natgillin/translations-raw huggingface dataset:
4.5) og hos særlige populationer, herunder genetiske subpopulationer (se pkt.
− Situations where an increase in plasma levels may occur, such as interactions (see section 4.5) and special populations including genetic subpopulations (see section 5.2)
• kvalme, forstoppelse, luft i tarmen, fordøjelsesproblemer, diarré
• nausea, constipation, wind, indigestion, diarrhoea
Ved atorvastatindoser over 20 mg anbefales klinisk monitorering.
At atorvastatin doses exceeding 20 mg, clinical monitoring of these patients is recommended.
& Data udtrykt som x-gange ændring angiver et simpelt forhold mellem samtidigt administreret lægemiddel og atorvastatin alene (dvs. 1-gang = ingen ændring).
& Data given as x-fold change represent a simple ratio between co-administration and atorvastatin alone (i.e., 1
• hvide blodceller i urinprøver
• urine tests that are positive for white blood cells
↑ 5,9 gange
↑ 5.9 fold
• Risikoen for hæmoragisk apopleksi var øget hos patienter, som før forsøgets start havde haft lakunært infarkt (20/708 for atorvastatin versus 4/701 for placebo; HR 4,99; 95% CI: 1,71-14,61), men risikoen for koronar apopleksi faldt også hos disse patienter (79/708 for atorvastatin versus 102/701 for placebo; HR 0,76; 95% CI: 0,57-1,02).
• The risk of hemorrhagic stroke was increased in patients who entered the study with prior lacunar infarct (20/708 for atorvastatin versus 4/701 for placebo; HR 4.99; 95% CI, 1.71-14.61), but the risk of ischemic stroke was also decreased in these patients (79/708 for atorvastatin versus 102/701 for placebo; HR 0.76; 95% CI, 0.57-1.02).
Homozygot familiær hyperkolesterolæmi
Homozygous familial hypercholesterolaemia
Zarator (se Bilag I) 10 mg filmovertrukne tabletter Zarator (se Bilag I) 20 mg filmovertrukne tabletter Zarator (se Bilag I) 40 mg filmovertrukne tabletter Zarator (se Bilag I) 80 mg filmovertrukne tabletter
LIPITOR and associated names (see Annex I) 10 mg film-coated tablets LIPITOR and associated names (see Annex I) 20 mg film-coated tablets LIPITOR and associated names (see Annex I) 40 mg film-coated tablets LIPITOR and associated names (see Annex I) 80 mg film-coated tablets
Clarithromycin 500 mg x 2, 9 dage
Clarithromycin 500 mg BID, 9 days
I atorvastatingruppen blev LDL-kolesterol reduceret til et gennemsnit på 2,04 mmol/l 0,8 (78,9 mg/dl 30) fra baseline 3,98 mmol/l 0,7 (150 mg/dl 28) og i pravastatingruppen til et gennemsnit på 2,85 mmol/l  0,7
In the atorvastatin group, LDL-C was reduced to a mean of 2.04 mmol/L ± 0.8 (78.9 mg/dl ± 30) from baseline 3.89 mmol/l ± 0.7 (150 mg/dl ± 28) and in the pravastatin group, LDL-C was reduced to a mean of 2.85 mmol/l ± 0.7 (110 mg/dl ± 26) from baseline 3.89 mmol/l ± 0.7 (150 mg/dl ± 26) (p<0.0001).
Risikoen for at få muskelrelaterede bivirkninger som rabdomyolyse øges, hvis De samtidigt bruger visse typer medicin (se pkt.
The risk of muscle related side effects e.g rhabdomyolysis is known to increase when certain medicines are taken at the same time (see Section 2 “Taking other medicines”).
Zarators sikkerhedsprofil, baseret på data fra kliniske studier og omfattende erfaring efter markedsføring, fremgår af nedennævnte tabel.
Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse reaction profile for {PRODUCT NAME}.
Moderate CYP3A4-hæmmere (f.eks. erythromycin, diltiazem, verapamil og fluconazol) kan øge plasmakoncentrationen af atorvastatin (se tabel 1).
Moderate CYP3A4 inhibitors (e.g. erythromycin, diltiazem, verapamil and fluconazole) may increase plasma concentrations of atorvastatin (see Table 1).. An increased risk of myopathy has been observed with the use of erythromycin in combination with statins.
Spørg Deres læge, før De tager Zarator, hvis De lider af alvorlige vejrtrækningsproblemer.
Check with your doctor or pharmacist before taking {PRODUCT NAME} − if you have severe respiratory failure.
Risikoen for disse bivirkninger kan øges ved samtidig brug af fibrater og atorvastatin.
The risk of these events may be increased with the concomitant use of fibric acid derivatives and atorvastatin.
Farmakoterapeutisk gruppe: Lipid-modificerende midler, HMG-CoA-reduktasehæmmere.
Pharmacotherapeutic group: Lipid modifying agents, HMG-CoA-reductase inhibitors, ATC code: C10AA05
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterpakning
MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTERS
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se Bilag I - Udfyldes nationalt]
Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally]
Påvirkning af skeletmuskulaturen
Skeletal muscle effects
Andre bivirkninger med Zarator:
Other possible side effects with {PRODUCT NAME}:
Ikke almindelig: Urticaria, hududslæt, kløe, alopeci.
Uncommon: urticaria, skin rash, pruritus, alopecia.
Zarator er kontraindiceret under graviditet (se pkt.
{PRODUCT NAME} is contraindicated during pregnancy (see section 4.3).
• betændelse i næsen, halssmerter, næseblod
• inflammation of the nasal passages, pain in the throat, nose bleed
Meget sjælden: Leversvigt
Very rare: anaphylaxis.
I et randomiseret, dobbelt-blindt, placebokontrolleret studie, Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA) blev effekten af atorvastatin på letal og ikke-letal koronar hjertesygdom undersøgt.
The effect of atorvastatin on fatal and non-fatal coronary heart disease was assessed in a randomized, double-blind, placebo-controlled study, the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA).
Zarator er også indiceret til at nedsætte total-kolesterol og LDL-kolesterol hos patienter med homozygot familiær hyperkolesterolæmi som supplement til anden lipidsænkende behandling, f.eks. LDL-aferese, eller hvis anden behandling ikke er tilgængelig.
{PRODUCT NAME} is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
Kreatinkinase (CK)-måling
Creatine kinase measurement
Brug ikke Zarator efter den udløbsdato (anv.
Do not use {PRODUCT NAME} after the expiry date which is stated on the container and outer packaging after {EXP}.
Ved atorvastatindoser over 40 mg anbefales klinisk monitorering.
At atorvastatin doses exceeding 40 mg, clinical monitoring of these patients is recommended.
Erythromycin 500 mg x 4, 7 dage
Erythromycin 500 mg QID, 7 days
Hvis De har haft nogle af ovenstående problemer, vil lægen tage en blodprøve før og muligvis under behandlingen med Zarator.
If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your {PRODUCT NAME} treatment to predict your risk of muscle related side effects.
Hyperkolesterolæmi
Hypercholesterolaemia
Rifampicin 600 mg x 1, 5 dage (adskilt indgift)
Rifampin 600 mg OD, 5 days (doses separated)
Monoterapi med ezetimibe er forbundet med muskelrelaterede bivirkninger, herunder rabdomyolyse.
The use of ezetimibe alone is associated with muscle related events, including rhabdomyolysis.
• kraftesløshed, utilpashed, svaghed, brystsmerter, hævede ankler (vand i kroppen), forhøjet temperatur
• fatigue, feeling unwell, weakness, chest pain, swelling especially in the ankles (oedema), raised temperature
↑ 2,5 gange
↑ 2.5 fold
LÆGEMIDDELFORM Filmovertrukne tabletter [Udfyldes nationalt]
PHARMACEUTICAL FORM Film-coated tablet.
Meget sjældne (det sker hos færre end 1 ud af 10.000 patienter):
Very rare: affect less than 1 user in 10,000:
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) <[Udfyldes nationalt]>
MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Zarator indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
Gemfibrozil 600 mg x 2, 7 dage
Gemfibrozil 600 mg BID, 7 days
Virkningen opretholdes under vedvarende behandling.
The response is maintained during chronic therapy.
Kvinder i den fertile alder
Use in the elderly
Derudover bør det overvejes at nedsætte initialdosis af atorvastatin, hvis der behandles samtidig med en potent CYP3A4-hæmmer, og passende klinisk monitorering af disse patienter anbefales (se pkt.
In addition, in the case of potent CYP3A4 inhibitors, a lower starting dose of atorvastatin should be considered and appropriate clinical monitoring of these patients is recommended (see section 4.5).
Startdosis er sædvanligvis 10 mg 1 gang dagligt.
The usual starting dose is 10 mg once a day.
↑ 2,3 gange
↑ 2.3 fold
Fosamprenavir 1.400 mg x 2, 14 dage
Fosamprenavir 1400 mg BID, 14 days
• ophobning af galde i leveren (kolestase; gulfarvning af huden og det hvide i øjnene)
• cholestasis (yellowing of the skin and whites of the eyes) • tendon injury
6.5 Emballagetype og pakningsstørrelser [Udfyldes nationalt]
6.5 Nature and contents of container [To be completed nationally]
Nelfinavir 1.250 mg x 2, 14 dage
Nelfinavir 1250 mg BID, 14 days
Amlodipin 10 mg enkeltdosis 80 mg enkeltdosis
Amlodipine 10 mg, single dose 80 mg, SD ↑ 18% No specific recommendation.
Digoxin 0,25 mg x 1, 20 dage ↑ 15% Patienter, der tager digoxin, skal monitoreres passende.
Diltiazem 240 mg OD, 28 days 40 mg, SD ↑ 51% After initiation or following dose adjustments of diltiazem, appropriate clinical monitoring of these patients is recommended.
Forebyggelse af kardiovaskulære hændelser hos patienter, som har en høj risiko for debut af en kardiovaskulær hændelse (se pkt.
Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.
Atorvastatincalcium
Atherosclerosis
↑ 4,4 gange
↑ 9.4 fold
Monoterapi med fibrater kan i sjældne tilfælde være forbundet med muskelrelaterede bivirkninger, herunder rabdomyolyse.
The use of fibrates alone is occasionally associated with muscle related events, including rhabdomyolysis.
Der anbefales en lavere maksimaldosis af atorvastatin hos patienter, der får medicin, der øger atorvastatins plasmakoncentration.
When patients are receiving medicinal products that increase the plasma concentration of atorvastatin, a lower maximum dose of atorvastatin is recommended.
Letal koronar hjertesygdom og ikke-letalt myokardieinfarkt
CHD = coronary heart disease; MI = myocardial infarction.
• ledsmerter, muskelsmerter og rygsmerter
• joint pain, muscle pain and back pain
Zarator har ubetydelig indflydelse på evnen til at føre bil eller betjene maskiner.
4.7 Effects on ability to drive and use machines {PRODUCT NAME} has negligible influence on the ability to drive and use machines.
Andre lægemidlers påvirkning af atorvastatin
Effect of co-administered medicinal products on atorvastatin
Sjælden: Myopati, myositis, rabdomyolyse, senelidelser heunder seneruptur.
Rare: myopathy, myositis, rhabdomyolysis, tendonopathy, sometimes complicated by rupture.
& Data angivet som procentvis ændring angiver procentvis forskel i forhold til atorvastatin alene (dvs.
& Data given as % change represent % difference relative to atorvastatin alone (i.e., 0% = no change)
Almindelig: Myalgi, artralgi, ekstremitetssmerter, muskelspasmer, hævede led, rygsmerter.
Musculoskeletal and connective tissue disorders Common: myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain.
Itraconazol 200 mg x 1, 4 dage 40 mg enkeltdosis
Itraconazole 200 mg OD, 4 days
↑ 35% Nedsat initialdosis samt klinisk monitorering anbefales.
40mg SD ↑ 35% Lower starting dose and clinical monitoring of these patients is recommended.
Sjældne (det sker hos mellem 1 og 10 ud af 10.000 patienter):
Rare: affects 1 to 10 users in 10,000:
↑ 8,7 gange
↑ 8.7 fold
Sikkerheden ved anvendelse af atorvastatin under graviditet er ikke fastslået.
Safety in pregnant women has not been established.
Almindelige (det sker hos mellem 1 og 10 ud af 100 patienter):
Common side effects (affects 1 to 10 users in 100) include:
80 mg x 1 i 15 dage
80 mg OD for 15 days
Almene symptomer og reaktioner på administrationsstedet Ikke almindelig: Utilpashed, asteni, brystsmerter, perifært ødem, træthed, feber.
General disorders and administration site conditions Uncommon: malaise, asthenia, chest pain, peripheral oedema, fatigue, pyrexia.
Fusidinsyre
Fusidic acid
Fremstiller: [Udfyldes nationalt]
Excipients: [To be completed nationally]
Zarator indeholder:
In this leaflet:
Rifampicin 600 mg x 1, 7 dage (samtidig indgift)
Rifampin 600 mg OD, 7 days (co-administered)
Fosamprenavir 700 mg x 2/ Ritonavir 100 mg x 2, 14 dage
Fosamprenavir 700 mg BID/ Ritonavir 100 mg BID, 14 days
↑ 3% Nedsat initialdosis samt klinisk monitorering anbefales.
40mg SD ↑ 3% Lower starting dose and clinical monitoring of these patients is recommended.
Den sædvanlige startdosis af Zarator er 10 mg 1 gang dagligt.
The usual starting dose of {PRODUCT NAME} is 10 mg once a day.
Totale kardiovaskulære hændelser og revaskulariserings-indgreb
Fatal CHD plus non-fatal MI Total cardiovascular events and revascularization procedures Total coronary events
Ikke almindelig: Hypoglykæmi, vægtstigning, vægttab.
Uncommon: hypoglycaemia, weight gain, anorexia
Brug af Zarator sammen med mad og drikke Se pkt.
Taking {PRODUCT NAME} with food and drink See Section 3 for instructions on how to take {PRODUCT NAME}.
10 mg x 1 i 28 dage
10 mg OD for 28 days
40 mg x 1 i 22 dage
40 mg OD for 22 days
80 mg x 1 i 8 dage
80 mg OD for 8 days
Lopinavir 400 mg x 2/ Ritonavir 100 mg x 2, 14 dage
Lopinavir 400 mg BID/ Ritonavir 100 mg BID, 14 days
• Risikoen for hæmoragisk apopleksi var øget hos patienter, som før forsøgets start havde haft hæmoragisk apopleksi (7/45 i atorvastatingruppen versus 2/48 i placebogruppen; HR 4,06; 95% CI: 0,84-19,57).
• The risk of hemorrhagic stroke was increased in patients who entered the study with prior hemorrhagic stroke (7/45 for atorvastatin versus 2/48 for placebo; HR 4.06; 95% CI, 0.84-19.57), and the risk of ischemic stroke was similar between groups (3/45 for atorvastatin versus 2/48 for placebo; HR 1.64; 95% CI, 0.27-9.82).
Anden medicin kan måske påvirke behandlingen med Zarator, eller Zarator kan påvirke behandlingen med anden medicin:
There are some medicines that may change the effect of {PRODUCT NAME} or their effect may be changed by {PRODUCT NAME}.
• leverbetændelse
• hepatitis (liver inflammation)
Darunavir 300 mg x 2/ Ritonavir 100 mg x 2, 9 dage
Darunavir 300 mg BID/ Ritonavir 100 mg BID, 9 days
Lægen har ordineret Zarator til Dem personligt.
− This medicine has been prescribed for you.
Ikke almindelig: Opkastning, abdominalsmerter, ructus, pancreatitis.
Uncommon: vomiting, abdominal pain upper and lower, eructation, pancreatitis.
Medicin uden recept: perikon.
− Medicines obtained without a prescription: St John's Wort
Klinisk monitorering anbefales.
Clinical monitoring of these patients is recommended
Ved samtidig behandling med moderate CYP3A4-hæmmere bør en lavere maksimaldosis af atorvastatin derfor overvejes, og passende klinisk monitorering af patienten anbefales.
Therefore, a lower maximum dose of atorvastatin should be considered and appropriate clinical monitoring of the patient is recommended when concomitantly used with moderate CYP3A4 inhibitors.
Fenofibrat 160 mg x 1, 7 dage 40 mg enkeltdosis
Fenofibrate 160 mg OD, 7 days
Patienten bør sættes på en standard kolesterolsænkende diæt, inden der gives Zarator.
The patient should be placed on a standard cholesterol-lowering diet before receiving {PRODUCT NAME} and should continue on this diet during treatment with {PRODUCT NAME}.
• brystforstørrelse hos mænd og kvinder
• gynecomastia (breast enlargement in men and women).
↑ 37% Samtidig indtagelse af store mængder grapefruitjuice og atorvastatin kan ikke anbefales.
Grapefruit Juice, 240 mL OD * 40 mg, SD ↑ 37% Concomitant intake of large quantities of grapefruit juice and atorvastatin is not recommended.
Zarator skal anvendes med forsigtighed hos patienter med leverinsufficiens (se pkt.
Hepatic impairment {PRODUCT NAME} should be used with caution in patients with hepatic impairment (see sections 4.4 and 5.2).
• opkastning, bøvsen, mavesmerter, betændelse i bugspytkirtlen (viser sig ved voldsomme mavesmerter)
• vomiting, belching, abdominal pain upper and lower, pancreatitis (inflammation of the pancreas leading to stomach pain)
↑ 3,3 gange
↑ 3.3 fold
Pædiatrisk population
Paediatric use
I tilfælde, hvor samtidig behandling med disse lægemidler og atorvastatin ikke kan undgås, skal lavere initial- og maksimaldoser af atorvastatin overvejes.
In cases where co-administration of these medicinal products with atorvastatin cannot be avoided lower starting and maximum doses of atorvastatin should be considered and appropriate clinical monitoring of the patient is recommended (see Table 1).
10 mg x 1 i 4 uger
10 mg OD for 4 weeks
80 mg x 1 i 10 dage
80 mg OD for 10 days
Hvis De holder op med at tage Zarator Spørg lægen eller på apoteket, hvis der er noget, De er i tvivl om.
If you have any further questions on the use of this medicine or wish to stop your treatment, ask your doctor or pharmacist.
Almindelig: Hyperglykæmi.
Metabolism and nutrition disorders Common: hyperglycaemia.
20 mg x 1 i 4 dage
20 mg OD for 4 days
• udslæt , hudkløe, nældefeber, hårtab
• rash, skin rash and itching, hives, hair loss
ÆNDRINGER TIL DE RELEVANTE AFSNIT I PRODUKTRESUMÉET
SUMMARY OF PRODUCT CHARACTERISTICS
Ikke almindelige (det sker hos mellem 1 og 10 ud af 1.000 patienter):
Uncommon side effects (affects 1 to 10 users in 1000) include:
Leverpåvirkninger
Recurrent stroke
FARMACEUTISKE OPLYSNINGER
Co-administered medicinal product
Meget sjælden: Anafylaksi.
Very rare: hepatic failure.
Hvis De har taget for mange Zarator
− if you regularly drink a large amount of alcohol
40 mg x 1 i 4 dage
40 mg OD for 4 days
10 mg x 1 i 4 dage
10 mg OD for 4 days
Patienter med nyreinsufficiens
Women of childbearing potential
Hver tablet indeholder 40 mg atorvastatin (som atorvastatincalciumtrihydrat).
Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin calcium trihydrate).
Cimetidin 300 mg x 4, 2 uger 10 mg x 1 i 4 uger
Cimetidine 300 mg QID, 2 weeks
Hver tablet indeholder 10 mg atorvastatin (som atorvastatincalciumtrihydrat).
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate).
Hver tablet indeholder 20 mg atorvastatin (som atorvastatincalciumtrihydrat).
Each film-coated tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate).
↑ 3,9 gange
↑ 3.9 fold
Kontakt lægen, skadestuen eller apoteket, hvis De har taget flere Zarator tabletter, end der står i her, eller flere end lægen har foreskrevet, og De føler Dem utilpas.
If you take more {PRODUCT NAME} than you should If you accidently take too many {PRODUCT NAME} tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.
Hver tablet indeholder 80 mg atorvastatin (som atorvastatincalciumtrihydrat).
Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin calcium trihydrate).
Atorvastatins virkning på andre lægemidler
Effect of atorvastatin on co-administered medicinal products
DATO FOR ÆNDRING AF TEKSTEN <MM/ÅÅÅÅ> <[Udfyldes nationalt]>
DATE OF REVISION OF THE TEXT [To be completed nationally]
40 mg enkeltdosis
40 mg SD ↑ 30%
Det skal De vide, før De begynder at tage Zarator Sådan skal De tage Zarator Bivirkninger
What {PRODUCT NAME} is and what it is used for Before you take {PRODUCT NAME} How to take {PRODUCT NAME} Possible side effects
• nakkesmerter, muskelsvaghed
• neck pain, muscle fatigue
Metabolisme
Biotransformation
Det bør derfor overvejes at seponere atorvastatin-behandling under behandling med fusidinsyre (se pkt.
The concurrent use of atorvastatin and fusidic acid is not recommended, therefore, temporary suspension of atorvastatin may be considered during fusidic acid therapy (see section 4.5).
Hvis De er i den fødedygtige alder, skal De bruge sikker prævention, mens De tager Zarator.
Do not take {PRODUCT NAME} if you are able to become pregnant unless you use reliable contraceptive measures.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN <[Udfyldes nationalt]> <[Se bilag I - Udfyldes nationalt]> [For referral procedures] {Navn og adresse} <{tlf}> <{fax}> <{email}>
NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name}
Ikke almindelig: Nakkesmerter, muskelsvaghed.
Uncommon: neck pain, muscle fatigue.
SÅDAN SKAL DE TAGE ZARATOR
HOW TO TAKE {PRODUCT NAME}
• uskarpt syn
− Renal impairment
Se pkt.
− Keep this leaflet.
Aterosklerose
Excipients
DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE ZARATOR
BEFORE YOU TAKE {PRODUCT NAME}
• høretab
• hearing loss
Udseende og pakningstørrelser Udseende [Udfyldes nationalt]
What {PRODUCT NAME} looks like and contents of the pack [To be completed nationally]
Navn
Content
Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
(Invented) name Strength Pharmaceutical form
EMEA's procedurenr.
EMEA Number
1 fyldt injektionssprøjte med automatisk kanylehætte (blister)
1 pre-filled syringe with automatic needle guard (blistered)
1 fyldt injektionssprøjte (blister)
1 pre-filled syringe (blistered)
1 fyldt injektionssprøjte (uden blister)
1 pre-filled syringe (non-blistered)
Liste over navne, lægemiddelform, lægemidlets styrke, administrationsvej, ansøger i medlemsstaterne
List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicant in the Member States
Grækenland Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel
United Kingdom Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel
Varighed af behandlingen:
Duration of treatment:
Normalt bør den maksimale behandligsvarighed ikke overstige en uge.
Usually, the maximum treatment duration should not exceed one week.
Hvis du har glemt at tage X
If you forget to take X
Hvis det er hensigtsmæssigt, kan et glas vand tages bagefter.
If convenient, a glass of water can be taken afterwards.
Ovenstående liste over lægemidler er repræsentativ, men ikke udtømmende.
The above list of substances is representative and not exhaustive.
[For orale formuleringer]: Det anbefales at tage oral <X> før måltider.
[For oral formulations]: It is recommended to take oral <X> before meals.
Du må ikke tage {Handelsnavn} i mere end 7 dage uden at rådføre dig med din læge.
Do not take {Tradename} for longer than 7 days without consulting your doctor.
Denne produktinformation kan om nødvendig efterfølgende opdateres af de relevante myndigheder i medlemslandene i samarbejde med reference-medlemslandet i henhold til procedurerne i kapitel 4 af Title III af Direktiv 2001/83/EC.
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Tag din medicin, så snart du kommer i tanker om det.
Take your medicine as soon as you remember.
Giv ikke mere end 3 gange indenfor en 24 timers periode.
Do not give more than 3 times in a 24 hour time period.
Patienten skal forsøge at tage hver dosis på det planlagte tidspunkt.
Patients should try to take each dose at the scheduled time.
Det kan desuden være nødvendigt at reducere dosis.
The dose may also need to be reduced.
I overensstemmelse med ICH-E14-guidelines blev et uddybende QT-studie udført.
In accordance with ICH-E14 guidelines, a thorough QT study was performed.
Behandling med domperidon bør stoppes.
Treatment with domperidone should be stopped.
Hvis {Produktnavn} er til et barn, så spørg din læge efter en formulering til børn.
If {Product name} is for a child, ask your doctor for the children's formulation.
Symptomerne forsvinder som regel efter 3-4 dage, når du tager dette lægemiddel.
Symptoms usually resolve with 3-4 days of taking this medicine.
Spørg din læge, før du tager dette lægemiddel.
Ask your doctor for advice before taking this medicine.
Der sås ingen teratogenicitet hos mus og kaniner.
No teratogenicity was observed in mice and rabbits