pulmotech maa
Pulmotech Maa (Technetium Tc99m Albumin Aggregated) is a medication supplied as an injection, powder, lyophilized, for suspension.
Technetium Tc99m Albumin Aggregated · by Cis Bio Intl
Key facts
- Active ingredient
- Technetium Tc99m Albumin Aggregated
- Form
- Injectable
- Strength
- Technetium TC99M Albumin Aggregated 2MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Cis Bio Intl
- FDA application
- BLA210089
What is Pulmotech Maa?
From the FDA label: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. The particle size distribution of the aggregated albumin is such that not less than 90% are 10 to 90 micrometers in size. There are no aggregated albumin particles greater than 150 micrometers in size as determined by circular equivalents. PULMOTECH MAA (kit for the preparation of technetium Tc 99m albumin aggregated) injection provides a sterile, non-pyrogenic, non-radioactive, 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, a radioactive diagnostic agent, for intravenous or intraperitoneal use. Each reaction vial contains 2 mg of albumin aggregated, albumin human (7.1 mg), stannous chloride (0.1 mg minimum; 0.22 mg maximum stannous and stannic), sodium chloride (9 mg). Hydrochloric acid may have been added for pH adjustment. The pH is between 5 and 7. It contains no preservatives. 11.2 Physical Characteristics Technetium-99m decays by…
How to use
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. ( 2.4 ) See Full Prescribing Information for radiation safety, patient preparation, drug preparation, administration, imaging, and radiation dosimetry information. ( 2.1 , 2.2 , 2.5 , 2.6 , 2.7 ) 2.1 Radiation Safety – Drug Handling After radiolabeling of PULMOTECH MAA, the vial contains Technetium Tc 99m Albumin Aggregated Injection. Handle Technetium Tc 99m Albumin Aggregated Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions ( 5.4 )] . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Technetium Tc 99m Albumin…
Side effects
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. Cardiovascular Disorders : Deaths in patients with severe pulmonary hypertension Immune System Disorders : Hypersensitivity reactions such as anaphylaxis, impairment of cardiac and circulatory functions in the form of changes in respiration, pulse, and blood pressure, chest pain, and syncope, urticaria, reddening of the face, sweating, and nausea Skin and Subcutaneous Tissue Disorders : Injection site reactions The following adverse reactions have been reported: Death in patients with severe pulmonary hypertension, anaphylaxis, impairment of cardiac and circulatory functions in the form of changes in respiration, pulse, and blood pressure, chest pain, and possible syncope, urticaria, reddening of the face, sweating, nausea, and injection site…
Warnings
Important safety information
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. ( 5.4 ) 5.1 Patients with Pulmonary Hypertension Deaths have been reported in patients with severe pulmonary hypertension after the administration of technetium Tc 99m albumin aggregated products [see Adverse Reactions ( 6 )] . Assess patients for history or signs of pulmonary hypertension. PULMOTECH MAA is contraindicated in patients with severe pulmonary hypertension [see Contraindications ( 4 )] . Administer the lowest number of particles possible, have emergency resuscitation equipment available, and monitor patients for adverse reactions . 5.2 Hypersensitivity Reactions Serious hypersensitivity reactions including anaphylaxis have been reported in patients treated with products containing albumin human, including PULMOTECH MAA [see Adverse Reactions ( 6 )] . Obtain a history of allergy or hypersensitivity reactions. PULMOTECH MAA is contraindicated in patients with a history of hypersensitivity to albumin human [see Contraindications ( 4 )] . Have emergency resuscitation equipment and trained personnel available prior to administration of Technetium Tc 99m Albumin Aggregated Injection. Monitor all patients for hypersensitivity reactions. 5.3 Risk of Temporary Impediment to Blood Flow in Patients with Right-to-Left Heart Shunts In patients with right-to-left heart shunts, risk for temporary mechanical impediment to blood flow may exist due to the rapid entry of aggregated albumin into the systemic circulation. Administer the lowest possible number of particles of Technetium Tc 99m Albumin Aggregated Injection in these patients. 5.4 Radiation Risks Technetium Tc 99m albumin aggregated 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 health care 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 Pulmotech Maa
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 )
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
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Use copay cards
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Frequently asked questions
- Is there a coupon or discount for Pulmotech Maa?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Pulmotech Maa. 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 Pulmotech Maa?
- Pulmotech Maa is marketed by Cis Bio Intl. You can see Cis Bio Intl's full profile, rating, and other products on pharmaranks.
- Is Pulmotech Maa a brand-name or generic drug?
- Pulmotech Maa is a brand-name product with the active ingredient Technetium Tc99m Albumin Aggregated.
- Is Pulmotech Maa available over the counter?
- No. Pulmotech Maa 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 Pulmotech Maa come in?
- Pulmotech Maa is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Pulmotech Maa FDA-registered?
- Pulmotech Maa is on record with the U.S. FDA under application number BLA210089. You can verify this on its official FDA label.
- Is Pulmotech Maa safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Pulmotech Maa. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Pulmotech Maa?
- Pulmotech Maa's side effects are taken directly from its FDA label. From the label: 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 ) ] .… 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.
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