Examples of using Tredaptive in English and their translations into German
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Medicine
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Colloquial
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Official
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Ecclesiastic
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Financial
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Ecclesiastic
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Political
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Computer
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Programming
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Official/political
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Political
What is Tredaptive?
Tredaptive is used on its own only in patients who cannot take statins.
How is Tredaptive used?
Other information about Tredaptive.
Why has Tredaptive been approved?
BEFORE YOU TAKE TREDAPTIVE.
Excipient Tredaptive contains lactose.
They included a total of 2,349 patients who were taking either Tredaptive or nicotinic acid.
Children and adolescents Tredaptive has not been studied in children and adolescents who are under 18 years of age.
Side effects of Tredaptive are.
Tredaptive In the event of an overdose, it is reasonable to employ the usual symptomatic and supportive measures.
Two studies looked at the effectiveness of Tredaptive in modifying blood fat levels.
Tredaptive is not recommended for use in children under 18 years of age because of a lack of information on its safety and effectiveness in this group.
For the full list of all side effects reported with Tredaptive, see the Package Leaflet.
Tredaptive is normally given together with a statin(the standard medicine used to reduce cholesterol) when the effectiveness of a statin taken alone is inadequate.
Undesirable effects In clinical trials, over 2500 patients received Tredaptive alone or with an HMG-CoA reductase inhibitor.
What Tredaptive looks like and contents of the pack Each modified-release tablet is a capsule-shaped, white to off-white tablet, with“ 552” debossed on one side.
Use in paediatric patients Safety and effectiveness of Tredaptive in paediatric patients have not been established.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy shouldbe made taking into account the benefit of breast-feeding to the child and the benefit of Tredaptive to the woman.
Hypophosphatemia As with other nicotinic acid medicinal products, Tredaptive was associated with small decreases in phosphorus levels.
Do not take Tredaptive if• you are allergic(hypersensitive) to nicotinic acid, to laropiprant, or to any of the other ingredients of Tredaptive(listed in section 6).• you currently have liver problems.• you have an ulcer in your stomach.• you have arterial bleeding.
Use in patients with hepatic or renal insufficiency Use of Tredaptive in patients with hepatic or renal insufficiency has not been studied.
Overall adverse reactions with Tredaptive In addition to flushing, clinical adverse reactions reported by the investigators as possibly, probably, or definitely related to Tredaptive in≥ 1% of patients treated with Tredaptive alone(n=947) or co-administered with statin(n=1601) and clinically meaningful adverse reactions(< 1%), for up to one year are listed below.
Flushing In two large clinical trials measuring patient-reported flushing symptoms,patients taking Tredaptive experienced less flushing than those taking nicotinic acid prolonged-release formulations.
In these studies, the percentage of patients taking Tredaptive, nicotinic acid(pooled prolonged-release formulations) or pooled placebo/ simvastatin who discontinued due to any flushing-related symptom(redness, warmth, itching and tingling) was 7.2%, 16.6%, and 0.4%, respectively.
For patients switching from immediate-release nicotinic acid to Tredaptive, therapy should be initiated at the 1000 mg/ 20 mg dose and advanced to the 2000 mg/ 40 mg maintenance dose after four weeks.
Tredaptive is used if you need to improve cholesterol and fat levels in your blood(primary hypercholesterolaemia(heterozygous familial and non-familial) or mixed dyslipidaemia):• when you cannot control your cholesterol levels with a statin(class of cholesterol-lowering medicines working in the liver);• when you cannot tolerate a statin or when a statin is not recommended for you.
The first study compared the effectiveness of Tredaptive with that of nicotinic acid alone or placebo(a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients.
Acute coronary syndrome As with other nicotinic acid medicinal products, caution should be used when Tredaptive is used in patients with unstable angina or in the acute phase of an MI, particularly when such patients are also receiving vasoactive medicinal products such as nitrates, calcium channel blockers, or adrenergic blocking agents.
Physicians contemplating combined therapy with statins and Tredaptive should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and when the dose of either medicinal product is increased.
