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Medicalindependent.ie2

Lyrica® (pregabalin)
Prescribing Information
Refer to Summary of Product Characteristics (SmPC) before prescribing.
Presentation:
Lyrica is supplied in hard capsules containing 25mg, 50mg, 75mg, 100mg, 150mg, 200mg or
300mg of pregabalin.
Indications: Treatment of peripheral and central neuropathic pain in adults. Treatment of epilepsy, as
adjunctive therapy in adults with partial seizures with or without secondary generalisation. Treatment of
Generalised Anxiety Disorder (GAD) in adults.
Dosage: Adults: 150 to 600mg per day, given in either two or three divided doses taken orally. Treatment may
be initiated at a dose of 150mg per day and, based on individual patient response and tolerability, may be
increased to 300mg per day after an interval of 3-7 days (for neuropathic pain) or 7 days (for epilepsy or GAD),
the dose may be increased to 450mg per day after an additional 7 day interval (for GAD), and to a maximum
dose of 600mg per day after a further 7-day interval. Treatment should be discontinued gradually over a
minimum of one week. Renal impairment/ Haemodialysis: dosage adjustment necessary; see SmPC. Hepatic
impairment:
No dosage adjustment required. Elderly: Dosage adjustment required if impaired renal function.
Children and adolescents: The safety and efficacy of Lyrica in children below the age of 12 years and in
adolescents (12-17 years of age) have not been established. No data are available.
Contra-indications: Hypersensitivity to active substance or excipients.
Warnings and precautions: There have been reports of hypersensitivity reactions, including cases of
angioedema. Pregabalin should be discontinued immediately if symptoms of angioedema, such as facial,
perioral, or upper airway swelling occur. Patients with galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption should not take Lyrica. Some diabetic patients who gain weight may require
adjustment to hypoglycaemic medication. Occurrence of dizziness and somnolence could increase accidental
injury (fall) in elderly patients.
There have also been post marketing reports of loss of consciousness, confusion and mental impairment.
Cases of renal failure have been reported and discontinuation of pregabalin did show reversibility of this
adverse effect.
In controlled studies, a higher proportion of patients treated with pregabalin reported blurred vision than did
patients treated with placebo which resolved in a majority of cases with continued dosing. In the clinical studies
where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes
was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes
was greater in placebo-treated patients.
In the postmarketing experience, visual adverse reactions have also been reported, most of which refer to
transient vision loss, visual blurring or other changes of visual acuity. Discontinuation of pregabalin may result
in resolution or improvement of these visual symptoms.
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents. A meta-
analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of
suicidal ideation and behaviour. The data does not exclude the possibility of an increased risk for pregabalin.
Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be
considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of
suicidal ideation or behaviour emerge.
Insufficient data for withdrawal of concomitant antiepileptic medication, once seizure control with adjunctive
Lyrica has been reached, in order to reach monotherapy with Lyrica. After discontinuation of short and long-
term treatment withdrawal symptoms have been observed in some patients; insomnia, headache, nausea,
anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion (including epilepticus and grand
mal convulsion can occur during treatment and shortly after withdrawal), sweating and dizziness. The patient
should be informed about this at the start of the treatment. Concerning discontinuation of long-term treatment
there are no data of the incidence and severity of withdrawal symptoms in relation to duration of use and dosage
of pregabalin. (see side effects). There have been post-marketing reports of congestive heart failure in some
patients receiving pregabalin. These were mostly elderly, cardiovascular compromised patients who received
treatment for a neuropathic indication. Pregabalin should be used with caution in these patients. Discontinuation
of pregabalin may resolve the reaction. There have been post-marketing reports of reduced lower
gastrointestinal tract function when pregabalin is co-administrated with medication that has the potential to
produce constipation (i.e. opioid analgesics). Measures to prevent constipation may be considered. Cases of
abuse (take care in patient with a history of abuse) and encephalopathy (take care in patients with underlying
conditions) has been reported.
Ability to drive and use machines: May affect ability to drive or operate machinery.
Interactions: Pregabalin appears to be additive in the impairment of cognitive and gross motor function caused
by oxycodone and may potentiate the effects of ethanol and lorazepam. In the postmarketing experience, there
are reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medications.
Pregnancy and lactation: Lyrica should not be used during pregnancy unless benefit outweighs risk. Effective
contraception must be used in women of childbearing potential. Breast-feeding is not recommended during
treatment with Lyrica. Fertility: There is no clinical data on the effect of pregabalin on female fertility. In
clinical trials there was no effect on sperm mobility in healthy males after 3 months of treatment with a dose of
600 mg/day.
Side effects:
Adverse reactions during clinical trials were usually mild to moderate. Most commonly (>1/10)
reported side effects in placebo-controlled, double-blind studies were somnolence and dizziness. Commonly
(>1/100, <1/10) reported side effects were appetite increased, euphoric mood, confusion, libido decreased,
irritability, ataxia, disturbance in attention, coordination abnormal, memory impairment, tremor, dysarthria,
paraesthesia, vision blurred, diplopia, disorientation, balance disorder, insomnia, vertigo, dry mouth,
constipation, vomiting, flatulence, erectile dysfunction, fatigue, oedema peripheral, feeling drunk, lethargy,
sedation, oedema, gait abnormal and weight increased. See SmPC for less commonly reported side effects.
After discontinuation of short and long-term treatment withdrawal symptoms have been observed in some
patients; insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain,
hyperhidrosis and dizziness. Concerning discontinuation of long-term treatment there are no data of the
incidence and severity of withdrawal symptoms in relation to duration of use and dosage of pregabalin. (see
warnings and precautions)
In the post-marketing experience, the most commonly reported adverse events observed when pregabalin was
taken in overdose included somnolence, confusional state, agitation, and restlessness.
Legal category: S1A
Date of revision: September 2010
Package quantities, marketing authorisation numbers:
Lyrica 25mg, EU/1/04/279/003, 56 caps;
Lyrica 25mg EU/1/04/279/004, 84 caps;
Lyrica 50mg, EU/1/04/279/009, 84 caps;
Lyrica 75mg, EU/1/04/279/012, 56 caps;
Lyrica 100mg, EU/1/04/279/015, 84 caps;
Lyrica 150mg, EU/1/04/279/018, 56 caps;
Lyrica 200mg, EU/1/04/279/021, 84 caps;
Lyrica 300mg, EU/1/04/279/024, 56 caps;
Marketing Authorisation Holder: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK.
Lyrica is a registered trade mark
LY 15_1
Further information
is available on request from:
Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Republic
of Ireland
References:
Date of Preparation

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