technetium tc 99m mertiatide kit
Pharmaranks rates Technetium Tc 99m Mertiatide Kit 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Technetium Tc 99m Mertiatide Kit (Technetium Tc-99m Mertiatide Kit) is a medication supplied as an injection, powder, lyophilized, for solution.
Technetium Tc-99m Mertiatide Kit · by Jubilant Draximage
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Technetium Tc-99m Mertiatide Kit
- Form
- Injectable
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Jubilant Draximage
- FDA application
- NDA216820
What is Technetium Tc 99m Mertiatide Kit?
From the FDA label:11.1 Chemical Characteristics Kit for the Preparation of Technetium Tc 99m Mertiatide Injection is a sterile, multiple-dose kit for the preparation of technetium Tc 99m mertiatide injection, a radioactive diagnostic agent for intravenous use. The active ingredient, betiatide, is N-[N-[N-[(benzoylthio) acetyl]glycyl]glycyl]-glycine and has a molecular weight of 367.38 g/mol. After reconstitution with sodium pertechnetate Tc 99m injection, the radioactive agent technetium Tc 99m mertiatide (disodium[N-[N-[N- (mercaptoacetyl) glycyl]glycyl] glycinato (2-) - N,N′,N″,S′]oxotechnetate (2-)) is formed in situ. Each 10 mL vial contains 1 mg betiatide, 20 mg lactose monohydrate, 40 mg sodium tartrate dihydrate, 0.07 mg (minimum) stannous chloride dihydrate and 0.2 mg (maximum) total tin expressed as stannous chloride dihydrate. Prior to lyophilization, hydrochloric acid is added for pH adjustment. The vial contents are sealed under argon. After radiolabeling with sodium pertechnetate Tc 99m injection, each vial contains up to 3,700 MBq (100 mCi) of technetium Tc 99m mertiatide in 0.9% sodium chloride injection in approximately 10 mL volume as a sterile, clear, and colorless solution with a pH between 5 and 6. betiatide-chem-stuct tc-99m-mertiatide 11.2 Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. The principal photon…
How to use
Instruct patients to drink a sufficient amount of water before administration and continue to drink and to void frequently following administration. ( 2.2 ) Recommended dose in adult patients:185 MBq to 370 MBq (5 mCi to 10 mCi) as an intravenous bolus injection. ( 2.3 ) Recommended dose in pediatric patients aged 30 days and older: 2.6 MBq/kg to 5.2 MBq/kg (0.07 mCi/kg to 0.14 mCi/kg) with a minimum dose of 37 MBq (1 mCi) as an intravenous bolus injection. ( 2.3 ) See Full Prescribing Information for radiation safety, drug preparation, administration, and radiation dosimetry information. ( 2.1 , 2.4 , 2.5 , 2.6 , 2.7 ) 2.1 Radiation Safety – Drug Handling After radiolabeling, the kit produces Technetium Tc 99m Mertiatide Injection. Handle Technetium Tc 99m Mertiatide Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions ( 5.1 )] . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Technetium Tc 99m Mertiatide Injection. Radiopharmaceuticals should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. 2.2 Patient…
Side effects
The following adverse reactions associated with the use of Technetium Tc 99m Mertiatide Injection were identified in clinical studies or postmarketing reports. Because some of these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac disorders : tachycardia. Gastrointestinal disorders : nausea, vomiting. General disorders and administration site conditions : shaking chills, fever. Nervous system disorders : seizure. Respiratory, thoracic and mediastinal disorders : wheezing, dyspnea. Skin and subcutaneous tissue disorders : itching, rash. Vascular disorders : elevation in blood pressure. Reported adverse reactions are: tachycardia, nausea, vomiting, shaking chills, fever, seizure, wheezing, dyspnea, itching, rash, and elevation in blood pressure. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc. at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
Important safety information
Radiation risks: Ensure safe handling to minimize radiation exposure to patients and healthcare providers. ( 5.1 ) 5.1 Radiation Risks Technetium Tc 99m Mertiatide Injection contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration [ see Dosage and Administration ( 2.2 ) ] .
Who should not take Technetium Tc 99m Mertiatide Kit
None. None. (4)
Overdose — what happens if you take too much
In the event of an overdose of technetium Tc 99m mertiatide, hydration and frequent micturition should be encouraged to minimize the absorbed radiation dose to patient. A diuretic might also be considered. If possible, an estimate of the radiation effective dose given to the patient should be made.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- How is Technetium Tc 99m Mertiatide Kit rated?
- pharmaranks gives Technetium Tc 99m Mertiatide Kit a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Technetium Tc 99m Mertiatide Kit?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Technetium Tc 99m Mertiatide Kit. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Technetium Tc 99m Mertiatide Kit?
- Technetium Tc 99m Mertiatide Kit is marketed by Jubilant Draximage. You can see Jubilant Draximage's full profile, rating, and other products on pharmaranks.
- Is Technetium Tc 99m Mertiatide Kit a brand-name or generic drug?
- Technetium Tc 99m Mertiatide Kit is a brand-name product with the active ingredient Technetium Tc-99m Mertiatide Kit.
- Is Technetium Tc 99m Mertiatide Kit available over the counter?
- No. Technetium Tc 99m Mertiatide Kit is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Technetium Tc 99m Mertiatide Kit come in?
- Technetium Tc 99m Mertiatide Kit is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Technetium Tc 99m Mertiatide Kit FDA-registered?
- Technetium Tc 99m Mertiatide Kit is on record with the U.S. FDA under application number NDA216820. You can verify this on its official FDA label.
- Has Technetium Tc 99m Mertiatide Kit been recalled by the FDA?
- Technetium Tc 99m Mertiatide Kit has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Technetium Tc 99m Mertiatide Kit safe?
- There's no single safe-or-not verdict. pharmaranks gives Technetium Tc 99m Mertiatide Kit a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Technetium Tc 99m Mertiatide Kit?
- Technetium Tc 99m Mertiatide Kit's side effects are taken directly from its FDA label. From the label: The following adverse reactions associated with the use of Technetium Tc 99m Mertiatide Injection were identified in clinical studies or postmarketing reports. Because some of these reactions are voluntarily reported from a population of uncertain size,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
abiraterone acetate
Abiraterone Acetate
acular
Ketorolac Tromethamine
acular ls
Ketorolac Tromethamine
aimovig
Erenumab-Aooe
albendazole
Albendazole
alphagan p
Brimonidine Tartrate
Compare Technetium Tc 99m Mertiatide Kit head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
technetium tc 99m mertiatide kit
70/100