FrancophonIA/ELRC3.0 huggingface dataset:
English: Active immunisation of horses from 5 months of age against West Nile disease by reducing the number of viraemic horses.
Danish: Aktiv immunisering af heste fra 5-måneders alderen mod West Nile sygdom ved at nedsætte antallet af viræmiske heste.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusive adjuvanser) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at MRL-værdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Administer one dose of 1 ml, by intramuscular injection, preferably in the neck region, according to the following schedule:
Danish: Administrer 1 dosis (1 ml) ved intramuskulær injektion, gerne i halsregionen, i henhold til følgende program:
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Danish: I henhold til artikel 71 i Europa-Parlamentets og Rådets direktiv 2001/82/EF, med senere ændringer, kan en medlemsstat i overensstemmelse med medlemsstatens nationale lovgivning forbyde fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af veterinærlægemidlet på hele eller en del af sit område, hvis det godtgøres:
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Danish: En beslutning om at anvende vaccinen før eller efter brug af et andet lægemiddel til dyr skal derfor tages med udgangspunkt i det enkelte tilfælde.
English: If infection is suspected as a result of a positive IgM response, additional testing would need to be conducted to conclusively determine whether the animal was infected or vaccinated.
Danish: Ved mistanke om infektion efter et positivt IgM-svar vil det være nødvendigt at udføre yderligere testning for endeligt at kunne afgøre, om dyret var inficeret eller vaccineret.
English: Each dose of 1 ml contains:
Danish: Hver dosis á 1 ml indeholder:
English: Any person intending to manufacture, import, possess, sell, supply and use Proteq West Nile must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Danish: Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og/eller anvende Proteq West Nile, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse finder sted.
English: • Primary vaccination course: first injection from 5 months of age, second injection 4-6 weeks later,
Danish: • Basisvaccination: første injektion fra 5-måneders alderen, anden injektion 4-6 uger senere.
English: A hypersensitivity reaction may occur in rare cases, which may require appropriate symptomatic treatment.
Danish: I sjældne tilfælde kan der ses hypersensitivitetsreaktion, der kan kræve korrekt symptomatisk behandling.
English: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest France
Danish: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest Frankrig
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten vises til lægen.
English: Box of 1, 2, 5 or 10 vial(s) of 1 dose.
Danish: Æske med 1, 2, 5 eller 10 hætteglas á 1 dosis.
English: Type I glass vial, with a butyl elastomer closure, sealed with an aluminium cap.
Danish: Hætteglas, type I glas, med en butylelastomerprop, forseglet med en aluminiumshætte.
English: EXP {month/year} Use immediately after opening
Danish: EXP {måned/år} Efter anbrud anvendes straks.
English: However, since the IgM response following vaccination is infrequent, a positive IgM-ELISA test result is a strong indicator of natural infection with West Nile Virus.
Danish: Da et IgM-respons efter vaccination er ualmindeligt, er en positiv IGM-ELISA test en stærk indikator for en naturlig infektion med West Nile virus.
English: The safety of the vaccine has been demonstrated in foals from 5 months of age.
Danish: Sikkerheden af vaccinen er vist hos føl fra 5-måneders alderen.
English: Withdrawal Period: Zero days
Danish: Tilbageholdelsestid: 0 dage
English: Use immediately after opening.
Danish: Anvendes straks efter anbrud.
English: Horses.
Danish: Hest.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre æske
English: A slight increase in temperature (max. 1.5 °C) may occur in rare cases for 1 day, exceptionally 2 days.
Danish: I sjældne tilfælde kan der forekomme en let temperaturforøgelse (max. 1,5 °C) i 1 dag, undtagelsesvis i 2 dage.
English: Pregnancy and lactation: This vaccine can be used during pregnancy and lactation.
Danish: Drægtighed og laktation: Kan anvendes under drægtighed og laktation.
English: Homogeneous opalescent suspension.
Danish: Homogen opaliserende suspension.
English: Duration of immunity: 1 year after a full primary vaccination course of two injections.
Danish: Varighed af immunitet: 1 år efter komplet basisvaccinationsprogram bestående af 2 injektioner.
English: The manufacture, import, possession, sale, supply and/or use of Proteq West Nile may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Danish: Fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af Proteq West Nile kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til national lovgivning.
English: To be supplied only on veterinary prescription
Danish: Må kun udleveres efter veterinærrecept.
English: However, the vaccine has also been shown to be safe in a field study including animals of 2 months of age.
Danish: Vaccinen har imidlertid også vist sig at være sikker i et feltstudie, der omfattede 2 måneder gamle dyr.
English: Manufacturer responsible for batch release: MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, 69800 Saint Priest, France
Danish: Fremstiller ansvarlig for batchfrigivelse: MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, 69800 Saint Priest, Frankrig
English: Onset of immunity: 4 weeks after the first dose of the primary vaccination course.
Danish: Indtræden af immunitet: 4 uger efter første dosis af basisvaccinationen.
English: Apathy, usually resolving within two days, and reduced appetite may be observed in rare cases the day after vaccination.
Danish: I sjældne tilfælde kan der iagttages apati, der sædvanligvis forsvinder inden for 2 dage, og nedsat ædelyst dagen efter vaccination.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT
Danish: ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER
English: The vaccine strain vCP2017 is a recombinant canarypox virus expressing the preM/E genes of West Nile virus.
Danish: Vaccinestammen vCP2017 er en rekombinant canarypox virus, der afgiver preM/E gener af West Nile virus.
English: As a consequence, these proteins induce protective immunity against equine West Nile disease.
Danish: Som følge heraf inducerer proteinerne beskyttende immunitet over for West Nile sygdom hos hest.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER
English: Pain and local hyperthermia can occur in rare cases.
Danish: I sjældne tilfælde kan der forekomme smerte og lokal hyperthermi.
English: Horses
Danish: Hest
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: BILAG II A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG C. ANGIVELSE AF MRL-VÆRDIER
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: West Nile (vCP2017) ........................................................................................ 6.0 to 7.8 log10 CCID50
Danish: West Nile (vCP2017) ............................................................................................ 6,0-7,8 log10 CCID50
English: Pharmacotherapeutic group: Immunologicals for equidae, other immunologicals.
Danish: Farmakoterapeutisk gruppe: immunologiske præparater til medlemmer af hestefamilien (Equidae), andre immunologiske præparater, ATCvet-kode: QI05AX.
English: No adverse reactions other than those already mentioned in section 4.6 have been observed after the administration of more than 10 doses.
Danish: Efter administration af mere end 10 doser er der ikke observeret andre bivirkninger end de under 4.6. beskrevet.
English: Homogeneous opalescent suspension for injection Each dose of 1 ml contains:
Danish: Homogen opaliserende injektionsvæske, suspension 1 dosis (á 1 ml) indeholder:
English: CONTRAINDICATION
Danish: KONTRAINDIKATIONER
English: Carbomer ......................................................................................................................................... 4 mg For the full list of excipients, see section 6.1.
Danish: Carbomer ......................................................................................................................................... 4 mg Alle hjælpestoffer er anført under pkt.
English: A transient swelling (max. diameter 5 cm) which resolves within 4 days may appear commonly at the injection site.
Danish: Forbigående hævelse (max. diameter på 5 cm) på injektionsstedet kan almindeligvis forekomme.
English: Proteq West Nile suspension for injection
Danish: Proteq West Nile injektionsvæske, suspension
English: Sodium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Danish: Kaliumdihydrogenphosphat Vand til injektion.
English: West Nile recombinant canarypox virus (vCP2017) ....................................... 6.0 to 7.8 log10 CCID*50 * Cell culture infectious dose 50 %
Danish: West Nile rekombinant canarypox virus (vCP2017) ......................................... 6,0- 7,8 log10 CCID*50 * Cellekultur infektiøs dosis 50 %
English: No adverse reactions other than those already mentioned in the section “Adverse Reactions” have been observed after the administration of more than 10 doses.
Danish: Efter administration af mere end 10 doser, er der ikke observeret andre bivirkninger end de beskrevet under punktet ”Bivirkninger”.
English: Proteq West Nile suspension for injection for horses
Danish: Proteq West Nile injektionsvæske, suspension, til hest
English: Store and transport refrigerated Do not freeze
Danish: Opbevares og transporteres nedkølet.
English: EXP {month/year}
Danish: EXP
English: IM
Danish: Lot
English: 50 mg/g
Danish: Kutan anvendelse 50 mg/g
English: Belgium Galderma Benelux B.V. Gravinnen van Nassauboulevard 91 4811 BN Breda
Danish: Gravinnen van Nassauboulevard 91 4811 BN Breda
English: Luxembourg Galderma Benelux B.V. Gravinnen van Nassauboulevard 91 4811 BN Breda
Danish: Luxembourg Galderma Benelux B.V.
English: The Netherlands Galderma Benelux B.V. Gravinnen van Nassauboulevard 91 4811 BN Breda
Danish: Nederlandene Galderma Benelux B.V.
English: EXP {month/year}
Danish: EXP: { måneder/år }
English: See section “Contraindications”.
Danish: Se afsnittet 'Kontraindikationer'.
English: A clear yellow solution.
Danish: Klar gul opløsning.
English: Dispose of waste material in accordance with local requirements.
Danish: Bortskaffelse af affald i henhold til lokale krav.
English: SPECIAL WARNINGS, IF NECESSARY
Danish: SÆRLIGE ADVARSEL/ADVARSLER, OM NØDVENDIGT
English: Date of first authorisation: 09/12/2008 Date of last renewal:09/12/2013
Danish: Dato for første markedsføringstilladelse : 09.12.2008 Dato for seneste fornyelse af markedsføringstilladelse: 09.12.2013
English: People with known hypersensitivity to meloxicam should avoid contact with the veterinary medicinal product.
Danish: Personer med kendt overfølsomhed over for meloxicam bør undgå kontakt med veterinærlægemidlet.
English: Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.
Danish: Ca. 75% af den indgivne dosis elimineres via fæces og den resterende del med urinen.
English: Once broached use by ...
Danish: Efter anbrud anvendes inden ...
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see 4.3).
Danish: Veterinærlægemidlets sikkerhed under drægtighed og laktation er ikke fastlagt (Se 4.3).
English: Sodium Chloride Sodium Hydroxide Water for injection
Danish: Natriumchlorid Natriumhydroxid Vand til injektionsvæsker
English: Do not use after the expiry date stated on the carton and the vial.
Danish: Må ikke anvendes efter den udløbsdato (EXP), som er angivet på æsken og flasken.
English: This veterinary medicinal product does not require any special storage conditions.
Danish: Dette veterinærlægemiddel kræver ingen særlige opbevaringsbetingelser.
English: It reduces leukocyte infiltration into the inflamed tissue.
Danish: Det reducerer leukocyt-infiltrationen i det betændte væv.
English: Acticam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Danish: Acticam må ikke gives samtidig med andre NSAID-præparater eller glucocortikosteroider.
English: Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment.
Danish: Forudgående behandling med antiinflammatoriske substanser kan resultere i yderligere eller forstærkede bivirkninger, og derfor bør der indlægges en behandlingsfri periode på mindst 24 timer fra sådanne midler, inden behandling påbegyndes.
English: In the case of over dosage symptomatic treatment should be initiated.
Danish: I tilfælde af overdosering bør symptomatisk behandling initieres.
English: Colourless type I glass injection vial of 10 ml, closed with a grey EPDM rubber stopper and sealed with a flip off aluminium seal.
Danish: Farveløse hætteglas à 10 ml, lukket med en grå EPDM gummiprop og forseglet med en flip af aluminiumskappe.
English: The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Danish: Længden af den behandlingsfri periode bør dog fastlægges under hensyntagen til de farmakokinestiske egenskaber af tidligere anvendte præparater.
English: Pregnancy / Lactation
Danish: Drægtighed / laktation
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur http://www.ema.europa.eu
English: Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 μg/ml in dogs and 1.1 μg/ml in cats were reached approximately 2.5 hours and 1.5 hours post administration, respectively.
Danish: Efter subkutan administration er meloxicam fuldstændigt biotilgængeligt, og maksimale gennemsnitlige plasmakoncentrationer på 0,73 µg/ml hos hunde og 1,1 µg/ml hos katte opnåedes henholdsvis ca. 2,5 og 1,5 time efter administration.
English: Interactions with other medicinal products and other forms of interaction
Danish: Interaktioner med andre lægemidler og andre former for interaktion
English: Active substance: Meloxicam 5 mg.
Danish: Aktivt stof: Meloxicam 5 mg.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Danish: Undgå behandling af dehydrerede, hypovolæmiske eller hypotensive dyr, idet der foreligger en potentiel risiko for toksisk påvirkning af nyrerne.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: Eventuelle ubrugte lægemidler eller affald fra sådanne produkter skal bortskaffes i overensstemmelse med de lokale krav.
English: Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof, eller et eller flere af hjælpestofferne.
English: Musculo-skeletal disorders: single subcutaneous injection.
Danish: Sygdomme i bevægeapparatet: enkelt subkutan injektion.
English: or s.c. Cats: s.c.
Danish: Hund: IV eller SC Kat: SC
English: If side effects occur, treatment should be discontinued.
Danish: Hvis der forekommer bivirkninger, bør behandlingen afbrydes.
English: METHOD AND ROUTES OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJE
English: Ecuphar NV Legeweg 157-i B-8020 Oostkamp Belgium
Danish: Ecuphar NV Legeweg 157-i B-8020 Oostkamp Belgien
English: Acticam 5 mg/ml solution for injection for dogs and cats.
Danish: Acticam 5 mg/ml injektionsvæske, opløsning til hund og kat.
English: Cats: Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Danish: Kat: Reduktion af post-operative smerter efter ovariehysterektomi og mindre omfattende bløddelskirurgi.
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Danish: De bedes kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen, hvis De ønsker yderligere oplysninge r om dette veterinærlægemiddel.
English: PACKAGE LEAFLET Acticam 5 mg/ml solution for injection for dogs and cats
Danish: INDLÆGSSEDDEL Acticam 5 mg/ml injektionsvæske, opløsning til hund og kat
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse:
English: Ethanol anhydrous Poloxamer 188 Glycofurol Meglumine Glycine
Danish: Ethanol, vandfri Poloxamer 188
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code: QM01AC06
Danish: Farmakoterapeutisk gruppe: Antiinflammatoriske og antireumatiske lægemidler, non-steroider (oxicam)
English: EXP {month/year} Shelf life after first opening the container: 28 days
Danish: EXP: {måneder/år} Holdbarhed efter første åbning af beholderen: 28 dage.
English: Excipients: Ethanol, anhydrous 150 mg.
Danish: Hjælpestoffer: Ethanol, vandfri 150 mg.
English: In dogs, in very rare cases, haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been reported.
Danish: Hos hunde er der i meget sjældne tilfælde set hæmoragisk diarré, opkastning af blod samt mavesår.
English: Shelf-life after first opening the container: 28 days.
Danish: Opbevaringstid efter første åbning af beholderen: 28 dage.
English: Ethanol anhydrous 150 mg/ml.
Danish: Etanol 150 mg/ml.
English: Shelf-life after first opening the immediate packaging: 28 days.
Danish: Opbevaringstid efter første åbning af den indre emballage: 28 dage.
English: Do not use an oral follow-up therapy using meloxicam or other NSAIDs in cats, as no safe dosage for repeated oral administration has been established.
Danish: Oral opfølgningsbehandling med meloxicam eller andet NSAID-præparat må ikke anvendes til katte, da passende dosering for en sådan behandling ikke er fastlagt.
English: If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Danish: Hvis der forekommer bivirkninger, bør behandlingen afbrydes og dyrlægen kontaktes.
English: − rare (more than 1 but less than 10 animals in 10,000 animals)
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr) - Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr) - Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr) - Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter)
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class, which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Danish: Det virker ved hæmning af prostaglandinsyntesen, hvorved det har antiinflammatorisk, analgetisk, antieksudativ og antipyretisk effekt.
English: To be supplied only on veterinary prescription.
Danish: Lægemidlet er ikke veterinærreceptpligtigt.
English: MA (EU) Number
Danish: MA (EU) procedurenr.
English: Strength Pharmaceutical Form Route of Administration
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage
English: 3 inhalers (3 x 30 doses) (multipack)
Danish: 3 inhalatorer (3 x 30 doser) (multipakning)
English: A Decision was issued by the European Commission on 9 August 2005.
Danish: Europa-Kommissionen traf en afgørelse den 9. august 2005.
English: SUMMARY INFORMATION ON REFERRAL OPINION FOLLOWING ARBITRATION PURSUANT TO ARTICLE 30 OF COUNCIL DIRECTIVE 2001/83/EC FOR
Danish: SAMMENFATTENDE OPLYSNINGER OM UDTALELSE EFTER HENVISNING TIL VOLDGIFT I HENHOLD TIL ARTIKEL 30 I RÅDETS DIREKTIV 2001/83/EF OM
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER
English: The referral procedure started on 21 October 2004
Danish: Proceduren for indbragte sager indledtes den 21. oktober 2004.
English: Medicinal products containing calcium lactate gluconate and calcium carbonate have been nationally authorised in EU Member States, resulting in different Summaries of Product Characteristics based on individual national decisions.
Danish: Lægemidler indeholdende calciumlactogluconat og calciumcarbonat er blevet godkendt på nationalt plan i EU-medlemsstaterne, hvilket resulterer i forskellige produktresuméer på grundlag af de enkelte nationale afgørelser.
English: CHMP issued a positive opinion, on 21 April 2005, recommending the harmonisation of the SPC for
Danish: 2005 vedtog CHMP en positiv udtalelse, som anbefalede en harmonisering af produktresuméet for
English: A dossier in CTD format and a proposal for a harmonised SPC were submitted by the MAH on 22 September 2004.
Danish: Et dossier i CTD-format (fælles teknisk dokument) og et forslag til et harmoniseret produktresumé blev indgivet af indehaveren af markedsføringstilladelsen den 22. september 2004.
English: -Rickets and osteomalacia, in addition to vitamin D3 therapy
Danish: - Engelsk syge og osteomalaci i tillæg til vitamin D3 terapi.
English: An overall summary of the scientific evaluation is provided in Annex II together with the harmonised summary of product characteristics in Annex III.
Danish: Det samlede resumé af den faglige vurdering fremgår af bilag II.
English: Calcium Sandoz and associated names International Non-Proprietary Name (INN): Calcium lactate gluconate, Calcium carbonate
Danish: Internationalt fællesnavn ( INN): Calciumlactogluconat, calciumcarbonat