FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er ordnet under overskrifter om hyppighed, den hyppigste først, ved brug af de følgende konventionelle regler: Meget almindelig ( 1/10), almindelig ( 1/100 til < 1/10), ikke almindelig ( 1/1.000 til < 1/100), sjælden ( 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Rare (may affect up to 1 in 1,000 people): - As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Danish: Sjælden (forekommer hos op til 1 ud af 1.000 patienter): - Som følge af lave calcium-værdier: uregelmæssig hjerterytme (hjertearytmi; sekundære symptomer på hypokalcæmi).
English: - Sudden coldness with fainting, limpness or collapse.
Danish: Pludselig opstået kuldefølelse med besvimelse, slaphed eller kollaps.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med referencelægemidlet, som indeholder zoledronsyre, i alle undergrupper af den pædiatriske population ved behandling af tumorinduceret hyperkalcæmi (TIH) og forebyggelse af skeletrelaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser (se pkt.
English: - Cancer, co morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Danish: - Cancer, følgesygdomme (f.eks. anæmi, koagulationslidelse, infektion), rygning.
English: - Sleepiness.
Danish: Søvnighed.
English: Patients treated with Zoledronic acid Mylan should be given the package leaflet and the patient reminder card.
Danish: Patienter i behandling med Zoledronsyre Mylan bør få udleveret indlægssedlen og patienthuskekortet.
English: Caution is advised when zoledronic acid is administered with anti-angiogenic medicinal products as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Danish: Der tilrådes forsigtighed, når zoledronsyre indgives sammen med anti-angiogene lægemidler, da der er set en øget hyppighed af osteonekrose af kæberne hos patienter i samtidig behandling med disse lægemidler.
English: In patients who show evidence of renal deterioration during treatment, zoledronic acid should be withheld.
Danish: Hos patienter, der har påvist forværret nyrefunktion under behandling, bør zoledronsyre seponeres.
English: In a third phase III randomised, double-blind trial, zoledronic acid 4 mg or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
Danish: I et tredje fase III randomiseret, dobbeltblindet studie blev zoledronsyre 4 mg eller pamidronat 90 mg administreret hver 3. til 4. uge sammenlignet hos patienter med multipelt myelom eller brystkræft og mindst én knoglelæsion.
English: Zoledronic acid recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min).
Danish: Anbefalet dosis af zoledronsyre* 4.0 mg zoledronsyre 3.5 mg* zoledronsyre 3.3 mg* zoledronsyre 3.0 mg* zoledronsyre * Dosis er beregnet ud fra forudsætning om et mål-AUC på 0,66 (mg•t/l) (CLcr=75 ml/min).
English: Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients treated with zoledronic acid.
Danish: Nedsat indhold af calcium i blodet (hypokalcæmi), som kan medføre muskelkramper, tør hud, en brændende følelse, er indberettet for patienter i behandling med Zoledronsyre Mylan.
English: The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 cancer patients studied.
Danish: Den renale clearance af zoledronsyre korrelerer tydeligt med kreatininclearance, idet den renale clearance er ansvarlig for 7533% af kreatininclearance, hvilket viser en median på 8429 ml/min (varierende fra 22 til 143 ml/min) hos de 64 undersøgte cancerpatienter.
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, the following zoledronic acid dose is recommended (see also section 4.4):
Danish: Til patienter med knoglemetastaser, der før behandlingen initieres, har mild til moderat nyreinsufficiens, som i denne population er defineret som CLcr 30-60 ml/min, anbefales følgende dosis af zoledronsyre (se også pkt.
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic acid Mylan or after stopping treatment.
Danish: Fortæl det straks til din læge eller tandlæge, hvis du får sådanne symptomer, mens du er i behandling med Zoledronsyre Mylan eller efter behandlingsophør.
English: Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic acid Mylan or after stopping treatment.
Danish: Fortæl det straks til din læge, hvis du oplever symptomer så som nyopstået ømhed, smerte eller stivhed, eller en forværring af disse symptomer, mens du er i behandling med Zoledronsyre Mylan eller efter endt behandling.
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid and other bisphosphonates as well as use of other nephrotoxic medicinal products.
Danish: Faktorer, der kan øge potentialet for nedsættelse af nyrefunktionen, inkluderer dehydrering, allerede eksisterende nyreinsufficiens, adskillige cyklusser af zoledronsyre og andre bisfosfonater såvel som brug af andre nefrotoksiske lægemidler.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion Multipack: 4 (4 packs of 1) vials of 5 ml
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning Multipakning: 4 (4 pakninger af 1) hætteglas af 5 ml
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended.
Danish: Faktorer, der kan øge risikoen for nedsat nyrefunktion, inkluderer dehydrering, allerede eksisterende nyreinsufficiens, flere behandlingscyklusser af zoledronsyre eller andre bisfosfonater såvel som brug af andre nefrotoksiske lægemidler eller brug af en kortere infusionstid end anbefalet på nuværende tidspunkt.
English: Zoledronic acid was teratogenic in the rat at subcutaneous doses ≥ 0.2 mg/kg.
Danish: Zoledronsyre var teratogen hos rotter i subkutane doser på  0,2 mg/kg.
English: Healthcare professionals are advised not to dispose of unused Zoledronic acid Mylan via the domestic sewage system.
Danish: Sundhedspersonalet rådes til ikke at smide ubrugt zoledronsyre i kloakken.
English: Other medicines and Zoledronic acid Mylan Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Zoledronsyre Mylan Fortæl altid lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: BOX OF 10 VIALS
Danish: ÆSKE MED 10 HÆTTEGLAS
English: LIST OF EXCIPIENTS It also contains sodium citrate, sodium hydroxide, hydrochloric acid and water for injections.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også natriumcitrat, natriumhydroxid, saltsyre og vand til injektionsvæsker.
English: Zoledronic acid is contraindicated in breast-feeding women (see section 4.3).
Danish: Zoledronsyre er kontraindiceret hos kvinder, der ammer (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE MED 1 HÆTTEGLAS
English: Packs containing 1, 4 or 10 vials or multipacks containing 4 (4 cartons of 1) vials.
Danish: Pakninger med 1, 4 eller 10 hætteglas eller multipakninger med 4 (4 kartoner af 1) hætteglas.
English: BOX OF 4 VIALS
Danish: ÆSKE MED 4 HÆTTEGLAS
English: Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose
Danish: Udtag et passende volumen af den rekonstituerede opløsning (4 mg/5 ml): - 4,4 ml til 3,5 mg dosis
English: Placebo zoledronic acid 4 mg
Danish: Placebo zoledronsyre 4 mg
English: - The other ingredients are: sodium citrate, sodium hydroxide, hydrochloric acid and water for injections.
Danish: Øvrige indholdsstoffer: natriumcitrat, natriumhydroxid, saltsyre og vand til injektionsvæsker.
English: - To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the concentrate (5 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Danish: Når du skal tilberede en infusionsvæske indeholdende 4 mg zoledronsyre, skal du opløse koncentratet (5 ml) yderligere med 100 ml calciumfri eller en anden infusionsvæske uden indhold af divalente kationer.
English: - The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Danish: Opløsningen indeholdende zoledronsyre indgives ved en enkelt intravenøs infusion over 15 minutter i en separat infusionsslange.
English: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Danish: Svimmelhed, paræstesier, dysgeusi, hypoæstesi, hyperæstesi, tremor, døsighed
English: Pam 90 mg zoledronic acid 4 mg
Danish: Pam 90 mg zoledronsyre 4 mg
English: You should not be given Zoledronic acid Mylan if you are pregnant.
Danish: Du bør ikke få Zoledronsyre Mylan, hvis du er gravid.
English: Very rare (may affect up to 1 in 10,000 people): - As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Danish: Meget sjælden (forekommer hos op til 1 ud af 10.000 patienter): - Som følge af lave calcium-værdier: kramper følelsesløshed og tetani (sekundære symptomer på hypokalcæmi).
English: - Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
Danish: Mave-tarm-symptomer såsom kvalme og opkastning samt appetitløshed.
English: Tell your doctor about any of the following serious side effects straight away:
Danish: Giv lægen besked så hurtigt som muligt, hvis du bemærker en eller flere af nedenstående alvorlige bivirkninger:
English: - High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation,
Danish: Forhøjet blodtryk, åndenød, svimmelhed, angst, søvnforstyrrelser, smagsforstyrrelser, rysten, følelsesløshed eller prikkende fornemmelse i hænder eller fødder, diarré, forstoppelse, mavesmerter, mundtørhed.
English: Special precautions for disposal and other handling Prior to administration, 5 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution).
Danish: Regler for bortskaffelse og anden håndtering Før administration skal 5 ml koncentrat fra et hætteglas eller det påkrævede udtagende volumen af koncentratet fortyndes yderligere med 100 ml calciumfri infusionsvæske (0,9% w/v natriumchlorideller 5% w/v glucoseopløsning).
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C-8°C and at 25°C after dilution in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution (minimal concentration: 3 mg/100 ml; maximal concentration: 4 mg/100 ml).
Danish: Kemisk og fysisk stabilitet er blevet påvist i op til 48 timer ved 2°C-8°C og ved 25°C efter fortynding i 100 ml natriumchlorid 9 mg/ml (0,9%) injektionsvæske eller 5% w/v glucoseopløsning (mindste koncentration: 3 mg/100 ml; maksimal koncentration: 4 mg/100 ml).
English: This medicinal product must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Danish: Dette lægemiddel må ikke blandes med infusionsopløsninger indeholdende calcium eller andre divalente kationer såsom lakteret Ringer's væske, og bør administreres som en enkelt intravenøs infusion i en separat infusionsslange.
English: What you need to know before you are given Zoledronic acid Mylan
Danish: Det skal du vide, før du får Zoledronsyre Mylan
English: After dilution: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C-8°C and at 25°C after dilution in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution (minimal concentration: 3 mg/100 ml; maximal concentration: 4 mg/100 ml).
Danish: Efter fortynding: Kemisk og fysisk holdbarhed er vist i 48 timer ved 2°C-8°C og ved 25°C efter fortynding i 100 ml natriumchlorid 9 mg/ml (0,9%) injektionsvæske eller 5% w/v glucoseopløsning (minimalkoncentration: 3 mg/100 ml; maksimalkoncentration: 4 mg/100 ml).
English: Zoledronic acid Mylan contains sodium.
Danish: Zoledronsyre Mylan indeholder natrium
English: 117 allée des Parcs 69800 SAINT-PRIEST France
Danish: MYLAN S.A.S 117 allée des Parcs 69800 SAINT-PRIEST FRANKRIG
English: - Skin reactions (redness and swelling) at the infusion site, rash, itching.
Danish: Hudreaktioner (rødme og hævelse) på infusionsstedet, udslæt, kløe.
English: In clinical trials with zoledronic acid, patients with serum creatinine > 265 μmol/l or > 3.0 mg/dl were excluded.
Danish: I kliniske studier med zoledronsyre blev patienter med serum-kreatinin > 265 µmol/l eller > 3,0 mg/dl ekskluderet.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 5 ml.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1 hætteglas á 5 ml.
English: How to prepare and administer Zoledronic acid Mylan
Danish: Tilberedning og administration af Zoledronsyre Mylan
English: Do not mix Zoledronic acid Mylan concentrate with calcium-containing or other divalent cation-containing solutions such as lactated Ringer's solution.
Danish: Zoledronsyre Mylan koncetrat må ikke blandes med calciumholdige eller andre divalente kationholdige opløsninger såsom Ringer-lactat opløsning.
English: No dose adjustment is necessary in TIH patients with serum creatinine < 400 μmol/l or < 4.5 mg/dl (see section 4.4).
Danish: Det er ikke nødvendigt at dosisjustere patienter med TIH og serum-kreatinin < 400 μmol/l eller < 4,5 mg/dl (se pkt.
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post marketing setting in patients receiving zoledronic acid.
Danish: Osteonekrose af kæberne er blevet rapporteret med frekvensen ”ikke almindelig” i kliniske forsøg og efter markedsføring hos patienter behandlet med zoledronsyre.
English: - Flu-like symptoms including arthritis and joint swelling.
Danish: Influenza-lignende symptomer herunder gigt (artritis) og hævede led.
English: - Difficulty in breathing with wheezing or coughing.
Danish: Vejrtrækningsbesvær med hiven efter vejret eller hosten.
English: In the clinical studies, patients with serum creatinine > 400 μmol/l or > 4.5 mg/dl were excluded.
Danish: I kliniske studier blev patienter med serum-kreatinin > 400 μmol/l eller > 4,5 mg/dl ekskluderet.
English: Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with zoledronic acid in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Danish: Når behandling med zoledronsyre initieres hos patienter med multiple myelom eller knoglemetastatisk skade fra solide tumorer bør serum-kreatinin og kreatininclearence (CLcr) bestemmes.
English: You must not be given Zoledronic acid Mylan: - if you are breast-feeding.
Danish: Du må ikke få Zoledronsyre Mylan: - hvis du ammer.
English: What Zoledronic acid Mylan looks like and contents of the pack Zoledronic acid Mylan is a clear and colourless concentrate for solution for infusion.
Danish: Zoledronsyre Mylan er et klart og farveløst koncentrat til infusionsvæske.
English: - Do not use Zoledronic acid Mylan after the expiry date stated on the vial and carton after EXP. - The unopened vial does not require any specific storage conditions.
Danish: Brug ikke Zoledronsyre Mylan efter den udløbsdato, der står på hætteglasset og æsken efter EXP.
English: Studies with polyolefin bags (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution), showed no incompatibility with Zoledronic acid Mylan.
Danish: Undersøgelser med poser fremstillet af polyolefin (med natriumchlorid 9 mg/ml (0,9%) injektionsvæske eller 5% w/v glucoseopløsning) viste ingen uforligelighed med Zoledronsyre Mylan.
English: How Zoledronic acid Mylan is used
Danish: Hvordan skal Zoledronsyre Mylan opbevares
English: - Urticaria.
Danish: Nældefeber.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/001-004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/786/001-004
English: Patients must be assessed prior to administration of zoledronic acid to ensure that they are adequately hydrated.
Danish: Generelt Før indgift af zoledronsyre skal patienterne vurderes med henblik på at sikre, at de er velhydrerede.
English: Additional risk minimisation measures The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at der implementeres patienthuskekort vedrørende osteonekrose af kæberne.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/786/001
English: Zoledronic acid Mylan concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Danish: Rekonstitueret opløsning af Zoledronsyre Mylan må ikke blandes med calcium eller anden divalent kationholdig infusionsopløsning såsom Ringer-lactatopløsning, og bør indgives som en enkelt intravenøs opløsning i en separat infusionsslange.
English: While being treated with Zoledronic acid Mylan, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Danish: Mens du er i behandling med Zoledronsyre Mylan, skal du holde en god mundhygiejne (inkl.
English: Sodium citrate Sodium hydroxide Hydrochloric acid Water for injections
Danish: Natriumcitrat Natriumhydroxid Saltsyre
English: Skeletal morbidity rate 1.74 p-value
Danish: Skeletal morbiditet p-værdi
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Zoledronsyre Mylan 4 mg/5 ml koncentrat til infusionsvæske, opløsning Zoledronsyre
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING (INCLUDING BLUE BOX) LABEL FOR MULTIPACK OF 4 VIALS (4 PACKS OF 1) WRAPPED IN TRANSPARENT FOIL
Danish: ETIKET TIL MULTIPAKNINGER MED 4 HÆTTEGLAS (4 PAKNINGER AF 1) I TRANSPARENT FOLIE
English: To avoid potential incompatibilities, the infusion solution used for dilution must be either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Danish: For at undgå eventuelle uforligeligheder skal der som infusionsvæske til fortynding enten bruges natriumchlorid 9 mg/ml (0,9%) injektionsvæske eller 5% w/v glucoseopløsning.
English: Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Danish: Zoledronsyre Mylan 4 mg/5 ml koncentrat til infusionsvæske, opløsning Zoledronsyre
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/786/004
English: The concentrate is supplied in a clear and colourless glass vial with a rubber stopper and a plastic flip-off cap. One vial contains 5 ml of concentrate.
Danish: Koncentratet fås i et klart og farveløst hætteglas af glas med gummiprop og aftagelig plastikhætte.
English: The withdrawn amount of concentrate must be further diluted in 100 ml of sterile sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Danish: Den udtagne mængde af den rekonstituerede opløsning skal fortyndes i 100 ml sterilt 0,9% w/v natriumchlorid- eller 5% w/v glucoseopløsning.
English: Skeletal morbidity rate 0.77 p-value
Danish: Skeletal morbiditets rate p-værdi
English: 1.0 mg/dl or 88 μmol/l.
Danish: (> 1,4 mg/dl eller > 124 μmol/l).
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg zoledronic acid (as monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas indeholder 4 mg zoledronsyre (som monohydrat).
English: You must not be given Zoledronic acid Mylan if you are breast-feeding.
Danish: Du må ikke få Zoledronsyre Mylan, hvis du ammer.
English: Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Danish: Zoledronsyre Mylan 4 mg/5 ml koncentrat til infusionsvæske, opløsning rekonstitueret yderligere i 100 ml (se pkt.
English: - Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs).
Danish: Interstitiel lungesygdom (sygdom i alveolevævet).
English: How to store Zoledronic acid Mylan Your doctor, pharmacist or nurse knows how to store Zoledronic acid Mylan properly.
Danish: Lægen, apotekspersonalet eller sundhedspersonalet ved, hvordan Zoledronsyre Mylan skal opbevares korrekt (se afsnit 6).
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Zoledronsyre Mylan 4 mg/5 ml koncentrat til infusionsvæske, opløsning
English: Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
Danish: Ikke almindelig (forekommer hos op til 1 ud af 100 patienter):
English: To avoid potential incompatibilities, Zoledronic acid Mylan concentrate is to be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Danish: For at forhindre eventuelle uforligeligheder skal den rekonstituerede Zoledronsyre Mylan opløsning fortyndes med 0,9% w/v natriumklorid- eller 5% w/v glucoseopløsning.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING (WITHOUT BLUE BOX) BOX OF 1 VIAL AS PART OF A MULTIPACK COMPRISING 4 VIALS
Danish: ÆSKE MED 1 HÆTTEGLAS SOM DEL AF EN MULTIPAKNING, DER INDEHOLDER 4 HÆTTEGLAS
English: What Zoledronic acid Mylan is and what it is used for What you need to know before you are given Zoledronic acid Mylan How Zoledronic acid Mylan is used Possible side effects
Danish: Det skal du vide, før du får Zoledronsyre Mylan Sådan bliver du behandlet med Zoledronsyre Mylan Bivirkninger
English: What Zoledronic acid Mylan contains - The active substance is zoledronic acid.
Danish: Aktivt stof: zoledronsyre.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23.08.2012
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN