natgillin/translations-raw huggingface dataset:
Patienternes hydreringsstatus skal vurderes før og efter indgivelsen af Zoledronsyre Teva for at sikre, de er tilstrækkeligt hydrerede. 
The hydration status of patients must be assessed prior to and following administration of Zoledronic Acid Teva to ensure that they are adequately hydrated.
• Overfølsomhed over for det aktive stof, andre bisfosfonater eller over for et eller flere af hjælpestofferne anført i pkt. 
• Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1
Brug af anden medicin sammen med Zoledronsyre Teva Fortæl altid lægen, hvis du tager anden medicin eller har gjort det for nylig. 
Other medicines and Zoledronic Acid Teva Tell your doctorif you are taking, have recently taken or might take any other medicines.
Anbefalet dosis af Zoledronsyre Teva* 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). 
Zoledronic Acid Teva 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).
Studier med glasflasker, såvel som med flere typer af infusionsposer og infusionsslanger lavet af polyvinylchlorid, polyethylen og polypropylen (forfyldt med 9 mg/ml (0,9%) w/v natriumklorid- eller 5% w/v glukoseopløsning) viste ingen uforligelighed. 
Studies with glass bottles, as well as several types of infusion bags and infusion lines made from polyvinylchloride, polyethylene and polypropylene (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution), showed no incompatibility.
Zoledronsyre Teva har været forbundet med rapporter om nedsat nyrefunktion. 
Zoledronic acid has been associated with reports of renal dysfunction.
I en pooled analyse af sikkerhedsdata fra zoledronsyre-registreringsstudier vedrørende forebyggelse af knogle-relaterede hændelser hos patienter med fremskreden malign sygdom, der involverer knoglerne, var frekvensen af bivirkninger med relation til nedsat nyrefunktion, og som formodes at være relateret til zoledronsyre, følgende: 3,2% ved multipelt myelom, 3,1% ved prostatacancer, 4,3% ved brystcancer og 3,2% ved lunge- og andre solide tumorer. 
In a pooled analysis of safety data from zoledronic acid registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
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. 
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.
Tabel 2: Effektresultater (patienter med prostatacancer i hormonbehandling) 
Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy)
I et tredje fase III randomiseret, dobbeltblindt 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. 
In a third phase III randomised, double-blind trial, 4 mg zoledronic acid 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.
Zoledronsyre Teva behandling bør genoptages med samme dosis som givet før afbrydelse af behandlingen. 
Zoledronic Acid Teva treatment should be resumed at the same dose as that given prior to treatment interruption.
Resultater fra kliniske undersøgelser vedrørende behandling af TIH Kliniske studier af tumorinduceret hyperkalcæmi (TIH) viser, at effekten af zoledronsyre er karakteriseret ved fald i serumcalcium og urinudskillelse af calcium. 
Clinical studies in tumour-induced hypercalcaemia (TIH) demonstrated that the effect of zoledronic acid is characterised by decreases in serum calcium and urinary calcium excretion.
Børn og unge Zoledronsyre Teva bør ikke bruges til børn og unge under 18 år. 
Zoledronic Acid Teva is not recommended for use in adolescents and children below the age of 18 years.
Zoledronsyre var teratogen hos rotter i subkutane doser på ≥0,2 mg/kg. 
Zoledronic acid was teratogenic in the rat at subcutaneous doses ≥ 0.2 mg/kg.
Serumcalcium bør måles og hypokalcæmi korrigeres, inden Zoledronsyre Teva-behandling påbegyndes. 
Serum calcium should be measured and hypocalcaemia must be corrected before initiating Zoledronic Acid Teva therapy.
Hos patienter med let til moderat nedsat nyrefunktion, anbefales nedsatte doser af zoledronsyre (se afsnittet ”Dosering” ovenfor samt pkt. 
In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
Fortæl det straks til din læge eller tandlæge, hvis du får sådanne symptomer, mens du er i behandling med Zoledronsyre Teva eller efter behandlingsophør. 
Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic Acid Teva or after stopping treatment.
- Uregelmæssig hjerterytme (atrieflimren) er set hos patienter, der fik zoledronsyre for postmenopausal osteoporose. 
- Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri. 
This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”.
Ikke almindelig (forekommer hos op til 1 ud af 100 patienter): - Overfølsomhedsreaktioner. 
Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
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 Teva eller efter endt behandling. 
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 Teva or after stopping treatment.
Instruktion i fremstilling af reducerede doser Zoledronsyre Teva Udtag en passende volumen af koncentratet efter følgende: - 4,4 ml til 3,5 mg dosis 
Instructions for preparing reduced doses of Zoledronic Acid Teva Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose - 4.1 ml for 3.3 mg dose
Det skal du vide, før du får Zoledronsyre Teva 
What you need to know before you are given Zoledronic Acid Teva
− Opløsningen indeholdende zoledronsyre indgives ved en enkelt intravenøs infusion over 15 minutter i en separat infusionsslange. 
- The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Sjælden (forekommer hos op til 1 ud af 1.000 patienter): - Langsom hjerterytme. 
Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Patienter i behandling med Zoledronsyre Teva bør få udleveret indlægssedlen og patienthuskekortet. 
Patients treated with Zoledronic Acid Teva should be given the package leaflet and the patient reminder card.
Du bør ikke få Zoledronsyre Teva, hvis du er gravid. 
You should not be given Zoledronic Acid Teva if you are pregnant.
Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og flaskeetiketten efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
- Mave-tarm-symptomer såsom kvalme og opkastning samt appetitløshed. 
- Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
− Den færdigfremstillede Zoledronsyre Teva infusionsvæske bør anvendes straks. 
Diluted Solution - The readily prepared Zoledronic Acid Teva infusion solution should preferably be used immediately.
Hjælpestoffer: mannitol, natriumcitrat og vand til injektionsvæsker. 
LIST OF EXCIPIENTS Excipients: mannitol, sodium citrate and water for injections.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et hætteglas med 5 ml koncentrat indeholder 4 mg zoledronsyre (som monohydrat). 
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate).
Zoledronsyre Teva indeholder: 
What Zoledronic Acid Teva contains
Denne bivirkning består af en række symptomer der inkluderer feber, myalgi, hovedpine, smerter i arme og ben, kvalme, opkastning, diarré, artralgi og artritis med efterfølgende hævede led. 
This adverse drug reaction consists of a constellation of symptoms that includes fever, myalgia, headache, extremity pain, nausea, vomiting, diarrhoea arthralgia and arthritis with subsequent joint swelling.
Det er ikke nødvendigt at dosisjustere patienter med TIH og serum-kreatinin <400 μmol/l eller <4,5 mg/dl (se afsnit 4.4). 
No dose adjustment is necessary in TIH patients with serum creatinine < 400 μmol/l or < 4.5 mg/dl (see section 4.4).
- Øget svedtendens. 
- Increased sweating.
I kliniske forsøg med zoledronsyre blev patienter med serum-kreatinin >265 µmol/l eller >3,0 mg/dl ekskluderet. 
In clinical trials with zoledronic acid, patients with serum creatinine > 265 μmol/l or > 3.0 mg/dl were excluded.
Tabel 4: Effektresultater (patienter med brystcancer eller multipelt myelom) Enhver SRE (+TIH) 
Table 4: Efficacy results (breast cancer and multiple myeloma patients)
Zoledronsyre Teva er kontraindikeret hos kvinder, der ammer (se pkt. 
Zoledronic Acid Teva is contraindicated in breast-feeding women (see section 4.3).
- Aktivt stof/aktive stoffer: zoledronsyre. 
The active substance is zoledronic acid.
Dette lægemiddel må ikke blandes med infusionsopløsninger, opløsninger indeholdende calcium eller andre divalente kationer så som lakteret Ringer's væske og bør administreres som en enkelt intravenøs infusion i en separat infusionsslange. 
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.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) 
METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
- Hudreaktioner (rødme og hævelse) på infusionsstedet, udslæt, kløe. 
- Skin reactions (redness and swelling) at the infusion site, rash, itching.
− Vejrtrækningsbesvær med hiven efter vejret eller hosten. 
- Difficulty in breathing with wheezing or coughing.
Osteonekrose af kæberne er blevet rapporteret med frekvensen ”ikke almindelig” i kliniske forsøg og efter markedsføring hos patienter behandlet med Zoledronsyre Teva. 
Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving Zoledronic Acid Teva.
Almene symptomer og reaktioner på administrationsstedet 
General disorders and administration site conditions Common:
Blod og lymfesystem 
Blood and lymphatic system disorders Common:
- Interstitiel lungesygdom (sygdom i alveolevævet). 
Interstitial lung disease
Zoledronsyre Teva koncentrat 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. 
Zoledronic Acid Teva 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.
Dyspnø, hoste, bronkokonstriktion Interstitieal lungesygdom 
Dyspnoea, cough, bronchoconstriction
- Vægtøgning. 
- Urticaria.
- Forhøjet blodtryk, åndenød, svimmelhed, angst, søvnforstyrrelser, smagsforstyrrelser, rysten, 
- High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation,
− Når du skal tilberede en infusionsvæske indeholdende 4 mg zoledronsyre, skal du opløse Zoledronsyre Teva-koncentratet (5,0 ml) yderligere med 100 ml calciumfri eller anden infusionsvæske uden indhold af divalente kationer. 
How to prepare and administer Zoledronic Acid Teva - To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Teva concentrate (5 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Zoledronsyre Teva indeholder natriumklorid (salt) Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, dvs. det er praktisk taget ”natriumfrit”. 
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”.
Almindelig (forekommer hos op til 1 ud af 10 patienter): - Hovedpine og influenzalignende symptomer som feber, træthed, svaghed, døsighed, 
Common (may affect up to 1 in 10 people): - Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
I kliniske forsøg blev patienter med serum-kreatinin >400 μmol/l eller >4,5 mg/dl ekskluderet. 
In the clinical studies, patients with serum creatinine > 400 μmol/l or > 4.5 mg/dl were excluded.
Muskelspasmer, osteonekrose af kæberne* 
Muscle spasms, osteonecrosis of the jaw
Indehaveren af markedsføringstilladelsen skal sikre at, der implementeres patienthuskekort vedrørende osteonekrose af kæberne. 
Additional risk minimisation measures The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Du må ikke få Zoledronsyre Teva, hvis du ammer. 
You must not be given Zoledronic Acid Teva if you are breast-feeding.
Fremstiller Pharmachemie B.V. 
Manufacturer Pharmachemie B.V. Swensweg 5
Hud og subkutane væv 
Skin and subcutaneous tissue disorders Uncommon:
Desuden synes der at være en association mellem hypokalcæmi og de sekundære neurologiske bivirkninger, der er rapporteret i disse tilfælde, herunder kramper, hypæstesi og tetani (se pkt. 
Furthermore, there is evidence of an association between hypocalcaemia and secondary neurological events reported in these cases including;
Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden. 
Do not throw away any medicines via wastewater (or household waste).
strålebehandling eller operation af knogler, eller tumorinduceret hyperkalcæmi) hos voksne patienter med fremskreden malign sygdom og knoglemetastaser. 
- Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Den udtagne mængde af koncentratet skal fortyndes yderligere i 100 ml sterilt 9 mg/ml (0,9%) w/v natriumchlorid- eller 5% w/v glucoseinjektions-/infusionsvæske. 
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.
Sjælden (forekommer hos op til 1 ud af 1.000 patienter): - Som følge af lave calcium-værdier: uregelmæssig hjerterytme (hjertearytmi; sekundære symptomer på hypokalcæmi). 
− As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Før administration skal 5,0 ml koncentrat fra et hætteglas eller det påkrævede udtagende volumen af koncentratet fortyndes yderligere med 100 ml calciumfri infusionsvæske (9 mg/ml (0,9%) w/v natriumklorid- eller 5% w/v glucoseinjektions-/infusionsvæske). 
6.6 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).
Mens du er i behandling med Zoledronsyre Teva, skal du holde en god mundhygiejne (inkl. 
While being treated with Zoledronic Acid Teva, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Den rekonstituerede Zoledronsyre Teva-opløsning må ikke blandes med calciumholdige eller andre divalente kationholdige opløsninger som lakteret Ringers væske. 
Do not mix Zoledronic Acid Teva concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Før indgift af Zoledronsyre Teva skal patienterne vurderes med henblik på at sikre, de er vel hydrerede. 
Patients must be assessed prior to administration of Zoledronic Acid Teva to ensure that they are adequately hydrated.
Forebyggelse af skeletrelaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser 
Prevention of skeletal related events in patients with advanced malignancies involving bone Adults and elderly people
Instruktion for tilberedning af reducerede doser af Zoledronsyre Teva: Udtag det passende volumen af det flydende koncentrat efter følgende: 
Instructions for preparing reduced doses of Zoledronic Acid Teva: Withdraw the appropriate volume of the liquid concentrate, as follows: - 4.4 ml for 3.5 mg dose
(>1,4 mg/dl eller >124 μmol/l). 
1.0 mg/dl or 88 μmol/l.
For at forhindre eventuelle uforligeligheder skal Zoledronsyre Teva koncentratet fortyndes med 9 mg/ml (0,9%) w/v natriumklorid- eller 5% w/v glucoseinjektions-/infusionsvæske. 
To avoid potential incompatibilities, Zoledronic Acid Teva concentrate is to be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Et hætteglas indeholder 4 mg zoledronsyre (som monohydrat). 
One vial contains 4 mg zoledronic acid, (as monohydrate).
Forværring af nyrefunktion blev i kliniske studier defineret som følger: - Øgning på 0,5 mg/dl eller 44 μmol/l hos patienter med normal serum-kreatinin ved baseline 
In the clinical trials, renal deterioration was defined as follows: - For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 μmol/l), an increase of
Nyreinsufficiens TIH: 
TIH:
- Samtidig behandling: kemoterapi, angiogenesehæmmere (se pkt. 
- Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
Derudover har der været sporadiske rapporter om osteonekrose af andre steder, inklusive hoften og femur. 
Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with zoledronic acid.
For at forhindre eventuelle uforligeligheder skal den rekonstituerede opløsning fortyndes med 9 mg/ml (0,9%) w/v natriumklorid- eller 5% w/v glucoseinjektions-/infusionsvæske. 
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.
Zoledronsyre Teva 4 mg koncentrat til infusionsvæske, opløsning rekonstitueret yderligere i 100 ml (se pkt. 
Zoledronic acid Teva 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.
Advarsler og forsigtighedsregler: Kontakt lægen, før du begynder at få Zoledronsyre Teva: 
Warnings and precautions Talk to your doctor before you are given Zoledronic Acid Teva: - if you have or have had a kidney problem.
Zoledronsyre Teva 4 mg/5 ml koncentrat til infusionsvæske, opløsning zoledronsyre 
Zoledronic Acid Teva 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Nedsat nyrefunktion, osteonekrose af kæberne, akut fasereaktion, hypokalcæmi, atrieflimren, anafylaksi, interstitial lyngesygdom. 
The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Opbevaringsforhold efter rekonstitution af infusionsvæsken, se pkt. 
For storage condition after dilution of the medicinal product, see section 6.3.
Akut nyresvigt, hæmaturi, proteinuri 
Acute renal failure, haematuria, proteinuria Acquired Fanconi syndrome
- Øgning på 1,0 mg/dl eller 88 μmol/l hos patienter med abnorm kreatinin ved baseline 
0.5 mg/dl or 44 μmol/l; - For patients with an abnormal baseline creatinine (> 1.4 mg/dl or > 124 μmol/l), an increase of
Sådan bliver du behandlet med Zoledronsyre Teva 
How Zoledronic Acid Teva is given
Hvordan får du Zoledronsyre Teva - Zoledronsyre Teva gives som drop (infusion) i en vene. 
What Zoledronic Acid Teva looks like and contents of the pack Zoledronic Acid Teva is supplied as a concentrate for solution for infusion.
Luftveje, thorax og mediastinum 
Respiratory, thoracic and mediastinal disorders Common:
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). 
− As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Tilberedelse og indgift af Zoledronsyre Teva 
How to store Zoledronic Acid Teva
D. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription.
Det skal du vide, før du får Zoledronsyre Teva Sådan bliver du behandlet med Zoledronsyre Teva Bivirkninger 
What Zoledronic Acid Teva is and what it is used for What you need to know before you are given Zoledronic Acid Teva How Zoledronic Acid Teva is given Possible side effects
Der er rapporter om nedsat nyrefunktion i forbindelse med Zoledronsyre Teva. 
Important information about some of the ingredients in Zoledronic Acid Teva
Fortæl det straks til din læge, hvis du oplever nogen af disse symptomer.Hvis du har hypokalcæmi, skal den korrigeres, inden du får den første dosis af Zoledronsyre Teva. 
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid Teva.
alvorlig nedsat nyrefunktion. 
- Weight increase.
1 hætteglas med 5 ml 4 hætteglas med 5 ml 10 hætteglas med 5 ml 
10 x 5 ml vials
mavesmerter, mundtørhed. 
abdominal pain, dry mouth.
Zoledronsyre 4 mg 
Pam 90 mg zoledronic acid 4 mg
Zoledronsyre Teva 4 mg/5 ml koncentrat til infusionsvæske, opløsning 
NAME OF THE MEDICINAL PRODUCT Zoledronic Acid Teva 4 mg/5 ml concentrate for solution for infusion
- For at undgå væskemangel skal du følge lægens anvisninger og drikke rigeligt med vand inden infusionerne. 
- Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
Du bør ikke få Zoledronsyre Teva: 
You should not be given Zoledronic Acid Teva: - if you are breast-feeding.
Feber, træthed 
Pyrexia, fatigue
- Influenza-lignende symptomer herunder gigt (artritis) og hævede led. 
- Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) - Flu-like symptoms including arthritis and joint swelling - Painful redness and/or swelling of the eye.
1 hætteglas indeholder 4 mg zoledronsyre (som monohydrat). 
STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg of zoledronic acid (as monohydrate)
Den 4. juli 2015 
4 July 2015
Senest 30 dage efter Kommissionens beslutning 
Within 30 days following EC decision
Endelig rapport over undersøgelsen senest: 
Final study report by:
Materialet skal fremhæve risici og advarsler vedrørende genotoksiske reaktioner. 
This will highlight the risks and warnings of genotoxicity reactions.
Thiocolchicosid indgår i det projekt til synkronisering af PSUR, der forestås af lægemiddelstyrelsernes ledelser. 
Thiocolchicoside takes part in the PSUR synchronisation project of the Heads of Medicine Agencies.