Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated
Generic Name: kit for the preparation of technetium tc 99m albumin aggregated
Brand Names:
Pulmotech Maa
11 DESCRIPTION 11.1 Product Characteristics PULMOTECH MAA contains albumin aggregated obtained by fractionating material (source blood, plasma, serum, or placentas) from healthy human donors. The macroaggregated albumin (MAA) particles are formed by heat denaturation of stannous chloride treated albumin human under controlled conditions. Each vial contains 2,000,000 to 4,000,000 particles.
Overview
11 DESCRIPTION 11.1 Product Characteristics PULMOTECH MAA contains albumin aggregated obtained by fractionating material (source blood, plasma, serum, or placentas) from healthy human donors. The macroaggregated albumin (MAA) particles are formed by heat denaturation of stannous chloride treated albumin human under controlled conditions. Each vial contains 2,000,000 to 4,000,000 particles.
Uses
1 INDICATIONS AND USAGE PULMOTECH MAA, after radiolabeling with technetium-99m, is indicated for: Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adults. PULMOTECH MAA, after radiolabeling with technetium-99m is a radioactive diagnostic agent indicated for: Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. ( 1 ) Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adults. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION For lung perfusion scintigraphy, the following recommended activity is administered by intravenous injection. • Adults : 37 MBq to 148 MBq (1 mCi to 4 mCi) and 200,000 particles to 700,000 particles. ( 2.3 ) • Pediatric patients aged 4 weeks and older : 0.925 MBq/kg to 1.85 MBq/kg of body weight (0.025 mCi/kg to 0.05 mCi/kg); the minimum activity is 7.4 MBq (0.2 mCi). The number of particles will vary with age and body weight of the pediatric patient. ( 2.3 ) • Pediatric patients aged less than 4 weeks : 7.4 MBq to 18.5 MBq (0.2 mCi to 0.5 mCi); 10,000 particles to 50,000 particles. ( 2.3 ) For peritoneovenous shunts scintigraphy in adults: 37 MBq to 111 MBq (1 mCi to 3 mCi) and 200,000 particles to 700,000 particles by intraperitoneal injection.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Patients with Pulmonary Hypertension [ see Warnings and Precautions ( 5.1 ) ] . Hypersensitivity Reactions [ see Warnings and Precautions ( 5.2 ) ] . The following adverse reactions associated with the use of technetium Tc 99m albumin aggregated products including PULMOTECH MAA have been identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Warnings
5 WARNINGS AND PRECAUTIONS Patients with P ulmonary H ypertension : Administer the lowest number of particles possible and have emergency resuscitation equipment available. ( 5.1 ) Hypersensitivity Reactions : Have emergency resuscitation equipment and trained personnel available. Interrupt the administration if a reaction occurs during administration. Monitor patients. ( 5.2 ) Risk of Temporary Impediment to Blood Flow in Patients with Right-to-Left Heart Shunts : Administer the lowest possible number of particles. ( 5.3 ) Radiation Risks : Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. 4 CONTRAINDICATIONS PULMOTECH MAA is contraindicated in patients with: Severe pulmonary hypertension [see Warnings and Precautions ( 5.1 ) ]. A history of hypersensitivity to albumin human. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.2 )]. Severe pulmonary hypertension. ( 4 ) A history of hypersensitivity reactions to albumin human. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available data from case reports on Technetium Tc 99m Albumin Aggregated Injection use are insufficient to evaluate drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies with technetium Tc 99m albumin aggregated have not been conducted.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied PULMOTECH MAA (kit for the preparation of technetium Tc 99m albumin aggregated) injection contains 2 mg of albumin aggregated as a white lyophilized powder in a multiple-dose reaction vial, sealed under an atmosphere of nitrogen, for radiolabeling with Sodium Pertechnetate Tc 99m Injection to prepare Technetium Tc 99m Albumin Aggregated Injection.
Frequently Asked Questions
What is Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated used for?▼
1 INDICATIONS AND USAGE PULMOTECH MAA, after radiolabeling with technetium-99m, is indicated for: Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adults. PULMOTECH MAA, after radiolabeling with technetium-99m is a radioactive diagnostic agent indicated for: Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. ( 1 ) Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adults. ( 1 )
What are the side effects of Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Patients with Pulmonary Hypertension [ see Warnings and Precautions ( 5.1 ) ] . Hypersensitivity Reactions [ see Warnings and Precautions ( 5.2 ) ] . The following adverse reactions associated with the use of technetium Tc 99m albumin aggregated products including PULMOTECH MAA have been identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Can I take Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from case reports on Technetium Tc 99m Albumin Aggregated Injection use are insufficient to evaluate drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies with technetium Tc 99m albumin aggregated have not been conducted.
What are the important warnings for Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated?▼
5 WARNINGS AND PRECAUTIONS Patients with P ulmonary H ypertension : Administer the lowest number of particles possible and have emergency resuscitation equipment available. ( 5.1 ) Hypersensitivity Reactions : Have emergency resuscitation equipment and trained personnel available. Interrupt the administration if a reaction occurs during administration. Monitor patients. ( 5.2 ) Risk of Temporary Impediment to Blood Flow in Patients with Right-to-Left Heart Shunts : Administer the lowest possible number of particles. ( 5.3 ) Radiation Risks : Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. 4 CONTRAINDICATIONS PULMOTECH MAA is contraindicated in patients with: Severe pulmonary hypertension [see Warnings and Precautions ( 5.1 ) ]. A history of hypersensitivity to albumin human. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.2 )]. Severe pulmonary hypertension. ( 4 ) A history of hypersensitivity reactions to albumin human. ( 4 )
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This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.