FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Indhold: AS03-adjuvans bestående af squalen (10,69 mg), DL-α-tocopherol (11,86 mg) og polysorbat 80 (4,86 mg)
English: In a clinical study that evaluated reactogenicity in children 3 to 5 and 6 to 9 years of age who received a single half adult (i.e. 0.25 ml) dose of an AS03-containing vaccine containing HA from H1N1 manufactured using a different process, the frequency of the following adverse reactions was as shown in the table:
Danish: I et klinisk forsøg, hvor reaktogeniciteten blev evalueret hos børn i alderen 3-5 år og 6-9 år, som havde fået en enkelt halv voksendosis (a 0,25 ml) AS03-adjuveret vaccine, som indeholder HA fra H1N1, som er fremstillet ved en anden proces, var hyppigheden af nedennævnte bivirkninger som anført i tabellen:
English: Immune response to a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1):
Danish: Immunrespons mod en formulering af Arepanrix, som indeholder 3,75 mikrogram HA fra A/Indonesia/05/2005 (H5N1):
English: In a clinical study that evaluated reactogenicity in healthy adults aged 18-60 years who received two 0.5 ml doses (21 days apart) of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process, there were higher rates of most general solicited symptoms (such as fatigue, headache, arthralgia, shivering, sweating and fever) after the second dose compared to the first dose.
Danish: I et klinisk forsøg, hvor reaktogeniciteten blev evalueret hos raske voksne i alderen 18-60 år, som havde fået to 0,5 ml-doser (med 21 dages mellemrum) AS03-adjuveret vaccine, som indeholder HA fra H1N1v, som er fremstillet ved en anden proces, sås en øget hyppighed af de undersøgte generelle symptomer (f.eks. træthed, hovedpine, artralgi, kuldegysninger, svedtendens og feber) efter den anden dosis i forhold til efter den første dosis.
English: • Aching muscles, joint pain
Danish: • Ømme muskler, ledsmerter
English: Cross-reactive immune responses elicited by a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1):
Danish: Krydsreaktions-immunrespons fremkaldt af en formulering af Arepanrix, som indeholder 3,75 μg HA fra A/Indonesia/05/2005 (H5N1):
English: Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or operate machinery.
Danish: 4.8, kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Arepanrix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Danish: Arepanrix suspension og emulsion til injektionsvæske, emulsion Pandemisk influenzavaccine (H1N1) (split virion, inaktiveret, adjuveret)
English: AS03-containing vaccine containing HA from H1N1v manufactured using a different process
Danish: AS03-adjuveret vaccine, som indeholder HA fra H1N1v, som er fremstillet ved en anden proces
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Danish: Du kan finde yderligere information om Arepanrix på Det Europæiske Lægemiddelagenturs (EMEA's) hjemmeside: http://www.emea.europa.eu/.
English: The Applicant/MAH commits to provide abridged report for the following study performed in children Study Q-Pan H1N1-031 (9-17 yrs, Safety/ Immunogenicity) - abridged report for post dose 1 & post dose 2 (immuno & solicited and unsolicited symptoms, SAEs )
Danish: Forsøg Q-Pan H1N1-003 (6 måneder-8 år, dosisbestemmelse) - Forkortet rapport over post dosis 1wave 1 immunologiske data, definerede og spontane bivirkniger, SAE) - Forkortet rapport over post dosis 2wave 1 og 2 (immunologiske data, definerede og spontane bivirkniger, SAE)
English: Twenty-one days after the second dose, a 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in 94.4% of subjects aged 18-60 years and in 80.4% of subjects over 60 years of age.
Danish: En firdobbelt stigning i serum-neutraliserende antistoftiter blev set 21 dage efter anden dosis hos 94,4 % af personerne i alderen 18-60 år og 80,4 % af personerne over 60 år.
English: This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Danish: Adjuvansen består af squalen (10,69 mg), DL-α-tocopherol (11,86 mg) og polysorbat 80 (4,86 mg).
English: In a clinical study that evaluated the reactogenicity in children 10 to 17 years of age who received two 0.5 ml doses (21 days apart) of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process, there was no increase in reactogenicity after the second dose compared to the first dose.
Danish: I et klinisk forsøg, hvor reaktogeniciteten blev evalueret hos børn i alderen 10-17 år, som havde fået to doser a 0,5 ml (med 21 dages mellemrum) AS03-adjuveret vaccine, som indeholder HA fra H1N1v, som er fremstillet ved en anden proces, sås ikke en øget reaktogenicitet efter den anden dosis i forhold til efter den første dosis.
English: • Very limited safety and immunogenicity data obtained three weeks after a single administration of half the adult dose (i.e. 0.25 ml) to healthy children aged 3-9 years.
Danish: • Meget begrænsede sikkerheds- og immunogenicitetsdata opnået tre uger efter administration af en enkelt halv voksendosis (a 0,25 ml) til raske børn i alderen 3-9 år.
English: - abridged report for post dose 3 (immuno & solicited and unsolicited symptoms, SAEs)
Danish: - Forkortet rapport over post dosis 3 (immunologiske samt definerede og spontane bivirkniger, SAE)
English: If a second dose is administered there should be an interval of at least three weeks between the first and second dose.
Danish: Hvis der skal gives yderligere en dosis, skal denne gives mindst tre uger efter den første dosis.
English: - abridged report for post dose 1 & post dose 2 (immuno & solicited and unsolicited symptoms, SAEs )
Danish: - Forkortet rapport over post dosis 1 og post dosis 2 (immunologiske samt definerede og spontane bivirkniger, SAE)
English: CLINICAL PARTICULARS
Danish: Kliniske aspekter
English: STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to: 3.75 micrograms haemagglutinin/dose *Antigen: A/California/7/2009 (H1N1)v-like strain (X-179A)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Split influenzavirus, inaktiveret, indeholdende antigen* svarende til: 3,75 mikrogram hæmagglutinin/dosis *Antigen: A/California/7/2009 (H1N1)v-lignende stamme (X-179A)
English: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Danish: AS03-adjuvans bestående af squalen (10,69 mg), DL-α-tocopherol (11,86 mg) og polysorbat 80 (4,86 mg)
English: Immune response to an AS03-containing vaccine containing HA from H1N1v manufactured using a different process:
Danish: Immunrespons mod AS03-adjuveret vaccine, som indeholder HA fra H1N1v, som er fremstillet ved en anden proces
English: 2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4fold increase in titre;
Danish: seroprotektionsrate: andelen af forsøgspersoner med hæmagglutinationshæmningstiter (HI) ≥ 1:40; serokonverteringsrate: andelen af forsøgspersoner, som enten var seronegative før vaccination og opnåede en beskyttende post-vaccinationstiter på ≥ 1:40, eller som var seropositive før vaccination og opnåede en firdobbelt stigning af titer; serokonverteringsfaktor: forholdet mellem post-vaccinationsgeometrisk middeltiter (GMT) og prævaccinations-GMT.
English: The Applicant/MAH commits to set a maximum decrease of 20% of HA content for the Drug Substance and to review when data for H1N1 become available.
Danish: Kvalitative aspekter Ansøgeren/indehaveren af markedsføringstilladelsen forpligter sig til at sætte et maximum på 20 % reduktion i indhold af HA for det aktive stof og til at
English: OTHER SPECIAL WARNING(S), IF NECESSARY Suspension to be exclusively mixed with adjuvant emulsion before administration
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Suspensionen skal sammenblandes med adjuvans, emulsion, før administration.
English: Split influenza virus inactivated, containing antigen equivalent to: A/California/7/2009 (H1N1)v-like strain (X-179A)
Danish: Split influenzavirus, inaktiveret, indeholdende antigen svarende til: A/California/7/2009 (H1N1)v-lignende stamme (X-179A)
English: Immunogenicity data obtained at three weeks after administration of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in clinical studies suggest that a single dose may be sufficient.
Danish: Immunogenicitetsdata fra kliniske forsøg, opnået tre uger efter administration af AS03-adjuveret vaccine, som indeholder HA fra H1N1v, som er fremstillet ved en anden proces, tyder på, at en enkelt dosis kan være tilstrækkelig.
English: NAME OF THE MEDICINAL PRODUCT Arepanrix suspension and emulsion for emulsion for injection.
Danish: Arepanrix suspension og emulsion til injektionsvæske, emulsion.
English: Gastrointestinal disorders
Danish: Gastrointestinale symptomer Hovedpine - = ikke tilgængelig
English: There is no information on administration of Arepanrix with other vaccines and no information on administration of the AS03-containing vaccine containing HA from H1N1v manufactured using a different process with any other vaccines than non-adjuvanted seasonal influenza vaccine.
Danish: Der er heller ingen oplysninger om samtidig vaccination med en anden AS03-adjuveret vaccine, som indeholder aktivt stof fra H1N1v, som er fremstillet ved en anden fremstillingsproces og andre sæsoninfluenzavacciner, som ikke indeholder adjuvans.
English: Immune response to A/California/7/2009 (H1N1)v-like 61-70 years
Danish: Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme 61-70 år
English: Post dose 1
Danish: Efter første dosis
English: In a clinical study that evaluated reactogenicity in children aged 6 to 35 months who received two half adult (i.e. 0.25 ml) doses (21 days apart) of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process there was an increase in injection site reactions and general symptoms after the second dose compared to the first dose particularly in rates of axillary fever (≥38°C).
Danish: I et klinisk forsøg, hvor reaktogeniciteten blev evalueret hos børn i alderen 6-35 måneder, som fik to halve voksendoser (a 0,25 ml med 21 dages mellemrum) AS03-adjuveret vaccine, som indeholder HA fra H1N1v, som er fremstillet ved en anden proces, sås en øget hyppighed af bivirkningerne i gruppen ”Almene symptomer og reaktioner på administrationsstedet” efter den anden dosis i forhold til hvad der blev set efter den første dosis, specielt tilfælde af aksillær temperatur ( > 38 ºC).
English: Excipients: Thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Danish: Hjælpestoffer: Thiomersal, Natriumchlorid, Dinatriumhydrogenphosphat, Kaliumdihydrogenphosphat, Kaliumchlorid, Vand til injektionsvæsker
English: Immune response to A/California/7/2009 (H1N1)v-like 6-11 months
Danish: Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme 6-11 måneder
English: Immune response to A/California/7/2009 (H1N1)v-like 3-5 years
Danish: Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme 3-5 år
English: How Arepanrix is given
Danish: Sådan bliver du behandlet med Arepanrix
English: However, in another clinical study which evaluated reactogenicity in children 3 to 9 years who received two adult (i.e. 0.5 ml) doses (21 days apart) of an AS03-containing vaccine containing HA from H1N1 manufactured using a different process there was an increase in injection site reactions and general symptoms after the second dose compared to the first dose.
Danish: I et andet klinisk forsøg, hvor reaktogeniciteten blev vurderet hos børn i alderen 3-9 år, som havde fået to voksendoser (a 0,5 ml) AS03-adjuveret vaccine, som indeholder HA fra H1N1 (med anden fremstillingsproses) (med 21 dages mellemrum), sås imidlertid en øget hyppighed af almene symptomer og reaktioner på injektionsstedet efter den anden dosis i forhold til efter den første dosis.
English: In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
Danish: Det er ikke sikkert, at du bør vaccinieres, eller måske skal vaccinationen udsættes.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: BILAG II A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN C. SÆRLIGE FORPLIGTELSER, SOM SKAL OPFYLDES AF INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: Total enrolled subjects [95% CI]
Danish: Inkluderede personer i alt [95 % CI]
English: Total enrolled subjects N=97 [95% CI]
Danish: Inkluderede personer i alt n = 97 [95 % CI]
English: Seronegative subjects prior to vaccination N=76 [95% CI]
Danish: Seronegative personer før vaccination n = 76 [95 % CI]
English: Excipients: Sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Danish: Hjælpestoffer: Natriumchlorid, Dinatriumhydrogenphosphat, Kaliumdihydrogenphosphat, Kaliumchlorid, Vand til injektionsvæsker
English: Total enrolled subjects N=75 [95% CI]
Danish: Inkluderede personer i alt n = 75 [95 % CI]
English: If a second dose is administered there should be an interval of at least three weeks between the first and the second dose.
Danish: Gives yderligere en dosis, skal denne gives mindst tre uger efter den første dosis.
English: Seronegative subjects prior to vaccination N=43 [95% CI]
Danish: Seronegative personer før vaccination n = 43 [95 % CI]
English: Musculoskeletal and connective tissue disorders Very common: joint pain, muscle aches
Danish: Meget almindelig: ledsmerter, muskelsmerter
English: NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Arepanrix Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Danish: Suspension til Arepanrix injektionsvæske, emulsion Pandemisk influenzavaccine (H1N1) (split virion, inaktiveret, adjuveret)
English: • Generalised skin reactions including facial swelling and urticaria (hives)
Danish: • Reaktioner i huden f.eks. hævelser i ansigt og nældefeber (udslæt).
English: The Applicant/MAH commits to provide abridged report for the following study performed in adults Study Q-Pan H1N1-019 (18-60 yrs, TIV effect and coadministration)
Danish: Forsøg Q-Pan H1N1-019 (18-60 år, TIV effekt og co-administration)
English: In the event of other variation being observed, discard the vaccine.
Danish: Hvis den rekonstituerede vaccine ser anderledes ud, skal den kasseres.
English: Total enrolled subjects N=30 [95% CI]
Danish: Inkluderede personer i alt n = 30 [95 % CI]
English: Total enrolled subjects N=59 [95% CI]
Danish: Inkluderede personer i alt n = 59 [95 % CI]
English: Seronegative subjects prior to vaccination N=23 [95% CI]
Danish: Seronegative personer før vaccination n = 23 [95 % CI]
English: Drowsiness
Danish: Appetitløshed
English: GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448701 produkt.info@gsk.com
Danish: KG Tel: + 49 (0)89 360448701 produkt.info@gsk.com
English: The following information is intended for medical or healthcare professionals only: Arepanrix consists of two containers:
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale:
English: Total enrolled subjects N=60 [95% CI]
Danish: Inkludere de personer i alt n = 60 [95 % CI]
English: See section 6.5 for the number of doses per vial.
Danish: Antallet af doser pr. hætteglas er angivet i pkt.
English: Seronegative subjects prior to vaccination N=61 [95% CI]
Danish: Sero-negative personer før vaccination n = 61 [95 % CI]
English: Immune response to A/California/7/2009 (H1N1)v-like Half dose
Danish: Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme halv dosis fuld dosis personer i alt
English: Total enrolled subjects N=40 [95% CI]
Danish: Inkludere de personer i alt n = 40 [95 % CI]
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Danish: Tal med lægen, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: PHARMACEUTICAL FORM AND CONTENTS Adjuvant emulsion for injection 25 vials: emulsion
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Adjuvans, emulsion til injektionsvæske
English: Redness
Danish: Døsighed
English: • Being sick, stomach pain, acid indigestion
Danish: • Kvalme, mavesmerter, sure opstød / halsbrand.
English: Total enrolled subjects N=5 [95% CI]
Danish: Inkludere de personer i alt n = 5 [95 % CI]
English: Seronegative subjects prior to vaccination N=29 [95% CI]
Danish: Sero-negative personer før vaccination n = 29 [95 % CI]
English: Seronegative subjects prior to vaccination N=38 [95% CI]
Danish: Sero-negative personer før vaccination n = 38 [95 % CI]
English: Seronegative subjects prior to vaccination N=27 [95% CI]
Danish: Sero-negative personer før vaccination n = 27 [95 % CI]
English: Seronegative subjects prior to vaccination N=3 [95% CI]
Danish: Sero-negative personer før vaccination n = 3 [95 % CI]
English: Saint-Foy, Quebec,
Danish: IB Biomedical Corporation of Quebec i samarbejde med
English: It is not recommended for patients with severe kidney problems.
Danish: Det anbefales heller ikke til patienter med svære nyreproblemer.
English: The full EPAR for Zoledronic acid Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zoledronsyre Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Teva on 16 August 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zoledronsyre Teva den 16. august 2012.
English: This leads to less bone loss.
Danish: Dette bevirker et mindre tab af knoglemasse.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoledronic acid Teva.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Zoledronsyre Teva skal anvendes.
English: This means that Zoledronic acid Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Danish: Det betyder, at Zoledronsyre Teva er identisk med et »referencelægemiddel«, som allerede er godkendt i Den Europæiske Union (EU), og som hedder Zometa.
English: The usual dose of Zoledronic acid Teva is one infusion of 4 mg over at least 15 minutes.
Danish: Den normale dosis Zoledronsyre Teva er en infusion a 4 mg over mindst 15 minutter.
English: For more information about treatment with Zoledronic acid Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zoledronsyre Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: A risk management plan has been developed to ensure that Zoledronic acid Teva is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Zoledronsyre Teva anvendes så sikkert som muligt.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zoledronsyre Teva.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Teva has been shown to be comparable to Zometa.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er påvist, at Zoledronsyre Teva er sammenlignelig med Zometa.
English: It is available as a concentrate (4 mg/5 ml) to be used to make a solution for infusion (drip) into a vein, and as a solution for infusion (4 mg/100 ml).
Danish: Det leveres som koncentrat (4 mg/5 ml), der anvendes til fremstilling af en infusionsvæske, opløsning, til drop i en vene, og som en infusionsvæske, opløsning (4 mg/100 ml).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Teva, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Zoledronsyre Teva, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Zoledronic acid Teva must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Danish: Zoledronsyre Teva må kun anvendes af en læge med erfaring i brug af denne form for lægemiddel givet i en vene.
English: By preventing the breakdown of bones, Zoledronic acid Teva also helps to reduce the amount of calcium released into the blood.
Danish: Ved at forebygge nedbrydning af knoglerne medvirker Zoledronsyre Teva også til at mindske den mængde calcium, der afgives til blodet.
English: No additional studies were needed as Zoledronic acid Teva is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
Danish: Der krævedes ingen supplerende undersøgelser, da Zoledronsyre Teva er et generisk lægemiddel, der gives ved infusion og indeholder det samme aktive stof som referencelægemidlet Zometa.
English: Therefore, the CHMP's view was that, as for Zometa, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Zometa.
English: What measures are being taken to ensure the safe and effective use of Zoledronic acid Teva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zoledronsyre Teva?
English: Because Zoledronic acid Teva is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Zoledronsyre Teva er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Zoledronic acid Teva can also be used to treat the hypercalcaemia caused by tumours.
Danish: Zoledronsyre Teva kan også anvendes til at behandle hypercalcæmi forårsaget af tumorer.
English: The active substance in Zoledronic acid Teva, zoledronic acid, is a bisphosphonate.
Danish: Det aktive stof i Zoledronsyre Teva, zoledronsyre, er et bisphosphonat.
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Danish: Komplikationerne kan bl.a. være brud (knoglebrud), rygmarvskompression (når rygmarven presses sammen af knoglen), knoglelidelser, der kræver stråleterapi eller operation, og forhøjet calciumindhold i blodet (hypercalcæmi).
English: What are the benefits and risks of Zoledronic acid Teva?
Danish: Hvilke fordele og risici er der forbundet med Zoledronsyre Teva?
English: Zoledronic acid Teva can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Danish: Zoledronsyre Teva kan anvendes til forebyggelse af knoglekomplikationer hos voksne med fremskreden kræft, der angriber knoglerne.