Nano Therapeutics Pvt. Ltd. - Heart Stent Manufacturing Company Surat, India
Nano Therapeutics Pvt. Ltd. - Heart Stent Manufacturing Company Surat, India

Brain Lesions MRI

Maxscan is indicated in adults and children 2 years of age and older to provide contrast enhancement during magnetic resonance imaging (MRI) of intracranial lesions with abnormal vascularity or those supected of causing an abnormality in the bold-brain barrier. Maxscan enhanced MRI helps in the diagnosis and characterization of neoplastic disease, acoustic neuroma, subacute infarction, inflammatory disease, certain vascular abnormalities and certain demyelinating abnormalities (e.g., multiple sclerosis). Maxscanis used in magnetic resonance (MR) studies to help differntiate changes that occur secondary to brain tumor resection (e.g., encephalomalacia, gliosis) or to postoperative irradiation or chemotherapy (e.g., edema, is chemia, demyelination, necrosis) from changes that represent residual or recurrent tumors to accurately assess treatment results. MRI with Maxscan is particularly useful in patients with normal unenchanted studies who have central nervous system (CNS) symptoms, in patients with CNS tumors that are difficult to separate from surrounding edema and in patients who have undergone surgery to differentiate recurrence of the lesions from postoperative changes. In patients with suspected meningitis, Maxscan enhanced MRI may be particularly useful in defining the active inflammatory process of the meninges and focal lesions.

Indications

Spinal Lesions MRI
Maxscan is indicated in adults to improve lwsion contrast during MR body imaging (excluding the heart) in the evaluation of suspected hepatic lesions, endornetrial or cervical carcinomas or pelvic masses, breast lesions (suspected or known), and musculoskeletal lesions. MRI of the breast is also used in patients with postoperative scarring and silicon implants to exclude or demonstrate Whole Body MRI

Whole Body MRI
Maxscan is indicated in adults and children 2 years of age and older to provid contrast enhancement and facilitate visualization of lesions in the spine and associated tissues. Maxscan provides enhanced contrast of epidural abscesses, which makes it possible to differentiate them from adjacent compressed thecal sac. lt facilitates the diagnosis of disk space infection and osteomyelitis. lt helps localize portions of paraspinal masses most likely to yield a positive percutaneous biopsy and it helps distinguish active spinal infections from those that have responded adequately to antibiotic therapy. Spinal Lesions MRI MRI with Maxscan may be useful in differentiating postoperative epidural fibrosis (scar tissue) from recurrent disk herniation in patients with symptoms of failed back surgery syndrome to avoid unnecessary and possibly damaging reoperation if scar tissue is the cause.

Cardiac MRI Maxscan enhanced MRI is used in the evaluation of patients with great vessel disease (e.g., aortic aneurysm, aortic dissection, congenital abnormalities, vena cava obstrugtion): in patients with ischemic cardiac disease to examine the heart for regions of wall thinning and intracardiac thrombus to assess chamber size, myocardial mass, wall motion, and wall thickening and to detect regions of acute infarction; and in patients with congenital heart disease to evaluate malrotations of the heart and for post-surgery assessment.Also, enhanced MRI helps in the assessment of coronary artery reperfusion after thrombolysis.

Adverse Reactions

Cardiovascular : Hypotension, vasodilation, pallor, phlebitis, nonspecific ECG changes, substemal pain, angina. GNS: headache, dizziness, agitation, paresthesia, tinnitus, visula field defect, convulsions, hyperesthesia.
Gastrointestinal : nausea, vomiting, gastrointestinal distress, stomach pain, thirst, increased salivation, taste abnormality.
Respiratory : dry mouth, throat irritation, rhinorrhea, wheezing, sneezing, laryngismus, cough, dyspnea/apnea.
Cutaneous / Mucous Membranes : rash, sweating, urticaria, pruritus.
Miscellaneous : injection site discomfort (coldness, burning, warmth, pain), toothache, generalized wealkness, fever, localized edema, tiredness, anaphylactoid reactions (characterized by cardiovascular, respiratory and cutaneous symptoms), conjunctivitis.

Precautions

Maxscan is to be administered strictly by i.v. injection. It will cause tissue irritation and pain if administered extravascularly or if it leaks interstitially. A sweet taste may be experienced briefly by patients receiving a bolus injection of Maxscan iv. Pregnancy / Reproduction Pregnancy. Adequate and well-controlled studies in humans have not been done. Although there if no evidence that the magnetic and electric fields associated with MRI have an effect on human development, in vitro studies and theoretical predictions raise concern regarding the risk of exposure to MR to the developing. embryo and foetus. More studies are needed to establish the safety of MRI in pregnant patients. Studies in rats with Maxscan at doses 2.5 times and in rabbits at doses 7.5 & 12.5 times the human dose have shown that this agent causes slight ret ardation in development.
Breast-feeding
Problems in humans have not been documented. Since Maxscan is distributed in small amounts into breast milk, temporary discontinuation of breast-feeding should be considered for at least 24 hours following its administration.

Dosage & Administration
  • Patient should be on fast for at least 2 hrs before the examination.
  • The drug is given as bolus injection and can be followed by contrast enhanced MRI
  • Maxscan should not be drawn into the syringe until immediately before use. Any unused portion must be discarded Maxscan on completion of the procedure.
  • The patient should be in supine position while administering the injection and should be kept under supine position for Maxscan at least half an hour after the injection.
  • Do not use the solution if it is discoloured or particulate matter is present.
  • The imaging procedure should be completed within 1 hour since optimal contrast is generally observed in cranial Maxscan investigations within 27 minutes following injection of Maxscan and in spinal investigations during the early post Maxscan administration phase (10 to 30 minutes). The following dosage guidelines apply to dults and children (above 2 years).
  • Recommended Dose: 0.2 ml / kg b.w. (0.1 mmol / kg. b.w.).
  • Route of Administration : IV. (into a large vein, if possible).
  • Rate of Administration : 10 ml / minute or as a bolus injection at 10 ml / i 5 seconds.
  • Maximum Toatal Dose : 20 ml.

To ensure complete injection of the contrast medium the injection should be followed by a 5m 1 normal saline flush If strong clinical suspicion of an intracranial or intraspinal lesion persists despite a normal MRI scan the diagnostic yield oft the examination may be giving another injection of Maxscan equivalent. to the original total dose within 30 minutes and performing MRI again.

Overdosage

Systemic consequences of overdose with Maxscan have not been reported.

Contraindications
  • Maxscan should not be administered to patients with known or suspected hypersensitivity to Gadopentetate Dimeglumine.
  • Renal failure
  • Sickle cell anaemia
Storage

Store at controlled room temperature 20°C to 30°C. Do not freeze. Protect from direct sunlight, Inspect container for particulate matter before use. Discard unused portion.