DRUG DESCRIPTION
Omnivist (gadopentetate dimeglumine) Injection is the N-methylglucamine salt of the gadolinium complex of diethylenetriamine pentaacetic acid, and is an injectable contrast medium for magnetic resonance imaging (MRI).
OMNIVIST (gadopentetate dimeglumine) Injection is provided as a sterile, clear, and colorless to slightly yellow aqueous solution for intravenous injection.
OMNIVIST (gadopentetate dimeglumine) Injection is a 0.5-mol/L solution of 1-deoxy-1-(methylamino)-D-glucitol dihydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl] glycinato (5-) ]gadolinate(2-)(2:1) with a molecular weight of 938, an empirical formula of C28H54GdN5O20, and has the following structural formula.
Each mL OMNIVIST of Injection contains 469.01 mg gadopentetate dimeglumine, 0.99 mg meglumine, 0.40 mg diethylenetriamine pentaacetic acid and water for injection. OMNIVIST (gadopentetate dimeglumine) Injection contains no antimicrobial preservative.
- INDICATIONS
- Central Nervous System
- OMNIVIST (gadopentetate dimeglumine) Injection is indicated for use with magnetic resonance imaging (MRI) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. OMNIVIST (gadopentetate dimeglumine) Injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors.
- Extracranial/Extraspinal Tissues
- OMNIVIST (gadopentetate dimeglumine) is indicated for use with MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the head and neck.
- Body
OMNIVIST (gadopentetate dimeglumine) Injection is indicated for use in MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the body.
- DOSAGE AND ADMINISTRATION
- The recommended dosage of OMNIVIST (gadopentetate dimeglumine) Injection is 0.2 mL/kg (0.1 mmol/ kg) administered intravenously, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 lbs has not been studied systematically.
- Drug Handling: To ensure complete injection of the contrast medium, the injection should be followed by a 5-mL normal saline flush. The imaging procedure should be completed within 1 hour of injection of OMNIVIST (gadopentetate dimeglumine) Injection.
- Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present.
- Any unused portion must be discarded in accordance with regulations dealing with the disposal of such materials.
- HOW SUPPLIED
- OMNIVIST (gadopentetate dimeglumine) Injection is a clear, colorless to slightly yellow solution containing 469.01 mg/ mL of gadopentetate dimeglumine. OMNIVIST (gadopentetate dimeglumine) Injection is supplied in the following sizes:
- OMNIVIST 10mL equal to 4.69g,
- OMNIVIST 15mL equal to 7.04,
- OMNIVIST 20mL equal to 9.38g
- Storage
- OMNIVIST (gadopentetate dimeglumine) Injection should be stored at controlled room temperature, between 15-30° C (59- 86° F) and protected from light. DO NOT FREEZE. Should freezing occur in the vial OMNIVIST (gadopentetate dimeglumine) Injection should be brought to room temperature before use. If allowed to stand at room temperature for a minimum of 90 minutes, OMNIVIST (gadopentetate dimeglumine) Injection should return to a clear, colorless to slightly yellow solution. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged. Should solids persist, discard vial.
Available at all leading pharmacies in Pakistan
on prescription only.
For further queries.
Tel: +92 21 34123535, 34123636, 0346-3636201
UAN: +92 21 111-graton (472-866)
Fax: +92 21 34937304
Email: info@gratonpharma.com
Web: www.gratonpharma.com |
