natgillin/translations-raw huggingface dataset:
Patienter i behandling med Zoledronsyre Mylan bør få udleveret indlægssedlen og patienthuskekortet. 
Patients treated with Zoledronic acid Mylan should be given the package leaflet and the patient reminder card.
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. 
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.
Hos patienter, der har påvist forværret nyrefunktion under behandling, bør zoledronsyre seponeres. 
In patients who show evidence of renal deterioration during treatment, zoledronic acid should be withheld.
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. 
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.
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). 
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).
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. 
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.
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.
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. 
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):
Fortæl det straks til din læge eller tandlæge, hvis du får sådanne symptomer, mens du er i behandling med Zoledronsyre Mylan eller efter behandlingsophør. 
Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic acid Mylan or after stopping treatment.
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. 
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.
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. 
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.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning Multipakning: 4 (4 pakninger af 1) hætteglas af 5 ml 
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion Multipack: 4 (4 packs of 1) vials of 5 ml
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. 
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.
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.
Sundhedspersonalet rådes til ikke at smide ubrugt zoledronsyre i kloakken. 
Healthcare professionals are advised not to dispose of unused Zoledronic acid Mylan via the domestic sewage system.
Brug af anden medicin sammen med Zoledronsyre Mylan Fortæl altid lægen, hvis du bruger anden medicin eller har gjort det for nylig. 
Other medicines and Zoledronic acid Mylan Tell your doctor if you are taking, have recently taken or might take any other medicines.
ÆSKE MED 10 HÆTTEGLAS 
BOX OF 10 VIALS
LISTE OVER HJÆLPESTOFFER Indeholder også natriumcitrat, natriumhydroxid, saltsyre og vand til injektionsvæsker. 
LIST OF EXCIPIENTS It also contains sodium citrate, sodium hydroxide, hydrochloric acid and water for injections.
Zoledronsyre er kontraindiceret hos kvinder, der ammer (se pkt. 
Zoledronic acid is contraindicated in breast-feeding women (see section 4.3).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE MED 1 HÆTTEGLAS 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL
Pakninger med 1, 4 eller 10 hætteglas eller multipakninger med 4 (4 kartoner af 1) hætteglas. 
Packs containing 1, 4 or 10 vials or multipacks containing 4 (4 cartons of 1) vials.
ÆSKE MED 4 HÆTTEGLAS 
BOX OF 4 VIALS
Udtag et passende volumen af den rekonstituerede opløsning (4 mg/5 ml): - 4,4 ml til 3,5 mg dosis 
Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose
Placebo zoledronsyre 4 mg 
Placebo zoledronic acid 4 mg
Øvrige indholdsstoffer: natriumcitrat, natriumhydroxid, saltsyre og vand til injektionsvæsker. 
- The other ingredients are: sodium citrate, sodium hydroxide, hydrochloric acid and water for injections.
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. 
- 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.
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.
Svimmelhed, paræstesier, dysgeusi, hypoæstesi, hyperæstesi, tremor, døsighed 
Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Pam 90 mg zoledronsyre 4 mg 
Pam 90 mg zoledronic acid 4 mg
Du bør ikke få Zoledronsyre Mylan, hvis du er gravid. 
You should not be given Zoledronic acid Mylan if you are pregnant.
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). 
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).
Mave-tarm-symptomer såsom kvalme og opkastning samt appetitløshed. 
- Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
Giv lægen besked så hurtigt som muligt, hvis du bemærker en eller flere af nedenstående alvorlige bivirkninger: 
Tell your doctor about any of the following serious side effects straight away:
Forhøjet blodtryk, åndenød, svimmelhed, angst, søvnforstyrrelser, smagsforstyrrelser, rysten, følelsesløshed eller prikkende fornemmelse i hænder eller fødder, diarré, forstoppelse, mavesmerter, mundtørhed. 
- High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation,
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). 
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).
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). 
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).
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. 
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.
Det skal du vide, før du får Zoledronsyre Mylan 
What you need to know before you are given Zoledronic acid Mylan
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). 
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).
Zoledronsyre Mylan indeholder natrium 
Zoledronic acid Mylan contains sodium.
MYLAN S.A.S 117 allée des Parcs 69800 SAINT-PRIEST FRANKRIG 
117 allée des Parcs 69800 SAINT-PRIEST France
Hudreaktioner (rødme og hævelse) på infusionsstedet, udslæt, kløe. 
- Skin reactions (redness and swelling) at the infusion site, rash, itching.
I kliniske studier 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.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1 hætteglas á 5 ml. 
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 5 ml.
Tilberedning og administration af Zoledronsyre Mylan 
How to prepare and administer Zoledronic acid Mylan
Zoledronsyre Mylan koncetrat må ikke blandes med calciumholdige eller andre divalente kationholdige opløsninger såsom Ringer-lactat opløsning. 
Do not mix Zoledronic acid Mylan concentrate with calcium-containing or other divalent cation-containing solutions such as lactated Ringer's solution.
Det er ikke nødvendigt at dosisjustere patienter med TIH og serum-kreatinin < 400 μmol/l eller < 4,5 mg/dl (se pkt. 
No dose adjustment is necessary in TIH patients with serum creatinine < 400 μmol/l or < 4.5 mg/dl (see section 4.4).
Osteonekrose af kæberne er blevet rapporteret med frekvensen ”ikke almindelig” i kliniske forsøg og efter markedsføring hos patienter behandlet med zoledronsyre. 
Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post marketing setting in patients receiving zoledronic acid.
Influenza-lignende symptomer herunder gigt (artritis) og hævede led. 
- Flu-like symptoms including arthritis and joint swelling.
Vejrtrækningsbesvær med hiven efter vejret eller hosten. 
- Difficulty in breathing with wheezing or coughing.
I kliniske studier 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.
Når behandling med zoledronsyre initieres hos patienter med multiple myelom eller knoglemetastatisk skade fra solide tumorer bør serum-kreatinin og kreatininclearence (CLcr) bestemmes. 
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.
Du må ikke få Zoledronsyre Mylan: - hvis du ammer. 
You must not be given Zoledronic acid Mylan: - if you are breast-feeding.
Zoledronsyre Mylan er et klart og farveløst koncentrat til infusionsvæske. 
What Zoledronic acid Mylan looks like and contents of the pack Zoledronic acid Mylan is a clear and colourless concentrate for solution for infusion.
Brug ikke Zoledronsyre Mylan efter den udløbsdato, der står på hætteglasset og æsken efter EXP. 
- 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.
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. 
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.
Hvordan skal Zoledronsyre Mylan opbevares 
How Zoledronic acid Mylan is used
Nældefeber. 
- Urticaria.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/786/001-004 
MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/001-004
Generelt Før indgift af zoledronsyre skal patienterne vurderes med henblik på at sikre, at de er velhydrerede. 
Patients must be assessed prior to administration of zoledronic acid to ensure that they are adequately hydrated.
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.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/786/001 
MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/001
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. 
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.
Mens du er i behandling med Zoledronsyre Mylan, skal du holde en god mundhygiejne (inkl. 
While being treated with Zoledronic acid Mylan, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Natriumcitrat Natriumhydroxid Saltsyre 
Sodium citrate Sodium hydroxide Hydrochloric acid Water for injections
Skeletal morbiditet p-værdi 
Skeletal morbidity rate 1.74 p-value
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Zoledronsyre Mylan 4 mg/5 ml koncentrat til infusionsvæske, opløsning Zoledronsyre 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
ETIKET TIL MULTIPAKNINGER MED 4 HÆTTEGLAS (4 PAKNINGER AF 1) I TRANSPARENT FOLIE 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING (INCLUDING BLUE BOX) LABEL FOR MULTIPACK OF 4 VIALS (4 PACKS OF 1) WRAPPED IN TRANSPARENT FOIL
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. 
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 Mylan 4 mg/5 ml koncentrat til infusionsvæske, opløsning Zoledronsyre 
Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/786/004 
MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/004
Koncentratet fås i et klart og farveløst hætteglas af glas med gummiprop og aftagelig plastikhætte. 
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.
Den udtagne mængde af den rekonstituerede opløsning skal fortyndes i 100 ml sterilt 0,9% w/v natriumchlorid- eller 5% w/v glucoseopløsning. 
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.
Skeletal morbiditets rate p-værdi 
Skeletal morbidity rate 0.77 p-value
(> 1,4 mg/dl eller > 124 μmol/l). 
1.0 mg/dl or 88 μmol/l.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas indeholder 4 mg zoledronsyre (som monohydrat). 
STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg zoledronic acid (as monohydrate).
Du må ikke få Zoledronsyre Mylan, hvis du ammer. 
You must not be given Zoledronic acid Mylan if you are breast-feeding.
Zoledronsyre Mylan 4 mg/5 ml koncentrat til infusionsvæske, opløsning rekonstitueret yderligere i 100 ml (se pkt. 
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.
Interstitiel lungesygdom (sygdom i alveolevævet). 
- Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs).
Lægen, apotekspersonalet eller sundhedspersonalet ved, hvordan Zoledronsyre Mylan skal opbevares korrekt (se afsnit 6). 
How to store Zoledronic acid Mylan Your doctor, pharmacist or nurse knows how to store Zoledronic acid Mylan properly.
LÆGEMIDLETS NAVN Zoledronsyre Mylan 4 mg/5 ml koncentrat til infusionsvæske, opløsning 
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion
Ikke almindelig (forekommer hos op til 1 ud af 100 patienter): 
Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
For at forhindre eventuelle uforligeligheder skal den rekonstituerede Zoledronsyre Mylan opløsning fortyndes med 0,9% w/v natriumklorid- eller 5% w/v glucoseopløsning. 
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.
ÆSKE MED 1 HÆTTEGLAS SOM DEL AF EN MULTIPAKNING, DER INDEHOLDER 4 HÆTTEGLAS 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING (WITHOUT BLUE BOX) BOX OF 1 VIAL AS PART OF A MULTIPACK COMPRISING 4 VIALS
Det skal du vide, før du får Zoledronsyre Mylan Sådan bliver du behandlet med Zoledronsyre Mylan Bivirkninger 
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
Aktivt stof: zoledronsyre. 
What Zoledronic acid Mylan contains - The active substance is zoledronic acid.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23.08.2012
Hovedpine og influenzalignende symptomer som feber, træthed, svaghed, døsighed, kulderystelser samt knogle-, led- og/eller muskelsmerter. 
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.
- 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 abnormal baseline creatinine (> 1.4 mg/dl or > 124 μmol/l), an increase of
NR NR NR 
BATCH NUMBER
Sjælden (forekommer hos op til 1 ud af 1.000 patienter): 
Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Opbevar Zoledronsyre Mylan utilgængeligt for børn. 
- Keep Zoledronic acid Mylan out of the sight and reach of children.
Emballagetype og pakningsstørrelser 
Component of a multipack.
Smerte i ekstremiteter, artralgi, muskuloskeletal smerte Almene symptomer og reaktioner på administrationsstedet Meget almindelig: 
Pain in extremities, arthralgia, musculoskeletal pain
Blisterpakning (OPA/alu/PVC-alu) 
Blister (OPA/Alu /PVC-Alu) 10 x 1 tablets (unit dose)
Dato for første tilladelse: 6.oktober 2008 Dato for seneste fornyelse: 6. oktober 2013 
Date of first authorisation: 06 October 2008 Date of latest renewal: 06 October 2013
Applikationen kan om nødvendigt gentages. 
The application can be repeated, if necessary.
• På anmodning fra Det Europæiske Lægemiddelagentur 
• At the request of the European Medicines Agency
2 af disse var børn på 2 og 5 år, og 2 var unge på 16 år. 
Of these, 2 were children aged 2 and 5 years and 2 were adolescents of 16 years.
Temperaturen må ikke overstige 37 °C. 
The temperature must not exceed 37°C.
Må ikke nedfryses igen. 
Do not re-freeze.
I overensstemmelse med artikel 114 i direktiv 2001/83/EF skal den officielle batchfrigivelse foretages af et statslaboratorium eller af et laboratorium, der er udpeget til dette formål. 
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
• Anvendelsen af EVICEL er ikke blevet undersøgt i følgende procedurer, og der er derfor ingen oplysninger, der viser om det er effektivt ved disse procedurer: 
• The use of EVICEL has not been studied in the following procedures, and there is therefore no information to show that it would be effective in these procedures:
Hyppigheden af disse bivirkninger var almindelig. 
The frequency of all of these effects was common.
En opdateret RMP skal fremsendes 
An updated RMP should be submitted
Hvis du føler dig utilpas, så fortæl det straks til lægen, også selvom dine symptomer er forskellige fra dem, der lige er blevet beskrevet. 
If you feel unwell tell your doctor immediately, even if your symptoms are different from those just described.
Sådanne stoffer bør så vidt muligt fjernes, før produktet påføres. 
Such substances should be removed to the greatest possible extent before applying the product.
Hvis datoerne for fremsendelse af en PSUR og opdateringen af en RMP er sammenfaldende, kan de fremsendes samtidig. 
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Ved Cmax udgjorde plasmakoncentrationen kun 1-2% af den påførte dosis. 
At the Cmax, the plasma concentration represented only 1-2% of the applied dose.