OCTREOSCAN- indium in -111 pentetreotide kit

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

INDIUM IN-111 PENTETREOTIDE (UNII: M312JJ6Z32) (INDIUM IN-111 PENTETREOTIDE - UNII:M312JJ6Z32)

Commercializzato da:

Curium US LLC

INN (Nome Internazionale):

INDIUM IN-111 PENTETREOTIDE

Composizione:

PENTETREOTIDE 10 ug in 1 mL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Octreoscan, after radiolabeling, is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors. None known.

Dettagli prodotto:

The Octreoscan kit (NDC 69945-050-40) is supplied with the following components: (i) 10 mcg pentetreotide [N-(diethylenetriamine-N,N,N',N”-tetraacetic acid-N”-acetyl)-D-phenylalanyl-L-hemicystyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-L-hemicystyl-L-threoninol cyclic (2→7) disulfide], (also known as octreotide DTPA), (ii) 2 mg gentisic acid [2, 5-dihydroxybenzoic acid], (iii) 4.9 mg trisodium citrate, anhydrous, (iv) 0.37 mg citric acid, anhydrous, and (v) 10 mg inositol. Before 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. In addition, the kit also contains the following items: (1) a 25 G x 5/8” needle (B-D, Monoject) used to transfer Indium In 111 Chloride Solution to the Octreoscan Reaction Vial, (2) pressure sensitive label, and (3) a package insert. The Octreoscan kit should be stored refrigerated at 2° to 8°C (36° to 46°F). After reconstitution, store at controlled room temperature 20° to 25°C (68° to 77°F). Indium In 111 Pentetreotide Injection must be used within 6 hours of preparation.

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

OCTREOSCAN- INDIUM IN -111 PENTETREOTIDE
CURIUM US LLC
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OCTREOSCAN
(KIT FOR THE PREPARATION OF INDIUM IN 111 PENTETREOTIDE INJECTION)
DIAGNOSTIC - FOR INTRAVENOUS USE.
RX ONLY
DESCRIPTION
Octreoscan is a kit for the preparation of Indium In 111 Pentetreotide
Injection, a
radioactive diagnostic agent. It is a kit consisting of two
components:
1) A 10-mL Octreoscan Reaction Vial which contains a lyophilized
mixture of:
(i) 10 mcg pentetreotide
[N-(diethylenetriamine-N,N,N′,N″-tetraacetic acid-N″-
acetyl)-D-phenylalanyl-L-hemicystyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-L-
hemicystyl-L-threoninol cyclic (2→7) disulfide], (also known as
octreotide DTPA),
(ii) 2 mg gentisic acid [2, 5-dihydroxybenzoic acid],
(iii) 4.9 mg trisodium citrate, anhydrous,
(iv) 0.37 mg citric acid, anhydrous, and
(v) 10 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) A 10-mL vial of Indium In 111 Chloride Solution, which contains:
1.1 mL or 111
MBq/mL (3 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 mcg/mL (ferric
ion, 1.2 mcg/mL).
The vial contents are sterile and nonpyrogenic. No bacteriostatic
preservative is present.
Indium In 111 Pentetreotide Injection is prepared by combining the two
kit components
(_see _INSTRUCTIONS FOR THE PREPARATION OF INDIUM IN 111
PENTETREOTIDE INJECTION). Indium In-111 reacts with the
TM
™
diethylenetriaminetetraacetic acid portion of the pentetreotide
molecule to form indium
In 111 pentetreotide. The pH of the resultant Indium In 111
Pentetreotide Injection is
between 3.8 and 4.3. No bacteriostatic preservative is present.
The Indium In 111 Pentetreotide Injection is suitable for intravenous
administration as is,
or it may be diluted to a maximum volume of 3 mL with 0.9% Sodium
Chlorid