Betiatide

Prescription

الأسماء التجارية: Kit for the Preparation of Technetium Tc99m Mertiatide

الشكل الصيدلاني

Injection

طريق الإعطاء

INTRAVENOUS

الشركة المصنِّعة

Sun Pharmaceutical Industries, Inc.

About This Medication

DESCRIPTION Kit for the Preparation of Technetium Tc99m Mertiatide is used for the preparation of technetium Tc 99m mertiatide, a diagnostic radiopharmaceutical. It is supplied as a sterile, nonpyrogenic, lyophilized powder. Each vial contains betiatide (N-[N-[N-[(benzoylthio) acetyl]glycyl]glycyl]-glycine). After reconstitution with sterile sodium pertechnetate Tc 99m injection, the technetium Tc 99m mertiatide (disodium[N-[N-[N-(mercaptoacetyl) glycyl]glycyl] glycinato (2-) - N,N′,N″,S′]oxotechnetate (2-)) which is formed is suitable for intravenous administration. Each 10 milliliter vial contains 1 milligram betiatide, 0.05 milligram (minimum) stannous chloride dihydrate (SnCl 2 ∙2H 2 O) and 0.2 milligram (maximum) total tin expressed as stannous chloride dihydrate (SnCl 2 ∙2H 2 O), 40 milligrams sodium tartrate dihydrate (Na 2 C 4 H 2 O 6 ∙2H 2 O), and 20 milligrams lactose monohydrate. Prior to lyophilization, sodium hydroxide or hydrochloric acid may be added for pH adjustment. The pH of the reconstituted drug is between 5.0 and 6.0. No bacteriostatic preservative is present. The contents are sealed under argon. Betiatide is light sensitive and must be protected from light. Betiatide and technetium Tc 99m mertiatide have the following structural formulas: Chemical Structure

المواد الفعالة

المادة الفعالة	التركيز
Betiatide	-

المؤشرات العلاجية والاستخدام

INDICATIONS AND USAGE Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See Pediatric Use .) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.

الجرعة وطريقة الإعطاء

DOSAGE AND ADMINISTRATION The suggested dose range employed in the average adult patient (70kg) for renal function and imaging studies is 185 MBq (5 mCi) to 370 MBq (10 mCi). In pediatric patients the recommended dose range is 2.6 MBq/kg (70 μCi/kg) to 5.2 MBq/kg (140 μCi/kg) with a minimum dose of 37 MBq (1 mCi). The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Aseptic procedures and a shielded syringe should be employed in withdrawing doses for administration to patients. The user should wear waterproof gloves during the administration procedure.

Side Effects Overview

ADVERSE REACTIONS The following adverse reactions have been reported: nausea, vomiting, wheezing, dyspnea, itching, rash, tachycardia, hypertension, shaking chills, fever, and seizure.

التحذيرات والاحتياطات

WARNINGS None known.

موانع الاستعمال

CONTRAINDICATIONS None known.

Frequently Asked Questions

INDICATIONS AND USAGE Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See Pediatric Use .) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.

DOSAGE AND ADMINISTRATION The suggested dose range employed in the average adult patient (70kg) for renal function and imaging studies is 185 MBq (5 mCi) to 370 MBq (10 mCi). In pediatric patients the recommended dose range is 2.6 MBq/kg (70 μCi/kg) to 5.2 MBq/kg (140 μCi/kg) with a minimum dose of 37 MBq (1 mCi). The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Parenteral drug products should be inspected visually for …

WARNINGS None known.

CONTRAINDICATIONS None known.

Betiatide is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Betiatide drug label (National Library of Medicine)
• openFDA — Betiatide label data (U.S. Food & Drug Administration)
• NDC Directory — Betiatide (FDA National Drug Code)

إخلاء المسؤولية الطبية

المعلومات الواردة في هذه الصفحة مخصصة للأغراض التعليمية فقط ولا ينبغي استخدامها بديلًا عن المشورة الطبية المتخصصة أو التشخيص أو العلاج.

استشر دائمًا طبيبك أو أي مقدم رعاية صحية مؤهل بشأن أي أسئلة تتعلق بحالة طبية أو دواء.

مصادر البيانات: DailyMed (NLM), openFDA, MFDS