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Annex i

NAME OF THE MEDICINAL PRODUCT
DaTSCAN 74 MBq/ml solution for injection QUALITATIVE AND QUANTITATIVE COMPOSITION
Ioflupane (123I) 74 MBq/ml at reference time (0.07-0.13 μg/ml of ioflupane). 2.5 ml vials contain 185 MBq and 5 ml vials contain 370 MBq ioflupane (123I) (specific activity range 2.5-4.5 x 1014 Bq/mmol) at reference time. This medicinal product contains 5% volume ethanol. For a full list of excipients see section 6.1 PHARMACEUTICAL FORM
Solution for injection. Clear colourless solution 4. CLINICAL
PARTICULARS
4.1 Therapeutic
indications
This medicinal product is for diagnostic use only. DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum: • In patients with clinically uncertain Parkinsonian Syndromes, in order to help differentiate Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinson’s Disease, Multiple System Atrophy and Progressive Supranuclear Palsy. DaTSCAN is unable to discriminate between Parkinson's Disease, Multiple System Atrophy and Progressive Supranuclear Palsy. To help differentiate probable dementia with Lewy bodies from Alzheimer’s disease. DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia. Posology and method of administration
DaTSCAN should only be used in patients referred by physicians experienced in the management of movement disorders and/or dementia. Radiopharmaceutical agents should only be used by qualified personnel with the appropriate government authorisation for the use and manipulation of radionuclides within a designated clinical setting. DaTSCAN is a 5% (v/v) ethanolic solution for intravenous injection and should be used without dilution. Clinical efficacy has been demonstrated across the range 111-185 MBq. Do not exceed 185 MBq and do not use when the activity is below 110 MBq. In the event of overdosage, refer to section 4.9. To minimise the potential for pain at the injection site during administration, a slow intravenous injection (not less than 15-20 seconds) via an arm vein is recommended. Patients must undergo appropriate thyroid blocking treatment prior to injection to minimise thyroid uptake of radioactive iodine, for example by oral administration of approximately 120 mg potassium iodide 1-4 hours prior to injection and again 12-24 hours post-injection of DaTSCAN. SPECT imaging should take place between three and six hours post-injection. Images should be acquired using a gamma camera fitted with a high-resolution collimator and calibrated using the 159 keV photopeak and a ± 10% energy window. Angular sampling should preferably be not less than 120 views over 360 degrees. For high resolution collimators the radius of rotation should be consistent and set as small as possible (typically 11-15cm). Experimental studies with a striatal phantom, suggest that optimal images are obtained with matrix size and zoom factors selected to give a pixel size of 3.5-4.5 mm for those systems currently in use. A minimum of 500k counts should be collected for optimal images. Normal images are characterised by two symmetrical crescent-shaped areas of equal intensity. Abnormal images are either asymmetric or symmetric with unequal intensity and/or loss of crescent. DaTSCAN is not recommended for use in children or adolescents due to a lack of data on safety and efficacy. 4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients. Pregnancy. Special warnings and precautions for use
This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and the appropriate licences of the local competent official organisations. Formal studies have not been carried out in patients with significant renal or hepatic impairment. In the absence of data, DaTSCAN is not recommended in cases of moderate to severe renal or hepatic impairment. This medicinal product contains 5% volume ethanol (alcohol), up to 197 mg per dose, equivalent to 5 ml beer, 2 ml wine. Harmful for those suffering from alcoholism. To be taken into account in high-risk groups such as patients with liver disease or epilepsy. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed in humans. Ioflupane binds to the dopamine transporter. Medicines that bind to the dopamine transporter with high affinity may therefore interfere with DaTSCAN diagnosis. These include amfetamine, benzatropine, buproprion, cocaine, mazindol, methylphenidate, phentermine and sertraline. Medicines shown during clinical trials not to interfere with DaTSCAN imaging include amantadine, trihexyphenidyl, budipine, levodopa, metoprolol, primidone, propranolol and selegiline. Dopamine agonists and antagonists acting on the postsynaptic dopamine receptors are not expected to interfere with DaTSCAN imaging and can therefore be continued if desired. Drugs shown in animal studies not to interfere with DaTSCAN imaging include pergolide. Pregnancy and lactation
DaTSCAN is contraindicated in pregnancy. Animal reproductive toxicity studies have not been performed with this product. Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus. Administration of ioflupane (123I) at a dose of 185 MBq results in an absorbed dose to the uterus of 3.0 mGy. A radiation dose above 0.5 mGy would be regarded as a potential risk to the foetus. Where it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy. Any woman who has missed a period should be assumed pregnant until proven otherwise. Where uncertainty exists, it is important that radiation exposure should be the minimum consistent with achieving satisfactory imaging. Alternative techniques which do not involve ionising radiation should be considered. It is not known whether ioflupane (123I) is excreted in human milk. Before administering a radioactive medicinal product to a breast-feeding mother, consideration should be given as to whether the investigation could be reasonably delayed until the mother has ceased breast-feeding and as to whether the most appropriate choice of radiopharmaceutical has been made, bearing in mind the secretion of radioactivity in breast milk. If administration is considered necessary, breast-feeding should be interrupted for 3 days and substituted by formula feeding. During this time, breast milk should be expressed at regular intervals and the expressed feeds should be discarded. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. 4.8 Undesirable
No serious adverse reactions related to DaTSCAN administration have been reported. The following
common (≥1/100 to <1/10) side effects are recognised for DaTSCAN:

Metabolism and nutrition disorders
Appetite increased

Nervous system disorders
Headache
Formication (paraesthesia)

Ear and labyrinth disorders
Vertigo
The following uncommon (≥1/1,000 to ≤1/100) side effects are recognised for DaTSCAN:

General disorders and administration site conditions
Injection site pain (intense pain following administration into small veins)
For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. The
activity administered must be such that the resulting radiation dose is as low as reasonably achievable
bearing in mind the need to obtain the intended diagnostic result. Exposure to ionising radiation is linked
with cancer induction and a potential for development of hereditary defects. For diagnostic nuclear
medicine investigations, the current evidence suggests that these adverse events will occur with
negligible frequency because of the low radiation dose incurred.
4.9 Overdose
In cases of overdosage of radioactivity, frequent micturition and defaecation should be encouraged in order to minimise radiation dosage to the patient. Care should be taken to avoid contamination from the radioactivity eliminated by the patient using such methods. 5. PHARMACOLOGICAL
PROPERTIES
5.1 Pharmacodynamic
properties
Pharmacotherapeutic group: Diagnostic radiopharmaceutical for central nervous system imaging, ATC
code: V09A B 03.
Due to the low quantities of ioflupane injected, pharmacological effects are not expected following
intravenous administration of DaTSCAN at the recommended dosage.

Ioflupane is a cocaine analogue. Studies in animals have shown that ioflupane binds with high affinity to
the presynaptic dopamine transporter and so radiolabelled ioflupane (123I) can be used as a surrogate
marker to examine the integrity of the dopaminergic nigrostriatal neurons. Ioflupane also binds to the
serotonin transporter on 5-HT neurons but with lower (approximately 10-fold) binding affinity.
There is no experience in types of tremor other than essential tremor.
Clinical studies in patients with dementia with Lewy bodies
In a pivotal clinical trial including evaluation of 288 subjects with dementia with Lewy bodies (DLB)
(144 subjects), Alzheimer’s disease (124 subjects), vascular dementia (9 subjects) or other (11 subjects),
the results of an independent, blinded visual assessment of the DaTSCAN images were compared to the
clinical diagnosis as determined by physicians experienced in the management and diagnosis of
dementias. Clinical categorisation into the respective dementia group was based on a standardised and
comprehensive clinical and neuropsychiatric evaluation. The values for the sensitivity of DaTSCAN in
determining probable DLB from non-DLB ranged from 75.0% to 80.2% and specificity from 88.6% to
91.4%. The positive predictive value ranged from 78.9% to 84.4% and the negative predictive value
from 86.1% to 88.7%. Analyses in which both possible and probable DLB patients were compared with
non-DLB dementia patients demonstrated values for the sensitivity of DaTSCAN ranging from 75.0%
to 80.2% and specificity from 81.3% to 83.9% when the possible DLB patients were included as
non-DLB patients. The sensitivity ranged from 60.6% to 63.4% and specificity from 88.6% to 91.4%
when the possible DLB patients were included as DLB patients.
5.2 Pharmacokinetic
properties
Ioflupane (123I) is cleared rapidly from the blood after intravenous injection; only 5% of the administered activity remains in whole blood at 5 minutes post-injection. Uptake in the brain is rapid, reaching about 7% of injected activity at 10 minutes post-injection and decreasing to 3% after 5 hours. About 30% of the whole brain activity is attributed to striatal uptake. At 48 hours post-injection, approximately 60% of the injected radioactivity is excreted in the urine, with faecal excretion calculated at approximately 14%. Preclinical safety data
Acute toxicity studies employing ioflupane at dosage levels of 0.06 mg/kg, in excess of 6,500 times the maximum human (70 kg) single dose on a bodyweight basis, failed to reveal any mortality or signs of systemic toxicity in rats or rabbits. In 14 day repeat dose studies no evidence of toxicity was observed in rats or rabbits following daily doses of 0.6 mg/kg ioflupane, more than 65,000 times the maximum human (70 kg) single dose on a bodyweight basis. Behavioural effects due to pharmacological activity were observed in these studies. Studies on reproductive toxicity have not been conducted. Ioflupane showed no evidence of mutagenic potential in in vitro or in vivo mutagenicity studies. Studies to assess the carcinogenic potential of ioflupane have not been performed. 6. PHARMACEUTICAL
PARTICULARS
List of excipients
Acetic acid Sodium acetate Ethanol Water for injections 6.2 Incompatibilities
6.3 Shelf-life
2.5 ml presentation: 7 hours from the activity reference time stated on the label (35 hours from the end of manufacture). 5.0 ml presentation: 20 hours from the activity reference time stated on the label (48 hours from the end of manufacture). Special precautions for storage
Nature and contents of container
The product is supplied in a single colourless 10 ml glass vial sealed with a rubber closure and metal overseal. The 2.5 ml presentation contains 185 MBq at reference in 2.5 ml of solution. The 5.0 ml presentation contains 370 MBq at reference in 5.0 ml of solution. Not all pack sizes may be marketed. Special precautions for disposal
Normal safety precautions for handling radioactive materials should be observed. After use, all materials associated with the preparation and administration of radiopharmaceuticals, including any unused product and its container, should be decontaminated or treated as radioactive waste and disposed of in accordance with the conditions specified by the local competent authority. Contaminated material must be disposed of as radioactive waste via an authorised route. MARKETING AUTHORISATION HOLDER
GE Healthcare Limited Little Chalfont Bucks HP7 9NA United Kingdom MARKETING AUTHORISATION NUMBERS
EU/1/00/135/001 (2.5 ml) EU/1/00/135/002 (5.0 ml) DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 27 July 2000 Date of last renewal: 27 July 2005 DATE OF REVISION OF THE TEXT
11 DOSIMETRY
Iodine-123 has a physical half-life of 13.2 hours. It decays emitting gamma radiation with a predominant energy of 159 keV and X-rays of 27 keV. The estimated absorbed radiation doses to an average adult patient (70 kg) from intravenous injection of ioflupane (123I) are listed below. The values are calculated assuming urinary bladder emptying at 4.8-hour intervals and appropriate thyroid blocking (Iodine-123 is a known Auger electron emitter). Frequent bladder emptying should be encouraged after dosing to minimise radiation exposure. Absorbed radiation dose
Target Organ
μGy/MBq
Effective Dose
The effective dose (E) resulting from administration of a 185 MBq dose of DaTSCAN injection is 4.35 mSv (per 70 kg individual). The above data are valid in normal pharmacokinetic behaviour. When renal or hepatic function is impaired, the effective dose and the radiation dose delivered to organs might be increased. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Any unused product or waste material should be disposed of in accordance with local requirements. See also section 6.6.

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