FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om Zoledronsyre medac findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: How to prepare and administer Zoledronic acid medac
Danish: Tilberedelse og administration af Zoledronsyre medac
English: The following adverse reactions, listed in Table 1, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Danish: Tabel med liste over bivirkninger De følgende bivirkninger, der er opført i Tabel 1, er samlet fra kliniske studier og post-marketing rapporter efter fortrinsvis kronisk behandling med 4 mg zoledronsyre:
English: METHOD OF ADMINSTRATION Dilute before use.
Danish: ADMINISTRATIONSMETODE Fortyndes inden brug.
English: 82.6% (p=0.005)* 88.4% (p=0.002)*
Danish: 45,3 % (p = 0,104) 82,6 % (p = 0,005)* 88,4 % (p = 0,002)*
English: - Difficulty in breathing with wheezing or coughing.
Danish: - Vejrtrækningsbesvær med hiven efter vejret eller hosten.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om Zoledronsyre medac på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: − In vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
Danish: Følgende egenskaber er vist i prækliniske studier: - In vivo: Hæmning af osteoklastisk knogleresorption, hvilket ændrer knoglemarvens mikromiljø og mindsker bidraget til tumorcellevæksten, den anti-angiogenetiske aktivitet og anti-smerte aktiviteten.
English: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing) Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
Danish: Asteni, perifere ødemer, reaktioner ved injektionsstedet (inklusive smerter, irritation, hævelse, induration), brystsmerter, vægtøgning, anafylaktisk reaktion/shock, urticaria
English: 1 x5ml vial.
Danish: 1 x5 ml hætteglas.
English: Patients must be assessed prior to administration of zoledronic acid to ensure that they are adequately hydrated.
Danish: Før administration af zoledronsyre skal patienterne vurderes med henblik på at sikre, at de er velhydrerede.
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, omfatter dehydrering, allerede eksisterende nedsat nyrefunktion, adskillige cyklusser af zoledronsyre og andre bisfosfonater, såvel som brug af andre nefrotoksiske lægemidler.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zoledronic acid medac 4 mg/5 ml sterile concentrate Intravenous use.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Zoledronsyre medac 4 mg/5 ml sterilt koncentrat Intravenøs anvendelse.
English: Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 personer): - Langsom hjerterytme.
English: - Flu-like symptoms including arthritis and joint swelling.
Danish: - Influenza-lignende symptomer herunder gigt (artitis) og hævede led.
English: In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Danish: I kliniske studier blev behandling med zoledronsyre først genoptaget, når kreatinin-niveauet vendte tilbage til inden for 10 % af baselineværdien (se pkt.
English: • Zoledronic acid medac 4 mg/100 ml solution for infusion contains 4 mg zoledronic acid in 100 ml of infusion solution for immediate use in patients with normal renal function.
Danish: • Zoledronsyre medac 4 mg/100 ml infusionsvæske, opløsning, indeholder 4 mg zoledronsyre i 100 ml infusionsvæske, opløsning, som er klar til brug hos patienter med normal nyrefunktion.
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 en konsekvens af lave calcium-værdier: uregelmæssig hjerterytme (hjertearytmi;
English: Grounds for the variation to the terms of the marketing authorisation(s)
Danish: Begrundelser for ændring af betingelserne for markedsføringstilladelsen/-erne
English: The following conventional classification is used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare
Danish: Følgende konventionelle klassifikation er anvendt: 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: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 1 BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 1 FLASKE
English: What Zoledronic acid medac looks like and contents of the pack Zoledronic acid medac is supplied as a concentrate for solution for infusion in a 5 ml plastic vial made of clear, colourless plastic (cycloolefine copolymer) with rubber stopper (type I bromobutyl) and sealed with flip-off seal (aluminium and polypropylene).
Danish: Zoledronsyre medac leveres som koncentration til infusionsvæske, opløsning, i et 5 ml hætteglas af plastic fremstillet af klar, farveløs plastic (cykloolefin copolymer) med gummiprop (type I brombutyl) og forseglet med ”flip-off” forsegling (aluminium og polypropylen).
English: If the solution is not used immediately, storage prior to use is the responsibility of the user and should be in a refrigerator at 2 °C - 8 °C.
Danish: Hvis den ikke anvendes straks, er opbevaringstid og -betingelser før brug brugerens ansvar og bør være i køleskab ved 2-8 °C.
English: Very common: Common:
Danish: Meget almindelig:
English: - The other ingredients are: mannitol, sodium citrate, water for injections.
Danish: − Øvrige indholdsstoffer: mannitol, natriumcitrat, vand til injektionsvæsker.
English: Respiratory, thoracic and mediastinal disorders Uncommon: Rare:
Danish: Luftveje, thorax og mediastinum Ikke almindelig:
English: - are having dental treatment or are due to undergo dental surgery; tell your dentist that you are being treated with Zoledronic acid medac and inform your doctor about your dental treatment.
Danish: I så fald bør du fortælle tandlægen, at du er i behandling med Zoledronsyre medac og informer din læge om din tandlægebehandling.
English: Zoledronic acid medac 4 mg/100 ml solution for infusion must not be mixed with other infusion solutions and should be administered as a single intravenous solution in a separate infusion line.
Danish: Zoledronsyre medac 4 mg/100 ml infusionsvæske, opløsning, må ikke blandes med andre infusionsvæsker og bør administreres som en enkelt intravenøs opløsning i en separat infusionsslange.
English: One bottle contains 100 ml of solution.
Danish: En flaske indeholder 100 ml opløsning.
English: 4 x 5 ml vials
Danish: 4 x 5 ml hætteglas
English: Table 1: Preparation of reduced doses of Zoledronic acid medac 4 mg/100 ml solution for infusion
Danish: Tabel 1: Tilberedning af nedsatte doser af Zoledronsyre medac 4 mg/100 ml, infusionsvæske, opløsning
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: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 1 VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 1 HÆTTEGLAS
English: Hypomagnesaemia, hypokalaemia Hyperkalaemia, hypernatraemia
Danish: Hyperkaliæmi, hypernatriæmi
English: 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.
Danish: Almindelig (kan forekomme hos flere end 1 ud af 10 personer): - Hovedpine og influenzalignende symptomer som feber, træthed, svaghed, døsighed,
English: ≥ 4.5 mg/dl for patients with TIH and ≥ 265 µmol/l or ≥ 3.0 mg/dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/min), the use of zoledronic acid is not recommended in patients with severe renal impairment.
Danish: I betragtning af zoledronsyres potentielle indflydelse på nyrefunktionen, manglende kliniske sikkerhedsdata hos patienter med svært nedsat nyrefunktion (i kliniske studier defineret som serum kreatinin ≥400 µmol/l eller ≥4,5 mg/dl hos patienter med TIH, og ≥265 µmol/l eller ≥3,0 mg/dl hos patienter med henholdsvis cancer og knoglemetastaser) i forhold til baseline og kun begrænsede farmakokinetiske data hos patienter med svært nedsat nyrefunktion ved baseline (kreatininclearance <30 ml/min) kan zoledronsyre ikke anbefales til patienter med svært nedsat nyrefunktion.
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),
Danish: Bivirkningerne er klassificeret under overskrifter om hyppighed, de hyppigste først, ved brug af den følgende konvention: 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: Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia)
Danish: Hypertension, hypotension, atrieflimren, hypotension førende til synkope eller kredsløbssvigt
English: Talk to your doctor before you are given Zoledronic acid medac, if you - have or have had a kidney problem.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du får Zoledronsyre medac, hvis du - har eller har haft en nyrelidelse.
English: LIST OF EXCIPIENTS Excipients: mannitol, sodium citrate, water for injections.
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestoffer: mannitol, natriumcitrat, vand til injektionsvæsker.
English: Table 4: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Danish: Tabel 3: Resultater for virkning (solide tumorer ud over bryst- og prostatacancer) Enhver SRE (+TIH)
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer)
Danish: Tabel 4: Resultater for virkning (solide tumorer ud over bryst- og prostatacancer)
English: Do not mix Zoledronic acid medac concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Danish: Zoledronsyre medac koncentrat må ikke blandes med calciumholdige opløsninger eller andre opløsninger, der indeholder divalente kationer såsom lakteret Ringers væske.
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 påbegyndes, har let til moderat nedsat nyrefunktion, som i denne population er defineret som CLcr 30-60 ml/min, anbefales den følgende dosis af zoledronsyre (se også pkt.
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 blev patienter med serum-kreatinin >265 µmol/l eller >3,0 mg/dl ekskluderet.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C.
Danish: Hvis den ikke anvendes straks, er opbevaringstid og -betingelser før brug brugerens ansvar og bør normalt ikke overstige 24 timer ved 2-8 °C.
English: Rare: Very rare:
Danish: Sjælden: Meget sjælden:
English: Zoledronic acid medac 4 mg/100 ml solution for infusion should be given as a single intravenous infusion in no less than 15 minutes.
Danish: Zoledronsyre medac 4 mg/100 ml infusionsvæske, opløsning, skal administreres som en enkelt intravenøs infusion over minimum 15 minutter.
English: Within three days after zoledronic acid administration, an acute phase reaction has been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Danish: Inden for 3 dage efter administration af zoledronsyre er en akut fasereaktion blevet indrapporteret, med symptomer som knoglesmerter, feber, træthed, artralgi, myalgi, stivhed og artritis med efterfølgende hævede led.
English: The withdrawn amount of the concentrate must be further diluted in 100 ml of sterile sodium chloride 9 mg/ml (0.9%) solution or 5% w/v glucose solution.
Danish: Det udtagne volumen af koncentratet skal fortyndes yderligere i 100 ml steril 0,9 % w/v natriumchloridopløsning eller 5 % w/v glucoseopløsning.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/001<1 vial>
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/779/001<1 vial>
English: Remove the volume of Zoledronic acid medac 4 mg/100 ml solution indicated from the bottle and replace with an equal volume of sterile sodium chloride 9 mg/ml (0.9%) solution for injection, or 5% glucose.
Danish: Udtag mængden af Zoledronsyre medac 4 mg/100 ml opløsning, som angivet på flasken og erstat med en tilsvarende mængde sterilt natriumklorid 9 mg/ml (0,9 %), injektionsvæske, opløsning, eller 5 % glucose.
English: One vial contains 5 ml of concentrate for solution for infusion.
Danish: Et hætteglas indeholder 5 ml koncentrat til infusionsvæske, opløsning.
English: Multipack: 4 x 1 bottle of 100 ml Multipack: 10 x 1 bottle of 100 ml
Danish: Multipakning 4 x 1 flaske med 100 ml.
English: One vial contains 4 mg zoledronic acid.
Danish: Et hætteglas indeholder 4 mg zoledronsyre.
English: Radiation therapy to bone
Danish: Strålebehandling af knogler
English: Table 5: Efficacy results (breast cancer and multiple myeloma patients)
Danish: Tabel 4: Resultater for virkning (patienter med brystcancer eller myelomatose)
English: Plastic vial made of clear, colourless cycloolefine copolymer with Type I bromobutyl rubber stopper and sealed with aluminium polypropylene flip-off seal.
Danish: Plastik hætteglas fremstillet af klar, farveløs, cykloolefin copolymer med type I-prop af brombutylgummi og forseglet med aluminium/polypropylen ”flip-off” forsegling.
English: Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline (see section 4.2).
Danish: Zoledronsyre medac bør kun genoptages, når serum-kreatinin igen er inden for 10 % af baseline (se pkt.
English: Replace with the following volume of sterile sodium chloride 9 mg/ml (0.9%), or 5% glucose solution for injection (ml)
Danish: Erstat med følgende volumen af steril natriumchlorid 9 mg/ml (0,9 %), eller 5 % glucose injektionsvæske, opløsning (ml)
English: Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid (see section 4.4).
Danish: Der er rapporteret om forværring af nyrefunktionen, progression til nyresvigt og dialyse hos patienter efter den indledende dosis og efter enkeltdosis af 4 mg zoledronsyre (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One bottle with 100 ml solution contains 4 mg zoledronic acid (as monohydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En flaske med 100 ml opløsning indeholder 4 mg zoledronsyre (som monohydrat).
English: One ml solution contains 0.04 mg zoledronic acid (as monohydrate).
Danish: 1 ml opløsning indeholder 0,04 mg zoledronsyre (som monohydrat).
English: Zoledronic acid medac 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: Zoledonsyre medac må ikke blandes med calcium eller anden divalent kationholdig infusionsopløsning, såsom Ringers lactatopløsning, og bør administreres som en enkelt intravenøs opløsning i en separat infusionsslange.
English: In patients with mild to moderate renal impairment, reduced Zoledronic acid medac 4 mg/100 ml solution for infusion doses are recommended (see section “Posology” above and section 4.4).
Danish: Hos patienter med let til moderat nedsat nyrefunktion anbefales nedsatte doser af Zoledronsyre medac 4 mg/100 ml infusionsvæske, opløsning (se pkt.
English: Blood creatinine and blood urea increased, hypocalcaemia
Danish: Øgninger i serum-kreatinin og serum-urea, hypokalcæmi
English: What Zoledronic acid medac looks like and contents of the pack Zoledronic acid medac is supplied as solution for infusion in a 100 ml colourless glass bottle (type I) with rubber stoppers (halobutyl, fluoropolymer coated) and aluminium flip-off caps.
Danish: Zoledronsyre medac leveres som infusionsvæske, opløsning, i 100 ml farveløs glasflaske (type 1) med gummipropper (halobutyl, overtrukne med fluorpolymer) og ”flip-off” låg af aluminium.
English: Prevention of skeletal related events in patients with advanced malignancies involving bone Adults and elderly people
Danish: Forebyggelse af skeletrelaterede hændelser hos patienter med fremskredne maligniteter, som omfatter knoglerne
English: Colourless glass bottle type I with fluoropolymer coated halobutyl rubber stopper and aluminium flipoff cap.
Danish: Farveløs glasflaske af type I med en prop af halobutylgummi, der er overtrukket med fluorpolymer og et ”flip-off” låg af aluminium.
English: trembling, tingling or numbness of the hands or feet, diarrhoea, abdominal pain, dry mouth.
Danish: følelsesløshed eller prikkende fornemmelse i hænder eller fødder, diarré, mavesmerter,
English: Zoledronic acid medac belongs), or any of the other ingredients of this medicine (listed in section 6).
Danish: Zoledronsyre medac tilhører) eller et af de øvrige indholdsstoffer i Zoledronsyre medac
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 påbegyndes hos patienter med myelomatose eller knoglemetastatisk skade fra faste tumorer bør serum-kreatinin og kreatininclearence (CLcr) bestemmes.
English: The first randomised, double-blind, placebo-controlled study compared zoledronic acid 4 mg to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Danish: Resultater fra kliniske studier vedrørende forebyggelse af skeletrelaterede hændelser hos patienter med fremskredne maligniteter, som omfatter knoglerne Det første randomiserede, dobbeltblinde placebo-kontrollerede studie sammenlignede zoledronsyre 4 mg med placebo med henblik på forebyggelse af skeletrelaterede hændelser (SRE'er) hos patienter med prostatacancer.
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Danish: Tabel 5: Resultater for virkning (patienter med brystcancer eller myelomatose) Enhver SRE (+TIH)
English: Efficacy results are provided in Table 5.
Danish: Resultaterne for virkning kan ses i Tabel 5.
English: Fracture adverse events of long bones in the lower extremities were reported in approximately 24% (femur) and 14% (tibia) of zoledronic acid-treated patients versus 12% and 5% of pamidronate-treated patients with severe osteogenesis imperfecta, regardless of disease type and causality but overall incidence of fractures was comparable for the zoledronic acid and pamidronate-treated patients: 43% (32/74) versus 41% (31/76).
Danish: Bivirkninger i form af frakturer på lange knogler i de nedre ekstremiteter var rapporteret hos ca. 24 % (femur) og 14 % (tibia) af zoledronsyrebehandlede patienter versus 12 % og 5 % af pamidronatbehandlede patienter med svær osteogenesis imperfecta uanset sygdomstype og kausalitet.
English: You should not be given Zoledronic acid medac - if you are breast-feeding.
Danish: Du må ikke få Zoledronsyre medac - hvis du ammer.
English: Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Danish: Analyser af multiple hændelser viste en risikoreduktion på 30,7 % i udviklingen af skeletrelaterede hændelser i zoledronsyre 4 mg-gruppen sammenlignet med placebo.
English: - Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs).
Danish: - Interstitiel lungesygdom (sygdom i alveolevævet).
English: • Keep Zoledronic acid medac out of the sight and reach of children.
Danish: • Opbevar Zoledronsyre medac utilgængeligt for børn.
English: Osteonecrosis
Danish: Zoledronsyre
English: - Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
Danish: - For at undgå væskemangel skal du følge lægens anvisninger og drikke rigeligt med vand inden hver behandling.
English: Efficacy results are provided in Table 2.
Danish: Resultaterne for virkning kan ses i Tabel 2.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis den ikke anvendes straks, er opbevaringstid og -betingelser før brug brugerens ansvar og bør normalt ikke overstige 24 timer ved 2-8 °C, medmindre fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: To avoid potential incompatibilities, Zoledronic acid medac concentrate is to be diluted with sodium chloride 9 mg/ml (0.9%) solution or 5% glucose solution.
Danish: For at forhindre eventuelle uforligeligheder skal zoledronsyre medac koncentratet fortyndes med 0,9 % w/v natriumchloridopløsning eller 5 % w/v glucoseopløsning.
English: Efficacy results are provided in Table 4.
Danish: Resultaterne for virkning kan ses i Tabel 4.
English: PHARMACEUTICAL FORM Solution for infusion Clear, colourless solution.
Danish: LÆGEMIDDELFORM Infusionsvæske, opløsning Klar, farveløs opløsning
English: You must not be given Zoledronic acid medac if you are breast-feeding.
Danish: Du må ikke få Zoledronsyre medac, hvis du ammer.
English: Zoledronic acid medac 4mg/5ml concentrate for solution for infusion Sanochemia Pharmazeutika AG
Danish: Zoledronsyre medac 4 mg/5 ml koncentrat til infusionsvæske, opløsning Sanochemia Pharmazeutika AG
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL ON MULTIPACKS WITH 4 VIALS WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET PÅ MULTIPAKNINGER MED 4 HÆTTEGLAS PAKKET I TRANSPARENT FOLIE (INKLUSIVE ”BLÅ BOKS”)