Aurophen Infants Pain And Fever

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Uses

Sodium Fluoride F 18 Injection USP is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity.

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11.1 Chemical Characteristics

Sodium Fluoride F 18 Injection USP is a positron emitting radiopharmaceutical, containing no-carrier-added, radioactive fluoride F18 that is used for diagnostic purposes in conjunction with PET imaging. It is administered by intravenous injection. The active ingredient, sodium fluoride F18, has the molecular formula Na[18F] with a molecular weight of 40.99, and has the following chemical structure:

Sodium Fluoride F 18 Injection USP is provided as a ready-to-use, isotonic, sterile, pyrogen-free, preservative-free, clear and colorless solution. Each mL of the solution contains between 370 MBq to 7400 MBq (10 mCi to 200 mCi) sodium fluoride F18, at the EOS reference time, in 0.9% aqueous sodium chloride. The pH of the solution is between 4.5 and 8. The solution is presented in 10 mL, 25 ml, 30 ml, and 50 ml multiple- dose glass vials with variable total volume and total radioactivity in each vial.

11.2 Physical Characteristics

Fluoride F18 decays by positron (β+) emission and has a half-life of 109.7 minutes. Ninety-seven percent of the decay results in emission of a positron with a maximum energy of 633 keV and 3% of the decay results in electron capture with subsequent emission of characteristic X-rays of oxygen. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron (Table 2). Fluorine F18 atom decays to stable 18O-oxygen.

Table 2: Principal Emission Data for Fluoride F18
Radiation/Emission	% per Disintegration	Mean Energy
* Produced by positron annihilation [3] Kocher, D.C. Radioactive Decay Data Tables DOE/TIC-11026, 69, 1981.
Positron (β+)	96.73	249.8 keV
Gamma (±)*	193.46	511.0 keV

The specific gamma ray constant (point source air kerma coefficient) for fluoride F18 is 5.7 R/hr/mCi (1.35 x 10 -6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4 mm lead (Pb). A range of values for the attenuation of radiation results from the interposition of various thickness of Pb. The range of attenuation coefficients for this radionuclide is shown in Table 3. For example, the interposition of an 8 mm thickness of Pb with a coefficient of attenuation of 0.25 will decrease the external radiation by 75%.

Table 3:Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding
Shield Thickness (Pb) mm	Coefficient of Attenuation
0	0.00
4	0.50
8	0.25
13	0.10
26	0.01
39	0.001
52	0.0001

Table 4 lists the fraction of radioactivity remaining at selected time intervals from the calibration time. This information may be used to correct for physical decay of the radionuclide.

Table 4: Physical Decay Chart for Fluoride F18
Time Since Calibration	Fraction Remaining
* Calibration time
0*	1.00
15 minutes	0.909
30 minutes	0.826
60 minutes	0.683
110 minutes	0.500
220 minutes	0.250
440 minutes	0.060
12 hours	0.011
24 hours	0.0001

Sources

Aurophen Infants Pain And Fever Manufacturers

Aurohealth Llc

Aurophen Infants Pain And Fever | Hot Shots Nm, Llc Dba Midwest Positron Technology, Lc

2.1 Radiation Safety - Drug Handling Wear waterproof gloves and effective shielding when handling Sodium Fluoride F 18 Injection. Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Sodium Fluoride F 18 Injection. The dose of Sodium Fluoride F 18 Injection should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed. The final dose for the patient should be calculated using proper decay factors from the time of EOS, and measured by a suitable radioactivity calibration system before administration [Description(11.2)]. 2.2 Radiation Safety - Patient Preparation To minimize the radiation-absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to ingest at least 500 mL of fluid immediately prior and subsequent to the administration of Sodium Fluoride F 18 Injection. Encourage the patient to void one-half hour after administration of Sodium Fluoride F 18 Injection and as frequently thereafter as possible for the next 12 hours. 2.3 Drug Preparation and Administration Calculate the necessary volume to administer based on calibration time and dose. Inspect Sodium Fluoride F 18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit. Do not administer Sodium Fluoride F 18 Injection containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations. Aseptically withdraw Sodium Fluoride F 18 Injection from its container. 2.4 Recommended Dose for Adults
Administer 300–450 MBq (8–12 mCi) as an intravenous injection.
2.5 Recommended Dose for Pediatric Patients
In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq– 148 MBq (0.5 mCi- 4 mCi) were used.
2.6 Radiation Dosimetry
The age/weight- based estimated absorbed radiation doses (mGy/MBq) from intravenous injection of Sodium Fluoride F 18 Injection are shown in Table 1. These estimates were calculated based on human data and using the data published by the Nuclear Regulatory Commission [1] and the International Commission on Radiological Protection for Sodium Fluoride Injection [2]. The bone, bone marrow and urinary bladder are considered target and critical organs.
Table 1: Estimated Absorbed Radiation Doses after Intravenous Administration of Sodium Fluoride F 18 Injection Estimated Radiation Dose mGy/MBq Organ Adult
70 kg* 15 year
56.8 kg† 10 year
33.2 kg† 5 year
19.8 kg† 1 year
9.7 kg† * Data from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals, NUREG/CR-6345, page 10, 1996. † Data from ICRP publication 53, Radiation Dose to Patients from Radiopharmaceuticals (), Ann ICRP, Volume 18, , pages15 and 74, 1987 Adrenals 0.0062 0.012 0.018 0.028 0.052 Brain 0.0056 N/A N/A N/A N/A Bone surfaces 0.060 0.050 0.079 0.13 0.30 Breasts 0.0028 0.0061 0.0097 0.015 0.030 Gallbladder wall 0.0044 N/A N/A N/A N/A Stomach wall 0.0038 0.008 0.013 0.019 0.036 Small intestine 0.0066 0.012 0.018 0.028 0.052 Upper large intestine wall 0.0058 0.010 0.016 0.026 0.046 Lower large intestine wall 0.012 0.016 0.025 0.037 0.063 Heart wall 0.0039 N/A N/A N/A N/A Kidneys 0.019 0.025 0.036 0.053 0.097 Liver 0.0040 0.0084 0.013 0.021 0.039 Lungs 0.0041 0.0084 0.013 0.020 0.039 Muscle 0.0060 N/A N/A N/A N/A Ovaries 0.011 0.016 0.023 0.036 0.063 Pancreas 0.0048 0.0096 0.015 0.023 0.044 Red marrow 0.028 0.053 0.088 0.18 0.38 Skin 0.0040 N/A N/A N/A N/A Spleen 0.0042 0.0088 0.014 0.021 0.041 Testes 0.0078 0.013 0.021 0.033 0.062 Thymus 0.0035 N/A N/A N/A N/A Thyroid 0.0044 0.0084 0.013 0.020 0.036 Urinary bladder wall 0.25 0.27 0.4 0.61 1.1 Uterus 0.019 0.023 0.037 0.057 0.099 Other tissue N/A 0.010 0.015 0.024 0.044 Effective Dose
Equivalent mSv/MBq 0.027 0.034 0.052 0.086 0.17 2.7 Imaging Guidelines Imaging of Sodium Fluoride F 18 Injection can begin 1–2 hours after administration; optimally at 1 hour post administration. Encourage the patient to void immediately prior to imaging the fluoride F18 radioactivity in the lumbar spine or bony pelvis.

No Recall
Aurohealth Llc

Aurophen Infants Pain And Fever | Aurohealth Llc

this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning) shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed syringe designed for use with this product. Do not use any other dosing device. remove bottle cap and insert syringe tip through opening at top of the bottle tip bottle upside down and draw medicine into the syringe fill to dose level dispense liquid slowly into child’s mouth, toward inner cheek repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours replace cap tightly to maintain child resistance Dosing Chart * or as directed by a doctor Weight (lb)
Age(yr)
Dose(mL)*
under 24
under 2 years
ask a doctor
24-35
2-3 years
5 mL

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

No Recall
Aurohealth Llc

Aurophen Infants Pain And Fever | Aurohealth Llc

this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning) shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed syringe designed for use with this product. Do not use any other dosing device. remove bottle cap and insert syringe tip through opening at top of the bottle tip bottle upside down and draw medicine into the syringe fill to dose level dispense liquid slowly into child’s mouth, toward inner cheek repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours replace cap tightly to maintain child resistance
Dosing Chart * or as directed by a doctor
Weight (lb)
Age (yr)
Dose (mL)*
under 24
under 2 years
ask a doctor
24-35
2-3 years
5 mL

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

No Recall
Aurohealth Llc

Aurophen Infants Pain And Fever | Aurohealth Llc

this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning) shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed syringe designed for use with this product. Do not use any other dosing device. remove bottle cap and insert syringe tip through opening at top of the bottle tip bottle upside down and draw medicine into the syringe fill to dose level dispense liquid slowly into child’s mouth, toward inner cheek repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours replace cap tightly to maintain child resistance Dosing Chart * or as directed by a doctor
Weight (lb)
Age (yr)
Dose (mL)*
under 24
under 2 years
ask a doctor
24-35
2-3 years
5 mL

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

No Recall
Aurohealth Llc

Aurophen Infants Pain And Fever | Aurohealth Llc

this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning) shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed syringe designed for use with this product. Do not use any other dosing device. remove bottle cap and insert syringe tip through opening at top of the bottle tip bottle upside down and draw medicine into the syringe fill to dose level dispense liquid slowly into child’s mouth, toward inner cheek repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours replace cap tightly to maintain child resistance
Dosing Chart * or as directed by a doctor
Weight (lb)
Age (yr)
Dose (mL)*
under 24
under 2 years
ask a doctor
24-35
2-3 years
5 mL

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

No Recall
Aurohealth Llc

Aurophen Infants Pain And Fever | Aurohealth Llc

this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning) shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed syringe designed for use with this product. Do not use any other dosing device. remove bottle cap and insert syringe tip through opening at top of the bottle tip bottle upside down and draw medicine into the syringe fill to dose level dispense liquid slowly into child’s mouth, toward inner cheek repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours replace cap tightly to maintain child resistance
Dosing Chart * or as directed by a doctor
Weight (lb)
Age (yr)
Dose (mL)*
under 24
under 2 years
ask a doctor
24-35
2-3 years
5 mL

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

No Recall