natgillin/translations-raw huggingface dataset:
Specielle populationer Patienter med nedsat nyrefunktion Dosisjustering er ikke nødvendig hos patienter med mild eller moderat nyreinsufficiens, hvor kreatinin - clearance er lig med eller større end 30 ml/ min.
Special Populations Patients with renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal or greater than 30 ml/ min.
På grund af manglende klinisk erfaring kan Bondenza ikke anbefales til patienter, hvor kreatininclearance er lavere end 30 ml/ min (se pkt 4. 4 og 5. 2).
Bondenza is not recommended for patients with a creatinine clearance below 30 ml/ min due to limited clinical experience (see section 4.4 and section 5.2).
2 Patienter med nedsat leverfunktion Dosisjustering er ikke nødvendig (se pkt 5. 2).
2 Patients with hepatic impairment No dose adjustment is required (see section 5.2).
Ældre population Dosisjustering er ikke nødvendig (se pkt 5. 2).
Elderly Population No dose adjustment is required (see section 5.2).
Pædiatrisk population Anvendelse af Bondenza er ikke relevant hos børn og der er ingen erfaring med behandling af børn.
Paediatric Population There is no relevant use of Bondenza in children, and Bondenza was not studied in the paediatric population.
Indgivelsesmåde:
Method of Administration:
Tabletterne skal synkes hele med et glas postevand (180 til 240 ml), med patienten sidder eller står op.
Tablets should be swallowed whole with a glass of plain water (180 to 240 ml) while the patient is sitting or standing in an upright position.
Bondenza må kun indtages sammen med postevand.
Plain water is the only drink that should be taken with Bondenza.
Vær opmærsom på, at visse typer mineralvand kan indeholde en højere koncentration af calcium og derfor ikke må benyttes.
Please note that some mineral waters may have a higher concentration of calcium and therefore, should not be used.
Patienten må ikke tygge eller sutte på tabletterne på grund af risiko for oropharyngeal ulceration.
Patients should not chew or suck the tablet, because of a potential for oropharyngeal ulceration.
- Hypocalcæmi (se pkt 4. 4)
- Hypocalcaemia (see section 4.4)
- Overfølsomhed over for ibandronsyre eller over for et eller flere af hjælpestofferne.
- Hypersensitivity to ibandronic acid or to any of the excipients.
Gastrointestinale sygdomme Bisphosphonater har været forbundet med dysphagi, esophagitis og esophagale eller gastriske ulcerationer.
Gastrointestinal Disorders Bisphosphonates have been associated with dysphagia, oesophagitis and oesophageal or gastric ulcers.
Dette gælder specielt patienter med forlænget esophagus transittid.
Therefore patients, especially those with a history of prolonged oesophageal transit time, should pay particular attention to and be able to comply with the dosing instructions (see section 4.2).
Lægen skal være opmærksom på ethvert tegn eller symptom på esophagus reaktion under behandlingen, og patienten skal instrueres i at standse behandlingen med Bondenza og søge læge, hvis der udvikles symptomer på spiserørsirritation som f. eks. nyopstået eller forværret dysphagi, synke - smerter, retrosternal smerte eller halsbrand.
Physicians should be alert to signs or symptoms signalling a possible oesophageal reaction during therapy, and patients should be instructed to discontinue Bondenza and seek medical attention if they develop symptoms of oesophageal irritation such as new or worsening dysphagia, pain on swallowing, retrosternal pain, or heartburn.
Idet både nonsteroide antiinflammatoriske lægemidler og bisphosphonater er forbundet med gastrointestinal irritation, bør der udvises forsigtighed ved samtidig administration.
Since Nonsteroidal Anti-Inflamatory Drugs and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Hypocalcæmi Eksisterende hypocalcæmi bør behandles, før behandling med Bondenza initieres.
Hypocalcaemia Existing hypocalcaemia must be corrected before starting Bondenza therapy.
Andre forstyrrelser i knogle - og mineralstofskiftet bør ligeledes behandles effektivt.
Other disturbances of bone and mineral metabolism should also be effectively treated.
Det er vigtigt, at patienterne har et tilstrækkeligt indtag af calcium og D- vitamin.
Adequate intake of calcium and vitamin D is important in all patients.
Nedsat nyrefunktion På grund af begrænset klinisk erfaring, kan Bondenza ikke anbefales til patienter med kreatinin - clearance lavere end 30 ml/ min (se pkt 5. 2).
Renal impairment Due to limited clinical experience, Bondenza is not recommended for patients with a creatinine clearance below 30 ml/ min (see section 5.2).
Knoglenekrose i kæben Knoglenekrose i kæben, normalt set ved tandudtrækning og / eller lokal infektion (herunder osteomyelitis), er rapporteret blandt cancerpatienter, der får behandlingsregimer primært med intravenøst administrerede bisphosphonater.
Osteonecrosis of the Jaw Osteonecrosis of the jaw, generally associated with tooth extraction and/ or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates.
Mange af disse patienter fik også kemoterapi samt kortikosteroider.
Many of these patients were also receiving chemotherapy and corticosteroids.
3 Under behandling, bør patienterne undgå invasive tandbehandlinger.
3 A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e. g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
For de patienter, der udvikler knoglenekrose i kæben, under behandling med bisphosphonater, kan en tandoperation forværre tilstanden.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
En individuel klinisk vurdering, baseret på fordele og ulemper, bør udføres af den behandlende læge, og tilpasses behandlingsplanen for hver enkelt patient.
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/ risk assessment.
Galactoseintolerans Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/ galactosemalabsorption.
Galactose intolerance Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicinal product.
Dette er i overensstemmelse med resultater fra dyreforsøg.
In particular, products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk, are likely to interfere with absorption of Bondenza, which is consistent with findings in animal studies.
4. 2).
Therefore, patients should fast overnight (at least 6 hours) before taking Bondenza and continue fasting for 1 hour following intake of Bondenza (see section 4.2).
Calciumtilskud, antacida samt visse orale lægemidler indeholdende multivalente kationer (som f. eks. aluminium, magnesium, jern), vil sandsynligvis påvirke absorptionen af Bondenza.
Calcium supplements, antacids and some oral medicinal products containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Bondenza.
Metaboliske interaktioner anses ikke for sandsynlige, da ibandronsyre ikke hæmmer de primære humane lever P450 isoenzymer og har vist sig ikke at inducere levercytokrom P450 systemet hos rotter.
Metabolic interactions are not considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats.
85% - 87% (bestemt in vitro ved terapeutiske koncentrationer), og der er derfor en ringe mulighed for interaktioner med andre lægemidler på grund af displacering.
Furthermore, plasma protein binding is approximately 85% - 87% (determined in vitro at therapeutic concentrations), and thus there is a low potential for interaction with other medicinal products due to displacement.
Udskillelsen ser ikke ud til at omfatte kendte syre – eller basetransport- systemer, som anvendes i forbindelse med udskillelsen af andre aktive substanser.
The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other active substances.
I et to- års studie hos postmenopausale kvinder med osteoporose (BM 16549) var incidensen af øvre gastrointestinale hændelser hos patienter, som samtidig tog acetylsalicylsyre eller NSAIDs, den samme hos patienter, som tog ibandronsyre 2, 5 mg daglig eller 150 mg én gang om måneden efter et og to år.
In a two-year study in postmenopausal women with osteoporosis (BM 16549), the incidence of upper gastrointestinal events in patients concomitantly taking aspirin or NSAIDs was similar in patients taking ibandronic acid 2.5 mg daily or 150 mg once monthly after one and two years.
Hos over 1500 patienter, som indgik i studie BM 16549, der sammenlignede månedlig behandling med ibandronsyre med daglig behandling, anvendte 14% og 18% H2- receptorantagonister eller syrepumpehæmmere efter henholdsvis et og to år.
Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% and 18% of patients used histamine (H2) blockers or proton pump inhibitors after one and two years, respectively.
Incidensen af øvre gastrointestinale hændelser var den samme hos patienter, som blev behandlet med 150 mg Bondenza én gang om måneden, som hos patienter, som blev behandlet med 2, 5 mg ibandronsyre daglig.
Among these patients, the incidence of upper gastrointestinal events in the patients treated with Bondenza 150 mg once monthly was similar to that in patients treated with ibandronic acid 2.5 mg daily.
20% øgning i biotilgængeligheden af ibandronsyre, formentlig som et resultat af den reducerede gastriske surhedsgrad.
In healthy male volunteers and postmenopausal women, intravenous administration of ranitidine caused an increase in ibandronic acid bioavailability of about 20%, probably as a result of reduced gastric acidity.
Da øgningen ligger inden for den normale variabilitet for biotilgængeligheden af ibandronsyre, anses dosisjustering ikke for nødvendig, når Bondenza administreres sammen med H2- antagonister eller andre aktive substanser, som øger gastrisk pH.
However, since this increase is within the normal variability of the bioavailability of ibandronic acid, no dose adjustment is considered necessary when Bondenza is administered with H2- antagonists or other active substances which increase gastric pH.
Farmakokinetiske interaktionsundersøgelser hos postmenopausale kvinder har vist, at der ikke er interaktion med tamoxifen eller hormon substitutions- behandling (østrogen).
Pharmacokinetic interaction studies in postmenopausal women have demonstrated the absence of any interaction potential with tamoxifen or hormone replacement therapy (oestrogen).
Der fandtes ingen interaktion ved samtidig behandling med melphalan/ prednisolon hos patienter med myelomatose.
No interaction was observed when co-administered with melphalan/ prednisolone in patients with multiple myeloma.
Graviditet Der er ikke tilstrækkelig erfaring med anvendelse af ibandronsyre til gravide.
Pregnancy There are no adequate data from the use of ibandronic acid in pregnant women.
Forsøg med rotter har vist en vis reproduktionstoksisitet (se pkt 5. 3).
Studies in rats have shown some reproductive toxicity (see section 5.3).
Amning Det vides ikke om ibandronsyre udskilles i modermælk.
Lactation It is not known whether ibandronic acid is excreted in human milk.
Forsøg med diegivende rotter har vist til - stedeværelse af små mængder ibandronsyre i mælken efter intravenøs administration.
Studies in lactating rats have demonstrated the presence of low levels of ibandronic acid in the milk following intravenous administration.
Bondenza bør ikke anvendes under amning.
Bondenza should not be used during lactation.
Sikkerheden af ibandronsyre 2, 5 mg daglig er undersøgt hos 1251 patienter, som indgik i 4 placebo - kontrollerede kliniske undersøgelser; 73% af disse patienter var fra det pivotale tre- års studie (MF 4411).
The safety of ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo- controlled clinical studies; 73% of these patients came from the pivotal three-year treatment study (MF 4411).
Den generelle sikkerhedsprofil for ibandronsyre 2, 5 mg daglig var sammenlignelig med placebo i alle studier.
The overall safety profile of ibandronic acid 2.5 mg daily in all these studies was similar to that of placebo.
Det totale antal patienter som havde en bivirkning med sandsynlig eller mulig relation til forsøgsmedicinen, var i det pivotale behandlingsforsøg (MF 4411) 19, 8% for ibandronsyre og 17, 9% for placebo.
The overall proportion of patients who experienced an adverse reaction, i. e. adverse event with a possible or probable relationship to trial medication, in the pivotal treatment study (MF 4411) was 19.8% for ibandronic acid and 17.9% for placebo.
I et to- års studie hos postmenopausale kvinder med osteoporose (BM 16549) var sikkerheden af Bondenza 150 mg én gang om måneden den samme som for ibandronsyre 2, 5 mg daglig.
In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of Bondenza 150 mg once monthly and ibandronic acid 2.5 mg daily was similar.
Andelen af patienter med bivirkninger var 22, 7% og 25, 0% for Bondenza 150 mg én gang om måneden og 21, 5% og 22, 5% for ibandronsyre 2, 5 mg daglig efter henholdsvis et og to år.
The overall proportion of patients who experienced an adverse reaction, was 22.7% and 25.0% for Bondenza 150 mg once monthly and 21.5% and 22.5% for ibandronic acid 2.5 mg daily after one and two years, respectively.
Intensiteten af de fleste bivirkninger var let til moderat.
The majority of adverse reactions were mild to moderate in intensity.
Af tabel 1 og 2 fremgår de bivirkninger i studiet BM 16549, som forekom hos mere end 1% af de patienter, som fik Bondenza, enten 150 mg én gang om måneden eller 2, 5 mg daglig, og hos patienter, som fik ibandronsyre 2, 5 mg daglig i MF 4411.
Table 1 and table 2 list adverse reactions occurring in more than 1% of patients treated with Bondenza 150 mg monthly or 2.5 mg daily in study BM 16549 and in patients treated with ibandronic acid 2.5 mg daily in study MF 4411.
Tabellerne viser de bivirkninger, som forekom hyppigere i de to studier end hos patienter, som fik placebo i studie MF 4411.
The tables show the adverse reactions in the two studies that occurred with a higher incidence than in patients treated with placebo in study MF 4411.
Data efter et år fra BM 16549 er vist i tabel 1 og kumulative data efter 2 år fra BM 16549 er vist i table 2.
Data at one year from BM 16549 are represented in Table 1 and cumulative data for the two years from BM 16549 are represented in table 2.
Almindelige bivirkninger (> 1/ 100, ≤ 1/ 10) i fase III osteoporose- studier som af investigator blev betragtet som muligt eller sandsynligt relateret til behandlingen - Data fra et- års studie BM 16549 og tre- års data fra placebokontrolleret frakturstudie MF 4411
Common adverse reactions (> 1/ 100, ≤ 1/ 10) in phase III osteoporosis studies that were considered by the investigator to be possibly or probably related to treatment - One year data from study BM 16549 and three year data from placebo-controlled fracture study MF 4411
Et- års data fra studie BM 16549
One year data in study BM 16549
Tre- års data fra studie MF 4411
Three year data in study MF 4411
Organklasse / bivirkninger Mave- tarmkanalen
System Organ Class/ Adverse reaction Gastrointestinal system
Bondenza ibandronsyre 150 mg én gang 2, 5 mg daglig om måneden (N=395) (N=396) (%) (%)
Bondenza 150 mg ibandronic acid once monthly 2.5 mg daily (N=396) (N=395) (%) (%)
ibandronsyre Placebo 2, 5 mg daglig (N=975) (N=977) (%) (%)
ibandronic acid Placebo 2.5 mg daily (N=975) (N=977) (%) (%)
Gastroesophageal refluxsygdom
Gastro-oesophageal reflux disease
0, 4 0, 1
0.4 0.1
Diarré Mavesmerter
Diarrhoea
2, 5 1, 8 3, 5 2, 8 5
2.5 1.8
1, 4 1, 0 2, 1 2, 9
1.4 1.0
Organklasse / bivirkninger
System Organ Class/ Adverse reaction
Dyspepsi Kvalme Flatulens Nervesystemet
Abdominal pain Dyspepsia Nausea Flatulence Nervous system
3, 3 5, 8 3, 3 3, 5 0, 5 1, 0
3.5 2.8 3.3 5.8 3.3 3.5 0.5 1.0
4, 3 2, 9 1, 8 2, 3 0, 4 0, 7
2.1 2.9 4.3 2.9 1.8 2.3 0.4 0.7
Almene symptomer og reaktioner på indgivelsesstedet
Headache General disorders
Træthed Knogler, led, muskler og bindevæv
Influenza like illness* Fatigue Musculoskeletal system
Artralgier Myalgier Hud og subkutane væv
Arthralgia Myalgia Skin disorders
Udslæt MedDRA version 6, 1
Rash MedDRA version 6.1
* Der er rapporteret om forbigående influenzalignende symptomer efter indtagelse af Bondenza 150 mg én gang om måneden, typisk i forbindelse med første dosis.
* Transient, influenza-like symptoms have been reported with Bondenza 150 mg once monthly, typically in association with the first dose.
Symptomerne var almindeligvis af kort varighed og af let eller moderat intensitet og forsvandt under fortsat behandling uden særlige forholdsregler.
Such symptoms were generally of short duration, mild or moderate in intensity, and resolved during continuing treatment without requiring remedial measures.
Influenzalignende sygdom inkluderer hændelser rapporteret som akut fase reaktion eller symptomer herunder myalgier, artralgier, feber, kulderystelser, træthed, kvalme, appetitløshed eller knoglesmerter.
Influenza-like illness includes events reported as acute phase reaction or symptoms including myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, or bone pain.
Kumulative almindelige bivirkninger (> 1/ 100, ≤ 1/ 10) i fase III osteoporose- studier som af investigator blev betragtet som muligt eller sandsynligt relateret til behandlingen - Data fra to- års studiet BM 16549 og tre- års data fra placebokontrolleret frakturstudie MF 4411
Cumulative common adverse reactions (> 1/ 100, ≤ 1/ 10) in Phase III osteoporosis studies that were considered by the investigator to be possibly or probably related to treatment - Two year data from study BM 16549 and three year data from placebo-controlled fracture study MF 4411
To- års kumulative BM 16549
Two year cumulative data in study BM 16549
bivirkninger Mave- tarmkanalen
System Organ Class/ Adverse reaction Gastrointestinal system
150 mg én gang om måneden (N=396) (%)
Bondenza 150 mg ibandronic acid once monthly 2.5 mg daily (N=396) (N=395) (%) (%)
2, 5 mg daglig (N=977) (%)
ibandronic acid Placebo 2.5 mg daily (N=975) (N=977) (%) (%)
Gastritis Gastroesophageal refluxsygdom
Gastritis Gastro-oesophageal reflux disease
1, 0 0, 8
1.0 0.3 0.8 1.0
0, 3 1, 0
0.7 0.5 0.5 0.1
0, 7 0, 5
Oesophagitis Diarrhoea Abdominal pain Dyspepsia Nausea Nervous system
0, 5 0, 1
0 1.0 2.5 2.0 4.0 3.0 4.0 6.3 3.0 3.5
Esophagitis Diarré Mavesmerter Dyspepsi Kvalme Nervesystemet
0.5 0.4 1.4 1.0 2.1 2.9 4.0 2.7 1.8 2.3
0 2, 5 4, 0 4, 0 3, 0
Headache General disorders
1, 0 2, 0 3, 0 6, 3 3, 5
0.8 1.5
0, 5 1, 4 2, 1 4, 0 1, 8
0.8 0.6
0, 4 1, 0 2, 9 2, 7 2, 3
Influenza like illness* Musculoskeletal system
Hovedpine
3.3 0.3
0, 8
0.3 0.2
1, 5
Muscle cramp Musculoskeletal pain Arthralgia
0, 8
0.5 1.0 1.0 0.5 1.0 0.5
0, 6
0.1 0.4 0 0 0.4 0.4
ibandronsyre Placebo
System Organ Class/ Adverse reaction
Influenzalignende sygdom * Knogler, led, muskler og bindevæv
Myalgia Musculoskeletal stiffness Skin disorders
1, 0 1, 5 1, 0
1.5 0.3 1.0 0
Udslæt MedDRA version 7, 0
Rash MedDRA version 7.1
1, 2
0.8 1.0
Bivirkninger, som optræder med en frekvens på mindre eller lig med 1%
Adverse reactions occurring at a frequency of less than or equal to 1%
Følgende liste viser de bivirkninger, rapporteret fra studie MF 4411, som optrådte hyppigere med ibandronsyre 2, 5 mg daglig end med placebo og fra studie BM 16549, som optrådte hyppigere med Bondenza 150 mg én gang om måneden end med ibandronsyre 2, 5 mg daglig.
The following list provides information on adverse reactions reported in study MF 4411 occurring more frequently with ibandronic acid 2.5 mg daily than with placebo and study BM 16549 occurring more frequently with Bondenza 150 mg once monthly than with ibandronic acid 2.5 mg daily.
Inden for hver gruppe af bivirkninger med samme frekvens er bivirkningerne opstillet efter, hvor alvorlige bivirkningerne er.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:
Ikke almindelige (1/ 100 – 1/ 1000) Mave- tarmkanalen:
Uncommon (1/ 100 – 1/ 1,000) Gastro-intestinal Disorders:
gastritis, esophagitis herunder esophageale ulcerationer eller strikturer, opkastning, dysphagi
gastritis, oesophagitis including oesophageal ulcerations or strictures, vomiting, dysphagia
Nervesystemet:
Nervous System Disorders:
Knogler, led, muskler og bindevæv:
Musculoskeletal and Connective Tissue Disorders:
svimmelhed rygsmerter
dizziness back pain
Sjældne (1/ 1000 – 1/ 10. 000)
Rare (1/ 1,000 – 1/ 10,000)
Mave- tarmkanalen:
Gastro-intestinal Disorders:
Immunsystemet:
Immune System Disorders:
Hud og subkutane væv:
Skin and Subcutaneous Tissue Disorders:
duodenitis overfølsomhedsreaktioner angioødem, ansigtsødem, urticaria
duodenitis hypersensitivity reactions angioedema, face oedema, urticaria
For disse patienter var der ingen forskel i incidensen af øvre gastrointestinale bivirkninger, uanset om de fik 150 mg én gang om måneden eller 2, 5 mg daglig.
For these patients, there was no difference in the incidence of upper gastrointestinal adverse events with the 150 mg once monthly regimen compared to the 2.5 mg daily regimen.
7 Laboratoriefund I det pivotale tre- års studie med ibandronsyre 2, 5 mg daglig (MF 4411) var der ingen forskel i forhold til placebo for abnorme laboratoriefund med hensyn til lever – eller nyredysfunktion, svækket hæmatologisk system, hypocalcæmi eller hypophosphatæmi.
Laboratory test findings In the pivotal three-year study with ibandronic acid 2.5 mg daily (MF 4411) there was no difference compared with placebo for laboratory abnormalities indicative of hepatic or renal dysfunction, an impaired haematologic system, hypocalcaemia or hypophosphataemia.
Der var tilsvarende ingen forskelle mellem grupperne i studiet BM 16549 efter et og to år.
Similarly, no differences were noted between the groups in study BM 16549 after one and two years.
Erfaringer efter markedsføringen Knoglenekrose i kæben er rapporteret blandt patienter, der behandles med bisphosphonater.
Post-marketing Experience Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
Hovedparten af rapporterne omhandler cancerpatienter, men lignende tilfælde er også set blandt patienter, der behandes for osteoporose.
The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis.
Knoglenekrose i kæben er normalt ledsaget af tandudtrækning og / eller lokal infektion (herunder osteomyelitis).
Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
Cancerdiagnose, kemoterapi, strålebehandling, kortikosteroider og dårlig mundhygiejne er også anset som risikofaktorer (se pkt 4. 4).
Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4).
4. 9 Overdosering
7 4.9 Overdose
Der er ingen tilgængelig specifik information vedrørende behandling af overdosering med Bondenza.
No specific information is available on the treatment of over dosage with Bondenza.
Baseret på erfaringer fra lignende præparater inden for samme klasse vides det dog, at overdosering kan forårsage øvre gastrointestinale bivirkninger (som f. eks. mavebesvær, dyspepsi, esophagitis, gastritis eller mavesår) eller hypocalcæmi.
However, based on a knowledge of this class of compounds, oral over-dosage may result in upper gastrointestinal adverse reactions (such as upset stomach, dyspepsia, oesophagitis, gastritis, or ulcer) or hypocalcaemia.