PDR
`
`PhysicianS
`Desk .
`Reference
`For Radio ogy and
`Nuc ear Medicine
`
`Editorial Consultants:
`LEONARD M. FREEMAN, M.D.
`Professor of Radiology
`Albert Einstein College of Medicine
`M. DONALD BLAUFOX. M.D .. Ph.D .
`Professor of Radiology
`and Associate Professor of Medicine
`Albert Einstein College of Medicine
`
`Publisher: CHARLES E. BAKER JR.
`Director of Production: JEROME M. LEVINE
`Managing Editor: BARBARA B. HUFF
`Manager of Production Services: ELIZABETH H. CARUSO
`Editorial Assistants: EMILY B. BROGELER, GWYNN ED L.
`KELLY, F. EDYTHE PATERNITI
`Production Associate: FRANK DELLA SALA
`Business Manager: EDWARD R. BARNHART
`Representative: FRED A. SOEDER
`Director of Printing: RALPH PELUSO
`Circulation Director: MARC ROSS
`Research Director: STEPHEN J. SORKENN , R.Ph.
`Associate Research Director: JAMES D. GLICKMAN
`ISBN 0-87489-986-9
`
`rn Copyright<Cl 1977 by Litton Industries, Inc.
`
`Published by Medical Economics Company, a
`Litton Litton division. at Oradell, N.J. 07649. All rights
`reserved . None of the content of this publication may
`be reproduced , stored in a retrieval system,
`or transmitted in any form or by any means (electronic,
`mechanical , photocopying , recording, or otherwise)
`without the prior written permission of the publisher.
`
`
`
`
`MAIA Exhibit 1005
`MAIA V. BRACCO
`IPR PETITION
`
`

`

`154
`
`Squibb & Sons-Cont.
`
`within 24 hours. Any residual Sinografin
`within the uterine cavity is usually expelled
`immediately upon removal of the cannula.
`Storage
`Store at room temperature (20-25° C.) and pro(cid:173)
`tect against exposure to strong light. The Sino(cid:173)
`gratin solution may vary in color from essen(cid:173)
`tially colorless to light amber; however, solu(cid:173)
`tions which have become strongly discolored
`should not be used. Sinografin should be used
`as promptly as possible following withdrawal
`into the syringe, and the syringe should be
`rinsed as soon as possible after injection, to
`prevent freezing of the plunger.
`How Supplied
`In single-dose vials of 10 ml.
`
`SQUIBB CONTRAST AGENT ADJUNCT
`
`KINEVAC®
`(Sincalide for Injection)
`Description
`Kinevac (Sincalide for Injection) is a sterile,
`lyophilized, white powder of the synthetic C(cid:173)
`terminal octapeptide of cholecystokinin. Each
`vial provides 5 meg. sincalide with 45 mg. so(cid:173)
`dium chloride as a carrier; sodium hydroxide
`or hydrochloric acid may be added during man(cid:173)
`ufacture to adjust the pH to 5.5 to 6.5. When
`reconstituted with .5 ml. of Sterile Water for
`Injection U.S.P. each ml. contains 1 meg. sinca(cid:173)
`lide and 9 mg. sodium chloride. At the time of
`manufacture, the air in the vial is replaced by
`nitrogen.
`Actions
`When injected intravenously, sincalide pro(cid:173)
`duces a substantial reduction in gallbladder
`size by causing this organ to contract. The
`evacuation of bile that results is similar to that
`which occurs physiologically in response to
`endogenous cholecystokinin. The intravenous
`(bolus) administration of sincalide causes a
`prompt contraction of the gallbladder that
`becomes maximal in 5 to 15 minutes, as com(cid:173)
`pared with the stimulus of a fatty meal which
`causes a progressive contraction that becomes
`maximal after approximately 40 minutes. Gen(cid:173)
`erally, a 40 percent reduction in radiographic
`area of the gallbladder is considered satisfac(cid:173)
`tory contraction.
`Like cholecystokinin, sincalide, when given in
`conjunction with secretin stimulates pancre(cid:173)
`atic secretion; concurrent administration in(cid:173)
`creases the volume of pancreatic secretion and
`the output of bicarbonate and protein (en(cid:173)
`zymes) by the gland. This combined effect of
`secretin and sincalide permits the assessment
`of specific pancreatic function through meas(cid:173)
`urement and analysis of the duodenal aspirate.
`The parameters usually determined are: vol(cid:173)
`ume of the secretion; bicarbonate concentra(cid:173)
`tion; and amylase content (which parallels the
`content of trypsin and total protein).
`Indications
`Kinevac (Sincalide for Injection) is a diagnostic
`agent which may be used: (1) to provide a sam(cid:173)
`ple of gallbladder bile that may be aspirated
`from the duodenum for analysis of its composi(cid:173)
`tion, e.g., to determine the degree of cholesterol
`saturation, (2) in conjunction with secretin (see
`DOSAGE AND ADMINISTRATION) to stimu(cid:173)
`late pancreatic secretion for analysis of its
`composition and examination of cytology, e.g.,
`in suspected cancer of the pancreas, (3) for
`postevacuation cholecystography, where the
`physician deems this procedure indicated but
`wishes to avoid the fatty meal.
`Contraindications
`The preparation is contraindicated in patients
`sensitive to sincalide.
`Warnings
`Usage in Pregnancy: Although no terato(cid:173)
`genic or antifertility effects were seen in ani-
`
`Product Information
`
`mal studies, data are inadequate to determine
`the safety of sincalide in human pregnancy.
`Accordingly, sincalide should be used in preg(cid:173)
`nant women only when, in the judgment of the
`physician, the benefits outweigh the possible
`risk to the fetus.
`Usage in Children: The safety of sincalide for
`use in children has not been established.
`Precautions
`The oossibilitv exists that stimulation of !!all(cid:173)
`bladder contr~ction in patients with small gall(cid:173)
`bladder stones could lead to the evacuation of
`the stones from the gallbladder, resulting in
`their lodging in the cystic duct or in the com(cid:173)
`mon bile duct. The risk of such an event is con(cid:173)
`sidered to be minimal because sincalide, when
`given as directed, does not ordinarily cause
`complete contraction of the gallbladder.
`Adverse Reactions
`Gastrointestinal symptoms such as abdominal
`discomfort or pain, and an urge to defecate,
`frequently accompany the injection of sinca(cid:173)
`lide. These phenomena are usually manifesta(cid:173)
`tions of the physiologic action of the drug,
`which include delayed gastric emptying and
`increased intestinal motility, and are not to be
`construed as necessarily indicating an abnor(cid:173)
`mality of the biliary tract unless there is other
`clinical or radiologic evidence of disease. Nau(cid:173)
`sea, dizziness, and flushing occur occasionally.
`Dosage and Administration
`For prompt contraction of the gallbladder, a
`dose of 0.02 meg. sincalide per kg. (1.4 mcg./70
`kg.) is injected intravenously over a 30- to 60-
`second interval; if satisfactory contraction of
`the gallbladder does not occur in 15 minutes, a
`second dose, 0.04 meg. sincalide per kg., may be
`administered. When Kinevac (Sincalide for
`Injection) is used in cholecystography, roent(cid:173)
`genograms are usually taken at five-minute
`intervals after the injection. For visualization
`of the cystic duct, it may be necessary to take
`roentgenograms at one-minute intervals dur(cid:173)
`ing the first five minutes after the injection.
`For the Secretin-Kinevac test of pancreatic
`function, the patient receives a dose of 0.25
`units secretin per kg. infused intravenously
`over a 60-minute period. Thirty minutes after
`the initiation of the secretin infusion, a sepa(cid:173)
`rate LV. infusion of Kinevac (Sincalide for In(cid:173)
`jection) at a total dose of 0.02 meg. per kg. is
`administered over a 30-minute interval. For
`example, the total dose for a 70 kg. patient is
`1.4 meg. of sincalide; therefore, dilute 1.4 ml. of
`reconstituted Kinevac solution to 30 ml. with
`Sodium Chloride Injection U.S.P. and adminis(cid:173)
`ter at a rate of 1 ml. per minute.
`Reconstitution and Storage
`Kinevac (Sincalide for Injection) may be stored
`at room temperature prior to reconstitution.
`To reconstitute, aseptically add 5 ml. of Sterile
`Water for Injection U.S.P. to the vial; the solu(cid:173)
`tion may be kept at room temperature and
`should be used within 24 hours of reconstitu(cid:173)
`tion, after which time any unused portion
`should be discarded.
`How Supplied
`In vials containing 5 meg. of sincalide.
`
`MEDOTOPES®
`SQUIBB RADIOPHARMACEUTICA~S
`
`ANGIOTENSIN IIMMUTOPE® KIT
`For Quantitative Measurement of Plasma
`Renin Activity by Radioimmunoassay
`For In Vitro Diagnostic Use
`For Professional Use Only
`The Angiotensin I IMMUTOPE KIT is in(cid:173)
`tended for the determination of plasma renin
`activity by radioimmunoassay.
`The Angiotensin I IMMUTOPE Kit contains
`sufficient materials for 200 tubes. Each kit
`contains 1 bottle of 1251 Angiotensin I Buffer
`(200 ml., with a total activity of less than 1.7
`microcuries, containing a buffer, protein car(cid:173)
`rier, and preservative); 6 vials of Angiotensin I
`
`Standard (2 ml. each; 0 pg., 50 pg., 100 pg., 200
`pg., 300 pg., and 500 pg., containing a carrier
`and solvent); 1 vial of Angiotensin I Antiserum
`(10 ml., containing stabilizers, and an agent for
`pH adjustment); 1 vial of Angiotensin I Control
`(2 ml., containing a sheep serum diluent, mi(cid:173)
`crobial inhibitor, and enzyme inhibitors); 1 vial
`of Angiotensin I Adsorbent Charcoal Tablets
`(210 tablets, containing fillers, buffers, and an
`excipient); 1 vial of Angiotensin I Plasma
`Buffer (5 ml,, with a pH of 7.4, containing fill(cid:173)
`ers, buffers, and an excipient); 1 vial of Dimer(cid:173)
`caprol Solution (2 ml., containing a stabilizer
`and solvent); and 1 vial of 8-Hydroxyquinoline
`Sulfate (330 mg.).
`In addition to the complete kit described above
`1251 Angiotensin I Buffer, Angiotensin I Stan:
`dard, Angiotensin I Antiserum, and Angioten(cid:173)
`sin I Control can be purchased individually.
`
`Digoxin CLASP™ RIA Kit
`For Quantitative Measurement of Serum or
`Plasma Digoxin Levels by Radioimmunoassay
`For IN VITRO Diagnostic Use
`For Professional Use Only
`The Digoxin CLASP RIA Kit is intended for
`the quantitative measurement of serum or
`plasma digoxin levels by radioimmunoassay.
`The Digoxin CLASP RIA Kit is available in a
`100-tube package. Each kit contains 5 vials of
`1251 Digoxigenin (lyophilized, with a total activ(cid:173)
`ity of less than 0.45 microcurie per vial and
`containing buffers, a carrier, and a preserva·
`tive); 6 bottles of Digoxin Standard (1 ml. each;
`0 ng., 0.5 ng., 1.0 ng., 2.0 ng., 3.0 ng., and 5.0 ng.
`with a preservative); 100 Digoxin Antibody
`Coated Tubes (with a binding agent); and 1 bot(cid:173)
`tle of Digoxin Control (1 ml. in sheep serum
`with a preservative).
`
`GASTRIN IMMUTOPE ® KIT
`For In Vitro Diagnostic Use
`For Quantitative Measurement of Serum
`Gastrin Levels by Radioimmunoassay
`The Gastrin IMMUTOPE Kit for the measure(cid:173)
`ment of serum gastrin levels by radioimmuno(cid:173)
`assay is available in a 100-test package. The kit
`contains one vial of 1251 Gastrin, one vial of
`Gastrin Standard A, one vial of Gastrin Stan(cid:173)
`dard B, one vial of Gastrin Antiserum, one vial
`of Barbital Buffer Mixture, one vial of Egg AI·
`humin Powder, and one vial of Ion Exchange
`Resin.
`
`MACROTEC®
`(Aggregated Albumin)
`Description
`Macrotec is a sterile, non pyrogenic, lyophiliz_ed
`preparation of aggregated albumin. Each Vlal
`of Macrotec contains 0.08 mg. tin as chloridd
`1.5 mg. denatured human serum albumin, a.nh
`10 mg. Normal Human Serum Albumin WI.t
`trace amounts of sodium acetate, acetic acJd,
`and hydrochloric acid; contains no preserva(cid:173)
`tive.
`Macrotec was prepared from blood that was
`nonreactive when tested for hepatitis B surface
`antigen (HB8Ag).
`Reconstitution of Macrotec (Aggregated ~lbTu·
`min) with sterile sodium pertechnetate- m c
`forms an aqueous suspension of Techneta~
`(Tc-99m) Aggregated Albumin
`(Human
`~mTc-MAA).
`.
`Physical Characteristics
`Technetium 99mTc decays by isomeric trans!·
`tion with a physical half-life of 6.03 hours. 1 '!_'he
`principal photon that is useful for detection
`and imaging studies is listed in Table I.
`
`
`
`
`This material may be protected by Copyright law (Title 17 U.S. Code)
`
`