Sortal may be available in the countries listed below.
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Sortal in the following countries:
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Elmiron is a brand name of pentosan polysulfate sodium, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Elmiron available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Elmiron. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
There are no current U.S. patents associated with Elmiron.
Glacial Acetic Acid may be available in the countries listed below.
Glacial Acetic Acid (JAN, USAN) is known as Acetic Acid in the US.
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Glossary
| JAN | Japanese Accepted Name |
| USAN | United States Adopted Name |
MirtaPel may be available in the countries listed below.
Mirtazapine is reported as an ingredient of MirtaPel in the following countries:
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Famotab may be available in the countries listed below.
Famotidine is reported as an ingredient of Famotab in the following countries:
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In the US, Fluorescein (fluorescein/proparacaine ophthalmic) is a member of the drug class ophthalmic diagnostic agents.
US matches:
BAN
S01JA01
0002321-07-5
C20-H12-O5
332
Diagnostic agent, ophthalmic
Diagnostic agent, pancreas function
Spiro[isobenzofuran-1(3H),9'-[9H]xanthen]-3-one, 3',6'-dihydroxy-
Spiro[isobenzofuran-1(3H),9'-[9H]xanthen]-3-one, 3',6'-dihydroxy-, disodium salt
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| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
Brodilin may be available in the countries listed below.
Clenbuterol hydrochloride (a derivative of Clenbuterol) is reported as an ingredient of Brodilin in the following countries:
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Pravastatine Na Merck may be available in the countries listed below.
Pravastatin sodium salt (a derivative of Pravastatin) is reported as an ingredient of Pravastatine Na Merck in the following countries:
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Relieving occasional constipation.
Diocto Syrup is a stool softener. It works by helping fat and water into the stool mass to soften the stool.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Diocto Syrup. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Diocto Syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Diocto Syrup may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Diocto Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Diocto Syrup.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Bitter taste; cramping; diarrhea; nausea; throat irritation.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Diocto side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; stomach cramps.
Store Diocto Syrup at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep in a tight, light-resistant container. Keep Diocto Syrup out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Diocto Syrup. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Capocard may be available in the countries listed below.
Captopril is reported as an ingredient of Capocard in the following countries:
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Flixonase Nasal may be available in the countries listed below.
Fluticasone propionate (a derivative of Fluticasone) is reported as an ingredient of Flixonase Nasal in the following countries:
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Chloram may be available in the countries listed below.
Chloramphenicol is reported as an ingredient of Chloram in the following countries:
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Betamican Accuhaler may be available in the countries listed below.
Salmeterol xinafoate (a derivative of Salmeterol) is reported as an ingredient of Betamican Accuhaler in the following countries:
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Generic Name: risperidone (Intramuscular route)
ris-PER-i-done
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from the observational studies to what extent these mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Risperidone is not approved for the treatment of patients with dementia-related psychosis .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antipsychotic
Chemical Class: Benzisoxazole
Risperidone injection is used to treat the symptoms of psychotic (mental) disorders, such as schizophrenia. It may be used alone or together with other medicines (e.g., lithium or valproate) to treat patients with bipolar disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of risperidone injection in the pediatric population. Safety and efficacy have not been established.
Elderly people may be especially sensitive to the effects of risperidone. This may increase the chance of having side effects during treatment. This medicine should not be used for behavioral problems in older adults with dementia.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of risperidone injection in the elderly. However, elderly patients are more likely to have age-related heart problems, which may require caution and an adjustment in the dose for patients receiving risperidone injection.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into one of your muscles.
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Stop taking this medicine and check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
Risperidone injection can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine may cause drowsiness, trouble with thinking, or trouble with controlling body movements. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.
This medicine may make it more difficult for your body to cool itself down. Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke. Also, use extra care not to become too cold while you are taking risperidone injection. If you become too cold, you may feel drowsy, confused, or clumsy.
Risperidone injection may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.
This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicines including other narcotics; medicine for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Risperdal Consta side effects (in more detail)
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Diclonex may be available in the countries listed below.
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Diclonex in the following countries:
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In the US, Oxy Balance (salicylic acid topical) is a member of the drug class topical acne agents and is used to treat Acne and Perioral Dermatitis.
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Salicylic Acid is reported as an ingredient of Oxy Balance in the following countries:
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Vici Monico may be available in the countries listed below.
Ascorbic Acid is reported as an ingredient of Vici Monico in the following countries:
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The kit consists of reaction vials which contain the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Albumin Aggregated Injection for diagnostic use by intravenous injection.
Each 10 mL reaction vial contains 2.5 mg of albumin aggregated, 5.0 mg of Albumin Human, 0.06 mg (minimum) stannous chloride (maximum stannous and stannic chloride 0.11 mg) and 1.2 mg of sodium chloride; the contents are in a lyophilized form under an atmosphere of nitrogen. Sodium hydroxide or hydrochloric acid has been used for pH adjustment. No bacteriostatic preservative is present.
The Albumin Human was non-reactive when tested for Hepatitis-B Surface Antigen (HBsAg), antibodies to Human immunodeficiency Virus (HIV-1/HIV-2), antibody to Hepatitis C Virus (anti-HCV) and Antigen to Human Immunodeficiency Virus (HIV-1). The aggregated particles are formed by denaturation of Albumin Human in a heating and aggregation process. Each vial contains 4 to 8 million particles. By light microscopy, more than 90% of the particles are between 10 and 70 micrometers, while the typical average size is 20 to 40 micrometers; none is greater than 150 micrometers.
Technetium Tc 99m Albumin Aggregated Injection for intravenous use is in its final dosage form when sterile isotonic sodium pertechnetate solution is added to each vial. No less than 90% of the pertechnetate Tc-99m added to a reaction vial is bound to aggregate at preparation time and remains bound throughout the 6 hour lifetime of the preparation.
Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.1 The principal photon that is useful for detection and imaging studies is listed in Table 1
Table 1. Principal Radiation Emission Data
1 Kocher, David C.; “Radioactive Decay Data Tables’’, DOE/TIC-11026, 108, (1981) | ||
Radiation | Mean %/Disintegration | Mean Energy (keV) |
Gamma-2 | 89.07 | 140.5 |
® Registered Trademark of Jubilant DraxImage Inc.
EXTERNAL RADIATION
The specific gamma ray constant for Tc 99m is 0.78 R/mCi-hr at 1 cm. The first half value layer is 0.017 cm of lead. A range of values for the relative attenuation of the radiation resulting from the interposition of various thicknesses of lead is shown in Table 2. For example, the use of 0.25 cm thickness of lead will attenuate the radiation emitted by a factor of about 1000.
Table 2. Radiation Attenuation by Lead (Pb) Shielding
Shield Thickness (Pb) cm | Coefficient of Attenuation |
0.017 0.08 0.16 0.25 0.33 | 0.5 10-1 10-2 10-3 10-4 |
To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.
Table 3
Physical Decay Chart :Tc-99m half-life 6.02 hours
| * Calibration Time | |||
Hours | Fraction Remaining | Hours | Fraction Remaining |
0* 1 2 3 4 | 1.000 0.891 0.794 0.708 0.631 | 5 6 8 10 12 | 0.562 0.501 0.398 0.316 0.251 |
Immediately following intravenous injection, more than 80% of the albumin aggregated is trapped in the pulmonary alveolar capillary bed. The imaging procedure can thus be started as soon as the injection is complete. Assuming that a sufficient number of radioactive particles has been used, the distribution of radioactive aggregated particles in the normally perfused lung is uniform throughout the vascular bed, and will produce a uniform image. Areas of reduced perfusion will be revealed by a corresponding decreased accumulation of the radioactive particles, and are imaged as areas of reduced photon density.
Organ selectivity is a direct result of particle size. Below 1 to10 micrometers, the material is taken up by the reticuloendothelial system. Above 10 micrometers, the aggregates become lodged in the lung by a purely mechanical process. Distribution of particles in the lungs is a function of regional pulmonary blood flow.
The albumin aggregated is sufficiently fragile for the capillary micro-occlusion to be temporary. Erosion and fragmentation reduce the particle size, allowing passage of the aggregates through the pulmonary alveolar capillary bed. The fragments are then accumulated by the reticuloendothelial system.
Lung to liver ratios greater than 20:1 are obtained in the first few minutes post-injection. Elimination of the technetium Tc-99m aggregated albumin from the lungs occurs with a half-life of about 2 to 3 hours. Cumulative urinary excretion studies show an average of 20% elimination of the injected technetium Tc-99m dose 24 hours post-administration.
Following administration of technetium Tc-99m albumin aggregated by intraperitoneal injection, the radiopharmaceutical mixes with the peritoneal fluid. Clearance from the peritoneal cavity varies from insignificant, which may occur with complete shunt blockage, to very rapid clearance with subsequent transfer into the systemic circulation when the shunt is patent.
Serial images should be obtained of both the shunt and lung (target organ). However, an adequate evaluation of the difference between total blockage of the shunt and partial blockage may not be feasible in all cases.
Technetium Tc 99m Albumin Aggregated Injection is a lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients.
Technetium Tc 99m Albumin Aggregated Injection may be used in adults as an imaging agent to aid in the evaluation of peritoneovenous (LeVeen) shunt patency.
Technetium Tc 99m Albumin Aggregated Injection should not be administered to patients with severe pulmonary hypertension.
The use of Technetium Tc 99m Albumin Aggregated Injection is contraindicated in persons with a history of hypersensitivity reactions to products containing human serum albumin.
Although adverse reactions specifically attributable to Technetium Tc 99m Albumin Aggregated Injection have not been noted, the literature contains reports of deaths occurring after the administration of albumin aggregated to patients with pre-existing severe pulmonary hypertension. Instances of hemodynamic or idiosyncratic reactions to preparations of technetium Tc-99m albumin aggregated have been reported.
General
The contents of the kit before preparation are not radioactive. However, after the sodium pertechnetate Tc-99m is added, adequate shielding of the final preparation must be maintained.
In patients with right to left heart shunts, additional risk may exist due to the rapid entry of albumin aggregated into the systemic circulation. The safety of this agent in such patients has not been established. Hypersensitivity reactions are possible whenever protein-containing materials such as pertechnetate labeled albumin aggregated are used in man. Epinephrine, antihistamines, and cortico-steroids should be available for immediate use.
The intravenous administration of any particulate materials such as albumin aggregated imposes a temporary small mechanical impediment to blood flow. While this effect is probably physiologically insignificant in most patients, the administration of albumin aggregated is possibly hazardous in acute cor pulmonale and other states of severely impaired pulmonary blood flow.
The components of the kit are sterile and non-pyrogenic. It is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation.
Contents of the vials are intended only for use in the preparation of Technetium Tc 99m Albumin Aggregated Injection and are NOT to be administered directly to the patient.
The technetium Tc-99m labeling reactions involved depend on maintaining the stannous ion in the reduced state. Hence, sodium pertechnetate Tc-99m containing oxidants should not be employed.
The preparation contains no bacteriostatic preservative. Technetium Tc 99m Albumin Aggregated Injection should be stored at 2 to 8ºC (36 to 46ºF) and discarded 6 hours after reconstitution.
Technetium Tc 99m Albumin Aggregated Injection is physically unstable and consequently the particles settle with time. Failure to agitate the vial adequately before use may result in nonuniform distribution of radioactive particles.
If blood is drawn into the syringe, unnecessary delay prior to injection may result in clot formation in situ.
Do not use if clumping of the contents is observed.
Technetium Tc 99m Albumin Aggregated Injection, as well as other radioactive drugs, must be handled with care. Once sodium pertechnetate Tc 99m is added to the vial, appropriate safety measures must be used to minimize radiation exposure to clinical personnel. Care must also be taken to minimize the radiation exposure to patients in a manner consistent with proper patient management.
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc 99m Albumin Aggregated Injection affects fertility in males or females.
Pregnancy Category C
Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc 99m Albumin Aggregated Injection. It is also not known whether Technetium Tc 99m Albumin Aggregated Injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. There have been no studies in pregnant women. Technetium Tc 99m Albumin Aggregated Injection should be given to a pregnant woman only if clearly needed.
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 Tc-99m is excreted in human milk during lactation. Therefore, formula feedings should be substituted for breast feedings.
Pediatric Use
The lowest possible number of particles should be used in right-to-left shunting, in neonates, and in severe pulmonary disease.
The literature contains reports of deaths occurring after the administration of albumin aggregated to patients with pre-existing severe pulmonary hypertension. Instances of hemodynamic or idiosyncratic reactions to preparations of technetium Tc-99m albumin aggregated have been reported (see WARNINGS).
The recommended intravenous dose range for the average (70 kg) ADULT patient for lung imaging is 37 to 148 megabecquerels (1-4 millicuries) of Technetium Tc 99m Albumin Aggregated Injection after reconstitution with oxidant-free Sodium Pertechnetate Tc 99m Injection.
The suggested intraperitoneal dosage range used in the average patient (70 kg) for peritoneovenous (LeVeen) shunt patency evaluation is 37 to 111 megabecquerels (1 to 3 millicuries). Adequate measures should be taken to assure uniform mixing with peritoneal fluid. Serial images of both the shunt and target organ should be obtained and correlated with other clinical findings. Alternatively, the drug may be administered by percutaneous transtubal injection. The suggested percutaneous transtubal (efferent limb) dosage range for the average patient (70 kg) is 12 to 37 megabecquerels (0.3 to 1.0 millicurie) in a volume not to exceed 0.5 mL.
The recommended number of particles per single injection is 200 000 to 700 000 with the suggested number being approximately 350 000. Depending on the activity added and volume of the final reconstituted product, the volume of the dose may vary from 0.2 to 1.4 mL.
The number of particles available per dose of Technetium Tc 99m Albumin Aggregated Injection will vary depending on the physical decay of the technetium Tc- 99m that has occurred. The number of particles in any dose and volume to be administered may be calculated as follows:
Assume the average number of particles per vial = 6.0 x 106.
If:
VTc = volume of solution added to reaction vial
D = desired dose to be administered in MBq (mCi)
C = concentration at calibration time of sodium pertechnetate solution to be added to the reaction vial in MBq/mL (mCi/mL)
Va = volume to be administered in mL
P = number of particles in dose to be administered
Fr = fraction of technetium Tc-99m remaining after the time of calibration (see Table 3)
Then:
Va = D and P = Va x 6.0 x 106
C x Fr VTc
In PEDIATRIC patients, the suggested intravenous dose to be employed for perfusion lung imaging is in the range of 0.925 to 1.85 MBq per kilogram (25 to 50 μCi/kg) of body weight; a usual dose is 1.11 MBq per kilogram (30 μCi/kg), except in newborns, in whom the administered dose should be 7.4 to 18.5 MBq (200 to 500 μCi). Not less than the minimum dose of 7.4 MBq (200 μCi) should be employed for this procedure. The number of particles will vary with age and weight of the pediatric patient as indicated in Table 5.
Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit.
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Mix the contents of the vial by gentle inversion just prior to with drawing a patient dose.
Mix the contents of the syringe just before injection. If blood is drawn into the syringe, any unnecessary delay prior to injection may lead to clot formation. For optimum results and because of rapid lung clearance of the radiopharmaceutical, it is suggested that the patient be positioned under the imaging apparatus before administration. Slow injection is recommended. Lung imaging may begin immediately after intravenous injection of the radiopharmaceutical. Due to high kidney uptake, imaging later than one-half hour after administration will yield poor results.
RADIATION DOSIMETRY
The estimated absorbed radiation doses2 to an average ADULT patient (70 kg) from an intravenous injection of 148 MBq (4 mCi) of Technetium Tc 99m Albumin Aggregated Injection are shown in Table 4.
Table 4
Absorbed Radiation Doses
| 2 Method of calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11 (1975). | ||
Organs | mGy/148 MBq | rads/4 mCi |
Total body Lungs Liver Spleen Kidneys Bladder Wall 2.0 hr. void 4.8 hr. void Testes 2.0 hr. void 4.8 hr. void Ovaries 2.0 hr. void 4.8 hr. void | 0.60 8.8 0.72 0.68 0.44
1.2 2.2
0.24 0.26
0.30 0.34 | 0.060 0.88 0.072 0.068 0.044
0.12 0.22
0.024 0.026
0.030 0.034 |
In PEDIATRIC patients, the radiation absorbed doses using the maximum recommended dose for lung imaging are based on 1.85 MBq (50 μCi) per kilogram of body weight [except in the newborn where the maximum recommended dose of 18.5 MBq (500 μCi) is used] and are shown in Table 5, which lists the maximum dose for pediatric patients from newborn to adults. Note the recommendations regarding number of particles to be administered.
Table 6 represents the absorbed radiation dose resulting from the intraperitoneal administration of 111 megabecquerels (3 millicuries) of technetium Tc 99m albumin aggregated.
(1) 2.0 hour voiding interval | |||||||||||||
Age | Newborn | 1 year | 5 years | 10 years | 15 years | ||||||||
Weight (kg) | 3.5 | 12.1 | 20.3 | 33.5 | 55.0 | ||||||||
Max. Recommended Dose in Megabecquerels and Millicuries | MBq | mCi | MBq | mCi | MBq | mCi | MBq | mCi | MBq | mCi | |||
Range of Particles Administered | 10 000 to | 50 000 to | 200 000 to | 200 000 to | 200 000 to | ||||||||
Absorbed Radiation Dose in milliGreys and Rads for the Maximum Dose | mGy | rads | mGy | rads | mGy | rads | mGy | rads | mGy | rads | |||
ORGANS Total Body Lungs Liver Bladder Wall Ovaries Testes |
0.60 19.00 1.40 2.10 0.38 0.31 |
0.06 1.9 0.14 0.21(1) 0.038 0.031 |
0.30 6.60 0.60 1.50 0.20 0.13 |
0.03 0.66 0.06 0.15(1) 0.020 0.013 |
0.31 5.80 0.62 3.10 0.19 0.19 |
0.031 0.58 0.062 0.31(2) 0.019 0.019 |
0.48 8.70 1.80 3.90 0.44 0.20 |
0.048 0.87 0.18 0.39(2) 0.044 0.020 |
0.41 7.70 1.20 4.10 0.41 0.36 |
0.041 0.77 0.12 0.41 0.041 0.036 | |||
*Assumptions:
1. Used biologic data from Kaul et al., Berlin, 1973.
2. For the newborn, 1-year old, and 5-year old, the “S” values calculated from the preliminary phantoms of ORNL were used. The 10-year old, 15-year old and adult “S” values were taken from Henrichs et al., Berlin, 1980.
Table 6
Absorbed Radiation Doses
Organs | Shunt Patency | Shunt Patency | ||
mGy | rads | mGy | rads | |
Lung Ovaries & Testes Organs in the Peritoneal Cavity Total Body | 6.9 0.18 to 0.30
- 0.36 | 0.69 0.018 to 0.030
- 0.036 | 1.68 1.68
1.68 0.57 | 0.168 0.168
0.168 0.057 |
Assumptions:
Calculations for the absorbed radiation dose are based upon an effective half-time of 3 hours for the open shunt and 6.02 hours for the closed shunt and an even distribution of the radiopharmaceutical in the peritoneal cavity with no biological clearance.
HOW SUPPLIED
DRAXIMAGE® MAA
Kit for the Preparation of Technetium Tc 99m Albumin Aggregated Injection
Each kit contains 30 reaction vials, each vial containing in lyophilized form, sterile and non-pyrogenic:
Albumin Aggregated 2.5 mg
Albumin Human 5.0 mg
Stannous Chloride (minimum) 0.06 mg
(Maximum stannous and stannic chloride 0.11 mg)
Sodium Chloride 1.2 mg
HCl and / or NaOH has been used for pH adjustment. The vials are sealed under an atmosphere of nitrogen.
Thirty labels with radiation warning symbols and a package insert are supplied in each carton.
STORAGE
Store the unreconstituted reaction vials at 2 to 25ºC (36 to 77ºF). After labeling with Technetium Tc 99m, store the solution at 2 to 8ºC (36 to 46ºF) in a suitable lead shield and discard after 6 hours.
DIRECTIONS FOR PREPARATION
Note: Use aseptic procedures throughout and take precautions to minimize radiation exposure by use of suitable shielding. Waterproof gloves should be worn during the preparation procedure.
Before reconstituting a vial, it should be inspected for cracks and/or a melted plug or any other indication that the integrity of the vacuum seal has been lost.
To prepare Technetium Tc 99m Albumin Aggregated Injection:
Remove the protective disc from a reaction vial and swab the rubber septum with either an alcohol swab or a suitable bacteriostatic agent to disinfect the surface.
Place the vial in a suitable lead vial shield which has a fitted cap. Obtain 2 to 8 mL of a sterile pyrogen-free Sodium Pertechnetate Tc 99m Injection using a shielded syringe. The recommended maximum amount of Tc-99m to be added to a reaction vial is 3.7 GBq (100 mCi). Sodium pertechnetate Tc-99m solutions containing an oxidizing agent are not suitable for use.
Using a shielded syringe, add the Sodium Pertechnetate Tc 99m Injection to the reaction vial aseptically.
Place the lead cap on the vial shield and mix the contents of the shielded vial by repeated gentle inversion until all the material is suspended. Avoid formation of foam. Using proper shielding, the vial should be visually inspected to ensure that the suspension is free of foreign matter before proceeding. Do not administer if foreign particulates are found in the preparation. To ensure maximum tagging, allow the preparation to stand for 15 minutes after mixing.
Assay the product in a suitable calibrator, record the radioassay information on the label with radiation warning symbol, and attach it to the vial shield.
Withdrawals for administration must be made aseptically using a sterile needle (18 to 21 gauge) and syringe. Since the vials contain nitrogen to prevent oxidation of the complex, the vials should not be vented. If repeated withdrawals are made from the vial, replacement of the contents with air should be minimized.
The finished preparation should be refrigerated at 2 to 8ºC (36 to 46ºF) when not in use and discarded after 6 hours. (The preparation contains no bacteriostatic preservative.) The vial should also be retained during its life in the reaction vial shield with cap in place.
DISPOSAL
The residual materials may be discarded in the ordinary trash, provided the radioactivity in the vials and syringes measures no more than background with an appropriate low-range survey meter. All identifying labels should be destroyed before discarding.
This reagent kit is approved by the U.S. Nuclear Regulatory Commission for distribution to persons licensed to use byproduct material identified in §35.200 of 10 CFR Part 35, to persons who have a similar authorization issued by an Agreement State, and, outside the United States, to persons authorized by the appropriate authority.
Jubilant DraxImage Inc.
Kirkland, Québec, H9H 4J4 Canada.
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA017881 | 12/30/1987 | |
| Labeler - Jubilant DraxImage Inc. (243604761) |
| Registrant - Jubilant DraxImage Inc. (243604761) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Jubilant HollisterStier General Partnership | 246762764 | MANUFACTURE | |
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Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Edluar. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.