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What I’ve missed in the First Pass...
7 Increasing diagnostic confi dence
and reproducibility*
7 Multiple station imaging with one injection
7 Low dose due to very high relaxivity**
The First Blood Pool Agent 7 High resolution MRA
* Goyen M, et. al. MR angiography of aortoiliac occlusive disease: a phase III study of the safety and effectiveness of the blood-pool contrast agent MS-325. Radiology. 2005 Sep; 236(3): 825-33
** Rohrer M, et. al. Comparison of magnetic properties of MRI contrast media solutions at different magnetic field strengths. Invest Radiol. 2005 Nov; 40(11): 715-24
Vasovist® 0.25 mmol/ml, solution for injection. Composition: 1 ml Vasovist® solution for injection contains 244 mg (0.25 mmol) of gadofosveset trisodium as active substance. 10 ml solution contains 2.44 g, 15 ml solution contains 3.66 g and 20 ml solution
contains 4.88 g of gadofosveset trisodium in a vial. Excipients: Fosveset, sodium hydroxide, hydrochloric acid, water for injections. Indications: This medicinal product is for diagnostic use only. Vasovist® is indicated for contrast-enhanced magnetic resonance
angiography for visualisation of abdominal or limb vessels in patients with suspected or known vascular disease. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special warnings: Diagnostic procedures involving the
use of MRI contrast agents should be conducted under the supervision of a physician with the prerequisite training. Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of potential
severe reactions to the contrast agent itself. The usual safety precautions for MRI must be observed. As with other contrast enhanced diagnostic procedures, post-procedure observation of the patient is recommended. Hypersensitivity warning: The possibility of
a reaction, including serious, life-threatening, fatal, anaphylactoid, or cardiovascular reactions, or other idiosyncratic reactions should always be considered especially in those patients with a known clinical hypersensitivity, previous reaction of contrast media,
a history of asthma, or other allergic disorders. Delayed reactions may occur (after hours to days). Caution should also be exercised in the following cases: Hypersensitivity reactions: If hypersensitivity reactions occur, administration of the contrast medium must
be discontinued immediately and – if necessary – specific therapy instituted via a venous access. It is therefore advisable to use a flexible indwelling cannula for i.v. contrast medium administration. Due to the possibility of severe hypersensitivity reactions after
intravenous contrast administration, preparedness for institution of emergency measures is necessary, e.g., appropriate medicinal products, an endotracheal tube, and a respirator should be at hand. Renal impairment: Since gadofosveset is cleared from the body
primarily by urinary excretion, caution should be exercised in patients with impaired renal function. Dose adjustment in renal impairment is not necessary. There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-
containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min / 1.73 m
2
) or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period. As there is a possibility
that NSF may occur with Vasovist®, it should therefore only be used in these patients after careful risk/benefit assessment, and if the diagnostic information cannot be obtained by other means. All patients should be screened, in particular patients over the age
of 65, for renal dysfunction by obtaining a history and/or laboratory tests. Haemodialysis shortly after Vasovist® administration in patients currently receiving haemodialysis may be useful at removing Vasovist® from the body. In a clinical trial it was shown that
gadofosveset can effectively be removed from the body by dialysis using high flux filters. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis. Electrocardiographic
Changes: Elevated levels of gadofosveset (e.g. repeated use in the short term [within 6 – 8 hours], or an inadvertent overdose > 0.05 mmol/kg) may be associated with mild QT prolongation (8.5 msec by Fridericia correction). In the situation of elevated levels of
gadofosveset or underlying QT prolongation the patient should be carefully observed including cardiac monitoring. Undesirable effects: The most common adverse drug-related reactions were pruritus, paresthesia, headache, nausea, vasodilatation, burning
sensation and dysgeusia. Most of the undesirable effects were mild to moderate in intensity. Most of the adverse reactions (80%) occurred within 2 hours. Delayed reactions (after hours to days) may occur. In clinical trials five serious adverse events have been
reported in patients who received 0.03 mmol/kg gadofosveset. These events were coronary artery disease, hyperglycemia, gangrene, chest pain and anaphylactoid reaction. The anaphylactoid reaction was considered as probably related and was resolved within
5 minutes. The frequencies of the adverse drug-related reactions reported below are based on clinical trial data (n = 1,321 patients) covering all doses (relationship attributed by the clinical investigator). Infections and infestations: Nasopharyngitis, cellulitis, urinary
tract infection. Immune system disorders: Hypersensitivity. Metabolism and nutrition disorders: Hyperglycaemia, hypocalcemia, hypokalemia, hyperkalemia, electrolyte imbalance, hypernatremia, decreased appetite. Psychiatric disorders: Anxiety, hallucination, ing Date: 28.05.2008
abnormal dreams. Nervous system disorders: Headache, paraesthesia, dysgeusia, burning sensation, ageusia, dizziness (excl. vertigo), tremor, hypoesthesia, parosmia, muscle contractions involuntary. Eye disorders: Lacrimation increased, asthenopia, abnormal
sensation in eye. Ear and labyrinth disorders: Ear pain. Cardiac disorders: Atrioventricular block first degree, tachycardia, cardiac flutter, myocardial ischaemia, atrial fibrillation, bradycardia, palpitations. Vascular disorders: Vasodilatation, hypertension, phlebitis,
arteriosclerosis, hypotension. Respiratory, thoracic and mediastinal disorders: Dyspnea, respiratory depression, cough. Gastrointestinal disorders: Nausea, vomiting, retching, diarrhoea, abdominal discomfort, abdominal pain, dry mouth, flatulence, hypoesthesia Publish
lips, salivary hypersecretion, dyspepsia, pharyngolaryngeal pain. Skin and subcutaneous tissue disorders: Pruritus, urticaria, erythema, rash, sweating increased, clamminess. Musculoskeletal, connective tissue and bone disorders: Muscle cramps, muscle spasms,
neck pain, pain in limb, muscle tightness, sensation of heaviness. Renal and urinary disorders: Hematuria, microalbuminuria, glycosuria, micturition urgency, renal pain, urinary frequency. Reproductive system and breast disorders: Pelvic pain. General disorders
and administration site conditions: Feeling cold, pain, chest pain, fatigue, feeling abnormal, groin pain, injection site pain, injection site coldness, injection site erythema, pyrexia, rigors (chills), weakness, chest pressure sensation, feeling hot, injection site
thrombosis, injection site bruising, injection site inflammation, injection site burning, injection site extravasation, injection site haemorrhage, injection site pruritus, sensation of pressure. Investigations: Electrocardiogram QT prolonged, electrocardiogram ST
segment depression, electrocardiogram T wave amplitude decreased, electrocardiogram abnormal. Injury and poisoning: Anaphylactoid reaction, phantom limb pain. As with other intravenous contrast agents, this medicinal product can be associated with
anaphylactoid / hypersensitivity reactions characterised by cutaneous, respiratory and/or cardiovascular manifestations which may lead to shock. Date of preparation of this text is November 2007. Please note! For current prescribing information refer to the
package insert and/or contact your local Bayer Schering Pharma organisation. Bayer Schering Pharma AG, 13342 Berlin, Germany,
www.bayer-schering-diagnostics.de Adverse reactions can be reported to
GPV.CaseProcessing@bayerhealthcare.com EU2008.1125
www.bloodpoolagents.com
8425_bs_va_ad_update_bl.indd 1 28.05.2008 16:37:10 Uhr
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