Examples of using Numient in English and their translations into German
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Colloquial
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Official
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Ecclesiastic
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Medicine
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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
How does Numient work?
Other information about Numient.
Numient replacements and reviews.
If you stop taking Numient.
Do not stop taking or change your dose of Numient without talking to your doctor first even if you feel better.
Other medicines and Numient.
Numient must not be used in patients with narrow angle glaucoma(an eye disorder) or pheochromocytoma a tumour of the adrenal glands.
Do not stop taking Numient suddenly.
Serious events of gastrointestinal haemorrhage(uncommon) and of allergic oedema(uncommon)were reported in the clinical studies with Numient.
If your diet contains too much protein(meat, eggs, milk,cheese), Numient may not work as well as it should.
Next, patients were randomized to a double-blind, 13-week studytreatment period of either optimized immediate release levodopa/carbidopa treatment or Numient.
If you have never had levodopa before,the usual starting dose for Numient is one 95 mg capsule three times a day for three days.
For patients currently treated with other levodopa/DDC inhibitor modified-release medicinal products,limited information regarding conversion to Numient is available.
Talk to your doctor or pharmacist if you think the effect of Numient is too strong or too weak, or if you experience possible side effects.
Do not take Numient if you have taken a medicine called a‘non-selective monoamine oxidase(MAO) inhibitor' for treating depression in the last 14 days.
In between these periods, all patients received open-label Numient treatment for 1 week.
However, your doctor may decide to give you Numient if the expected benefits of treatment outweigh possible risks to the unborn child.
Numient is used in adults to treat the symptoms of Parkinson's disease, a progressive brain disorder that causes shaking and muscular stiffness and slows down movement.
In a study of 381patients with early stage Parkinson's disease, Numient at various doses was more effective at improving symptoms than placebo a dummy treatment.
The ADVANCE-PD study was a 22-week study consisting of a 3-week dose adjustment of pre-study immediate releaselevodopa/carbidopa treatment prior to a 6-week conversion to Numient.
Numient 145 mg/36.25 mg modified-release hard capsules EU/1/15/1044/004(25 modified-release hard capsules) EU/1/15/1044/005(100 modified-release hard capsules) EU/1/15/1044/006 240 modified-release hard capsules.
A symptom complex resembling neuroleptic malignant syndrome and rhabdomyolysis may occur with levodopa/carbidopa medicinal products,although no cases have been identified in clinical studies with Numient.
As a result of Numient's pharmacokinetic characteristics, the doses and dosing frequency of Numient are not directly interchangeable with those of other levodopa/DDC inhibitor immediate release medicinal products see section 5.2.
When patients are initially converted from immediate release levodopa/DDC inhibitor plus catechol-O- methyl transferase(COMT)inhibitors(such as entacapone) to Numient the dosing conversion guidelines provided in Table 2 are recommended for initial dosing.
Numient 95 mg/23.75 mg modified-release hard capsules Numient 145 mg/36.25 mg modified-release hard capsules Numient 195 mg/48.75 mg modified-release hard capsules Numient 245 mg/61.25 mg modified-release hard capsules.
In the pharmacokinetic studiesconducted in patients following a single dose of Numient, systemic exposure to levodopa generally increased with increasing age with AUC values being, on average, approximately 15% higher in elderly(≥65 years) than younger subjects< 65 years.
The effectiveness of Numient in patients with early Parkinson's disease was established in a randomized, double-blind, placebo-controlled, fixed-dose, parallel-group, 30-week clinical trial in 381 patients who had a median disease duration of 1 year and limited or no prior exposure to levodopa and dopamine agonists.
You need to stop using these medicines at least two weeks before you start Numient(see also under‘Other medicines and Numient'); if you have ever had neuroleptic malignant syndrome(NMS-a rare severe reaction to medicines used to treat severe mental disorders); if you have ever had non-traumatic rhabdomyolysis a rare muscle disorder.
The efficacy and safety of Numient in patients with advanced stage Parkinson's disease have been evaluated in 2 double-blind, active-controlled studies: parallel study ADVANCE-PD(study IPX066-B09-02; 22 weeks) and cross-over study ASCEND-PD study IPX066-B-09-06 Part 1; 11 weeks.
The final total daily dose of levodopa from Numient is about double that of the final total daily dose of levodopa from immediate release tablets while the final total daily dose of levodopa from Numient is about three times that of the final total daily dose of levodopa from the combination of levodopa/DDC inhibitor/entacapone.