FrancophonIA/ELRC3.0 huggingface dataset:
English: Experience in patients with lamivudine-resistant HBV at 240 weeks (study GS-US-174-0121) The efficacy and safety of 245 mg tenofovir disoproxil was evaluated in a randomised, double-blind study (GS-US-174-0121) in HBeAg positive and HBeAg negative patients (n = 280) with compensated liver disease, viraemia (HBV DNA ≥ 1,000 IU/ml), and genotypic evidence of lamivudine resistance (rtM204I/V +/- rtL180M).
Danish: Erfaring efter 240 uger hos patienter med lamivudin-resistent HBV (studie GS-US-174-0121) Virkningen og sikkerheden af 245 mg tenofovirdisoproxil blev evalueret i et randomiseret, dobbeltblindt studie (GS-US-174-0121) hos HBeAg-positive og HBeAg-negative patienter (n = 280) med kompenseret leversygdom, viræmi (HBV-dna ≥ 1.000 IE/ml) og genotype-evidens for lamivudinresistens (rtM204I/V +/- rtL180M).
English: Table 3: Tabulated summary of adverse reactions associated with tenofovir disoproxil based on clinical study and post-marketing experience
Danish: Tabel 3: Resumé af bivirkninger forbundet med tenofovirdisoproxil baseret på erfaringer fra kliniske studier og efter markedsføring
English: In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your child's hepatitis.
Danish: Hos patienter med fremskreden leversygdom eller levercirrose bør behandlingen ikke ophøre, da det hos nogle patienter kan medføre forværring af barnets hepatitis.
English: If your child accidentally takes too many Viread tablets, they may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Danish: Hvis Deres barn ved et uheld tager for mange Viread-tabletter, kan barnet have en øget risiko for mulige bivirkninger af denne medicin (se pkt.
English: What you need to know before you take Viread
Danish: Det skal De vide, før De begynder at tage Viread Tag ikke Viread
English: Light blue, almond-shaped, film-coated tablets, of dimensions 16.8 mm x 10.3 mm, debossed on one side with “GILEAD” and “4331” and on the other side with “300”.
Danish: Lyseblå, mandelformede, filmovertrukne tabletter, der måler 16,8 mm x 10,3 mm diameter og er præget med „GILEAD“ og „4331“ på den ene side og „300“ på den anden.
English: The average change from baseline for HIV-1 RNA and CD4 count at 48 weeks of treatment was similar in both treatment groups (-3.09 and -3.09 log10 copies/ml; +169 and 167 cells/mm3 in the tenofovir disoproxil 245 mg and stavudine groups, respectively).
Danish: Den gennemsnitlige ændring fra baseline for hiv 1-rna og CD4-tal i uge 48 af behandlingen var næsten ens i begge behandlingsgrupper (-3,09 og -3,09 log10 kopier/ml; +169 og 167 celler/mm3 i henholdsvis 245 mg tenofovirdisoproxil og stavudin gruppen).
English: Method of administration Viread tablets should be taken once daily, orally with food.
Danish: Administration Viread-tabletter skal tages oralt en gang dagligt sammen med mad.
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Danish: Indberetning af bivirkninger Hvis Deres barn oplever bivirkninger, bør De tale med Deres barns læge eller apoteket.
English: Your child does not need to take another tablet if they were sick more than 1 hour after taking Viread.
Danish: Deres barn behøver ikke tage en ny tablet, hvis Deres barn kaster op mere end en time efter, at barnet tog Viread-tabletten.
English: Viread 245 mg film-coated tablets are light blue, almond-shaped, film-coated tablets, of dimensions 16.8 mm x 10.3 mm, debossed on one side with “GILEAD” and “4331” and on the other side with “300”.
Danish: Viread 245 mg filmovertrukne tabletter er lyseblå, mandelformede filmovertrukne tabletter, der måler 16,8 mm x 10,3 mm, præget med „GILEAD“ og „4331“ på den ene side og „300“ på den anden side.
English: Check with your child's doctor or pharmacist if you are not sure.
Danish: Spørg barnets læge eller apotekspersonalet, hvis der er noget, De er i tvivl om.
English: HBsAg loss/ seroconversion n k n n a Based upon Long Term Evaluation algorithm (LTE Analysis) - Patients who discontinued the study at any time prior to week 384 due to a protocol defined endpoint, as well as those completing week 384, are included in the denominator.
Danish: 1/1n a Baseret på Long Term Evaluation algoritme (LTE-analyse) - Patienter, som afbrød studiet på et vilkårligt tidspunkt før uge 384 pga. et protokoldefineret endepunkt, såvel som dem, der fuldførte uge 384, inkluderes i nævneren.
English: INFORMATION IN BRAILLE Viread 245 mg [Outer packaging only]
Danish: Viread 245 mg [kun på den ydre emballage]
English: Monitoring of renal function is recommended for patients receiving Viread (see section 4.4).
Danish: Nyrefunktionen bør monitoreres hos patienter, som får Viread (se pkt.
English: Using a noncompleter/switch = failure analysis, 50% (21/42) of subjects receiving tenofovir disoproxil, 76% (28/37) of subjects receiving emtricitabine plus tenofovir disoproxil and 52% (11/21) of subjects receiving entecavir achieved HBV DNA < 400 copies/ml at week 168.
Danish: På basis af en analyse af personer, der ikke fuldførte/skiftede = svigt, opnåede 50% (21/42) af forsøgspersonerne, som fik tenofovirdisoproxil, 76% (28/37) af forsøgspersonerne, som fik emtricitabin plus tenofovirdisoproxil, og 52% (11/21) af forsøgspersonerne, som fik entecavir, HBV-dna < 400 kopier/ml ved uge 168.
English: Response to treatment with tenofovir disoproxil was comparable in treatment-naïve and treatmentexperienced subjects with 76% (38/50) of treatment-naïve and 80% (8/10) of treatment-experienced subjects achieving HBV DNA < 400 copies/mL (69 IU/ml) at Week 48.
Danish: Behandlingsresponset med tenofovirdisoproxil var sammenligneligt hos behandlingsnaive og behandlingserfarne forsøgspersoner, hvor 76% (38/50) behandlingsnaive og 80% (8/10) behandlingserfarne forsøgspersoner opnåede HBV-dna < 400 kopier/ml (69 IE/ml) ved uge 48.
English: Cmin: ↓ 34% Ritonavir:
Danish: Cmin: ↓ 21% Emtricitabin:
English: Table 9: Bone Mineral Density Evaluation at Baseline, Week 72 and 192
Danish: Tabel 9: Vurdering af knoglemineraltæthed ved baseline, uge 72 og uge 192
English: • It is also important to tell your doctor if your child is taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.
Danish: • Det er også vigtigt at fortælle Deres læge det, hvis Deres barn får ledipasvir/sofosbuvir, sofosbuvir/velpatasvir eller sofosbuvir/velpatasvir/voxilaprevir til behandling af hepatitis Cinfektion.
English: - Viread should not be administered concomitantly with adefovir dipivoxil.
Danish: - Viread bør ikke tages samtidigt med adefovirdipivoxil.
English: rhabdomyolysis1, muscular weakness1
Danish: Ikke almindelig: rabdomyolyse1, muskelsvækkelse1
English: Viread should not be administered concomitantly with adefovir dipivoxil.
Danish: Viread bør ikke tages samtidigt med adefovirdipivoxil.
English: Patients with lamivudine-resistant chronic hepatitis B: No new adverse reactions to tenofovir disoproxil were identified from a randomised, double-blind study (GS-US-174-0121) in which 280 lamivudine-resistant patients received treatment with tenofovir disoproxil (n = 141) or emtricitabine/tenofovir disoproxil (n = 139) for 240 weeks.
Danish: Patienter med lamivudin-resistent kronisk hepatitis B: Der blev ikke identificeret nye bivirkninger af tenofovirdisoproxil i et randomiseret, dobbeltblindt studie (GS-US-174-0121), hvor 280 lamivudinresistente patienter fik tenofovirdisoproxil (n = 141) eller emtricitabin/tenofovirdisoproxil (n = 139) i 240 uger.
English: If you throw up less than 1 hour after taking Viread, take another tablet.
Danish: Hvis De kaster op mindre end en time efter, at De har taget Viread, skal De tage en ny tablet.
English: Duration of therapy in adults and paediatric patients with chronic hepatitis B
Danish: Behandlingens varighed for voksne og pædiatriske patienter med kronisk hepatitis B.
English: Viread 245 mg film-coated tablets are also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.
Danish: Viread 245 mg filmovertrukne tabletter er også indiceret til behandling af hiv 1-inficerede unge med NRTI-resistens eller toksiciteter, der udelukker brugen af førstevalgsbehandling, i alderen 12 til < 18 år.
English: • Not for children who weigh under 17 kg or 22 kg and over.
Danish: • Ikke til børn, som vejer under 17 kg eller 22 kg og derover.
English: Silicon dioxide (E551)
Danish: Titandioxid (E171)
English: At 144 weeks of treatment, the average change from baseline remained similar in both treatment groups (-3.07 and -3.03 log10 copies/ml; +263 and +283 cells/mm3 in the tenofovir disoproxil 245 mg and stavudine groups, respectively).
Danish: I uge 144 af behandlingen forblev den gennemsnitlige ændring fra baseline næsten ens i begge behandlingsgrupper (-3,07 og -3,03 log10 kopier/ml; +263 og +283 celler/mm3 i henholdsvis 245 mg tenofovirdisoproxil-gruppen og stavudingruppen).
English: Genotypic evaluations were performed on all patients within this group with HBV DNA > 400 copies/ml at week 48 (n = 6), week 72 (n = 5), week 96 (n = 4), week 144 (n = 2), and week 192 (n = 3).
Danish: Genotypeevaluering blev udført for alle patienter i denne gruppe med HBV-dna > 400 kopier/ml ved uge 48 (n = 6), uge 72 (n = 5), uge 96 (n = 4), uge 144 (n = 2) samt uge 192 (n = 3).
English: If the patient vomits more than 1 hour after taking Viread they do not need to take another dose.
Danish: Hvis patienten kaster op mere end 1 time efter at have taget Viread, skal patienten ikke tage en ny dosis.
English: If renal abnormalities are detected or suspected then consultation with a nephrologist should be obtained to consider interruption of Viread treatment.
Danish: Hvis nyreabnormiteter påvises eller mistænkes, skal konsultation med en nefrolog foretages for at overveje at seponere behandlingen med Viread.
English: Tenofovir exposure achieved in adolescent patients receiving oral daily doses of tenofovir disoproxil 245 mg was similar to exposures achieved in adults receiving once-daily doses of tenofovir disoproxil 245 mg.
Danish: Den tenofovir-eksponering, der blev opnået hos unge patienter, som fik daglige orale doser på 245 mg tenofovirdisoproxil, svarede til de eksponeringer, der blev opnået hos voksne, som fik 245 mg tenofovirdisoproxil en gang daglig.
English: • Not for HIV-1 infected children under 12 years of age
Danish: • Ikke til hiv 1-inficerede børn under 12 år • Ikke til HBV-inficerede børn under 12 år.
English: Tenofovir exposure achieved in these paediatric patients receiving oral daily doses of tenofovir disoproxil 245 mg or 6.5 mg/kg body weight tenofovir disoproxil up to a maximum dose of 245 mg was similar to exposures achieved in adults receiving once-daily doses of tenofovir disoproxil 245 mg.
Danish: Den tenofovir-eksponering, der blev opnået hos disse pædiatriske patienter, som fik daglige orale doser på 245 mg tenofovirdisoproxil eller 6,5 mg/kg kropsvægt tenofovirdisoproxil op til en maksimal dosis på 245 mg svarede til de eksponeringer, der blev opnået hos voksne, som fik 245 mg tenofovirdisoproxil en gang daglig.
English: If you accidentally take too many Viread tablets, you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Danish: Hvis De ved et uheld tager for mange Viread-tabletter, kan De have en øget risiko for mulige bivirkninger af denne medicin (se pkt.
English: PLBtenofovir disoproxil
Danish: PLBtenofovirdisoproxil
English: • Lactic acidosis (excess lactic acid in the blood) is a rare (can affect up to 1 in every
Danish: • Laktatacidose (overskud af mælkesyre i blodet) er en sjælden (kan opstå op til 1 ud af 1.000 personer), men alvorlig bivirkning, som kan være dødelig.
English: HBV DNA (%) < 400 copies/ml (< 69 IU/ml) ALT (%) Normalised ALTd
Danish: HBV-dna (%) < 400 kopier/ml (< 69 IE/ml) ALAT (%) Normaliseret ALATd
English: • Not for children who weigh under 22 kg or 28 kg and over.
Danish: • Ikke til børn, som vejer under 22 kg eller 28 kg og derover.
English: Method of administration Viread 163 mg film-coated tablets should be taken once daily, orally with food.
Danish: Administration Viread 163 mg filmovertrukne tabletter skal tages oralt en gang dagligt sammen med mad.
English: If you throw up less than 1 hour after taking Viread, take another dose.
Danish: Hvis De kaster op mindre end en time efter, at De har taget Viread, skal De tage en ny dosis.
English: Co-administration of tenofovir disoproxil and didanosine is not recommended as it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Danish: Samtidig administration af tenofovirdisoproxil og didanosin anbefales ikke, da det resulterer i en stigning i systemisk eksponering for didanosin på 40-60%, hvilket kan øge risikoen for didanosinrelaterede bivirkninger (se pkt.
English: • Talk to your child's doctor or pharmacist if your child has had kidney disease or if tests have shown problems with their kidneys.
Danish: • Kontakt Deres barns læge eller apotekspersonalet hvis Deres barn tidligere har haft nyresygdomme, eller hvis undersøgelser har vist, at Deres barn har nyreproblemer.
English: If the patient vomits within 1 hour of taking Viread, another tablet should be taken.
Danish: Hvis patienten kaster op inden for 1 time efter at have taget Viread, skal der tages en ny tablet.
English: Method of administration Viread 204 mg film-coated tablets should be taken once daily, orally with food.
Danish: Administration Viread 204 mg filmovertrukne tabletter skal tages oralt en gang dagligt sammen med mad.
English: Experience in patients with persistent viral replication (study GS-US-174-0106) The efficacy and safety of tenofovir disoproxil 245 mg or tenofovir disoproxil 245 mg plus 200 mg emtricitabine has been evaluated in a randomised, double-blind study (study GS-US-174-0106), in HBeAg positive and HBeAg negative adult patients who had persistent viraemia (HBV DNA ≥ 1,000 copies/ml) while receiving adefovir dipivoxil 10 mg for more than 24 weeks.
Danish: Erfaring hos patienter med vedvarende viral replikation (studie GS-US-174-0106) Virkningen og sikkerheden af 245 mg tenofovirdisoproxil eller 245 mg tenofovirdisoproxil sammen med 200 mg emtricitabin er blevet evalueret i et randomiseret dobbelt-blindt studie (studie GS-US-174-0106) med HBeAg-positive og HBeAg-negative voksne patienter, som havde vedvarende viræmi (HBV-dna ≥ 1.000 kopier/ml), mens de fik 10 mg adefovirdipivoxil i mere end 24 uger.
English: In studies GS-US-174-0102 and GS-US-174-0103, after receiving double-blind treatment for 48 weeks (either tenofovir disoproxil 245 mg or adefovir dipivoxil 10 mg), patients rolled over with no interruption in treatment to open-label tenofovir disoproxil.
Danish: I studierne GS-US-174-0102 og GS-US-174-0103 skiftede patienterne uden behandlingsafbrydelse til open-label behandling med tenofovirdisoproxil efter at have fået dobbeltblind-behandling i 48 uger (enten 245 mg tenofovirdisoproxil eller 10 mg adefovirdipivoxil).
English: One gram of Viread granules contains 33 mg of tenofovir disoproxil (as fumarate).
Danish: Et gram Viread granulat indeholder 33 mg tenofovirdisoproxil (som fumarat).
English: Viread 245 mg tablets are not suitable for the following groups:
Danish: Viread 245 mg tabletter er ikke egnede til de følgende grupper:
English: asthenia
Danish: patienter)
English: - The other ingredients are ethylcellulose (E462), hydroxypropyl cellulose (E463), mannitol
Danish: - Øvrige indholdsstoffer: ethylcellulose (E462), hydroxypropylcellulose (E463), mannitol (E421) og siliciumdioxid (E551).
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Indberetning af bivirkninger Hvis De oplever bivirkninger, bør De tale med Deres læge eller apoteket.
English: Table 2: Interactions between tenofovir disoproxil and other medicinal products Medicinal product by therapeutic areas (dose in mg)
Danish: Tabel 2: Interaktioner mellem tenofovirdisoproxil og andre lægemidler
English: Each tablet contains 82 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 82 mg lactose (som monohydrat).
English: Viread 163 mg tablets are only suitable for:
Danish: Viread 163 mg tabletter er kun egnede til:
English: LIST OF EXCIPIENTS Contains mannitol.
Danish: Indeholder mannitol.
English: Genotypic evaluations performed on all patients with HBV DNA > 400 copies/ml at week 48 (n = 16), 96 (n = 5), 144 (n = 1), 192 (n = 2), 240 (n = 1), 288 (n = 1) and 384 (n = 2) of tenofovir disoproxil monotherapy showed that no mutations associated with tenofovir disoproxil resistance have developed.
Danish: Genotype-evalueringer, udført på alle patienter med HBV-dna > 400 kopier/ml ved uge 48 (n = 16), 96 (n = 5), 144 (n = 1), 192 (n = 2), 240 (n = 1), 288 (n = 1) og 384 (n = 2) af tenofovirdisoproxil-monoterapi viste, at der ikke udvikledes mutationer associeret med tenofovirdisoproxil-resistens.
English: Genotypic evaluations performed on all patients with HBV DNA > 400 copies/ml at week 48 (n = 39), 96 (n = 24), 144 (n = 6), 192 (n = 5), 240 (n = 4), 288 (n = 6) and 384 (n = 2) of tenofovir disoproxil monotherapy showed that no mutations associated with tenofovir disoproxil resistance have developed.
Danish: Genotype-evalueringer, udført på alle patienter med HBV-dna > 400 kopier/ml ved uge 48 (n = 39), 96 (n = 24), 144 (n = 6), 192 (n = 5), 240 (n = 4), 288 (n = 6) og 384 (n = 2) af tenofovirdisoproxil-monoterapi viste, at der ikke udvikledes mutationer associeret med tenofovirdisoproxil-resistens.
English: Viread 204 mg tablets are only suitable for:
Danish: Viread 204 mg tabletter er kun egnede til:
English: Table 10: Bone Mineral Density Evaluation at Baseline and Week 48
Danish: Tabel 10: Vurdering af knoglemineraltæthed ved baseline og uge 48
English: Whole body BMD at least 6% decrease b
Danish: Mindst 6% fald i BMD for hele kroppenb n/a n/a
English: As Viread may cause renal damage monitoring of renal function is recommended (see sections 4.4 and 4.8 Summary of the safety profile).
Danish: 4.4 og 4.8 Resumé af sikkerhedsprofil).
English: Method of administration Viread 123 mg film-coated tablets should be taken once daily, orally with food.
Danish: Administration Viread 123 mg filmovertrukne tabletter skal tages oralt en gang dagligt sammen med mad.
English: Table 1: Interactions between tenofovir disoproxil and other medicinal products Medicinal product by therapeutic areas (dose in mg)
Danish: Tabel 1: Interaktioner mellem tenofovirdisoproxil og andre lægemidler
English: Very common: hypophosphataemia1
Danish: Meget almindelig: hypofosfatæmi1 Ikke almindelig:
English: Pharmacokinetic parameters of tenofovir were determined following administration of a single dose of tenofovir disoproxil 245 mg to 40 non-HIV, non-HBV infected adult patients with varying degrees of renal impairment defined according to baseline creatinine clearance (CrCl) (normal renal function when CrCl > 80 ml/min; mild with CrCl = 50-79 ml/min; moderate with CrCl = 30-49 ml/min and severe with CrCl = 10-29 ml/min).
Danish: Farmakokinetiske parametre af tenofovir blev bestemt efter administration af en enkelt dosis af 245 mg tenofovirdisoproxil til 40 voksne patienter uden hiv-infektion, uden HBV-infektion med forskellige grader af nedsat nyrefunktion defineret i henhold til kreatininclearance (CrCl) ved baseline (normal nyrefunktion med CrCl > 80 ml/min; let nedsat nyrefunktion med CrCl = 50-79 ml/min; moderat nedsat nyrefunktion med CrCl = 30-49 ml/min og svært nedsat nyrefunktion med CrCl = 10-29 ml/min).
English: Viread 163 mg tablets are not suitable for the following groups:
Danish: Viread 163 mg tabletter er ikke egnede til følgende grupper:
English: Please refer to the Summary of Product Characteristics for Viread 33 mg/g granules.
Danish: Se Produktresumeét for Viread 33 mg/g granulat.
English: NA 5.14% 8.08% 10.05% 11.21%
Danish: 4.2, 4.4, 4.8 og 5.1.
English: • children and adolescents aged 2 to less than 18 years who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects.
Danish: • voksne • børn og unge i alderen 2 til under 18 år, der allerede er blevet behandlet med anden hiv-medicin, der ikke længere er helt effektivt på grund af udvikling af resistens, eller der forårsagede bivirkninger.
English: • You must mix the granules with soft food which does not require chewing, for example yoghurt,
Danish: • De skal blande granulatet med blød mad, der ikke skal tygges, f.eks. yoghurt, æblemos eller babymad.
English: If you have been told by your child's doctor that your child has an intolerance to some sugars, contact your child's doctor before they take this medicinal product.
Danish: Kontakt Deres barns læge, før Deres barn får dette lægemiddel, hvis lægen har fortalt Dem, at Deres barn ikke tåler visse sukkerarter.
English: If you notice that your child has any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your child's doctor immediately to seek necessary treatment.
Danish: De skal straks informere Deres læge for at få den nødvendige behandling, hvis De bemærker symptomer på infektion eller andre symptomer, såsom muskelsvaghed, svaghed begyndende i hænder og fødder, og som bevæger sig op igennem kroppen, hjertebanken, rysten eller hyperaktivitet.
English: Tenofovir is a nucleotide reverse transcriptase inhibitor, generally known as an NRTI and works by interfering with the normal working of an enzyme (in HIV reverse transcriptase, in hepatitis B DNA polymerase) that are essential for the viruses to reproduce themselves.
Danish: Tenofovir virker ved at gribe ind i den måde, som et enzym normalt arbejder på, og som er nødvendige, for at virus kan formere sig (ved hiv hedder enzymet reverse transkriptase, ved hepatitis B hedder det dna-polymerase).
English: Tenofovir disoproxiltenofovir disoproxil
Danish: Tenofovirdisoproxiltenofovirdisoproxil
English: You do not need to take another tablet if you were sick more than 1 hour after taking Viread.
Danish: De behøver ikke tage en ny tablet, hvis De kaster op mere end en time efter, at De tog Viread-tabletten.
English: After week 72, virologic suppression was maintained for those receiving double-blind tenofovir disoproxil followed by open-label tenofovir disoproxil (tenofovir disoproxil-tenofovir disoproxil group): 86.5% (45/52) of subjects in the tenofovir disoproxil-tenofovir disoproxil group had HBV DNA < 400 copies/ml at week 192.
Danish: Efter uge 72 blev virologisk suppression opretholdt hos de patienter, som fik dobbeltblindet tenofovirdisoproxil efterfulgt af open-label tenofovirdisoproxil (tenofovirdisoproxil-tenofovirdisoproxil-gruppen): 86,5% (45/52) af patienterne i tenofovirdisoproxil-tenofovirdisoproxil-gruppen havde HBV-dna < 400 kopier/ml ved uge 192.
English: Viread 204 mg tablets are not suitable for the following groups:
Danish: Viread 204 mg tabletter er ikke egnede til følgende grupper:
English: If the patient vomits within 1 hour of taking Viread, another dose should be taken.
Danish: Hvis patienten kaster op inden for 1 time efter at have taget Viread, skal der tages en ny dosis.
English: There are uncertainties associated with the long term effects of bone and renal toxicity.
Danish: Påvirkning af nyrer og knogler hos den pædiatriske population Der er usikkerheder i forbindelse med virkningen af langvarig behandling på knogle- og nyretoksicitet.
English: You do not need to take another dose if you were sick more than 1 hour after taking Viread.
Danish: De behøver ikke tage en ny dosis, hvis De kaster op mere end en time efter, at De tog Viread granulat.
English: NAME OF THE MEDICINAL PRODUCT Viread 245 mg film-coated tablets
Danish: Indlægsseddel: Information til patienten Viread 245 mg filmovertrukne tabletter