FrancophonIA/ELRC3.0 huggingface dataset:
English: Fabrazyme is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease.
Icelandic: Fabrazyme er notað sem langtíma ensímuppbótarmeðferð hjá sjúklingum þar sem staðfest greining á Fabry-sjúkdómi liggur fyrir.
English: Anaphylactoid reactions have been reported in the postmarketing setting.
Icelandic: Greint hefur verið frá bráðaofnæmislíkum viðbrögðum eftir markaðssetningu lyfsins.
English: Because this condition is slowly progressive, early detection and treatment is critical to achieve the best outcomes.
Icelandic: Þar sem sjúkdómurinn þróast hægt getur skipt sköpum til að útkoman verði sem best að hann sé greindur og að meðferð hefjist snemma.
English: - That it is the responsibility of the prescribing physician to provide appropriate training to the non-healthcare professional, such as the patient for self-administration or a caregiver who will administer the treatment at home, if the treating physician decides that this is appropriate.
Icelandic: - Að það sé á ábyrgð þess læknis sem ávísar lyfinu að veita þeim sem sér um meðferð heima, s.s. sjúklingi eða umönnunaraðila nauðsynlega þjálfun ef læknirinn ákveður að slíkt eigi við.
English: The initial infusion rate should be no more than 0.25 mg/min (15 mg/hour) to minimise the potential occurrence of infusion-associated reactions.
Icelandic: Í byrjun má innrennslið ekki vera meira en 0,25 mg/mín. (15 mg/klst.) til að draga úr líkum á innrennslistengdum aukaverkunum.
English: How to store Fabrazyme
Icelandic: Hvernig geyma á Fabrazyme
English: If you experience a reaction like this, you should tell your doctor immediately.
Icelandic: Ef þú finnur fyrir einhverjum þessarra aukaverkana, skal tafarlaust hafa samband við lækni.
English: Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate.
Icelandic: Hjálparefni: mannitól einbasískt natríumfosfat einhýdrat tvíbasískt natríumfosfat heptahýdrat.
English: Avoid forceful impact of the water for injections on the powder and avoid foaming.
Icelandic: Sprautið vatninu ekki of harkalega á duftið til að koma í veg fyrir að froða myndist í glasinu.
English: What Fabrazyme looks like and contents of the pack
Icelandic: Útlit Fabrazyme og pakkningastærðir
English: • (mottled purplish) skin discoloration
Icelandic: • litabreytingar í húð (fjólubláleitar skellur)
English: Each vial of Fabrazyme is intended for single use only.
Icelandic: Hvert hettuglas af Fabrazyme er einnota.
English: Slowly, withdraw 7.0 ml (equal to 35 mg) of the reconstituted solution from each vial up to the total volume required for the patient dose.
Icelandic: Dragið rólega 7,0 ml (samsvarar 35 mg) af blandaðri lausn úr hverju hettuglasi þar til náð er því heildarrúmmáli sem þarf í skammt sjúklingsins.
English: Prior to adding the reconstituted volume of Fabrazyme required for the patient dose, it is recommended to remove an equal volume of 0.9% sodium chloride intravenous solution, from the infusion bag.
Icelandic: Áður en viðeigandi rúmmáli af Fabrazyme blöndu, sem þörf er á fyrir sjúklinginn, er bætt í innrennslispokann er mælt með að fjarlægja sama rúmmál af 0,9% natríumklóríðlausn til inngjafar í bláæð úr innrennslispokanum.
English: Slowly, withdraw 1.0 ml (equal to 5 mg) of the reconstituted solution from each vial up to the total volume required for the patient dose.
Icelandic: Dragið rólega 1,0 ml (samsvarar 5 mg) af blandaðri lausn úr hverju hettuglasi þar til náð er því heildarrúmmáli sem þarf í skammt sjúklingsins.
English: Common (may affect up to 1 in 10 people): • chest pain
Icelandic: Algengar (geta komið fyrir hjá allt að 1 af hverjum 10 sjúklingum):
English: In one of these studies, 15 paediatric patients with available pharmacokinetics data, aged 8.5 to 16 years weighing 27.1 to 64.9 kg were treated with 1.0 mg/kg every 2 weeks.
Icelandic: 15 sjúklingar á aldrinum 8,5 til 16 ára og 27,1 til 64,9 kg að þyngd, þar sem upplýsingar um lyfjahvörf lágu fyrir, meðferð með 1,0 mg/kg á 2 vikna fresti.
English: Pregnancy There are no adequate data from the use of agalsidase beta in pregnant women.
Icelandic: Ekki liggja fyrir neinar fullnægjandi upplýsingar um notkun agalsídasa beta á meðgöngu.
English: Infusion associated reactions
Icelandic: Innrennslistengd viðbrögð
English: Fabrazyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Fabry disease.
Icelandic: Lyfið má eingöngu nota undir umsjá læknis sem þekkir til meðhöndlunar á Fabrys-sjúkdómi.
English: Renal function, as measured by glomerular filtration rate and serum creatinine, as well as proteinuria, remained stable in the majority of the patients.
Icelandic: Nýrnastarfsemi hélst stöðug hjá flestum sjúklingum, samkvæmt mælingum á gauklasíunarhraða (GFR) og kreatínínstyrk í sermi auk próteinmigu.
English: After patient tolerance is established, the infusion rate may be increased gradually with subsequent infusions.
Icelandic: Þegar gengið hefur verið úr skugga um að sjúklingurinn þoli lyfið vel má auka innrennslishraðann smám saman í næstu gjöfum.
English: Marketing Authorisation Holder and Manufacturer Marketing authorisation holder
Icelandic: Markaðsleyfishafi og framleiðandi
English: The marketing authorisation holder (MAH) shall agree the details of the educational programme for Fabrazyme home infusion with the National Competent Authorities prior to implementing the programme nationally.
Icelandic: Markaðsleyfishafi skal í samráði við viðeigandi yfirvöld í hverju aðildarríki fyrir sig koma sér saman um innihald fræðsluefnisins áður en efnið er gefið út í aðildarríkinu.
English: Fabrazyme 5 mg powder for concentrate for solution for infusion Reconstitute each vial of Fabrazyme 5 mg with 1.1 ml water for injections.
Icelandic: Fabrazyme 5 mg stofn fyrir innrennslisþykkni, lausn Sprautið 1,1 ml af vatni fyrir stungulyf í hvert hettuglas með Fabrazyme 5 mg.
English: Agalsidase beta clearance was not influenced by weight in this population.
Icelandic: Þyngdin hafði ekki áhrif á úthreinsun agalsídasa beta hjá þessum sjúklingahópi.
English: lacrimation increased eye pruritus, ocular hyperaemia
Icelandic: Þroti í eyrum, eyrnaverkur
English: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Icelandic: 25, 1105 BP Amsterdam, Holland
English: Lower dosing regimens have been used in clinical studies.
Icelandic: Í klínískum rannsóknum hafa verið notaðir minni skammtar.
English: Before further dilution, visually inspect the reconstituted solution in each vial for particulate matter and discoloration.
Icelandic: Áður en blandan er þynnt frekar á að skoða hvert hettuglas fyrir sig og gá hvort þar séu einhverjar agnir eða mislitun í lausninni.
English: • urticaria
Icelandic: • niðurgangur
English: Renal elimination of agalsidase beta is considered to be a minor pathway for clearance.
Icelandic: Brotthvarf agalsídasa beta um nýru er talin vera minni háttar úthreinsunarleið.
English: Baseline CL was 77 ml/min with a Vss of 2.6 l; half-life was 55 min. After IgG seroconversion, CL decreased to 35 ml/min, Vss increased to 5.4 l, and half-life increased to 240 min.
Icelandic: IgG minnkaði úthreinsun niður í 35 ml/mín., Vss jókst í 5,4 l og helmingunartíminn jókst í 240 mín.
English: - The active substance is agalsidase beta, one vial contains 35 mg. - The other ingredients are:
Icelandic: - Virka innihaldsefnið er agalsídasi beta, 35 mg eru í einu hettuglasi.
English: Subsequent infusions may need to occur in a clinical setting.
Icelandic: Vera má að frekari innrennsli þurfi að fara fram á sjúkrastofnun.
English: • increased sensitivity to pain
Icelandic: • þroti í eyrum • aukið sársaukanæmi
English: • Home infusion manual for healthcare professionals
Icelandic: Leiðbeiningar fyrir heilbrigðisstarfsfólk um innrennslismeðferð heima
English: • increased heart beat
Icelandic: • hraður hjartsláttur
English: Fabrazyme 5 mg powder for concentrate for solution for infusion agalsidase beta
Icelandic: Fabrazyme 5 mg stofn fyrir innrennslisþykkni, lausn
English: - The active substance is agalsidase beta, one vial contains 5 mg. - The other ingredients are:
Icelandic: - Virka innihaldsefnið er agalsídasi beta, 5 mg eru í einu hettuglasi.
English: After reconstitution with 1.1 ml water for injections, each vial of Fabrazyme contains 5 mg/ml of agalsidase beta.
Icelandic: Eftir blöndun með 1,1 ml af vatni fyrir stungulyf inniheldur hvert hettuglas af Fabrazyme 5 mg/ml af agalsídasa beta.
English: Investigations oxygen saturation decreased
Icelandic: • minnkuð súrefnisþéttni í blóði
English: EU/1/01/188/001 Fabrazyme 35 mg 1 vial of powder for concentrate for solution for infusion EU/1/01/188/002 Fabrazyme 35 mg 5 vials of powder for concentrate for solution for infusion EU/1/01/188/003 Fabrazyme 35 mg 10 vials of powder for concentrate for solution for infusion EU/1/01/188/004 Fabrazyme 5 mg 1 vial of powder for concentrate for solution for infusion EU/1/01/188/005 Fabrazyme 5 mg 5 vials of powder for concentrate for solution for infusion EU/1/01/188/006 Fabrazyme 5 mg 10 vials of powder for concentrate for solution for infusion
Icelandic: EU/1/01/188/001 Fabrazyme 35 mg 1 hettuglas með stofni fyrir innrennslisþykkni, lausn EU/1/01/188/002 Fabrazyme 35 mg 5 hettuglös með stofni fyrir innrennslisþykkni.
English: • Home infusion manuals for patients
Icelandic: Leiðbeiningar fyrir sjúklinga um innrennslismeðferð heima
English: Infusion associated reactions consisted most often of fever and chills.
Icelandic: Algengustu innrennslistengdu aukaverkanirnar voru hiti og kuldahrollur.
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Reconstitute each vial of Fabrazyme 35 mg with 7.2 ml water for injections.
Icelandic: 35 mg stofn fyrir innrennslisþykkni, lausn Sprautið 7,2 ml af vatni fyrir stungulyf í hvert hettuglas með Fabrazyme 35 mg.
English: After intravenous administration of agalsidase beta to adults with an infusion time of approximately 300 minutes and at a dose of 1 mg/kg body weight, biweekly, mean Cmax plasma concentrations ranged from 2000-3500 ng/ml, while the AUCinf ranged from 370-780 µg min/ml.
Icelandic: 300 mínútna innrennslistíma og skammtinum 1 mg/kg líkamsþunga á tveggja vikna fresti var meðal Cmax í plasma á bilinu 20003500 ng/ml en AUCinf var á bilinu 370-780 µg mín./ml. Vss var á bilinu 8,3-40,8 l, plasmaúthreinsun var á bilinu 119-345 ml/mín. og meðalhelmingunartími brotthvarfs 80-120 mínútur.
English: One vial of powder contains 5 mg of agalsidase beta.
Icelandic: Í einu hettuglasi með stofni eru 5 mg af agalsídasa beta.
English: - Regular review of the administration by the patient and/or caregiver needs to be performed to ensure maintenance of optimal practice.
Icelandic: - Endurmeta skal reglulega meðferð sem sjúklingur sjálfur eða umönnunaraðili annast til að viðhalda fullnægjandi þjálfun.
English: One vial of powder contains 35 mg of agalsidase beta.
Icelandic: Í einu hettuglasi með stofni eru 35 mg af agalsídasa beta.
English: After reconstitution it is a clear, colourless liquid, free from foreign matter.
Icelandic: Eftir blöndun fæst tær, litarlaus, agnalaus lausn.
English: The infusion-associated reactions were managed by a reduction in the infusion rate together with the administration of non-steroidal anti-inflammatory medicinal products, antihistamines and/or corticosteroids.
Icelandic: Brugðist var við innrennslistengdum aukaverkunum með því að draga úr innrennslishraða og gefa bólgueyðandi lyf, andhistamín og/eða barkstera.
English: • skin discoloration
Icelandic: • upplituð húð
English: Musculoskeletal and connective tissue disorders pain in extremity, myalgia, back pain, muscle spasms, arthralgia, muscle tightness, musculoskeletal stiffness musculoskeletal pain --
Icelandic: Verkur í útlimum, vöðvaþrautir, bakverkur, vöðvakrampi liðverkir, stífir vöðvar, stirðleiki í stoðkerfi
English: Very common adverse reactions included chills, pyrexia, feeling cold, nausea, vomiting, headache and paraesthesia.
Icelandic: Mjög algengar aukaverkanir eru m.a. kuldahrollur, sótthiti, kuldatilfinning, ógleði, uppköst, höfuðverkur og breytt húðskyn.
English: • syncope
Icelandic: • syfja
English: Use of Fabrazyme during breastfeeding is not recommended.
Icelandic: Ekki er mælt með notkun Fabrazyme á meðgöngu.
English: Immunogenicity
Icelandic: Ónæmingargeta (immunogenicity)
English: In addition, infusion-associated reactions were dose dependent.
Icelandic: Þar að auki voru innrennslisháðar aukaverkanir skammtaháðar.
English: EU/1/01/188/001 1 vial of powder for concentrate for solution for infusion EU/1/01/188/002 5 vials of powder for concentrate for solution for infusion EU/1/01/188/003 10 vials of powder for concentrate for solution for infusion
Icelandic: EU/1/01/188/001 1 hettuglas með stofni fyrir innrennslisþykkni, lausn EU/1/01/188/002 5 hettuglös með stofni fyrir innrennslisþykkni.
English: • nasopharyngitis
Icelandic: • nefrennsli
English: Dilution
Icelandic: hitatilfinning
English: In another study with 30 paediatric patients with available pharmacokinetics data, aged 5 to 18 years, treated with two lower dose regimens of 0.5 mg/kg every 2 weeks and 1.0 mg/kg every 4 weeks, mean CL was 4.6 and 2.3 ml/min/kg, respectively, mean Vss was 0.27 and 0.22 l/kg, respectively, and mean elimination half-life was 88 and 107 minutes, respectively.
Icelandic: 4 vikna fresti, meðalúthreinsun var 4,6 og 2,3 ml/mín./kg, fyrir hvorn hóp, meðal Vss var 0,27 og 0,22 l/kg fyrir hvorn hóp og meðalhelmingunartími útskilnaðar var 88 og 107 mínútur, fyrir hvorn hóp.
English: • difficulty in breathing
Icelandic: • erfiðleikar við öndun • kviðverkur
English: • itching
Icelandic: • auknir
English: Package leaflet: Information for the user Fabrazyme 35 mg powder for concentrate for solution for infusion
Icelandic: Upplýsingar fyrir notanda lyfsins Fabrazyme 35 mg stofn fyrir innrennslisþykkni, lausn
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 35 mg is supplied in clear Type I glass 20 ml vials.
Icelandic: Fabrazyme 35 mg stofn fyrir innrennslisþykkni, lausn Fabrazyme 35 mg er í glæru 20 ml hettuglasi af gerð I. Glasinu er lokað með silikonbútýltappa og álinnsigli með plastloki, sem rifið er af.
English: EU/1/01/188/004 1 vial of powder for concentrate for solution for infusion EU/1/01/188/005 5 vials of powder for concentrate for solution for infusion EU/1/01/188/006 10 vials of powder for concentrate for solution for infusion
Icelandic: EU/1/01/188/004 1 hettuglas með stofni fyrir innrennslisþykkni, lausn EU/1/01/188/005 5 hettuglös með stofni fyrir innrennslisþykkni.
English: Intravenous use.
Icelandic: verkur á innrennslisstað
English: • chest discomfort
Icelandic: • óþægindi fyrir brjósti
English: Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate
Icelandic: Tvíbasískt natríumfosfat heptahýdrat
English: • feeling hot
Icelandic: Tilfinninganæmi, skjálfti
English: The educational material for patients should include information on the following key elements: - The prescribing physician may decide that Fabrazyme may be administered at home.
Icelandic: - Læknir sem ávísar lyfinu getur ákveðið að Fabrazyme meðferð megi fara fram heima.
English: Respiratory, thoracic and mediastinal disorders dyspnoea, nasal congestion, throat tightness, wheezing, cough, dyspnoea exacerbated bronchospasm, pharyngolaryngeal pain, rhinnorhoea, tachypnoea, upper respiratory tract congestion hypoxia
Icelandic: Kláði, ofsakláði, útbrot, húðroði, almennur kláði, ofsabjúgur, andlitsþroti, dröfnuörðuútbrot
English: • infusion site reaction
Icelandic: • inflúensulík veikindi
English: • skin discomfort
Icelandic: • óþægindi í húð
English: Nervous system disorders headache, paraesthesia dizziness, somnolence, hypoaesthesia, burning sensation, lethargy, syncope hyperaesthesia, tremor
Icelandic: Sundl, svefndrungi, tilfinningadofi, brunatilfinning, svefnhöfgi, yfirlið
English: After reconstitution it is recommended to promptly dilute the vials, to minimise protein particle formation over time.
Icelandic: Eftir blöndun á að þynna lyfið þegar í stað, til að halda í lágmarki próteinögnum sem myndast geta með tímanum.
English: Since agalsidase beta (r-hαGAL) is a recombinant protein, the development of IgG antibodies is expected in patients with little or no residual enzyme activity.
Icelandic: Þar sem agalsídasi beta (r-hαGAL) er raðbrigða prótein er gert ráð fyrir myndun
English: Fabrazyme 5 mg powder for concentrate for solution for infusion Fabrazyme 5 mg is supplied in clear Type I glass 5 ml vials.
Icelandic: Fabrazyme 5 mg stofn fyrir innrennslisþykkni, lausn Fabrazyme 5 mg er í glæru 5 ml hettuglasi af gerð I. Glasinu er lokað með silikonbútýltappa og álinnsigli með plastloki, sem rifið er af.
English: • musculoskeletal pain
Icelandic: vöðvaverkir
English: Package leaflet: Information for the user Fabrazyme 5 mg powder for concentrate for solution for infusion
Icelandic: Upplýsingar fyrir notanda lyfsins Fabrazyme 5 mg stofn fyrir innrennslisþykkni, lausn
English: • pallor
Icelandic: • bakverkur
English: • ear swelling
Icelandic: • andlitsbjúgur
English: The majority of these reactions can be attributed to the formation of IgG antibodies and/or complement activation.
Icelandic: IgG mótefna og/eða virkjun complementkerfisins.
English: Fertility
Icelandic: Fabrazyme
English: Patients with antibodies to r-hαGAL have a greater potential to experience infusion-associated reactions (IARs), which are defined as any related adverse event occurring on the infusion day.
Icelandic: Meiri hætta er á innrennslistengdum aukaverkunum, sem skilgreindar eru sem hvers konar aukaverkanir sem tengjast inngjöfinni og koma upp á þeim degi sem innrennsli er gefið, hjá sjúklingum með mótefni gegn r-hαGAL.
English: • rhinitis
Icelandic: • brjóstsviði
English: • fatigue
Icelandic: • kláði
English: • wheezing
Icelandic: • augnroði
English: Gastrointestinal Disorders nausea, vomiting abdominal pain, abdominal pain upper, abdominal discomfort, stomach discomfort, hypoaesthesia oral, diarrhoea dyspepsia, dysphagia --
Icelandic: Hita- og kuldatilfinning, inflúensulík veikindi, verkur á innrennslisstað, einkenni á innrennslisstað segamyndun á stungustað, vanlíðan, bjúgur
English: • increased blood pressure • joint pain
Icelandic: hækkaður blóðþrýstingur
English: Reconstitute each vial of Fabrazyme 35 mg with 7.2 ml water for injections.
Icelandic: Sprautið 7,2 ml af vatni fyrir stungulyf í hvert hettuglasið með Fabrazyme 35 mg.
English: Fabrazyme 35 mg powder for concentrate for solution for infusion agalsidase beta
Icelandic: Fabrazyme 35 mg stofn fyrir innrennslisþykkni, lausn.
English: Immune system disorders anaphylactoid reaction
Icelandic: Bráðaofnæmislík viðbrögð
English: • bronchospasm
Icelandic: • brunatilfinning
English: LIST OF EXCIPIENTS
Icelandic: Listi aukaverkana
English: Renal impairment
Icelandic: Aukin táramyndun
English: Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of patients (see section
Icelandic: Hjá fáeinum sjúklingum hefur verið greint frá aukaverkunum sem benda til bráðs (Tegund I) ofnæmis (sjá kafla 4.4).
English: • tinnitus
Icelandic: • bjúgur
English: • upper respiratory tract congestion
Icelandic: • óeðlileg táramyndun • hægur hjartsláttur
English: If you use more Fabrazyme than you should
Icelandic: Ef stærri skammtur en mælt er fyrir um er notaður
English: • diarrhoea
Icelandic: • ofhitnun
English: 10 vials of powder for concentrate for solution for infusion.
Icelandic: 10 hettuglös með stofni fyrir innrennslisþykkni, lausn.
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Each vial of Fabrazyme contains a nominal value of 35 mg of agalsidase beta.
Icelandic: Hvert hettuglas af Fabrazyme inniheldur sem samsvarar 35 mg af agalsídasa beta.
English: Description of selected adverse reactions
Icelandic: - Leiðbeiningar um meðhöndlun hugsanlegra aukaverkana
English: Vascular disorders flushing, hypertension, pallor, hypotension, hot flush peripheral coldness --
Icelandic: Berkjukrampi, verkur í koki og barka, nefrennsli, hraðöndun, þroti í efri hluta öndunarfæra
English: • lethargy
Icelandic: • lasleiki
English: Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
Icelandic: Tel: +371 67 33 24 51
English: The educational material for healthcare professionals should include information on the following key elements: - Guidance regarding patient evaluation and selection and organisational requirements for home infusion.
Icelandic: Fræðsluefni fyrir sjúklinga á að innihalda upplýsingar um eftirfarandi lykilþætti:
English: It comes in a clear plastic bottle.
Icelandic: Lausnin er í glærri plastflösku.
English: Older people (≥ 65 years)
Icelandic: Aldraðir (≥ 65 ára)
English: 2100 Gödöllő
Icelandic: 2100 Gödöllö
English: Tell your dentist immediately if you experience such symptoms.
Icelandic: Segðu tannlækninum tafarlaust frá því ef þú finnur fyrir slíkum einkennum.
English: Swelling and/or pain at the infusion site may occur.
Icelandic: Þroti og/eða verkur á innrennslisstað getur komið fram.
English: Effect on height
Icelandic: Áhrif á hæð
English: 36 months.
Icelandic: 18 mánuðir.
English: All clinical fractures were verified based on the radiographic and/or clinical evidence.
Icelandic: Öll klínísk brot voru staðfest með myndgreiningu og/eða klínískum einkennum.
English: Swensweg 5, 2031GA Haarlem The Netherlands
Icelandic: Swensweg 5, 2031GA Haarlem Holland
English: Zoledronic acid Teva Generics may work for longer than one year, and your doctor will let you know if you need to be treated again.
Icelandic: Zoledronic acid Teva Generics getur verkað lengur en eitt ár og læknirinn mun láta þig vita ef þörf er fyrir meðferð að nýju.
English: Clinical vertebral fracture (2)
Icelandic: Klínísk hryggjarliðabrot (2)
English: Effect on bone mineral density (BMD)
Icelandic: BMD (bone mineral density)
English: Summary of vertebral fracture efficacy at 12, 24 and 36 months
Icelandic: Tafla 2 Samantekt á verkun á hryggjarliðabrot eftir 12, 24 og 36 mánuði
English: The pack sizes of 5 and 10 bottles are only available in multipacks.
Icelandic: Pakkningarnar með 5 og 10 flöskum eru einungis fáanlegar í fjölpakkningum.
English: In the HORIZON-RFT study 508 men were randomised into the study and 185 patients had BMD assessed at 24 months.
Icelandic: Í HORIZON rannsókninni á endurteknum brotum var 508 körlum slembiraðað inn í rannsóknina og hjá 185 sjúklingum var steinefnaþéttni metin eftir 24 mánuði.
English: The following information is intended for healthcare professionals only:
Icelandic: Eftirfarandi upplýsingar eru einungis ætlaðar heilbrigðisstarfsfólki
English: Zoledronic acid Teva Generics with food and drink Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Zoledronic acid Teva Generics, as directed by your doctor.
Icelandic: Notkun Zoledronic acid Teva Generics með mat eða drykk Gætið þess að drekka nægan vökva (að minnsta kosti eitt eða tvö glös) fyrir og eftir meðferð með Zoledronic acid Teva Generics, samkvæmt leiðbeiningum læknisins.
English: It is important to take calcium and vitamin D supplements (for example tablets) as directed by your doctor.
Icelandic: Mikilvægt er að taka kalsíum og D-vítamín aukalega (t.d. töflur) samkvæmt fyrirmælum læknisins.
English: Following the menopause bone loss occurs, bones become weaker and break more easily.
Icelandic: Eftir tíðahvörfin tapast beinvefur, beinin verða viðkvæmari og brotna auðveldlegar.
English: 100 ml
Icelandic: x 100 ml
English: Before you receive treatment with Zoledronic acid Teva Generics, tell your doctor if you have (or have had) pain, swelling or numbness in your gums, jaw or both, if your jaw feels heavy, or if you have lost a tooth.
Icelandic: Áður en þú færð meðferð með Zoledronic acid Teva Generics skaltu segja lækninum frá því ef þú ert með (eða hefur fengið) verk, þrota eða dofa í tannhold, kjálka eða hvoru tveggja, einnig ef þú hefur þyngslatilfinningu í kjálkanum eða hefur misst tönn.
English: Zoledronic acid demonstrated a consistent effect over 3 years, resulting in a 41% reduction in the risk of hip fractures (95% CI, 17% to 58%).
Icelandic: Sýnt var fram á að zoledronsýra hafði stöðug áhrif á 3 ára tímabili sem leiddi til þess að hættan á mjaðmarbroti minnkaði um 41% (95% CI, 17% til 58%).