natgillin/translations-raw huggingface dataset:
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Zoledronsyre Accord 4 mg/5 ml sterilt koncentrat zoledronsyre 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zoledronic Acid Accord 4 mg/5 ml sterile concentrate zoledronic acid
Forværring af nyrefunktion blev i kliniske studier defineret som følger: Øgning på 0,5 mg/dl eller 44 μmol/l hos patienter med normal serum-kreatinin ved baseline (<1,4 mg/dl eller <124 μmol/l). 
In the clinical trials, renal deterioration was defined as follows: For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 µmol/l), an increase of 0.5 mg/dl or 44 µmol/l; For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 µmol/l), an increase of 1.0 mg/dl or 88 µmol/l.
- Langsom hjerterytme. 
• Slow heart beat.
Indehaveren af markedsføringstilladelsen skal sikre, at der implementeres patienthuskekort vedrørende osteonekrose af kæberne. 
The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
- Mave-tarm-symptomer såsom kvalme og opkastning samt appetitløshed. 
• Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
Analyser af gentagne hændelser viste risikoreduktion på 30,7 % i udviklingen af skeletrelaterede hændelser i zoledronsyre 4 mggruppen sammenlignet med placebo. 
Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Det skal du vide, før du begynder at bruge Zoledronsyre Accord 3. 
What you need to know before you are given Zoledronic Acid Accord 3.
Patienter i behandling med Zoledronsyre Accord bør få udleveret indlægssedlen og patienthuskekortet. 
Patients treated with Zoledronic Acid Accord should be given the package leaflet and the patient reminder card. Posology
Zoledronsyre Accord indeholder natrium 
Zoledronic Acid Accord contains sodium
Zoledronsyre Accord indeholder 
What Zoledronic Acid Accord contains
6.6 Regler for bortskaffelse og anden håndtering Før administration skal 5 ml koncentrat fra et hætteglas eller den påkrævede mængde udtagne koncentrat fortyndes yderligere med 100 ml calciumfri infusionsvæske (0,9 % w/v natriumkloridopløsning til injektionsvæske eller 5 % w/v glucoseopløsning). 
Prior to administration, 5ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution).
In vivo: Hæmning af osteoklastisk knogleresorption, hvilket ændrer knoglemarvens mikromiljø og mindsker bidraget til tumorcellevæksten, den anti-angiogenetiske aktivitet og anti-smerte aktiviteten. 
The following properties have been demonstrated in preclinical studies: In-vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
Osteonekrose af kæberne er blevet rapporteret med frekvensen ”ikke almindelig” i kliniske forsøg og efter markedsføring hos patienter behandlet med Zoledronsyre Accord. 
Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the postmarketing setting in patients receiving Zoledronic Acid Accord
Zoledronsyre Accord-koncentrat må ikke blandes med calcium eller anden divalent kationholdig infusionsopløsning såsom Ringer-lactatopløsning, og bør indgives som en enkelt intravenøs opløsning i en separat infusionsslange. 
Zoledronic Acid Accord concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Meget almindelig ( 1/10) 
Very common (1/10)
Meget almindelig (1/10) 
Very common ( 1/10)
Den udtagne mængde af koncentrat skal fortyndes yderligere i 100 ml sterilt 0,9 % w/v natriumchlorid- eller 5 % w/v glucoseinjektions-/infusionsvæske. 
The withdrawn amount of concentrate must be further diluted in 100 ml of sterile 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
- Influenza-lignende symptomer herunder gigt (artitis) og hævede led. 
• Flu-like symptoms including arthritis and joint swelling.
Analyser af gentagne hændelser viste risikoreduktion på 36 % i udviklingen af skeletrelaterede hændelser i zoledronsyre 4 mg-gruppen sammenlignet med placebo. 
Multiple event analysis showed a 36% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Zoledronsyre Accord-koncentrat må ikke blandes med calciumholdige opløsninger eller andre opløsninger indeholdende divalente kationer som lakteret Ringers væske. 
Do not mix Zoledronic Acid Accord concentrate with calcium-containing or other divalent cation-containing solutions such as lactated Ringer's solution.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et hætteglas med 5 ml koncentrat indeholder 4 mg zoledronsyre (som monohydrat). 
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate) One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
Bivirkninger i form af frakturer på lange knogler i de nedre ekstremiteter var rapporteret hos ca. 24 % (femur) og 14 % (tibia) af zoledronsyrebehandlede patienter vs. 12 % og 5 % af pamidronatbehandlede patienter med svær osteogenesis imperfecta uanset sygdomstype og kausalitet. 
Fracture adverse events of long bones in the lower extremities were reported in approximately 24% (femur) and 14% (tibia) of zoledronic acid-treated patients vs 12% and 5% of pamidronate-treated patients with severe osteogenesis imperfecta, regardless of disease type and causality but overall incidence of fractures was comparable for the zoledronic acid and pamidronate-treated patients: 43% (32/74) vs 41% (31/76).
Det skal du vide, før du begynder at bruge Zoledronsyre Accord 
What you need to know before you are given Zoledronic Acid Accord
Almindelig ( 1/100 til < 1/10) 
Common ( 1/100 to < 1/10)
Sjælden ( 1/10.000 til < 1/1.000) 
Rare ( 1/10.000 to < 1/1.000)
Tabel 2: Effektresultater (patienter med prostatacancer i hormonbehandling) 
Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
- Hudreaktioner (rødme og hævelse) på infusionsstedet, udslæt, kløe. 
• Skin reactions (redness and swelling) at the infusion site, rash, itching.
Mens du er i behandling med Zoledronsyre Accord, skal du holde en god mundhygiejne (inkl. 
While being treated with Zoledronic Acid Accord, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Zoledronsyre Accord 4 mg/5 ml koncentrat til infusionsvæske, opløsning zoledronsyre 
Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion zoledronic acid
For at forhindre eventuelle uforligeligheder skal Zoledronsyre Accord-koncentrat fortyndes med 0,9 % w/v natriumklorid- eller 5 % w/v glucoseinjektions-/infusionsvæske. 
To avoid potential incompatibilities, Zoledronic Acid Accord concentrate is to be diluted with 0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution.
I kliniske forsøg blev patienter med serum-kreatinin > 400 μmol/l eller > 4,5 mg/dl ekskluderet. 
In the clinical studies, patients with serum creatinine > 400 µmol/l or > 4.5 mg/dl were excluded.
Vejrtrækningsbesvær med hiven efter vejret eller hosten. 
• Difficulty in breathing with wheezing or coughing.
Sjælden (forekommer hos op til 1 ud af 1.000 patienter): - Som følge af lave calcium-værdier: uregelmæssig hjerterytme (hjertearytmi; sekundære symptomer på hypokalcæmi). 
• As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Nældefeber. 
• Urticaria.
Ikke almindelig (forekommer hos op til 1 ud af 100 patienter): - Smerter i munden, tænder og/eller kæberne, hævelse eller ikke helende sår inde i munden eller kæben, udflåd af gullig betændelse, følelsesløshed eller følelsen af tyngde i kæberne eller løsnen af en tand. 
• Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Sådan skal du bruge Zoledronsyre Accord 4. 
How Zoledronic Acid Accord is used 4.
4.5), stråleterapi i nakke og hoved, kortikosteroider. 
Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
Du må ikke få Zoledronsyre Accord, hvis du ammer. 
You must not be given Zoledronic Acid Accord if you are breast-feeding.
Almindelig (forekommer hos op til 1 ud af 10 patienter): - Svært nedsat nyrefunktion (vil normalt blive afgjort af din læge ved hjælp af en speciel type blodprøver). 
• Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Instruktion for tilberedning af reducerede doser af Zoledronsyre Accord: Udtag det passende volumen af det flydende koncentrat som følger: 4,4 ml til 3,5 mg dosis 
Instructions for preparing reduced doses of Zoledronic Acid Accord: Withdraw the appropriate volume of the liquid concentrate, as follows: o 4.4 ml for 3.5 mg dose o 4.1 ml for 3.3 mg dose o 3.8 ml for 3.0 mg dose
Tilberedelse og indgift af Zoledronsyre Accord 
How to prepare and administer Zoledronic Acid Accord
Hvordan får du Zoledronsyre Accord - Zoledronsyre Accord gives som drop (infusion) i en vene. 
What Zoledronic Acid Accord looks like and contents of the pack Zoledronic Acid Accord is supplied as a liquid concentrate in a vial.
LÆGEMIDLETS NAVN Zoledronsyre Accord 4 mg/5 ml koncentrat til infusionsvæske, opløsning 
NAME OF THE MEDICINAL PRODUCT Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion
Ikke almindelig ( 1/1.000 til < 1/100) 
Uncommon ( 1/1.000 to < 1/100)
For at undgå eventuelle uforligeligheder skal der enten bruges 0,9 % w/v natriumchlorid- eller 5 % w/v glucoseinfusionsvæske til fortynding. 
To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/v sodium chloride or 5% w/v glucose solution.
Hvor meget Zoledronsyre Accord skal du have - Den normale enkeltdosis er 4 mg zoledronsyre. 
• The usual single dose given is 4 mg zoledronic acid.
Hvordan skal Zoledronsyre Accord opbevares 
How Zoledronic Acid Accord is given
Overfølsomhed over for det aktive stof, andre bisfosfonater eller over for et eller flere af hjælpestofferne anført i pkt. 
- Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1 - Breast-feeding (see section 4.6)
Derudover har der været sporadiske rapporter om osteonekrose af andre steder, inklusive hoften og femur. 
Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with Zoledronic Acid .
strålebehandling eller operation af knogler, eller tumorinduceret hyperkalcæmi) hos voksne patienter med fremskreden malign sygdom og knoglemetastaser. 
CLINICAL PARTICULARS 4.1 Therapeutic indications Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Kontakt lægen, apoteketspersonalet eller sundhedspersonalet, før du bruger Zoledronsyre Accord: hvis du har eller har haft en nyrelidelse. 
Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given Zoledronic Acid Accord
Muskel- og knoglesmerter 
Musculoskeletal and connective tissue disorders
Meget sjælden (forekommer hos op til 1 ud af 10.000 patienter): - Som følge af lave calcium-værdier: kramper, følelsesløshed og tetani (sekundære symptomer på hypokalcæmi). 
• As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Nedsat nyrefunktion, osteonekrose af kæberne, akut fasereaktion, hypokalcæmi, atrieflimren, anafylaksi, interstitiel lungesygdom. 
The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Zoledronsyre Accord 4 mg koncentrat til infusionsvæske, opløsning, fortyndet yderligere i 100 ml (se pkt. 
Zoledronic Acid Accord 4 mg concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Hvor ofte skal du have Zoledronsyre Accord - Hvis du er i forebyggende behandling for knoglekomplikationer pga. knoglemetastaser, vil du få en infusion af Zoledronsyre Accord hver tredje til fjerde uge. 
you will be given one infusion of Zoledronic Acid Accord every three to four weeks.
- Zoledronsyre Accord opbevares utilgængeligt for børn. 
• Keep Zoledronic Acid Accord out of the reach and sight of children.
Du må ikke få Zoledronsyre Accord: hvis du ammer. 
Do not receive Zoledronic Acid Accord:
Amning 
somnolence
Amning (se pkt. 
• Chest pain.
- Vægtøgning - Øget svedtendens Søvnighed. 
• Increased sweating.
Mannitol (E421) 
Mannitol (E421) Sodium citrate Water for injections
Sådan skal du bruge Zoledronsyre Accord 
How Zoledronic Acid Accord is used
Størstedelen af den antihypertensive effekt opnås som regel senest 4 uger efter behandlingsstart." 
Most of the antihypertensive effect is usually attained within 4 weeks of initiation of treatment.”
• Andre kontraindikationer 
• Other contraindications
De symptomatiske manifestationer af overdosis og anbefalinger om håndtering, hvis det forekommer, blev medtaget i dette punkt. 
The symptomatic manifestations of overdose and recommendations on management if it occurs were included in this section.
Samlet resumé af den videnskabelige vurdering af Atacand Plus og tilknyttede navne (se bilag I) 
Overall summary of the scientific evaluation of Atacand Plus and associated names (see Annex I)
Oplysningerne om administration af candesartan/HCT med eller uden mad, der tidligere var placeret i punkt 4.5, er blevet flyttet til punkt 4.2. 
The information on administration of candesartan/HCT with or without food be located previously in section 4.5 was moved to section 4.2.
CHMP vurderede følgende styrker for Atacand Plus tabletter til oral anvendelse: 8/12,5 mg, 16/12,5 mg, 32/12,5 mg og 32/25 mg. 
The CHMP considered the following strengths for Atacand Plus tablets indicated for oral use: 8/12.5 mg, 16/12.5 mg, 32/12.5 mg, and 32/25 mg.
De korte generelle sikkerhedsoplysninger fra kliniske undersøgelser af doser op til 16/12,5 mg, herunder tilbageholdelsestal, var ens i de fleste lande. 
The brief general safety information from clinical studies on doses up to 16/12.5 mg, including withdrawal figures was the same in most countries.
CHMP har tilføjet en sætning for at understrege den foretrukne praksis med at titrere med separate komponenter. 
An additional sentence was introduced by CHMP to stress the preferable practice to titrate with separate components.
Oplysninger om virkningen på evnen til at føre motorkøretøj eller betjene maskiner blev inkluderet i alle lande med en lidt anderledes ordlyd i et enkelt produktresumé. 
Information on effects on ability to drive and use machines was included in all countries with slightly different wording in one SPCs.
Hydrochlortiazid er et diuretikum, som reducerer blodvolumen, hvilket er med til at kontrollere blodtrykket. 
Hydroclorthiazide is a diuretic, reduces the volume of the blood, helping control the blood pressure.
Sætningen om de klinisk signifikante interaktioner blev korrigeret i henhold til den tidligere indbringelse med henblik på harmonisering vedrørende Atacand. 
The sentence on the clinical significant interactions was corrected in line with the previous Atacand harmonisation referral.
Andre punkter i produktresuméet blev harmoniseret i overensstemmelse hermed. 
Other sections of the SPC were harmonised accordingly.
CHMP godkendte den foreslåede, harmoniserede formulering: "Den anbefalede dosis for Atacand Plus er én tablet én gang om dagen. 
The CHMP endorsed the proposed harmonised wording: “The recommended dose of Atacand Plus is one tablet once daily.
Punkt 5.1 Farmakodynamiske egenskaber 
Section 5.1 Pharmacodynamic Properties
Tallene for udtræden af behandling på grund af bivirkninger lignede tallene for candesartan cilexetil/hydrochlorthiazid (2,3-3,3 %) og placebo (2,7-4,3 %)". 
Withdrawals from treatment due to adverse events were similar with candesartan cilexetil/hydrochlorothiazide (2.3 - 3.3%) and placebo (2.7 - 4.3%)”.
Punktet blev forkortet og harmoniseret under hensyntagen til den eksisterende faglige viden og i overensstemmelse med drøftelserne af andre punkter i produktresuméet. 
This section was shortened and harmonised taking into account the current scientific knowledge and in line with the discussions for other sections of the SPC.
I overensstemmelse med vejledningen vedrørende produktresuméer (2009) inkluderede to medlemsstater "Behandling af" efterfulgt af indikationen. 
In line with the SPC Guideline (2009), two MSs included “Treatment of” followed by the indication.
Dette punkt blev opdateret i overensstemmelse med vejledningen vedrørende produktresuméer (2009), herunder alle bivirkninger angivet i de fleste lande, som den harmoniserede tekst. 
This section was updated in accordance with the SPC Guideline (2009), including all ADRs listed in most countries, as the harmonised text.
Indlægsseddel og etikettering 
Package leaflet and labelling
Candesartan cilexetil er en angiotensinreceptorblokker (ARB). 
Candesartan cilexetil is an angiotensin receptor blocker (ARB).
Denne ordlyd blev taget i betragtning i det forslåede, harmoniserede produktresumé. 
This wording was considered in the proposed harmonised SPC.
Alle landes produktresuméer for candesartan/HCT 16/12,5 mg eller højere styrker omfattede en anbefaling af dosistitrering for candesartan, inden man går over til fastdosiskombinationen. 
All countries' SPCs for candesartan/HCT 16/12.5 mg or higher strengths included a recommendation on dose titration of candesartan before switching to the fixed dose combination.
VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR 
Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet presented by the European Medicines Agency
CHMP/PhVWP's rapport om brug af ACE-hæmmere og angiotensin II-receptorantagonister (AIIRA'er) i graviditetens første trimester (EMEA/CHMP/PhVWP/474692/2007) tyder imidlertid på, at en kontraindikation i graviditetens første trimester ikke er begrundet. 
However, the CHMP/PhVWP report on the use of ACE inhibitors and angiotensin II receptor antagonists (ARBs) during the 1st trimester of pregnancy (EMEA/CHMP/PhVWP/474692/2007) indicates that a contraindication during the first trimester of pregnancy is not justified; the use of AIIRAs in the first trimester of pregnancy is not recommended.
Disse underpunkter blev revideret i dette punkt af produktresuméerne i henhold til vejledningen vedrørende produktresuméer (2009). 
These subheadings in this section of the SPCs were revised in accordance with the SPC Guideline (2009).
Atacand Plus kan gives til patienter, hvis blodtryk ikke kan kontrolleres optimalt ved hjælp af candesartan cilexetil eller hydrochlorthiazid monoterapi eller Atacand Plus i lavere doser. 
Atacand Plus may be administered in patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy or Atacand Plus at lower doses.
Hydrochlorthiazid blev desuden udeladt, eftersom Atacand Plus indeholder hydrochlorthiazid. 
Furthermore, hydrochlorothiazide was omitted, as Atacand Plus contains hydrochlorothiazide.
• Fertilitet, graviditet og amning 
• Pregnancy and lactation
Der blev navnlig taget højde for opdateringer om klinisk effekt hos ældre hypertensive patienter, hvor resultater fra en undersøgelse af ældre patienter blev inddraget, HTC's farmakodynamiske virkning og den kliniske effekt af candesartan/HCT hos hypertensive patienter. 
In particular, updates on clinical efficacy in elderly hypertensive patients, where results from a trial in elderly patients were included, the pharmacodynamic effects of HCT, and the clinical efficacy of candesartan/HCT in hypertensive patients were considered.
Når det skønnes klinisk påkrævet, kan et direkte skift fra monoterapi til Atacand Plus overvejes. 
When clinically appropriate a direct change from monotherapy to Atacand Plus may be considered.
På grundlag af de fremlagte oplysninger har CHMP godkendt den harmoniserede tekst til AIIRA'erne som standardadvarsel uddybet af CHMP's arbejdsgruppe vedrørende lægemiddelovervågning for alle AIIRA'er: Brug af AIIRA'er anbefales ikke under graviditetens første trimester; brug af AIIRA'er er kontraindiceret under graviditetens andet og tredje trimester. 
Based on the information provided, the CHMP endorsed the harmonised text for the AIIRA as the standard warning elaborated by the CHMP's PhVWP for all AIIRA: the use of AIIRAs in the first trimester of pregnancy is not recommended; the use of AIIRAs in the second and third trimester is contraindicated.
På baggrund af ovenstående anser CHMP benefit/risk-forholdet for Atacand Plus for positivt og de harmoniserede produktinformationsdokumenter for at være passende. 
Based on the above, the CHMP considers the benefit risk ratio of Atacand Plus to be favourable and the harmonised PI to be appropriate.
CMPH vurderede, at benefit/risk-forholdet for candesartan cilexetil/hydrochlorthiazid for den nedenfor anførte indikation er positivt, og at den foreslåede ordlyd var understøttet og i overensstemmelse med den nuværende vejledning vedrørende produktresuméer: "Behandling af essentiel hypertension hos voksne patienter, hvis blodtryk ikke kan kontrolleres optimalt ved hjælp af candesartan cilexetil eller hydrochlorthiazid monoterapi". 
The CHMP considered that the benefit/risk balance of candesartan cilexetil/hydrochlorothiazide is positive for the below mentioned indication and the proposed wording was supported and in line with current SPC guideline: “Treatment of essential hypertension, in adult patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy”.
Punkt 4.6 Fertilitet, graviditet og amning 
Section 4.6 Pregnancy and Lactation
Navnlig for så vidt angår interaktioner med blandt andet kaliumbesparende diuretika eller andre lægemidler, som kan øge indholdet af kalium i blodet, andre lægemidler, som forårsager torsades de pointes, NSAID-præparater, kolestipol eller kolestyramin, ikke-depolariserende muskelafslappende lægemidler, kalciumtilskud eller D-vitamin, betablokkere og diazoxid, antikolinerge stoffer, amantadin, cytotoksiske lægemidler, alkoholindtagelse, barbiturater, anæstetika, antidiabetiske lægemidler, sammentrækkende aminer, jodholdige kontraststoffer og cyclosporin. 
In particular, regarding interactions with potassium sparing diuretics, or other medicinal products that may increase serum potassium levels, other medicinal products that induce torsades de pointes, NSAIDS, colestipol or cholestyramine, nondepolarising skeletal muscle relaxants, calcium supplements or vitamin D, betablockers and diazoxide, anticholinergic agents, amantadine, cytotoxic medicinal products, alcohol intake, barbiturates, anaesthetics, antidiabetic medicinal products, pressor amines, iodinated contrast media and cyclosporine, among others.
Punkterne om brug til ældre, patienter med intravaskulær volumendepletering, patienter med nyre- og leverinsufficiens og den pædiatriske population blev også harmoniseret. 
The sections on use in the elderly, patients with intravascular volume depletion, patients with renal impairment, patients with hepatic impairment and paediatric population were also harmonised.