FrancophonIA/ELRC3.0 huggingface dataset:
English: If you forget to take your medicine, take the dose as soon as possible anytime up to 8 hours prior to the next scheduled dose.
Danish: Hvis du har glemt at tage din dosis, skal du tage den manglende dosis så hurtigt som muligt, hvis der er mere end 8 timer til den næste planlagte dosis.
English: • Joint pain, muscle spasms, back pain, neck pain, pain/discomfort in limbs, decrease of grip strength
Danish: • Ledsmerter, muskelspasmer, rygsmerter, nakkesmerter, smerter/ubehag i lemmerne, nedsat gribestyrke
English: The no observed adverse effect levels (NOAELs) for foetal toxicity in mice (5 mg/kg/day) as well as maternal and foetal toxicity in rats (2.5 mg/kg/day) were associated with tedizolid plasma area under the curve (AUC) values approximately equivalent to the tedizolid AUC value associated with the oral human therapeutic dose.
Danish: Niveauet uden observeret negativ effekt (NOAEL) for tedizolid, hvad angår føtal toksicitet hos mus (5 mg/kg/dag) samt maternel og føtal toksicitet hos rotter (2,5 mg/kg/dag), svarede til AUC af omtrent samme størrelsesorden som AUC ved den orale humane terapeutiske dosis.
English: The mechanism of action is different from that of non-oxazolidinone class antibacterial medicinal products; therefore, cross-resistance between tedizolid and other classes of antibacterial medicinal products is unlikely.
Danish: Derfor er krydsresistens mellem tedizolid og andre klasser af antibakterielle lægemidler usandsynlig.
English: If less than 8 hours remains before the next dose, then wait until the next scheduled dose.
Danish: Hvis der er under 8 timer til den næste planlagte dosis, skal du vente til den næste dosis.
English: Important: Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Danish: Vigtigt: Se produktresuméet, før lægemidlet ordineres.
English: Crospovidone Magnesium stearate
Danish: Magnesiumstearat
English: Other medicines and Sivextro
Danish: Brug af anden medicin sammen med Sivextro
English: If you are given more Sivextro than you should Tell your doctor or nurse immediately if you are concerned that you may have been given too much Sivextro.
Danish: Kontakt lægen eller sundhedspersonalet med det samme, hvis du tror, at du måske har fået for meget Sivextro.
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: If less than 8 hours remains before the next dose, then the patient should wait until the next scheduled dose.
Danish: Hvis der er under 8 timer til næste dosis, skal patienten vente til næste dosis.
English: These events have been observed with another member of the oxazolidinone class when administered over a duration exceeding that recommended for tedizolid phosphate.
Danish: Disse bivirkninger er observeret ved administration af et andet antibiotikum i oxazolidinon-klassen over en længere periode end den, der anbefales for tedizolidphosphat.
English: Tedizolid phosphate is converted by endogenous plasma and tissue phosphatases to the microbiologically active moiety, tedizolid.
Danish: Tedizolidphosphat omdannes til tedizolid, den mikrobiologisk aktive del, af endogene fosfataser i plasma og væv.
English: Multiple sulfotransferase (SULT) isoforms (SULT1A1, SULT1A2, and SULT2A1) were identified in vitro that are capable of conjugating tedizolid which suggests that no single isozyme is critical to the clearance of tedizolid.
Danish: In vitro blev der identificeret flere sulfotransferase (SULT )-isoformer (SULT1A1, SULT1A2 og SULT2A1), der kan konjugere tedizolid.
English: Abdominal discomfort Dry mouth
Danish: Abdominalt ubehag Mundtørhed
English: Each film-coated tablet contains 200 mg tedizolid phosphate.
Danish: Hver filmovertrukket tablet indeholder 200 mg tedizolidphosphat.
English: The most commonly observed mutations in staphylococci and enterococci that result in oxazolidinone resistance are in one or more copies of the 23S rRNA genes (G2576U and T2500A).
Danish: Det er mutationer i en eller flere kopier af 23S rRNA-generne (G2576U og T2500A), der hyppigst resulterer i oxazolidinon-resistens hos stafylokokker og enterokokker.
English: • Hot flush or blushing/redness in the face, neck or upper chest
Danish: • Hedeture eller rødme i ansigtet eller på halsen og den øvre del af brystkassen
English: Sivextro 200 mg film-coated tablets
Danish: Sivextro 200 mg filmovertrukne tabletter
English: OUTER CARTON (VIAL)
Danish: YDRE ÆSKE (HÆTTEGLAS)
English: Tedizolid inhibits mitochondrial protein synthesis.
Danish: Tedizolid hæmmer proteinsyntesen i mitokondrierne.
English: • Acid reflux disease (heartburn, pain or difficulty swallowing), flatulence/passing wind
Danish: • Mavesyre-refluks (halsbrand, smerter ved synkning eller synkebesvær), luft i tarmene
English: Each vial is for single use only.
Danish: Kun til engangsbrug.
English: In such cases, prompt evaluation is recommended with referral to an ophthalmologist as necessary.
Danish: Ved disse symptomer skal patienten undersøges med det samme og om nødvendigt henvises til en øjenlæge.
English: Irritability Pyrexia
Danish: Kulderystelser Irritabilitet Pyreksi Perifert ødem
English: Vision blurred Vitreous floaters
Danish: Erytematøst udslæt Generaliseret udslæt Akne
English: Monoamine oxidase inhibition
Danish: Hæmning af monoaminoxidase
English: How you will be given Sivextro
Danish: Sådan vil du få Sivextro
English: In a clinical study comparing the single dose (2 mg) pharmacokinetics of midazolam (CYP3A4 substrate) alone or in combination with tedizolid phosphate (once-daily 200 mg oral dose for 10 days), midazolam AUC and Cmax when co-administered with tedizolid phosphate were 81% and 83% of midazolam AUC and Cmax when administered alone, respectively.
Danish: I et klinisk studie, der sammenlignede enkeltdosisfarmakokinetikken (2 mg) for midazolam (CYP3A4substrat) alene eller i kombination med tedizolidphosphat (200 mg oral dosis en gang dagligt i 10 dage), var midazolam AUC og Cmax, når det blev administreret sammen med tedizolidphosphat, henholdsvis 81% og 83% af midazolam AUC og Cmax, når dette blev administreret alene.
English: Mitochondrial dysfunction
Danish: Mitokondriesygdomme
English: Alternative therapies should be considered when treating patients with neutropenia and ABSSSI (see section 5.1).
Danish: Andre behandlingsregimer bør overvejes ved behandling af patienter med neutropeni og akutte bakterieinfektioner i hud og hudstrukturer (se pkt.
English: In rats, decreased foetal weights and increased skeletal variations including reduced ossification of the sternabrae, vertebrae, and skull were observed at the high dose of 15 mg/kg/day (6-fold the estimated human exposure based on AUCs) and were associated with maternal toxicity (reduced maternal body weights).
Danish: Hos rotter sås nedsat fostervægt og en øget forekomst af skeletale variationer, herunder nedsat ossifikation af sternebrae, vertebrae og kranium, ved den høje dosis på 15 mg/kg/dag (6-gange den estimerede humane eksponering baseret på AUC).
English: How to take Sivextro
Danish: Sådan skal du tage Sivextro
English: Renal impairment No dosage adjustment is required (see section 5.2).
Danish: Nedsat nyrefunktion Dosisjustering er ikke nødvendig (se pkt.
English: If a dose is missed it should be given to the patient as soon as possible anytime up to 8 hours prior to the next scheduled dose.
Danish: Hvis en patient ikke har fået en planlagt dosis, skal patienten så hurtigt som muligt have den glemte dosis, hvis der er mere end 8 timer til næste planlagte dosis.
English: Sivextro 200 mg powder for concentrate for solution for infusion
Danish: Sivextro 200 mg pulver til koncentrat til infusionsvæske, opløsning
English: The Cmax and AUC of tedizolid increased approximately dose proportionally within the single oral dose range of 200 mg to 1,200 mg and across the intravenous dose range of 100 mg to 400 mg. Steady-state concentrations are achieved within 3 days and indicate modest active substance accumulation of approximately 30%
Danish: Tedizolids Cmax og AUC steg omtrent dosisproportionalt inden for et enkeltdosisinterval på 200-1.200 mg ved oral administration og på 100-400 mg ved intravenøs administration.
English: • Itching (including itching due to allergic reaction), hair loss, acne, red and/or itchy rash or hives,
Danish: • Kløe (herunder kløe, der skyldes en overfølsomhedsreaktion), hårtab, bumser (akne), røde og/eller kløende udslæt eller nældefeber, øget svedtendens
English: Grip strength decreased Transaminases increased White blood cell count decreased
Danish: Nedsat gribestyrke Forhøjede aminotransferaser Nedsat leukocyttal
English: Pruritus allergic Rash maculo-papular Rash papular Rash pruritic
Danish: Allergisk pruritus Makulopapuløst udslæt Papuløst udslæt Kløende udslæt
English: Reconstitution
Danish: Opkastning
English: • Vaginal infection, inflammation or itching
Danish: • Infektion, irritation eller kløe i skeden
English: No evidence of neurotoxicity, including neurobehavioral changes or optic or peripheral neuropathy, was associated with tedizolid after 1, 3, 6 or 9 months of oral administration up to doses with plasma exposure levels (AUC) up to 8-fold greater than the expected human plasma exposure at the oral therapeutic dose.
Danish: 1, 3, 6 og 9 måneders oral administration af tedizolid i doser svarende til en plasmaeksponering (AUC), der var op til 8 gange større end den forventede humane plasmaeksponering ved den terapeutiske orale dosis, var ikke forbundet med tegn på neurotoksicitet, herunder ændringer i neuroadfærd eller optisk eller perifer neuropati.
English: • bleeding or bruising easily
Danish: • tilbøjelighed til at bløde eller få blå mærker
English: Sivextro 200 mg film-coated tablets tedizolid phosphate
Danish: Sivextro 200 mg filmovertrukne tabletter tedizolidphosphat
English: Abdominal pain upper Flatulence
Danish: Øvre abdominalsmerter Flatulens
English: Drug hypersensitivity
Danish: Paræstesi Hypæstesi
English: Hepatic impairment No dosage adjustment is required (see section 5.2).
Danish: Nedsat leverfunktion Dosisjustering er ikke nødvendig (se pkt.
English: In a clinical study comparing the single dose (10 mg) pharmacokinetics of rosuvastatin (BCRP substrate) alone or in combination with the oral administration of tedizolid phosphate 200 mg, rosuvastatin AUC and Cmax increased by approximately 70% and 55%, respectively, when coadministered with Sivextro.
Danish: I et klinisk studie, der sammenlignede enkeltdosisfarmakokinetikken (10 mg) for rosuvastatin (BCRPsubstrat) alene eller i kombination med oral administration af tedizolidphosphat 200 mg, steg AUC og Cmax for rosuvastatin med henholdsvis ca. 70% og 55%, når det blev administreret sammen med Sivextro.
English: • Infusion reactions (chills, shaking or shivering with fever, muscle pain, swelling of the face, weakness, fainting, shortness of breath, chest tightness and angina pectoris).
Danish: kraftesløshed, besvimelse, åndenød, trykken for brystet og brystsmerter (angina pectoris)).
English: Sivextro 200 mg powder for concentrate for solution for infusion tedizolid phosphate
Danish: Sivextro 200 mg pulver til koncentrat til infusionsvæske, opløsning tedizolidphosphat
English: Each vial of powder contains disodium tedizolid phosphate which is equal to 200 mg of tedizolid phosphate.
Danish: Hvert hætteglas indeholder dinatriumtedizolidphosphat svarende til 200 mg tedizolidphosphat.
English: Sivextro 200 mg powder for concentrate tedizolid phosphate
Danish: Sivextro 200 mg pulver til koncentrat tedizolidphosphat i.v.
English: Tedizolid is a reversible inhibitor of MAO in vitro; however, no interaction is anticipated when comparing the IC50 and the anticipated plasma exposures in man. No evidence of MAO-A inhibition was observed in Phase 1 studies specifically designed to investigate the potential for this interaction.
Danish: Der blev ikke fundet evidens for MAO-A-hæmning i fase 1-studier, som var specifikt designet til at undersøge muligheden for denne interaktion.
English: Urine odor abnormal
Danish: Unormal urinlugt
English: In a clinical study comparing the single dose (10 mg) pharmacokinetics of rosuvastatin (Breast Cancer Resistant Protein [BCRP] substrate) alone or in combination with tedizolid phosphate (once-daily 200 mg oral dose), rosuvastatin AUC and Cmax increased by approximately 70% and 55%, respectively, when coadministered with tedizolid phosphate.
Danish: I et klinisk studie, der sammenlignede enkeltdosisfarmakokinetikken (10 mg) for rosuvastatin (brystcancer-resistent protein [BCRP]-substrat) alene eller i kombination med tedizolidphosphat (200 mg oral dosis en gang dagligt), steg AUC og Cmax for rosuvastatin med henholdsvis ca. 70% og 55%, når det blev administreret sammen med tedizolidphosphat.
English: Adrenergic agents
Danish: Adrenergika
English: The Cmax and AUC of tedizolid increased approximately dose proportionally within the single oral dose range of 200 mg to 1,200 mg and across the intravenous dose range of 100 mg to 400 mg. Steady-state concentrations are achieved within 3 days and indicate modest active substance accumulation of approximately 30% following multiple once-daily oral or intravenous administration as predicted by a half-life of approximately 12 hours.
Danish: Steady state-koncentrationen nås i løbet af 3 dage og tyder på en beskeden akkumulation af aktivt stof på ca. 30 % efter flere orale eller intravenøse doser en gang dagligt som forudberegnet på grundlag af en halveringstid på ca. 12 timer.
English: Sivextro 200 mg tablets tedizolid phosphate
Danish: Sivextro 200 mg tabletter tedizolidphosphat
English: • Dryness in the nose, congestion in the chest, cough
Danish: • Næsetørhed, slim i lungerne, hoste
English: VIAL LABEL
Danish: ETIKET PÅ HÆTTEGLAS
English: If you take more Sivextro than you should
Danish: Hvis du har fået for meget Sivextro
English: • Infusion site pain or swelling.
Danish: • Smerter eller hævelse ved infusionsstedet.
English: After reconstitution each ml contains 50 mg tedizolid phosphate.
Danish: 1 ml koncentrat indeholder 50 mg tedizolidphosphat efter rekonstitution.
English: After reconstitution each mL contains 50 mg tedizolid phosphate.
Danish: 1 ml indeholder 50 mg tedizolidphosphat efter rekonstitution.
English: Haemodialysis does not result in meaningful removal of tedizolid from systemic circulation, as assessed in subjects with end-stage renal disease (eGFR <15 mL/min).
Danish: Ud fra patienter med terminal nyresygdom (eGFR < 15 ml/min) vurderes det, at hæmodialyse ikke fjerner tedizolid nævneværdigt fra den systemiske cirkulation.
English: Infusion site pain
Danish: Smerter ved infusionsstedet Irritabilitet
English: Clostridioides difficile colitis Dermatophytosis Oral candidiasis Respiratory tract infection
Danish: Oral candidiasis Luftvejsinfektion
English: Tedizolid is a reversible inhibitor of monoamine oxidase (MAO) in vitro; however, no interaction is anticipated when comparing the IC50 for MAO-A inhibition and the anticipated plasma exposures in man. Drug interaction studies to determine effects of 200 mg oral tedizolid phosphate at steady state on pseudoephedrine and tyramine pressor effects were conducted in healthy volunteers.
Danish: Der er udført lægemiddelinteraktionsstudier hos raske forsøgspersoner for at klarlægge, hvilken indvirkning 200 mg oralt tedizolidphosphat har på pseudoephedrins og tyramins pressoreffekt ved steady state.
English: • Dry mouth, constipation, indigestion, pain/discomfort in the belly (abdomen), retching, dry heaving, bright red blood in the stool
Danish: • Kløe (herunder kløe, der skyldes en overfølsomhedsreaktion), hårtab, bumser (akne), rødt og/eller kløende udslæt eller nældefeber, øget svedtendens
English: Keep the tube tightly closed.
Danish: Hold rørene tæt lukkede.
English: Section on contraindications remained unchanged.
Danish: Afsnittet om kontraindikationer forbliver uændret.
English: The following quality, efficacy and safety issues were addressed:
Danish: Følgende spørgsmål vedrørende kvalitet, virkning og sikkerhed er blevet behandlet:
English: Benefit/Risk considerations
Danish: Betragtninger vedrørende benefit/risk-forholdet
English: Classification and terminology were amended according to the MedDRA system organ class.
Danish: Klassifikation og terminologi er ændret i overensstemmelse med organklasse efter MedDRA-systemet.
English: The remaining 1% is present in the intra- and extracellular fluids.
Danish: Den resterende 1 % findes i intra- and ekstracellulærvæskerne.
English: Treatment of overdose:
Danish: Behandling af overdosering:
English: The mineral component of bones and teeth contains 99% of the body's calcium.
Danish: Knoglernes og tændernes mineraler indeholder 99 % af kroppens calcium.
English: Effects on ability to drive and use machines
Danish: Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
English: Based on the available information and a literature search, there does not seem to be any major safety issue associated with the administration of calcium in oral use.
Danish: Ud fra de foreliggende oplysninger og en litteratursøgning synes der ikke være knyttet større sikkerhedsproblemer til oral administration af calcium.
English: Aspartame (E951) Macrogol 6000
Danish: Aspartam (E951) Macrogol 6000
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRINGEN AF PRODUKTRESUMEET FREMLAGT AF EMEA
English: During pregnancy, the daily intake of calcium should not exceed 1500 mg.
Danish: Under graviditet bør den daglige tilførsel af calcium ikke overstige 1500 mg.
English: Physicochemical and biological aspects relevant to the uniform clinical performance of the product have been investigated and are controlled in a satisfactory way.
Danish: De fysisk-kemiske og biologiske forhold, som er af betydning for ensartede kliniske egenskaber af produktet, er undersøgt og reguleret på tilfredsstillende måde.
English: 1800 VILVOORDE Belgium
Danish: 1800 VILVOORDE Belgien
English: There is no information of relevance to the safety assessment in addition to what is stated in other parts of the SmPC.
Danish: Der er ingen yderligere relevant information vedrørende vurderingen af sikkerhed ud over hvad der er anført i andre dele af produktresumeet.
English: Emelet Postacím: 1525 Budapest, Pf. 118 Hungary
Danish: Postacím: 1525 Budapest, Pf. 118
English: The effervescent tablets should be dissolved in a glass of water (approx. 200 ml) and drunk immediately.
Danish: Brusetabletterne bør opløses i et glas vand (ca. 200 ml) og drikker umiddelbart.
English: Attn: Ugo Di Francesco & Dr. H. Blehova
Danish: : Ugo Di Francesco & Dr. H. Blehova
English: 81379 München, Germany
Danish: 81379 München, Tyskland
English: Av. Poeta Mistral n°2-2°, 1069-172 Lisboa, Portugal
Danish: Poeta Mistral n°2-2°, 1069-172 Lissabon, Portugal
English: uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000) or very rare (<1/10,000), including isolated reports.
Danish: Frekvenser er defineret som: Ikke almindelig (>1/1,000, <1/100), sjælden (>1/10,000, <1/1,000) eller meget sjælden (<1/10,000),
English: Attn: Dr. D. Werner
Danish: : Dr. D. Werner
English: Sodium hydrogen carbonate
Danish: Natriumhydrogencarbonat
English: Mr Carlo Candiani
Danish: Carlo Candiani
English: There have been literature reports alluding to possible increased absorption of aluminium with citrate salts.
Danish: Publikationer har antydet en mulig øget absorption af aluminium med citratsalte.
English: The quality of this product is considered to be acceptable when used in accordance with the conditions defined in the SPC.
Danish: Produktets kvalitet anses for at kunne godtages, når det anvendes under de i produktresuméet fastlagte betingelser.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, INDGIVELSESVEJ, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: Postboks 237 Økern 0510 Oslo, Norway
Danish: Postboks 237 Økern 0510 Oslo, Norge Att.
English: Attn: Dr. Volker Eisenreich
Danish: : Dr. Volker Eisenreich
English: However, several amendments to the SPC were introduced.
Danish: Der er imidlertid foretaget flere ændringer af produktresuméet.
English: About 50% of the total blood-calcium content is in the physiologically active ionised form, with approximately 5% being complexed to citrate, phosphate or other anions.
Danish: Ca. 50 % af det totale blodcalciumindhold findes i den fysiologiske aktive ioniserede form, med ca. 5 % kompleksbundet til citrat, fosfat eller andre anioner.
English: Distribution and metabolism:
Danish: Distribution and metabolisme
English: For this reason, tetracycline preparations should be administered at least two hours before or four to six hours after oral intake of calcium.
Danish: Derfor bør tetracyclin administreres mindst to timer før eller fire til seks timer efter oral indgift af calcium.
English: Pregnancy and lactation
Danish: Graviditet og amning
English: 4.2 Posology and method of administration Adults: 500 - 1500 mg per day Children: 500 - 1000 mg per day
Danish: 4.2 Dosering og indgivelsesmåde Voksne: 500 - 1500 mg daglig Børn: 500 - 1000 mg daglig
English: The remaining 45% of serum calcium is bound to proteins, principally albumin.
Danish: De resterende 45 % af serumcalcium er proteinbundet, primært til albumin.
English: Minor wording modification was introduced to section on pregnancy and lactation in order to add clarity and to put it in line with the guideline on summary of product characteristics.
Danish: Der er foretaget mindre ændringer i ordlyden af afsnittet om graviditet og amning for at gøre dette klarere og bringe det på linje med guidelinen for produktresuméer.
English: Attn: Mr Pieter De Pourcq
Danish: : Pieter De Pourcq
English: Some 25-50% of the ingested dose of calcium is absorbed, predominantly in the proximal part of the small intestine, and delivered to the exchangeable calcium pool.
Danish: Ca. 25-50 % af den indtagne dosis calcium bliver absorberet, overvejende i den proximale del af tyndtarmen, og videregivet til de udskiftelige calciumreserver.
English: Orange flavour powder (contains: orange essential oils, maltodextrin, arabic gum, sorbitol (E 420), dextrose)
Danish: Orange aroma (indeholdende: orangeolie, maltodextrin, gummi arabicum, sorbitol (E 420), dextrose)
English: During concomitant use, it may be necessary to increase the dose of Calcium Sandoz.
Danish: Ved samtidig behandling kan det være nødvendigt at øge dosis af Calcium Sandoz.
English: If necessary, the calcium dose should be reduced or therapy should be discontinued.
Danish: Om nødvendigt bør dosis af calcium reduceres eller behandlingen seponeres.
English: Calcium Sandoz has no influence on the ability to drive and use machines.
Danish: Calcium Sandoz har ingen indflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: Varnavas Hadjipanayis Ltd. 7A Androcleous Str. 1060 Nicosia
Danish: Varnavas Hadjipanayis Ltd. 7A Androcleous Str. 1060 Nicosia Cypern.
English: For patients with mild hypercalciuria (exceeding 300 mg/24 hours or 7.5 mmol/24 hours), or with a history of urinary calculi, monitoring of calcium excretion in the urine is required.
Danish: Hos patienter med mild hypercalciuri (som overstiger 300 mg/24 timer eller 7.5 mmol/24 timer), eller med en anamnese om nyresten, er monitorering af calciumudskillelsen i urinen påkrævet.
English: Attn: P. Miko
Danish: : P. Miko
English: Safety issues
Danish: Spørgsmål vedrørende sikkerhed
English: ATC codes: Calcium carbonate (A 12 AA 04), Calcium lactate gluconate (A 12 AA 06)
Danish: ATC koder: Calciumcarbonat (A 12 AA 04), Calcium lactogluconate (A 12 AA 06)
English: Whereas, - the scope of the referral was the harmonisation of the Summary of Product Characteristics, and harmonisation of the pharmaceutical documentation - module 3 (quality)
Danish: - Indbringelsen vedrører harmoniseringen af produktresuméet og harmoniseringen af den farmaceutiske dokumentation - modul 3 (kvalitet).