natgillin/translations-raw huggingface dataset:
Det primære endepunkt (fatal iskæmisk hjertesygdom samt ikke- fatal myokardieinfarkt blev signifikant nedsat af atorvastatin hos patienter behandlet med amlodipin (HR 0, 47 (0, 32- 0, 69) p=0, 00008), men ikke hos dem behandlet med atenolol (HR 0, 83 (0, 59- 1, 17), p=0, 287).
The primary endpoint (fatal CHD plus non-fatal MI) was significantly reduced by atorvastatin in patients treated with Amlodipine (HR 0.47 (0.32-0.69), p=0.00008), but not in those treated with Atenolol (HR 0.83 (0.59-1.17), p= 0.287).
I et randomiseret, dobbelt- blindt, multicenter, placebokontrolleret studie, Collaborative Atorvastatin Diabetes Study (CARDS) blev effekten af atorvastatin på fatal og ikke- fatal kardiovaskulær sygdom også vurderet hos patienter med type 2 diabetes i alderen 40- 75 år, uden kardiovaskulær sygdom i anamnesen og med LDL- kolesterol ≤ 4, 14 mmol/ l (160 mg/ dl) og triglycerid ≤ 6, 78 mmol/ l (600 mg/ dl).
The effect of atorvastatin on fatal and non-fatal cardiovascular disease was also assessed in a randomized, double-blind, multicenter, placebo-controlled trial, the Collaborative Atorvastatin Diabetes Study (CARDS) in patients with type 2 diabetes, 40-75 years of age, without prior history of
Patienterne blev behandlet med enten atorvastatin 10 mg dagligt (n=1428) eller placebo (n=1410) med en middelopfølgningsperiode på 3, 9 år.
Patients were treated with either atorvastatin 10 mg daily (n=1428) or placebo (n=1410) for a median follow-up of 3.9 years.
35 Den absolutte og relative risikoreduktion med atorvastatin er følgende:
The absolute and relative risk reduction effect of atorvastatin was as follows:
Slagtilfælde (fatal og ikke - fatal) 1
Strokes (Fatal and non-fatal) 1
På baggrund af forskelle i de samlede hændelseshyppigheder opstået over en middelopfølgningsperiode på 3, 9 år.
Based on difference in crude events rates occurring over a median follow-up of 3.9 years.
Distribution
37 Distribution
Atorvastatin er bundet ≥ 98% eller mere til plasmaproteiner.
Atorvastatin is ≥ 98% bound to plasma proteins.
36 Elimination
Excretion
Den systemiske eksponering var 6- 11 gange højere baseret på AUC( 0- 24).
Systemic exposure was 6-to 11-fold higher based on AUC(0-24).
Hypromellose Macrogol Titandioxid (E171) Talkum Simethicon Stearat emulgatorer
Hypromellose Polyethylene glycol Titanium dioxide (E171) Talc Simethicone Stearate emulsifiers Sorbic acid Candelilla wax
Blisterformen består af polyamid/ aluminium folie/ polyvinylchlorid og blisterfolien består af enten af varmeforsegling med papir/ polyester/ aluminium folie/ vinyl eller aluminium folie/ vinyl.
The blisters consist of a forming film made of polyamide/ aluminum foil/ polyvinyl chloride and a backing made of either paper/ polyester/ aluminum foil/ vinyl heat-seal coating or aluminum foil/ vinyl heat-seal coating.
November 21, 1996/ October 31, 2001
< {DD/MM/YYYY} > < {DD month YYYY} >
DATO FOR ÆNDRING AF TEKSTEN
< [To be completed nationally] >
38 1.
10.
< [Se bilag I - Udfyldes nationalt] > [For referral procedures] {(Sær) navn} 40 mg filmovertrukne tabletter
NAME OF THE MEDICINAL PRODUCT
1 filmovertrukken tablet indeholder 40 mg atorvastatin (som atorvastatincalciumtrihydrat).
Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin calcium (trihydrate)).
1 {(Sær) navn} 40 mg filmovertrukken tablet indeholder 131, 22 mg lactosemonohydrat.
Each {PRODUCT NAME} 40 mg film-coated tablet contains 131.22 mg lactose monohydrate.
Filmovertrukne tabletter Hvide elipseformet filmovertrukne tabletter præget med "40 ” på den ene side og" PD157 ” på den anden side
Film-coated tablet White elliptical, film-coated tablets debossed "40" on one side and "PD 157" on the other.
39 Hos patienter med manifest iskæmisk hjertesygdom eller andre patienter med øget risiko for iskæmiske hændelser er behandlingsmålet LDL- kolesterol < 3 mmol/ l (eller < 115 mg/ dl) og total- kolesterol < 5mmol/ l (eller < 190 mg/ dl).
41 For patients with established coronary heart disease or other patients at increased risk of ischemic events, the treatment goal is LDL-C < 3 mmol/ l (or < 115 mg/ dl) and total cholesterol < 5 mmol/ l (or < 190 mg/ dl).
40 4. 3 Kontraindikationer
4.3 Contraindications
- med overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne i dette
42 {PRODUCT NAME} is contraindicated in patients: − with hypersensitivity to the active substance or to any of the excipients of this medication − with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal − with myopathy − during pregnancy − while breast-feeding − in women of child-bearing potential not using appropriate contraceptive measures.
Hvis
43 − If such symptoms occur whilst a patient is receiving treatment with atorvastatin, their CPK levels should be measured.
P- glycoprotein- hæmmere
44 Inhibitors of P-glycoprotein
42 Proteasehæmmere
Protease inhibitors
Oral antikonception Samtidig anvendelse af {(Sær) navn} og et oralt antikonceptivum førte til forhøjede plasmakoncentrationer af norethindron og ethinylestradiol.
45 Oral contraceptives Coadministration of {PRODUCT NAME} with an oral contraceptive produced increases in plasma concentrations of norethindrone and ethinyl oestradiol.
Cholestipol Plasmakoncentrationer af atorvastatin og dets aktive metabolitter var lavere (ca.
Colestipol Plasma concentrations of atorvastatin and its active metabolites were lower (by approx.
43 Fenazon Samtidig anvendelse af gentagne doser {(Sær) navn} og fenazon viste kun lidt eller ingen synlig effekt på fenazon- clearance.
Phenazone Coadministration of multiple doses of {PRODUCT NAME} and phenazone showed little or no detectable effect in the clearance of phenazone.
Udviklingen af rotteafkom var forsinket og postnatal overlevelse nedsat efter indgift af atorvastatin til moderdyr i doser over 20 g/ kg dagligt (den klinisk systemiske dosis).
The development of rat offspring was delayed and post-natal survival reduced during exposure of the dams to atorvastatin at doses above 20 mg/ kg/ day (the clinical systemic exposure).
4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
46 4.7 Effects on ability to drive and use machines
44 Lidelser i immunsystemet
Immune system disorders
Lidelser i øre
47 Ear and Labyrinth Disorders
45 Forhøjet serum- kreatininfosfokinase (CK) niveau på mere end 3 gange den øvre referenceværdi er set hos 2, 5% af de patienter, som behandles med {(Sær) navn}, hvilket svarer til andre HMG- CoA - reduktasehæmmere i kliniske studier.
Elevated serum creatine phosphokinase (CPK) levels greater than 3 times upper limit of normal occurred in 2.5% of patients on {PRODUCT NAME}, similar to other HMG-CoA reductase inhibitors in clinical trials.
Atorvastatin reducerer LDL- produktionen og antallet af LDL- partikler.
48 Atorvastatin reduces LDL production and the number of LDL particles.
Atorvastatin giver en væsentlig og vedvarende forøgelse af LDL- receptoraktiviteten forbundet med en fordelagtig ændring i kvaliteten af cirkulerende LDL- partikler.
Atorvastatin produces a profound and sustained increase in LDL receptor activity coupled with a beneficial change in the quality of circulating LDL particles.
Atorvastatin reducerer effektivt LDL- kolesterol hos patienter med homozygot familiær hyperkolesterolæmi, en patientgruppe, som ikke sædvanligvis responderer på lipidsænkende behandling.
Atorvastatin is effective in reducing LDL-C in patients with homozygous familial hypercholesterolaemia, a population that has not usually responded to lipid- lowering medication.
46 Middel procentændring i total atheromavolumen (primært studiekriterie) fra baseline er – 0, 4% (p=0, 98) i atorvastatingruppen, og +2, 7% (p=0, 001) i pravastatingruppen (n=249).
The median percent change, from baseline, in total atheroma volume (the primary study criteria) was - 0.4% (p=0.98) in the atorvastatin group and +2.7% (p=0.001) in the pravastatin group (n=249).
I atorvastatingruppen reduceres LDL- kolesterol 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 (110 mg/ dl ±26) fra baseline 3, 89 mmol/ l ±0, 7 (150 mg/ dl ±26) (p < 0, 0001).
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).
Dette skyldes primært en risikoreduktion på 26% i genindlæggelse for angina pectoris med tegn på myokardieiskæmi (p=0, 018).
This was mainly due to a 26% reduction in re-hospitalisation for angina pectoris with
47 Den absolutte og relative risikoreduktion med atorvastatin er følgende:
The absolute and relative risk reduction effect of atorvastatin was as follows:
I et randomiseret, dobbelt- blindt, multicenter, placebokontrolleret studie, Collaborative Atorvastatin Diabetes Study (CARDS) blev effekten af atorvastatin på fatal og ikke- fatal kardiovaskulær sygdom også vurderet hos patienter med type 2 diabetes i alderen 40- 75 år, uden kardiovaskulær sygdom i anamnesen og med LDL- kolesterol ≤4, 14 mmol/ l (160 mg/ dl) og triglycerid ≤6, 78 mmol/ l (600 mg/ dl).
The effect of atorvastatin on fatal and non-fatal cardiovascular disease was also assessed in a randomized, double-blind, multicenter, placebo-controlled trial, the Collaborative Atorvastatin Diabetes Study (CARDS) in patients with type 2 diabetes, 40-75 years of age, without prior history of cardiovascular disease, and with LDL-C ≤ 4.14 mmol/ l (160 mg/ dl) and TG ≤ 6.78 mmol/ l (600 mg/ dl).
Patienterne blev behandlet med enten atorvastatin 10 mg dagligt (n=1. 428) eller placebo (n=1. 410) med en middelopfølgningsperiode på 3, 9 år.
Patients were treated with either atorvastatin 10 mg daily (n=1428) or placebo (n=1410) for a median follow-up of 3.9 years
48 Den absolutte og relative risikoreduktion med atorvastatin er følgende:
The absolute and relative risk reduction effect of atorvastatin was as follows:
Relativ risiko -
50
70% af hæmningen af HMG- CoA- reduktase skyldes aktive metabolitter.
Approximately 70% of circulating inhibitory activity for HMG-oA reductase is attributed to active metabolites.
49 Elimination
Excretion
- Ældre:
51 − Geriatric:
< [Se bilag I - Udfyldes nationalt] > [For referral procedures] {(Sær) navn} 80 mg filmovertrukne tabletter
< [See Annex I - To be completed nationally] > [For referral procedures] {PRODUCT NAME} 80mg film-coated tablet
1 filmovertrukken tablet indeholder 80 mg atorvastatin (som atorvastatincalciumtrihydrat).
Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin calcium (trihydrate)).
1 {(Sær) navn} 80 mg filmovertrukken tablet indeholder 262, 44 mg lactosemonohydrat.
Each {PRODUCT NAME} 80 mg film-coated tablet contains 262.44 mg lactose monohydrate.
Filmovertrukne tabletter Hvide elipseformet filmovertrukne tabletter præget med "80 ” på den ene side og" PD158 ” på den anden side
Film-coated tablet White elliptical, film-coated tablets debossed "80" on one side and "PD 158" on the other.
52 Hos patienter med manifest iskæmisk hjertesygdom eller andre patienter med øget risiko for iskæmiske hændelser er behandlingsmålet LDL- kolesterol < 3 mmol/ l (eller < 115 mg/ dl) og total- kolesterol < 5 mmol/ l (eller < 190 mg/ dl).
55 For patients with established coronary heart disease or other patients at increased risk of ischemic events, the treatment goal is LDL-C < 3 mmol/ l (or < 115 mg/ dl) and total cholesterol < 5 mmol/ l (or < 190 mg/ dl).
- med overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne i dette
56 {PRODUCT NAME} is contraindicated in patients: − with hypersensitivity to the active substance or to any of the excipients of this medication − with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal − with myopathy − during pregnancy − while breast-feeding − in women of child-bearing potential not using appropriate contraceptive measures.
Hvis
57 − If such symptoms occur whilst a patient is receiving treatment with atorvastatin, their CPK levels should be measured.
P- glycoprotein- hæmmere
58 Inhibitors of P-glycoprotein
55 Proteasehæmmere
Protease inhibitors
Oral antikonception Samtidig anvendelse af {(Sær) navn} og et oralt antikonceptivum førte til forhøjede plasmakoncentrationer af norethindron og ethinylestradiol.
59 Oral contraceptives Coadministration of {PRODUCT NAME} with an oral contraceptive produced increases in plasma concentrations of norethindrone and ethinyl oestradiol.
Effekten på lipiderne var imidlertid større, når {(Sær) navn} og cholestipol blev indgivet samtidig, end hvis stofferne blev givet hver for sig.
However, lipid effects were greater when {PRODUCT NAME} and colestipol were coadministered than when either medicinal products was given alone.
56 Fenazon Samtidig anvendelse af gentagne doser {(Sær) navn} og fenazon viste kun lidt eller ingen synlig effekt på fenazon- clearance.
Phenazone Coadministration of multiple doses of {PRODUCT NAME} and phenazone showed little or no detectable effect in the clearance of phenazone.
Det vides ikke, om dette lægemiddel eller dets metabolitter udskilles i modermælk hos mennesker.
It is not known whether this medicinal products or its metabolites are excreted in human milk.
4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
60 4.7 Effects on ability to drive and use machines
Almindelig (≥1/ 100, < 1/ 10); ikke almindelig (≥1/ 1000 og < 1/ 100); sjælden (≥1/ 10. 000 og < 1/ 1000); meget sjælden (≤1/ 10. 000).
Estimated frequencies of events are ranked according to the following convention: common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000 < 1/ 100); rare (≥ 1/ 10,00, < 1/ 1,000); very rare (≤ 1/ 10,000).
57 Lidelser i immunsystemet
Immune system disorders
Lidelser i øre
61 Ear and Labyrinth Disorders
58 Forhøjet serum- kreatininfosfokinase (CK) niveau på mere end 3 gange den øvre referenceværdi er set hos 2, 5% af de patienter, som behandles med {(Sær) navn}, hvilket svarer til andre HMG- CoA - reduktasehæmmere i kliniske studier.
Elevated serum creatine phosphokinase (CPK) levels greater than 3 times upper limit of normal occurred in 2.5% of patients on {PRODUCT NAME}, similar to other HMG-CoA reductase inhibitors in clinical trials.
Atorvastatin reducerer LDL- produktionen og antallet af LDL- partikler.
62 Atorvastatin reduces LDL production and the number of LDL particles.
59 Middel procentændring i total atheromavolumen (primært studiekriterie) fra baseline er – 0, 4% (p=0, 98) i atorvastatingruppen, og +2, 7% (p=0, 001) i pravastatingruppen (n=249).
The median percent change, from baseline, in total atheroma volume (the primary study criteria) was - 0.4% (p=0.98) in the atorvastatin group and +2.7% (p=0.001) in the pravastatin group (n=249).
4. 8.
63 The safety profile of atorvastatin in the MIRACL study was consistent with what is described in Section 4.8.
60 Den absolutte og relative risikoreduktion med atorvastatin er følgende:
The absolute and relative risk reduction effect of atorvastatin was as follows:
61 Den absolutte og relative risikoreduktion med atorvastatin er følgende:
The absolute and relative risk reduction effect of atorvastatin was as follows:
Distribution
65 Distribution
62 Elimination
Excretion
Hypromellose Macrogol Titandioxid (E171) Talkum Simethicon Stearat emulgatorer
Hypromellose Polyethylene glycol Titanium dioxide (E171) Talc Simethicone Stearate emulsifiers Sorbic acid
August 8, 2001
< [To be completed nationally] >
64 ETIKETTERING OG INDLÆGSSEDDEL
68 LABELLING AND PACKAGE LEAFLET
65 ETIKETTERING
69 LABELLING
66 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Hospitalspakning (blisterpakning med 200 eller 500 tabletter)
BLISTER PACK CARTON (for blisters of 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, 100 tablets) HOSPITAL PACK LABEL (for blisters of 200 & 500 tablets)
{(Sær) navn} 10 mg filmovertrukne tabletter Atorvastatincalcium
{PRODUCT NAME} 10 mg Film-coated tablets Atorvastatin calcium
1 filmovertrukken tablet indeholder 10 mg atorvastatin (som calciumtrihydrat).
1 film-coated tablet contains 10 mg atorvastatin (as calcium salt trihydrate).
6.
71 6.
Forseglet af sikkerhedshensyn.
Sealed for your protection.
Anv. senest:
EXP:
Se den enkelte pakning (kun etiket til hospitalspakning)
Batch/ EXP: see individual pack (label for sticker for hospital packs only)
{Navn og adresse} < {tlf} > < {fax} > < {email} >
< [To be completed nationally] > {Name and Address }< {tel }> < {fax }> < {e-mail }>
Batch/ Anv. senest:
Batch / EXP: see individual pack (label for sticker for hospital packs only)
Se den enkelte pakning (kun etiket til hospitalspakning)
GENERAL CLASSIFICATION FOR SUPPLY
GENEREL KLASSIFIKATION FOR UDLEVERING
< [To be completed nationally] >
{(Sær) navn} 10 mg filmovertrukne tabletter
{PRODUCT NAME} 10 mg Film-coated tablets
68 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister
73 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
< [Udfyldes nationalt] >
< [To be completed nationally] > {Name}
For blister på 7 tabletter – de enkelte ugedage kan trykkes på folien for hver tablet dvs.
{for blisters of 7 tablets – the abbreviated days of the week may be printed on the foil for each tablet i. e.
69 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
74 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
{(Sær) navn} 20 mg filmovertrukne tabletter Atorvastatincalcium
{PRODUCT NAME} 20 mg Film-coated tablets Atorvastatin calcium
1 filmovertrukken tablet indeholder 20 mg atorvastatin (som calciumtrihydrat).
1 film-coated tablet contains 20 mg atorvastatin (as calcium salt trihydrate).
6.
75 6.
Se den enkelte pakning (kun etiket til hospitalspakning)
Batch / EXP: see individual pack (label for sticker for hospital packs only)
{(Sær) navn} 20 mg filmovertrukne tabletter
{PRODUCT NAME} 20 mg Film-coated tablets
71 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister
77 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
72 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
78 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
{(Sær) navn} 40 mg filmovertrukne tabletter Atorvastatincalcium
{PRODUCT NAME} 40 mg Film-coated tablets Atorvastatin calcium
1 filmovertrukken tablet indeholder 40 mg atorvastatin (som calciumtrihydrat).
1 film-coated tablet contains 40 mg atorvastatin (as calcium salt trihydrate).
{(Sær) navn} 40 mg filmovertrukne tabletter
{PRODUCT NAME} 40 mg Film-coated tablets
74 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister
81 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
75 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
82 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
{(Sær) navn} 80 mg filmovertrukne tabletter Atorvastatincalcium
{PRODUCT NAME} 80 mg Film-coated tablets Atorvastatin calcium
1 filmovertrukken tablet indeholder 80 mg atorvastatin (som calciumtrihydrat).
1 film-coated tablet contains 80 mg atorvastatin (as calcium salt trihydrate).
{(Sær) navn} 80 mg filmovertrukne tabletter
{PRODUCT NAME} 80 mg Film-coated tablets
77 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister
85 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
78 INDLÆGSSEDDEL
86 PACKAGE LEAFLET
79 INDLÆGSSEDDEL:
87 PACKAGE LEAFLET:
INFORMATION TIL BREUGEREN
INFORMATION FOR THE USER
{(Sær) navn} 10 mg Filmovertrukne tabletter Atorvastatincalcium < [Se bilag I - Udfyldes nationalt] > [For referral procedures]
{PRODUCT NAME} 10 mg film-coated tablets Atorvastatin calcium< [See Annex I - To be completed nationally] > [For referral procedures]
De får måske brug for at læse den igen.
Read all of this leaflet carefully before you start taking this medicine. − Keep this leaflet.
- Ønsker De mere information, så kontakt læge eller apotek.
You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you.
nævnt i denne information, bør De fortælle det til Deres læge eller apotek.
It may harm them, even if their symptoms are the same as yours. − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Hvad {(Sær) navn} 10 mg er, og hvad det anvendes til 2.
What {PRODUCT NAME} 10 mg is and what it is used for 2.
Hvad De skal gøre, før De begynder at tage {(Sær) navn} 10 mg 3.
Before you take {PRODUCT NAME} 10 mg 3.
Hvordan De tager {(Sær) navn} 10 mg 4.
How to take {PRODUCT NAME}10 mg 4.
Hvilke mulige bivirkninger {(Sær) navn} 10 mg har 5.
Possible side effects 5.
Hvordan De opbevarer {(Sær) navn} 10 mg 6.
How to store {PRODUCT NAME} 10 mg 6.
HVAD {(SÆR) NAVN} 10 mg ER, OG HVAD DET ANVENDES TIL
WHAT {PRODUCT NAME} 10 mg IS AND WHAT IT IS USED FOR
{(Sær) navn} tilhører den gruppe af medicin, som hedder statiner, og som er en type kolesterolsænkende medicin.
{PRODUCT NAME} belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines.
{(Sær) navn} anvendes til at sænke fedtstoffer (lipider) som kolesterol og triglycerider i blodet, når fedtfattig diæt og livsstilsændringer ikke er tilstrækkelig.
{PRODUCT NAME} is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed.
Hvis De har en øget risiko for udvikling af hjertesygdom, kan {(Sær) navn} også anvendes til at nedsætte en sådan risiko, selv om De har normalt kolesteroltal.
If you are at an increased risk of heart disease, {PRODUCT NAME} can also be used to reduce such risk even if your cholesterol levels are normal.
- hvis De har en leversygdom
BEFORE YOU TAKE {PRODUCT NAME} 10 mg
- hvis De har en muskelsygdom, som hedder myopati (vedvarende eller uforklarlige muskelsmerter)
Do not take {PRODUCT NAME} 10 mg − if you are hypersensitive (allergic) to {PRODUCT NAME} or to any similar medicines used to lower blood lipids or to any of the other ingredients of the medicine – see Section 5 for details. − if you have or have ever had a disease which affects the liver − if you have had any unexplained abnormal blood tests for liver function − if you are a woman able to have children and not using reliable contraception − if you are pregnant, trying to become pregnant or breast-feeding − if you have a muscle disorder called myopathy (repeated or unexplained muscle aches or pains)
- hvis De har haft vedvarende eller uforklarlige muskelsmerter, eller hvis De eller andre i Deres
Take special care with {PRODUCT NAME} 10 mg The following are reasons why {PRODUCT NAME} may not be suitable for you: − If you have kidney problems
- hvis De tidligere har haft muskelproblemer i forbindelse med andre lipidsænkende midler (f. eks.
88 − If you have an under-active thyroid gland (hypothyroidism) − If you have had repeated or unexplained muscle aches or pains, a personnal history or family history of muscle problems − If you have had previous muscular problems during treatment with other lipid-lowering medicines (e. g. other ‘ -statin’ or ‘ -fibrate’ medicines) − If you regularly drink a large amount of alcohol − If you have a history of liver disease − If you are older than 70 years − If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.
Disse blodprøver vil blive anvendt til at vurdere risikoen for muskelrelaterede bivirkninger.
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.