natgillin/translations-raw huggingface dataset:
Tedizolids farmakokinetik blev vurderet hos unge forsøgspersoner (i alderen 12-17 år; n=20) efter oral og intravenøs administration af en enkelt dosis tedizolidphosphat på 200 mg. 
The pharmacokinetics of tedizolid were evaluated in adolescent subjects (12 to 17 years; n=20) following administration of a single oral or IV dose of tedizolid phosphate 200 mg.
Tedizolid virker bakteriostatisk på enterokokker, stafylokokker og streptokokker in vitro. 
Tedizolid is bacteriostatic against enterococci, staphylococci, and streptococci in vitro.
Reaktioner på infusionsstedet 
Infusion site
Brug ikke lægemidlet efter den udløbsdato, der står på hætteglasetiketten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the vial label after “EXP”.
Tedizolid udskilles i mælk hos rotter (se pkt. 
Tedizolid is excreted in the breast milk of rats (see section 5.3).
Opbevaringsforhold efter rekonstitution og fortynding, se pkt. 
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Sikkerhedsprofilen var sammenlignelig hos patienter, der fik monoterapi med tedizolidphosphat intravenøst, og patienter, der fik monoterapi med tedizolidphosphat oralt, bortset fra, at der blev rapporteret om flere gastrointestinale forstyrrelser ved oral administration. 
The safety profile was similar when comparing patients receiving intravenous tedizolid phosphate alone to patients who received oral administration alone, except for a higher reported rate of gastrointestinal disorders associated with oral administration.
Tedizolidphosphats sikkerhed og virkning ved administration i mere end 6 dage er ikke klarlagt. 
The safety and efficacy of tedizolid phosphate when administered for periods longer than 6 days have not been established.
Efter administration af en enkelt i.v.-dosis tedizolidphosphat på 200 mg hos 8 forsøgspersoner med svært nedsat nyrefunktion, defineret som eGFR < 30 ml/min, var Cmax stort set uændret, og AUC0-∞ var ændret med under 10 % i forhold til værdierne hos 8 raske forsøgspersoner. 
Following administration of a single 200 mg IV dose of tedizolid phosphate to 8 subjects with severe renal impairment defined as eGFR <30 mL/min, the Cmax was basically unchanged and AUC0-∞ was changed by less than 10% compared to 8 matched healthy subject controls.
Gentagen oral og intravenøs dosering af tedizolidphosphat hos rotter i toksikologistudier over 1 og 3 måneder medførte dosis- og tidsafhængig hypocellulær knoglemarv (nedsat forekomst af myelocytter, erytrocytter og megakaryocytter) og dermed forbundet nedsættelse af cirkulerende røde blodlegemer, hvide blodlegemer og blodplader. 
Repeated oral and intravenous dosing of tedizolid phosphate in rats in 1-month and 3-month toxicology studies produced dose- and time-dependent bone marrow hypocellularity (myeloid, erythroid, and megakaryocyte), with associated reduction in circulating RBCs, WBCs, and platelets.
Hvis en dosis er glemt Kontakt lægen eller sundhedspersonalet med det samme, hvis du tror, at en dosis måske er glemt. 
If you miss a dose of Sivextro Tell your doctor or nurse immediately if you are concerned that you may have missed a dose.
• Luftvejsinfektion (bihuler, hals og brystkasse) 
• Respiratory tract (sinuses, throat and chest) infection
Virkninger på den føtale udvikling hos mus, hvor der ikke blev set maternel toksicitet, omfattede nedsat fostervægt og en øget forekomst af ribbensbruskfusion (forstærkning af den normale genetiske disposition for sternale variationer i CD-1-stammen hos mus) ved den høje dosis på 25 mg/kg/dag (4 gange den estimerede humane eksponering baseret på AUC). 
Foetal developmental effects occurring in mice in the absence of maternal toxicity included reduced foetal weights and an increased incidence of costal cartilage fusion (an exacerbation of the normal genetic predisposition to sternal variations in the CD-1 strain of mice) at the high dose of 25 mg/kg/day (4-fold the estimated human exposure level based on AUCs).
Søvnløshed Søvnforstyrrelser Angst 
Insomnia Sleep disorder Anxiety Nightmare
Tedizolid virker primært mod grampositive bakterier. 
Tedizolid is primarily active against Gram-positive bacteria.
Det anvendes til at behandle infektioner i hud og hudstrukturer hos voksne. 
It is used to treat adults with infections of the skin and tissues below the skin.
For en sikkerheds skyld bør tedizolidphosphat undgås under graviditet. 
As a precautionary measure, it is preferable to avoid the use of tedizolid phosphate during pregnancy.
• Overfølsomhedsreaktion 
• Allergic reaction
Infusionsrelaterede reaktioner Perifert ødem 
Infusion related reaction Peripheral oedema
- hvis du tager lægemidler til behandling af depression af typen tricykliske antidepressiva, SSRI (selektive serotonin-genoptagelseshæmmere) eller MAO-hæmmere (monoaminoxidasehæmmere). 
- are taking certain medicines to treat depression, known as tricyclics, SSRIs (selective serotonin reuptake inhibitors) or MAOIs (monoamine oxidase inhibitors).
Sivextro-tabletterne fås i perforeret enkeltdosisblister med 6 x 1 tabletter. 
It is available in 6 × 1 tablets in perforated unit-dose blisters.
Det rekonstituerede koncentrat trækkes op af hætteglasset og tilsættes en infusionspose med 0,9% natriumchloridinfusionsvæske (foregår på hospitalet). 
The reconstituted solution will be withdrawn from the vial and added to an infusion bag of 0.9% sodium chloride in the hospital.
Der er observeret nedsat antal blodplader og neutrofile granulocytter samt nedsat hæmoglobinkoncentration hos enkelte forsøgspersoner under behandling med tedizolidphosphat. 
Decreased platelets, decreased haemoglobin and decreased neutrophils have been observed in a few subjects during treatment with tedizolid phosphate.
Det skal du vide, før du begynder at tage Sivextro 
What you need to know before you take Sivextro
Det skal du vide, før du får Sivextro 
What you need to know before you are given Sivextro
Patienten må ikke tage en dobbeltdosis som erstatning for den glemte dosis. 
Patients should not take a double dose to compensate for a missed dose.
Der er set en række bivirkninger ved brug af et andet lægemiddel i oxazolidinon-klassen over en længere periode end den, der anbefales for Sivextro. 
Certain side effects have been observed with another member of the oxazolidinone class when administered over a duration exceeding that recommended for Sivextro.
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), viste ingen klinisk relevant forskel i midazolam Cmax eller AUC. 
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), demonstrated no clinically meaningful difference in midazolam Cmax or AUC.
Tedizolid var positivt for genotoksicitet i en in vitro-analyse af kromosomafvigelser i lungeceller fra kinesisk hamster, men negativt i andre in vitro-analyser (Ames' analyse, mutagenicitet i lymfomer hos mus) og i en in vivo-analyse af mikronukleus i knoglemarv hos mus. 
Tedizolid was positive in an in vitro CHL cell chromosomal aberration assay, but negative for genotoxicity in other in vitro assays (Ames, mouse lymphoma mutagenicity) and in vivo in a mouse bone marrow micronucleus assay.
De gennemsnitlige værdier (SD) for tedizolid ved steady state var af samme størrelsesorden efter oral og intravenøs administration af tedizolidphosphat, idet Cmax var henholdsvis 2,2 (0,6) og 3,0 (0,7) mikrog/ml og AUC henholdsvis 25,6 (8,5) og 29,2 (6,2) mikrog·t/ml. 
At steady state, tedizolid mean (SD) Cmax values of 2.2 (0.6) and 3.0 (0.7) mcg/mL and AUC values of 25.6 (8.5) and 29.2 (6.2) mcg·h/mL were similar with oral and IV administration of tedizolid phosphate, respectively.
Lægemiddelmetaboliserende enzymer 
Drug metabolizing enzymes
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. 
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.
• Ledsmerter, muskelspasmer, rygsmerter, nakkesmerter, smerter/ubehag i lemmerne, nedsat gribestyrke 
• Joint pain, muscle spasms, back pain, neck pain, pain/discomfort in limbs, decrease of grip strength
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. 
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.
Derfor er krydsresistens mellem tedizolid og andre klasser af antibakterielle lægemidler usandsynlig. 
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.
Hvis der er under 8 timer til den næste planlagte dosis, skal du vente til den næste dosis. 
If less than 8 hours remains before the next dose, then wait until the next scheduled dose.
Vigtigt: Se produktresuméet, før lægemidlet ordineres. 
Important: Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Magnesiumstearat 
Crospovidone Magnesium stearate
Brug af anden medicin sammen med Sivextro 
Other medicines and Sivextro
Kontakt lægen eller sundhedspersonalet med det samme, hvis du tror, at du måske har fået for meget Sivextro. 
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.
Fortæl det altid til lægen eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig. 
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Hvis der er under 8 timer til næste dosis, skal patienten vente til næste dosis. 
If less than 8 hours remains before the next dose, then the patient should wait until the next scheduled dose.
Disse bivirkninger er observeret ved administration af et andet antibiotikum i oxazolidinon-klassen over en længere periode end den, der anbefales for tedizolidphosphat. 
These events have been observed with another member of the oxazolidinone class when administered over a duration exceeding that recommended for tedizolid phosphate.
Tedizolidphosphat omdannes til tedizolid, den mikrobiologisk aktive del, af endogene fosfataser i plasma og væv. 
Tedizolid phosphate is converted by endogenous plasma and tissue phosphatases to the microbiologically active moiety, tedizolid.
In vitro blev der identificeret flere sulfotransferase (SULT )-isoformer (SULT1A1, SULT1A2 og SULT2A1), der kan konjugere tedizolid. 
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.
Abdominalt ubehag Mundtørhed 
Abdominal discomfort Dry mouth
Hver filmovertrukket tablet indeholder 200 mg tedizolidphosphat. 
Each film-coated tablet contains 200 mg tedizolid phosphate.
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. 
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).
• Hedeture eller rødme i ansigtet eller på halsen og den øvre del af brystkassen 
• Hot flush or blushing/redness in the face, neck or upper chest
Sivextro 200 mg filmovertrukne tabletter 
Sivextro 200 mg film-coated tablets
YDRE ÆSKE (HÆTTEGLAS) 
OUTER CARTON (VIAL)
Tedizolid hæmmer proteinsyntesen i mitokondrierne. 
Tedizolid inhibits mitochondrial protein synthesis.
• Mavesyre-refluks (halsbrand, smerter ved synkning eller synkebesvær), luft i tarmene 
• Acid reflux disease (heartburn, pain or difficulty swallowing), flatulence/passing wind
Kun til engangsbrug. 
Each vial is for single use only.
Ved disse symptomer skal patienten undersøges med det samme og om nødvendigt henvises til en øjenlæge. 
In such cases, prompt evaluation is recommended with referral to an ophthalmologist as necessary.
Kulderystelser Irritabilitet Pyreksi Perifert ødem 
Irritability Pyrexia
Erytematøst udslæt Generaliseret udslæt Akne 
Vision blurred Vitreous floaters
Hæmning af monoaminoxidase 
Monoamine oxidase inhibition
Sådan vil du få Sivextro 
How you will be given Sivextro
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. 
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.
Mitokondriesygdomme 
Mitochondrial dysfunction
Andre behandlingsregimer bør overvejes ved behandling af patienter med neutropeni og akutte bakterieinfektioner i hud og hudstrukturer (se pkt. 
Alternative therapies should be considered when treating patients with neutropenia and ABSSSI (see section 5.1).
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). 
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).
Sådan skal du tage Sivextro 
How to take Sivextro
Nedsat nyrefunktion Dosisjustering er ikke nødvendig (se pkt. 
Renal impairment No dosage adjustment is required (see section 5.2).
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. 
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.
Sivextro 200 mg pulver til koncentrat til infusionsvæske, opløsning 
Sivextro 200 mg powder for concentrate for solution for infusion
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. 
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%
• Kløe (herunder kløe, der skyldes en overfølsomhedsreaktion), hårtab, bumser (akne), røde og/eller kløende udslæt eller nældefeber, øget svedtendens 
• Itching (including itching due to allergic reaction), hair loss, acne, red and/or itchy rash or hives,
Nedsat gribestyrke Forhøjede aminotransferaser Nedsat leukocyttal 
Grip strength decreased Transaminases increased White blood cell count decreased
Allergisk pruritus Makulopapuløst udslæt Papuløst udslæt Kløende udslæt 
Pruritus allergic Rash maculo-papular Rash papular Rash pruritic
Opkastning 
Reconstitution
• Infektion, irritation eller kløe i skeden 
• Vaginal infection, inflammation or itching
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. 
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.
• tilbøjelighed til at bløde eller få blå mærker 
• bleeding or bruising easily
Sivextro 200 mg filmovertrukne tabletter tedizolidphosphat 
Sivextro 200 mg film-coated tablets tedizolid phosphate
Øvre abdominalsmerter Flatulens 
Abdominal pain upper Flatulence
Paræstesi Hypæstesi 
Drug hypersensitivity
Nedsat leverfunktion Dosisjustering er ikke nødvendig (se pkt. 
Hepatic impairment No dosage adjustment is required (see section 5.2).
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. 
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.
kraftesløshed, besvimelse, åndenød, trykken for brystet og brystsmerter (angina pectoris)). 
• Infusion reactions (chills, shaking or shivering with fever, muscle pain, swelling of the face, weakness, fainting, shortness of breath, chest tightness and angina pectoris).
Sivextro 200 mg pulver til koncentrat til infusionsvæske, opløsning tedizolidphosphat 
Sivextro 200 mg powder for concentrate for solution for infusion tedizolid phosphate
Hvert hætteglas indeholder dinatriumtedizolidphosphat svarende til 200 mg tedizolidphosphat. 
Each vial of powder contains disodium tedizolid phosphate which is equal to 200 mg of tedizolid phosphate.
Sivextro 200 mg pulver til koncentrat tedizolidphosphat i.v. 
Sivextro 200 mg powder for concentrate tedizolid phosphate
Der blev ikke fundet evidens for MAO-A-hæmning i fase 1-studier, som var specifikt designet til at undersøge muligheden for denne interaktion. 
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.
Unormal urinlugt 
Urine odor abnormal
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. 
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.
Adrenergika 
Adrenergic agents
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. 
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.
Sivextro 200 mg tabletter tedizolidphosphat 
Sivextro 200 mg tablets tedizolid phosphate
• Næsetørhed, slim i lungerne, hoste 
• Dryness in the nose, congestion in the chest, cough
ETIKET PÅ HÆTTEGLAS 
VIAL LABEL
Hvis du har fået for meget Sivextro 
If you take more Sivextro than you should
• Smerter eller hævelse ved infusionsstedet. 
• Infusion site pain or swelling.
1 ml koncentrat indeholder 50 mg tedizolidphosphat efter rekonstitution. 
After reconstitution each ml contains 50 mg tedizolid phosphate.
1 ml indeholder 50 mg tedizolidphosphat efter rekonstitution. 
After reconstitution each mL contains 50 mg tedizolid phosphate.
Ud fra patienter med terminal nyresygdom (eGFR < 15 ml/min) vurderes det, at hæmodialyse ikke fjerner tedizolid nævneværdigt fra den systemiske cirkulation. 
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).
Smerter ved infusionsstedet Irritabilitet 
Infusion site pain
Oral candidiasis Luftvejsinfektion 
Clostridioides difficile colitis Dermatophytosis Oral candidiasis Respiratory tract infection
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. 
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.
• Kløe (herunder kløe, der skyldes en overfølsomhedsreaktion), hårtab, bumser (akne), rødt og/eller kløende udslæt eller nældefeber, øget svedtendens 
• Dry mouth, constipation, indigestion, pain/discomfort in the belly (abdomen), retching, dry heaving, bright red blood in the stool
Hold rørene tæt lukkede. 
Keep the tube tightly closed.
Afsnittet om kontraindikationer forbliver uændret. 
Section on contraindications remained unchanged.
Følgende spørgsmål vedrørende kvalitet, virkning og sikkerhed er blevet behandlet: 
The following quality, efficacy and safety issues were addressed:
Betragtninger vedrørende benefit/risk-forholdet 
Benefit/Risk considerations
Klassifikation og terminologi er ændret i overensstemmelse med organklasse efter MedDRA-systemet. 
Classification and terminology were amended according to the MedDRA system organ class.
Den resterende 1 % findes i intra- and ekstracellulærvæskerne. 
The remaining 1% is present in the intra- and extracellular fluids.
Behandling af overdosering: 
Treatment of overdose:
Knoglernes og tændernes mineraler indeholder 99 % af kroppens calcium. 
The mineral component of bones and teeth contains 99% of the body's calcium.
Virkninger på evnen til at føre motorkøretøj eller betjene maskiner 
Effects on ability to drive and use machines
Ud fra de foreliggende oplysninger og en litteratursøgning synes der ikke være knyttet større sikkerhedsproblemer til oral administration af calcium. 
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.
Aspartam (E951) Macrogol 6000 
Aspartame (E951) Macrogol 6000
BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRINGEN AF PRODUKTRESUMEET FREMLAGT AF EMEA 
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA