Active ingredients: Iodine (111 In) pentetreotide
Octreoscan - 111In-pentetreotide Radiopharmaceutical Preparation Kit, 111 MBq / mL
Indications Why is Octreoscan used? What is it for?
This medicinal product is a radiopharmaceutical product for diagnostic use only.
Octreoscan is used by scanning to locate specific cells in the stomach, intestines and pancreas such as:
- abnormal tissues or
- tumors.
This medicine is a powder for solution for injection and a radioactive substance. These two components must not be used separately. Once mixed by qualified personnel and given to the body, the medicine accumulates in specific cells.
The radioactive substance can be photographed from outside the body, using special machines that can record a scan. This scan shows the distribution of radioactivity within the human body. It also provides the physician with important information about the structure and function of a part. body specification.
The use of Octreoscan involves exposure to small amounts of radioactivity. Your doctor or nuclear medicine specialist has considered that the clinical benefit you will get from the radiopharmaceutical procedure outweighs the radiation risk.
Contraindications When Octreoscan should not be used
Otreoscan must not be used if you are allergic (hypersensitive) to pentetreotide or any of the other ingredients of Octreoscan.
Precautions for use What you need to know before taking Octreoscan
Take special care with Octreoscan
- if you have reduced kidney function, your doctor will only give you Octreoscan if absolutely necessary
- if you are pregnant or suspect that you are pregnant - if you are breast-feeding.
Before administration of Octreoscan you must:
- drink at least 2 liters of fluids, such as water, and urinate as much as possible before and 2-3 days after treatment. This prevents the accumulation of the active substance in the kidneys and bladder.
- Your doctor may also prescribe a laxative for you.
Children and adolescents
Consult your nuclear medicine specialist if you are under 18.
Interactions Which drugs or foods may change the effect of Octreoscan
Please tell your nuclear medicine doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription, as they may interfere with the interpretation of the images.
The following medicines can affect or be affected by Octreoscan:
- Octreotide, a medicine to treat the symptoms of some cancers. Your doctor may have you temporarily stop taking octreotide. If discontinuation of octreotide is considered, this should be done over a three-day period to avoid undesirable effects.
- Insulin
When Otreoscan is given to patients using high doses of insulin, they may experience severe decreases in blood glucose
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant, breast-feeding, think you may be pregnant or are planning to become pregnant, ask your nuclear medicine doctor for advice before you are given this medicine.
Please inform your nuclear medicine doctor before taking Octreoscan if there is a possibility that you may be pregnant, if you have missed a period or if you are breast-feeding. If in doubt, it is important that you consult the nuclear medicine specialist who will supervise the procedure.
If you are pregnant
Your nuclear medicine doctor will only give you Octreoscan if you are pregnant if the expected benefit outweighs the risks.
If you are breast-feeding
Tell your doctor if you are breastfeeding, as he may decide to postpone treatment until breastfeeding is complete. Your doctor may also ask you to stop breastfeeding and discard the milk until the radioactivity is gone from your body . Ask your nuclear medicine doctor when you can resume breastfeeding.
Consult your nuclear medicine specialist before taking any medicine.
Driving and using machines
Octreoscan is considered unlikely to affect the ability to drive or use machines.
Dosage and method of use How to use Octreoscan: Dosage
There are very strict laws on the use, handling and disposal of radiopharmaceutical products. Octreoscan will only be used in special and controlled areas. This product will be handled and administered to you only by persons trained and qualified to use it safely. These people they will pay particular attention to the safe use of this product and will keep you informed of their actions.
The nuclear medicine specialist overseeing the procedure will decide how much Octreoscan to use in your case. This will be the minimum quantity necessary to obtain the desired information.
The recommended amount for an adult to be administered in most cases ranges from
- 110-220 MBq (Mega Becquerel, the unit used to express radioactivity).
Use in children and adolescents
The doctor will only administer Octreoscan to patients in this age group if absolutely necessary.
Administration of Octreoscan and management of the procedure
Octreoscan is injected into a vein.
One injection is sufficient to perform the test required by the doctor.
Duration of the procedure
The nuclear medicine specialist will inform you about the usual length of the procedure.
Scans are usually done within a day or two of injection, depending on the information you want to get from the scans.
Sometimes the scans are repeated a few days after the exam to clearly understand the results.
After administration of Octreoscan, you must:
- avoid any close contact with children and pregnant women for the first few hours after the injection;
- drink at least 2 liters of liquids, such as water, and urinate frequently for 2-3 days after treatment to eliminate the product from the body.
- Your doctor will tell you if you need to take any special precautions after using this medicine. Contact your doctor if you have any questions.
Overdose What to do if you have taken too much Octreoscan
Overdose is unlikely as you will be given a "single dose of Octreoscan precisely controlled by the nuclear medicine specialist who supervises the procedure. However, in the event of an overdose, you will be treated appropriately. Drink as much as possible, eg water," to accelerate the elimination of the radioactive substance. If you have any questions about the use of Octreoscan, consult the nuclear medicine specialist who supervises the procedure.
Side Effects What are the side effects of Octreoscan
Like all medicines, Octreoscan can cause side effects, although not everybody gets them.
The administered radiopharmaceutical will transmit a low amount of ionizing radiation with a very low risk of cancer and hereditary abnormalities.
Side effects can occur with the following frequencies:
Uncommon, occurs in 1 to 10 users in 1,000
allergic reactions may occur with symptoms such as:
- hot flashes
- redness of the skin
- itch
- nausea or
- respiratory difficulties.
Hospital staff will treat these reactions if they occur.
Frequency not known (frequency cannot be estimated from the available data)
- cancer, however the risk is very low as low doses are used for this test.
If you notice any side effects, including any possible side effects not listed in this leaflet, please consult your nuclear medicine doctor.
Expiry and Retention
You must not store this medicine. This medicine is stored under the responsibility of the specialist in appropriate places. Storage of radiopharmaceuticals must comply with national legislation for radioactive materials. This information is exclusively for the specialist.
Octreoscan should not be used after the expiry date stated on the label.
Octreoscan should not be used if it is noted that the integrity of the tin can has been compromised and / or one of the vials is damaged.
Other information
What Octreoscan contains
Octreoscan consists of a pack containing two vials (A and B). Vial A contains 1.1 ml of solution, while Vial B contains a powder for solution for injection.
The active substances are:
- Vial A: Each vial contains 122 MBq of 111In as indium chloride in 1.1 mL (111 MBq / mL) at the target time of activity.
- Vial B: 10 micrograms of pentetreotide.
Mixed solution (A plus B): 111In-Pentetreotide 111 MBq / ml at the activity reference time.
The other excipients are:
- Vial A: hydrochloric acid, water for injections, ferric chloride hexahydrate.
- Vial B: sodium citrate dihydrate, citric acid monohydrate, inositol, gentisic acid.
What Octreoscan looks like and contents of the pack
The Octreoscan kit for radiopharmaceutical preparation of 111In-Pentetreotide, 122 MBq / 1.1 mL at activity reference time is supplied in a closed tin can containing two vials and a Sterican Luer Lock needle.
Vial A is a lead-shielded glass vial, which contains a clear and colorless solution.
Vial B is a glass vial with a gray butyl rubber stopper and a corrugated aluminum cap with an orange flip-off closure. Contains a white lyophilized powder.
The vials cannot be used separately.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
OCTREOSCAN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Octreoscan is supplied in two vials which cannot be used separately.
Vial A with 1.1 mL of solution containing at the reference time of activity (ART): (111In) Indium (III) chloride 122 MBq (111 MBq / mL)
Vial B contains: Pentetreotide 10 mcg
After reconstitution and labeling, the solution contains 111In-pentetreotide 111 MBq / mL.
Physical characteristics of 111In:
111In is a cyclotron product and decays into stable cadmium with a "half-life of 2.83 days. Emission characteristics:
Gamma rays 172 keV (90% abundance)
Gamma rays 247 keV (94% abundance) X-rays 23-26 keV
Radionuclide purity: 111In ≥ 99%, other gamma-ray emission nuclides ≤ 0.1%.
114mIn: max. 500 Bq for 1 MBq of 111In at the reference time / date of the activity. Half-life of 114mIn: 49.51 days
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation. The kit consists of two vials:
Vial A: Radiopharmaceutical precursor. Vial B: Powder for solution for injection.
Vial A is a lead-shielded glass vial, which contains a clear and colorless solution.
Vial B is a glass vial with a gray rubber stopper and a corrugated aluminum cap with an orange flip-off closure. Contains a white lyophilized powder.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Medicinal product for diagnostic use only.
111 In pentetreotide it binds specifically to somatostatin receptors.
After radiolabelling with (111In) Indium (III) chloride, the solution obtained is indicated to support the diagnosis and management of gastroenteropancreatic neuroendocrine tumors (GEP) and carcinoid tumors expressing these receptors, as it allows their localization. Tumors lacking somatostatin receptors are not visualized.
In a number of patients with GEP or carcinoid tumors, the density of the receptors is not sufficient to allow visualization with Octreoscan. Usually in about 50% of patients with insulinoma it is not possible to visualize the tumor.
04.2 Posology and method of administration
Dosage
Adults
The activity to be administered for single photon emission tomography (SPECT) depends on the available equipment. In general, an "activity equal to 110-220 MBq in a single" intravenous injection is sufficient. It should be administered with caution to avoid paravasal deposition of activity.
Elderly population
No special dosage regimens are required for the elderly.
Renal impairment
For renal impairment see section 4.4.
Pediatric population
The decision to give pentetreotide (111In) to a child should be made by a nuclear medicine specialist who has experience with somatostatin receptor scintigraphy, after considering the use of alternative radiopharmaceuticals with lower radiation exposure (in particular PET) Pentetreotide (111In) should be administered to a child only when alternative radiopharmaceuticals are not available or when these do not allow a satisfactory result to be achieved in the assessment of the child's clinical picture.
Method of administration
This medicine must be reconstituted before it is given to the patient.
For instructions on reconstitution of the medicinal product before administration, see section 12. For patient preparation, see section 4.4.
Image acquisition
The images can be acquired 4 and 24 hours or 24 and 48 hours after the injection. The images after 4 hours can be useful for the comparison and evaluation of the abdominal activity represented in the images after
24 hours. If the activity in the abdomen observed after 24 hours cannot be interpreted with certainty as absorption into the tumor or activity in the intestinal contents, the scintigraphy should be repeated at 48 hours. It is important to acquire two sets of images with at least one "SPECT (or SPECT / CT) acquisition. The" image acquisition can be repeated at 48 hours, 72 hours and / or 96 hours after injection, to allow for clearance of radioactivity. intestinal that interferes.
Physiological absorption occurs in the spleen, liver, kidneys and bladder. Thyroid, pituitary and intestines are visible in most patients.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
Pregnancy, see section 4.6
Individual benefit / risk justification
For each patient, the exposure to ionizing radiation must be justifiable on the basis of the possible benefit. In any case, the activity administered must be as low as possible to obtain the required diagnostic information.
Renal impairment
In patients with severe renal insufficiency the administration of 111In pentetreotide is not advisable because absent or reduced function of the main route of excretion could lead to an increased exposure to the radiation dose. Administration should only be considered if the probability of obtaining information diagnostics overcomes any risk due to radiation. Interpretable scintigrams can be obtained after hemodialysis during which it is possible to partially eliminate the high background activity. Before dialysis, the images do not give diagnostic indications due to the circulating activity.
After dialysis, higher than usual absorption was observed in the liver, spleen and intestinal tract and higher than usual activity in the circulation.
Pediatric population
Due to the potential risk of ionizing radiation, 111In-pentetreotide should not be used in patients under 18 years of age unless the expected diagnostic information outweighs the possible radiation risk.
Preparation of the patient
The patient should be well hydrated before the exam begins and urged to empty as often as possible during the first few hours after the exam to reduce radiation.
In patients who do not suffer from diarrhea it is necessary to administer a laxative to differentiate the accumulations of static activity, in the lesions of the intestinal tract or adjacent to it, from the mobile accumulations of the intestinal contents.
Non-receptor bound 111In-pentetreotide and non-peptide bound 111In are rapidly eliminated via the kidneys. To enhance the excretion process in order to reduce background noise and the radiation dose to the kidneys and bladder, a large intake of fluids (at least 2 liters) is required for 2-3 days after administration.
For patients on octreotide therapy, it is recommended that this therapy be temporarily suspended to avoid a possible blockade of somatostatin receptors. This recommendation is given on an empirical basis, but the absolute necessity of such a measure has not been demonstrated. In some patients, discontinuation of therapy may not be tolerated and cause rebound effects. This is notoriously the case in patients with insulinoma. in which the risk of sudden hypoglycaemia must be considered, and of patients with carcinoid syndrome.
If the physician responsible for the patient's therapeutic management considers that discontinuation of octreotide therapy is tolerable, a three-day withdrawal period is recommended.
Interpretation of images
Positive 111In-pentetreotide scintigraphy reflects the presence of "increased density of tissue receptors for somatostatin rather than malignancy. In addition, positive uptake is not specific to GEP and carcinoid tumors. A positive scan requires evaluation. the possibility that another pathology is present, characterized by elevated concentrations of local receptors for somatostatin. An increase in the density of somatostatin receptors may also occur in the following pathological conditions: tumors caused by embryologically derived tissue from the neural crest (paragangliomas, medullary thyroid carcinomas, neuroblastomas, pheochromocytomas), tumors of the pituitary, endocrine neoplasms of the lungs (carcinoma a small cell), meningiomas, breast carcinomas, lymphoproliferative diseases (Hodgkin's disease, non-Hodgkin's lymphomas) and the possibility of uptake in areas of lymphocyte concentration (subacute inflammation) should be considered.
After the procedure
Limit close contact with infants and pregnant women for the first few hours after administration of radiopharmaceuticals.
Specific warnings
In diabetic patients receiving high doses of insulin, pentetreotide administration may cause paradoxical hypoglycemia through "temporary inhibition of glucagon secretion."
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, ie it is essentially "sodium-free".
Precautions against environmental risk are reported in section 6.6.
04.5 Interactions with other medicinal products and other forms of interaction
No interactions have been described so far.
04.6 Pregnancy and breastfeeding
Women of childbearing age
When it is necessary to administer radiopharmaceuticals to a woman of childbearing age, it is important to determine whether she is pregnant. All women who have missed a period should be considered pregnant until proven otherwise. If there is doubt of a potential pregnancy (if the woman has missed a menstrual cycle, if the menstrual cycle is very irregular, etc.), alternative techniques that do not use ionizing radiation (if available) should be offered to the patient.
Pregnancy
There is no experience with the use of Octreoscan in pregnant women.
The radionuclide procedures that pregnant women undergo also expose the fetus to a dose of radiation. The administration of the maximum diagnostic activity of 220 MBq to the patient results in a dose absorbed by the uterus of 8.6 mGy. At this dosage range, lethal effects and the induction of malformations, growth delays and functional disturbances are not foreseeable; however, the risk of induction of cancer and hereditary defects may increase. Therefore, during pregnancy, only essential tests should be performed when the possible benefit outweighs the risk to the mother and fetus.
Feeding time
It is not known whether 111In-pentetreotide is excreted in human milk. Before administering radiopharmaceuticals to a breastfeeding mother, consideration should be given to postponing the administration of radionuclides until "cessation of breastfeeding" and determining which radiopharmaceutical is most appropriate, taking into account the secretion of activity in breast milk. . If administration is considered necessary, breastfeeding should be discontinued and the milk produced should be discarded.
04.7 Effects on ability to drive and use machines
Octreoscan has no or negligible effects on the ability to drive and use machines.
04.8 Undesirable effects
Undesirable effects attributable to administration of Octreoscan are uncommon (≥1 / 1000 to reported symptoms refer to vasovagal or anaphylactoid-type reactions to drugs.
Discontinuation of octreotide therapy as a preparation for scintigraphy may result in severe adverse effects, generally of the nature of a relapse of symptoms observed prior to initiation of this therapy.
Exposure to ionizing radiation is linked to cancer induction and the potential for hereditary defects. Since the effective dose is 12 mSv, when the maximum recommended activity of 220 MBq is administered, there is a low likelihood of these adverse events occurring.
04.9 Overdose
The pharmaceutical form (single-dose injection) makes accidental overdose unlikely.
In the event of the administration of a radiation overdose with 111In-pentetreotide, the absorbed dose to the patient should be reduced, whenever possible, by increasing the elimination of radionuclides from the body by frequent urination or forced diuresis and frequent emptying of the bladder.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: diagnostic radiopharmaceuticals for the detection of tumors. ATC code: V09I B 01.
Mechanism of action
Octreoscan binds to somatostatin receptors (mainly subtype 2 and subtype 5) in tissues where, as a result of the disease, cell surfaces contain these receptors in a more physiological density. In individual patients, in whom the disease has not led to an increase in receptor density, scintigraphy will not be effective.
In carcinoids and GEP tumors, the prevalence of increased receptor density in tumor tissue is generally quite high.
Pharmacodynamic effects
Only limited studies on pharmacodynamic effects have been conducted. The in vitro biological activity is approximately 30% of the biological activity of natural somatostatin. The in vivo biological activity, measured in rats, is less than that of equivalent amounts of ocreotide. In some patients, intravenous administration of 20 mcg of pentetreotide resulted in a measurable but very limited decrease in serum gastrin and glucagon levels in the blood. serum lasting less than 24 hours.
05.2 Pharmacokinetic properties
Absorption by the organs
111In-pentetreotide is absorbed by the following organs: liver (approx. 2% after 24 hours) and spleen (approx. 2.5% after 24 hours). Absorption into the thyroid and pituitary is present but not reproducible. Absorption into the kidneys is partly a reflection of ongoing elimination via the urine and partly due to delayed excretion by the kidney.
Elimination
Non-receptor bound 111In-pentetreotide and non-peptide bound 111In are rapidly eliminated via the kidneys. Within 24 hours of intravenous administration, approximately 80% of radiolabelled pentetreotide is excreted via the urinary tract. After 48 hours, 90% is excreted. Elimination via the gallbladder and subsequently the faeces is approximately 2% of the activity administered in patients with normal bowel function.
111In-pentetreotide is predominantly intact in urine for up to 6 hours of post-administration radioactivity. Subsequently, increasing amounts of bound non-peptide activity are excreted.
Half-life
111In decays to stable cadmium with a "half-life of 2.83 days.
05.3 Preclinical safety data
Preclinical safety tests did not provide any noteworthy findings. No tests have been conducted on carcinogenic potential, nor on the influence of pentetreotide on fertility or embryotoxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Vial A
Hydrochloric acid
Water for injections
Ferric chloride hexahydrate
Vial B
Sodium Citrate dihydrate
Citric acid monohydrate
Inositol
Gentisic acid.
The ready-to-use solution does not contain preservatives.
06.2 Incompatibility
This medicinal product must not be mixed with other medicinal products except those mentioned in section 12.
06.3 Period of validity
Vial A and consequently Vial B of Octreoscan expire 24 hours after the 111In activity reference time / date.
After reconstitution: 6 hours. Store below 25 ° C
06.4 Special precautions for storage
Store below 25 ° C.
For storage conditions of the reconstituted medicinal product see section 6.3.
Storage of radiopharmaceuticals must comply with national legislation for radioactive materials.
06.5 Nature of the immediate packaging and contents of the package
Both 10 mL vials meet the requirements for Type I glass. The vial containing pentetreotide is closed with a butyl rubber stopper. The vial containing 111In indium chloride is closed with a Teflon-coated butyl rubber stopper. Both vials are sealed with an aluminum cap.
Octreoscan is supplied as a single pack containing two vials that cannot be used separately, one of which has a lead shield. Both vials are packaged in a sealed closed tin can. This also contains a 0.90 x 70 mm / 20 G x 2 4/5 Sterican Luer Lock needle to be used for the marking procedure.
06.6 Instructions for use and handling
Radiopharmaceuticals should only be received, used and administered by authorized persons in designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the appropriate regulations and / or authorizations of the local competent official organization.
Radiopharmaceuticals must be prepared in a manner that satisfies both radiological safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken.
The contents of both vials are intended for use only in the preparation of the 111In-Pentetreotide solution for injection and should not be administered to the patient directly without having first undergone the preparation procedure.
If, at any point in the preparation of this product, the integrity of the vials is compromised, they should not be used.
Administration procedures should be performed in a way that minimizes the risk of contamination of the medicinal product and irradiation of the operators. It is mandatory to use adequate shielding.
The administration of radiopharmaceuticals creates risks for other people due to external radiation or contamination from spillage of urine, vomiting, etc. Consequently, radiation protection precautions must be taken in accordance with national regulations.
Instructions for waste disposal:
Unused quantities of 111In or Octreoscan must be allowed to decay until the activity drops to a lower level that is no longer considered radioactive under local regulations. It will then be possible to dispose of as harmless waste. Unused vials containing lyophilized pentetreotide can be disposed of. disposed of as harmless waste.
Unused product or waste material should be disposed of in accordance with local requirements.
07.0 MARKETING AUTHORIZATION HOLDER
Mallinckrodt Medical B.V., Westerduinweg 3
1755 LE Petten, Holland
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 029852011
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
27.02.1997 / 17.03.2010
10.0 DATE OF REVISION OF THE TEXT
06/2013
11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY
111In is a cyclotron product and decays with the emission of gamma radiation at an energy like the one shown in the following table and with a half-life of 2.83 days at cadmium-111 (stable).
The following radiation dosimetry is calculated on the basis of the MIRD system. The data listed below are present in publication no. 106 of the 2008 ICRP and were calculated on the basis of the following assumptions.
According to the biokinetic model described in publication no. 106 of the ICRP, it is assumed that 111In-pentreotide injected intravenously is immediately absorbed by the liver, spleen, kidneys and thyroid, while the rest is assumed to be homogeneously distributed in the rest of the organism. The retention data detected at the experimental level are better described by mono- or bi-exponential functions. Biokinetic data come from patients with carcinoid tumors and endocrine tumors in the gastrointestinal tract.
Absorption into tumor tissue present in any organ can therefore be included in the published organ absorption values. The primary route of excretion is renal and less than 2% is excreted in faeces. 85% excretion is observed in urine. after 24 hours it responds well to the model. Minimal excretion via the gastrointestinal tract is not included in the model, as its contribution to the absorbed dose under normal circumstances is negligible.
The effective dose resulting from the administration of an activity (maximum recommended) of 220 MBq for a 70 kg adult is approximately 12 mSv.
111 In pentetreotide it binds specifically to somatostatin receptors, so it is not possible to define a target organ. For an administered activity of 220 MBq, the radiation dose to target organs (kidney, liver and spleen) is 90, 22 and 125 mGy, respectively.
12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL
Do not use Octreoscan if there are obvious signs of deterioration.
Method of preparation:
Instructions for marking
1. Add the contents of vial A (111In chloride) to vial B (lyophilized pentetreotide) to obtain the product Indium (111In) pentetreotide; to withdraw indium chloride from its vial, use only the Sterican needle (0.90 x 70) provided with the dose sent to the patient.
2. Observe an incubation period of 30 minutes after reconstitution.
3. The preparation can be diluted with 2-3 mL of 0.9% sodium chloride solution if larger volume is desired to facilitate handling in the syringe.
4. The prepared solution must be clear and colorless; this condition can be verified behind a lead wall with a leaded glass window. If the solution does not comply, discard it.
5. Use a small sample of this volume (diluted or undiluted) for the quality control described in the following section.
6. The solution is now ready for use. The solution should be used within 6 hours.
Note: For reconstitution, do not use any other 111In chloride solution than that supplied in the same container with lyophilized pentetreotide.
After reconstitution and labeling, the pH of the aqueous solution is 3.8-4.3.
Quality control:
Discrimination between 111In-labeled peptides and 111In-labeled non-peptide compounds can be performed with silica gel impregnated glass fiber strips. Prepare a well-dried strip of approximately 10 cm in length and 2.5 cm in width, marking a starting line at 2 cm with additional marks at 6 and 9 cm. Apply 5 to 10 mcl of reconstituted and labeled solution on the initial line and develop in 0.1 M of freshly prepared sodium citrate solution, brought to pH 5 with HCl. In about 2-3 minutes, the front will reach the 9 cm mark. Cut the strip at the 6 cm mark and measure the activity of both halves. The bound non-peptide 111In moves with the front. Requirement: The lower end of the chromatogram must contain ≥ 98% of the applied activity chromatogram must contain ≥ 98% of the applied activity.
