokinetiske egenskaber er ikke påkrævet for vacciner.
English: The active substances are:
Danish: De aktive stoffer er :
English: This vaccine has been prescribed for your child and you should not pass it on to others.
Danish: Denne vaccine er blevet ordineret til dit barn og må ikke overdrages til andre.
English: Read all of this leaflet carefully before your child is vaccinated.
Danish: Du bedes venligst læse hele denne indlægsseddel omhyggeligt inden dit barn bliver vaccineret.
English: It has been shown that PTxd and FHA play a major role in protection against pertussis.
Danish: Det er blevet vist at PTxd og FHA har stor betydning for beskyttelsen mod pertussis.
English: Surveillance and antibody long term persistence studies are ongoing and will provide additional information in regards to the duration of protection.
Danish: Overvågningsstudier og undersøgelser af antistoffernes langtidsvarighed pågår og vil give yderligere oplysninger angående beskyttelsens varighed.
English: If you forget to take HEXAVAC: Your doctor will decide when to give the missed dose.
Danish: Hvis man glemmer at tage HEXAVAC : Din læge bestemmer hvornår den manglende dosis skal gives.
English: If your child is due to be vaccinated with HEXAVAC and other vaccines simultaneously, please ask your doctor for further information.
Danish: Hvis dit barn skal vaccineres med Hexavac og andre vacciner samtidig, rådføre dig med din læge for yderligere information.
English: The intradermal or subcutaneous routes must not be used either.
Danish: Intradermal eller subkutan indgivelse må heller ikke anvendes.
English: Sumneytown Pike West Point
Danish: Sumneytown Pike
English: For Hepatitis B surface antigen: Merck & Co. Inc.
Danish: For hepatitis B overflade-antigen: Merck & Co., Inc.
English: Do not freeze.
Danish: Må ikke opbevares frossen.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ELLER, NÅR EN SÅDAN IKKE FINDES, PÅ DEN INDRE EMBALLAGE
English: BATCH NUMBER Batch
Danish: BATCHNUMMER Batch
English: ^ Quantity of antigen in the final bulk product, according to W.H.O.
Danish: ^ Kvantitet af antigen i det færdige bulkprodukt, ifølge W.H.O.
English: Pennsylvania 19486 USA
Danish: West Point, Pennsylvania 19486, USA
English: If you have further questions, please ask your doctor or your pharmacist.
Danish: Har du yderligere spørgsmål, kan de stilles til lægen eller farmaceuten.
English: (TRS 673, 1992) Or equivalent antigenic quantity determined by a suitable immunochemical method
Danish: (TRS 673, 1992) Eller tilsvarende kvantitet af antigen målt ved en egnet immunokemisk metode.
English: Vaccination should be postponed in the case of fever or acute disease.
Danish: Vaccination bør udsættes i tilfælde af feber eller akut sygdom.
English: If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Danish: Bemærker du nogen bivirkninger som ikke er nævnt i denne indlægsseddel, kontakt venligt din læge eller farmaceut.
English: If the condition persists or worsens, you may have to bring your child to the doctor.
Danish: Hvis tilstanden varer ved eller forværres, skal barnet muligvis til lægen.