Trade Name: OCTREOSCAN

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Curium US LLC

Presentation: KIT, HUMAN PRESCRIPTION DRUG

Storage and handling

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • Octreoscan is a kit for the preparation of indium In-111 pentetreotide, a diagnostic radiopharmaceutical. It is a kit consisting of two components:
  • 1)u00a0u00a0u00a0u00a0 A 10-mL Octreoscan Reaction Vial which contains a lyophilized mixture of:
  • (i) 10 u03bcg pentetreotide [N-(diethylenetriamine-N,N,N',Nu201d-tetraacetic acid-Nu201d-acetyl)-D-phenylalanyl-L-hemicystyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-L-hemicystyl-L-threoninol cyclic (2u21927) disulfide], (also known as octreotide DTPA),(ii) 2.0 mg gentisic acid [2, 5-dihydroxybenzoic acid],(iii) 4.9 mg trisodium citrate, anhydrous,(iv) 0.37 mg citric acid, anhydrous, and(v) 10.0 mg inositol.
  • Pentetreotide has the following structural formula:
  • Prior to lyophilization, sodium hydroxide or hydrochloric acid may have been added for pH adjustment. The vial contents are sterile and nonpyrogenic. No bacteriostatic preservative is present.
  • 2)u00a0u00a0u00a0u00a0 A 10-mL vial of Indium In-111 Chloride Sterile Solution, which contains: 1.1 mL or 111 MBq/mL (3.0 mCi/mL) indium In-111 chloride in 0.02N HCl at time of calibration. The vial also contains ferric chloride at a concentration of 3.5 u03bcg/mL (ferric ion, 1.2 u03bcg/mL). The vial contents are sterile and nonpyrogenic. No bacteriostatic preservative is present.
  • Indium In-111 pentetreotide is prepared by combining the two kit components (n ). Indium In-111 reacts with the diethylenetriaminetetraacetic acid portion of the pentetreotide molecule to form indium In 111 pentetreotide. The pH of the resultant indium In-111 pentetreotide solution is between 3.8 and 4.3. No bacteriostatic preservative is present.
  • The indium In-111 pentetreotide solution is suitable for intravenous administration as is, or it may be diluted to a maximum volume of 3.0 mL with 0.9% Sodium Chloride Injection, U.S.P., immediately before intravenous administration. In either case, the labeling yield of indium In-111 pentetreotide should be determined before administration to the patient. A method recommended for determining the labeling yield is presented at the end of this package insert.
  • No data
  • Indium In-111 pentetreotide is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.
  • None known.
  • DO NOT ADMINISTER IN TOTAL PARENTERAL NUTRITION (TPN) ADMIXTURES OR INJECT INTO TPN INTRAVENOUS ADMINISTRATION LINES; IN THESE SOLUTIONS, A COMPLEX GLYCOSYL OCTREOTIDE CONJUGATE MAY FORM.
  • The sensitivity of scintigraphy with indium In-111 pentetreotide may be reduced in patients concurrently receiving therapeutic doses of octreotide acetate. Consideration should be given to temporarily suspending octreotide acetate therapy before the administration of indium In-111 pentetreotide and to monitoring the patient for any signs of withdrawal.
  • No data
  • The following adverse effects were observed in clinical trials at a frequency of less than 1% of 538 patients: dizziness, fever, flush, headache, hypotension, changes in liver enzymes, joint pain, nausea, sweating, and weakness. These adverse effects were transient. Also in clinical trials, there was one reported case of bradycardia and one case of decreased hematocrit and hemoglobin.
  • Pentetreotide is derived from octreotide which is used as a therapeutic agent to control symptoms from certain tumors. The usual dose for indium In-111 pentetreotide is approximately 5 to 20 times less than for octreotide and is subtherapeutic. The following adverse reactions have been associated with octreotide in 3% to 10% of patients: nausea, injection site pain, diarrhea, abdominal pain/discomfort, loose stools, and vomiting. Hypertension and hyper- and hypoglycemia have also been reported with the use of octreotide.
  • Before administration, a patient should be well hydrated. After administration, the patient must be encouraged to drink fluids liberally. Elimination of extra fluid intake will help reduce the radiation dose by flushing out unbound, labelled pentetreotide by glomerular filtration. It is also recommended that a mild laxative (e.g., bisacodyl or lactulose) be given to the patient starting the evening before the radioactive drug is administered, and continuing for 48 hours. Ample fluid uptake is necessary during this period as a support both to renal elimination and the bowel-cleansing process. In a patient with an insulinoma, bowel-cleansing should be undertaken only after consultation with an endocrinologist.
  • The recommended intravenous dose for imaging is 111 MBq (3.0 mCi) of indium In-111 pentetreotide prepared from an Octreoscan kit. The recommended intravenous dose for imaging is 222 MBq (6.0 mCi) of indium In-111 pentetreotide.
  • The dose should be confirmed by a suitably calibrated radioactivity ionization chamber immediately before administration.
  • As with all intravenously administered products, Octreoscan should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Preparations containing particulate matter or discoloration should not be administered. They should be disposed of in a safe manner, in compliance with applicable regulations.
  • Aseptic techniques and effective shielding should be employed in withdrawing doses for administration to patients. Waterproof gloves should be worn during the administration procedure.
  • Do not administer Octreoscan in TPN solutions or through the same intravenous line.
  • The estimated radiation dosesto the average adult (70 kg) from intravenous administration of 111 MBq (3 mCi) and 222 MBq (6 mCi) are presented in Table 4. These estimates were calculated by Oak Ridge Associated Universities using the data published by Krenning, et al.n
  • The Octreoscan kit (NDC 69945-050-40) is supplied with the following components:
  • In addition, the kit also contains the following items: (1) a 25 G x 5/8u201d needle (B-D, Monoject) used to transfer Indium In-111 Chloride Sterile Solution to the Octreoscan Reaction Vial, (2) pressure sensitive label, and (3) a package insert.
  • The Octreoscan kit should be stored refrigerated at 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F). After reconstitution, store at or below 25u00b0C (77u00b0F). Indium In-111 pentetreotide must be used within six hours of preparation.
  • Note: Read complete directions thoroughly before starting preparation.
  • No data
  • Octreoscan Reaction Vialn Sterile, non-pyrogenic. For intravenous use after drug preparation. See package insert for directions for use.
  • Made in USAn n n n Use only with Indium In 111 Chloride Sterile Solution.n n n n n n n A050V0n
  • R12/2018
  • Indium In 111 ChlorideSterile Solutionn Sterile, non-pyrogenic solution, contains no bacteriostatic preservation.n NOT FOR DIRECT ADMINISTRATIONn- Rx onlyn- WARNING:
  • Made in USAn n n n n n n A117C0n
  • R12/2018

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Indium In -111 Pentetreotide (OCTREOSCAN) which is also known as OCTREOSCAN and Manufactured by Curium US LLC. It is available in strength of .

Indium In -111 Pentetreotide (OCTREOSCAN) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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