Drytec (Technetium Tc99m Generator)

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Overview

What is Drytec (Technetium Tc99m Generator)?

The Drytec (Technetium Tc99m Generator) is prepared with fission-produced molybdenum Mo99 adsorbed on alumina in a lead-shielded column and provides a means for obtaining sterile pyrogen-free solutions of Sodium Pertechnetate Tc99m Injection in sodium chloride. The eluate should be crystal clear. With a pH of 4.5-7.5, hydrochloric acid and/or sodium hydroxide may have been used for Mo99 solution pH adjustment. Over the life of the generator, each elution will provide a yield of > 90% of the theoretical amount of technetium Tc99m available from the molybdenum Mo99 on the generator column.

Each eluate of the generator should not contain more than 0.0056 MBq (0.15 µCi) of molybdenum Mo99 per 37 MBq (1 mCi) of technetium Tc99m per administered dose at the time of administration, and not more than 10 µg of aluminum per mL of the generator eluate, both of which must be determined by the user before administration.

Since the eluate does not contain an antimicrobial agent, it should not be used after twelve hours from the time of generator elution.

What does Drytec (Technetium Tc99m Generator) look like?

What are the available doses of Drytec (Technetium Tc99m Generator)?

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What should I talk to my health care provider before I take Drytec (Technetium Tc99m Generator)?

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How should I use Drytec (Technetium Tc99m Generator)?

The Drytec (Technetium Tc99m Generator) is a source of sodium pertechnetate Tc99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits.

Sodium Pertechnetate Tc99m Injection is used as an agent for:

Thyroid ImagingSalivary Gland ImagingUrinary Bladder Imaging (direct isotopic cystography) for detection of vesico-ureteral refluxNasolacrimal Drainage System Imaging (dacryoscintigraphy)

Sodium Pertechnetate Tc99m Injection is used as an agent for:

Thyroid ImagingUrinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux

Sodium Pertechnetate Tc99m Injection is usually administered by intravascular injection. For imaging the urinary bladder and ureters (direct isotopic cystography), the Sodium Pertechnetate Tc99m Injection is instilled aseptically into the bladder via a urethral catheter, following which the catheter is flushed with approximately 200 mL of sterile saline directly into the bladder. The dosage employed varies with each diagnostic procedure. When imaging the nasolacrimal drainage system, instill the Sodium Pertechnetate Tc99m Injection by the use of a device such as a micropipette or similar method which will ensure the accuracy of the dose.

The suggested dose ranges employed for various diagnostic indications in average ADULT patients (70 kg) are:

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 whenever solution and container permit.

The solution to be administered as the patient dose should be crystal clear and contain no particulate matter.

What interacts with Drytec (Technetium Tc99m Generator)?

None known.

What are the warnings of Drytec (Technetium Tc99m Generator)?

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Radiation risks associated with the use of Sodium Pertechnetate Tc99m Injection are greater in pediatric patients than in adults. In general, the younger the patient, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving pediatric patients.

Long-term cumulative radiation exposure is associated with increased risk of cancer.

What are the precautions of Drytec (Technetium Tc99m Generator)?

General

Drytec generators received in advance of the calibration date and time will contain higher amounts of radioactive material. Care should be taken to assure that the generator is properly shielded. As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to insure minimum radiation exposure to occupational workers.

After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimize the radiation dose.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Since the eluate does not contain an antimicrobial agent, it should not be used after twelve hours from the time of generator elution.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether technetium Tc99m may affect fertility in males or females.

Pregnancy Category C

Animal reproductive studies have not been conducted with technetium Tc99m. It is also not known whether technetium Tc99m can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Technetium Tc99m should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.

Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

Nursing Mothers

Technetium Tc99m is excreted in human milk during lactation, and therefore formula feedings should be substituted for breast feedings.

Pediatric Use

See . See also description of additional risk under .

What are the side effects of Drytec (Technetium Tc99m Generator)?

Allergic reactions including anaphylaxis have been reported infrequently following the administration of sodium pertechnetate Tc99m.

What should I look out for while using Drytec (Technetium Tc99m Generator)?

None known.

Radiation risks associated with the use of Sodium Pertechnetate Tc99m Injection are greater in pediatric patients than in adults. In general, the younger the patient, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving pediatric patients.

Long-term cumulative radiation exposure is associated with increased risk of cancer.

What might happen if I take too much Drytec (Technetium Tc99m Generator)?

Sorry No Records found

How should I store and handle Drytec (Technetium Tc99m Generator)?

Store the generator and the eluate, Sodium Pertechnetate Tc99m Injection, below 25°C (77°F). Do not freeze.Store the saline eluent vial below 25°C (77°F). Do not freeze.Storage should be in accordance with local regulations for radioactive materials.Store the generator and the eluate, Sodium Pertechnetate Tc99m Injection, below 25°C (77°F). Do not freeze.Store the saline eluent vial below 25°C (77°F). Do not freeze.Storage should be in accordance with local regulations for radioactive materials.Store the generator and the eluate, Sodium Pertechnetate Tc99m Injection, below 25°C (77°F). Do not freeze.Store the saline eluent vial below 25°C (77°F). Do not freeze.Storage should be in accordance with local regulations for radioactive materials.Sodium Pertechnetate Tc99m Injection is supplied as a molybdenum Mo99 / Drytec (Technetium Tc99m Generator) in sizes of molybdenum Mo99 from 2.5 GBq up to 100 GBq, 68 mCi up to 2703 mCi, at reference date and time specified on the generator label. The Drytec (Technetium Tc99m Generator) contains the following amount of molybdenum Mo99 at the reference time and date stated on the label.The Drytec (Technetium Tc99m Generator) consists of:The following items are provided in the :Additional quantities of these components are supplied at the customer's request to allow further elution of the generator. Additional components will be supplied as either one of the following two packs:Sodium Pertechnetate Tc99m Injection is supplied as a molybdenum Mo99 / Drytec (Technetium Tc99m Generator) in sizes of molybdenum Mo99 from 2.5 GBq up to 100 GBq, 68 mCi up to 2703 mCi, at reference date and time specified on the generator label. The Drytec (Technetium Tc99m Generator) contains the following amount of molybdenum Mo99 at the reference time and date stated on the label.The Drytec (Technetium Tc99m Generator) consists of:The following items are provided in the :Additional quantities of these components are supplied at the customer's request to allow further elution of the generator. Additional components will be supplied as either one of the following two packs:Sodium Pertechnetate Tc99m Injection is supplied as a molybdenum Mo99 / Drytec (Technetium Tc99m Generator) in sizes of molybdenum Mo99 from 2.5 GBq up to 100 GBq, 68 mCi up to 2703 mCi, at reference date and time specified on the generator label. The Drytec (Technetium Tc99m Generator) contains the following amount of molybdenum Mo99 at the reference time and date stated on the label.The Drytec (Technetium Tc99m Generator) consists of:The following items are provided in the :Additional quantities of these components are supplied at the customer's request to allow further elution of the generator. Additional components will be supplied as either one of the following two packs:Sodium Pertechnetate Tc99m Injection is supplied as a molybdenum Mo99 / Drytec (Technetium Tc99m Generator) in sizes of molybdenum Mo99 from 2.5 GBq up to 100 GBq, 68 mCi up to 2703 mCi, at reference date and time specified on the generator label. The Drytec (Technetium Tc99m Generator) contains the following amount of molybdenum Mo99 at the reference time and date stated on the label.The Drytec (Technetium Tc99m Generator) consists of:The following items are provided in the :Additional quantities of these components are supplied at the customer's request to allow further elution of the generator. Additional components will be supplied as either one of the following two packs:Sodium Pertechnetate Tc99m Injection is supplied as a molybdenum Mo99 / Drytec (Technetium Tc99m Generator) in sizes of molybdenum Mo99 from 2.5 GBq up to 100 GBq, 68 mCi up to 2703 mCi, at reference date and time specified on the generator label. The Drytec (Technetium Tc99m Generator) contains the following amount of molybdenum Mo99 at the reference time and date stated on the label.The Drytec (Technetium Tc99m Generator) consists of:The following items are provided in the :Additional quantities of these components are supplied at the customer's request to allow further elution of the generator. Additional components will be supplied as either one of the following two packs:

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Clinical Information

Chemical Structure

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Clinical Pharmacology

The pertechnetate ion distributes in the body similarly to the iodide ion, but is not organified when trapped in the thyroid gland. It also concentrates in the thyroid gland, salivary glands, gastric mucosa, and choroid plexus. However, in contrast to the iodide ion, the pertechnetate ion is released unchanged from the thyroid gland.

After intravascular administration, the pertechnetate ion gradually equilibrates with the extracellular space. A fraction is promptly excreted via the kidneys.

Following the administration of Sodium Pertechnetate Tc99m Injection as an eye drop, the drug mixes with tears within the conjunctival space. Within seconds to minutes it leaves the conjunctival space and escapes into the inferior meatus of the nose through the nasolacrimal drainage system. During this process the pertechnetate ion passes through the canaliculi, the lacrimal sac and the nasolacrimal duct. In the event of any anatomical or functional blockage of the drainage system there will be a backflow resulting in tearing (epiphora). Thus, the pertechnetate escapes the conjunctival space in the tears.

While the major part of the pertechnetate escapes within a few minutes of normal drainage and tearing, it has been documented that there is some degree of transconjunctival absorption with a fractional turnover rate of 0.015/min. in normal individuals, 0.021/min. in patients without any sac, and 0.027/min. in patients with inflamed conjunctiva due to chronic dacryocystitis. Individual values may vary, but these rates are probably representative and indicate that the maximum possible pertechnetate absorbed will remain below one thousandth of that used in other routine diagnostic procedures.

Non-Clinical Toxicology

None known.

Radiation risks associated with the use of Sodium Pertechnetate Tc99m Injection are greater in pediatric patients than in adults. In general, the younger the patient, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving pediatric patients.

Long-term cumulative radiation exposure is associated with increased risk of cancer.

Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing (see Pediatric Use under ) and anaphylactoid reactions (see ).

Concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymixin B, colistin, viomycin, or cisplatin, when indicated, requires careful monitoring.

Drytec generators received in advance of the calibration date and time will contain higher amounts of radioactive material. Care should be taken to assure that the generator is properly shielded. As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to insure minimum radiation exposure to occupational workers.

After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimize the radiation dose.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Since the eluate does not contain an antimicrobial agent, it should not be used after twelve hours from the time of generator elution.

Allergic reactions including anaphylaxis have been reported infrequently following the administration of sodium pertechnetate Tc99m.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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