hypaque - cysto- Diatrizoate Meglumine injection, solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

diatrizoate meglumine (UNII: 3X9MR4N98U) (diatrizoic acid - UNII:5UVC90J1LK)

Inapatikana kutoka:

Amersham Health Inc.

INN (Jina la Kimataifa):

Diatrizoate Meglumine

Dawa fomu:

INJECTION, SOLUTION

Tungo:

30 g in 100 mL

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

HYPAQUE-CYSTO is indicated for retrograde cystourethrography in adult and pediatric patients. HYPAQUE-CYSTO has no absolute contraindication in its recommended use.

Bidhaa muhtasari:

Calibrated 500 mL dilution bottles containing 250 mL HYPAQUE-CYSTO; rubber stoppered, with hangers, inner removable seal and screw neck. Box of 10 (NDC 0407-0734-10) Protect from light. Contains no preservatives, therefore, discard any unused portion remaining in the container. Store at 15°C to 30°C (59°F to 86°F).

Tabia za bidhaa

HYPAQUE - CYSTO- DIATRIZOATE MEGLUMINE INJECTION, SOLUTION
AMERSHAM HEALTH INC.
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HYPAQUE-CYSTO™
(DIATRIZOATE MEGLUMINE INJECTION, USP)
30%
Sterile Aqueous Injection
NOT FOR INTRATHECAL USE
NOT FOR INTRAVASCULAR USE
FOR RETROGRADE CYSTOURETHROGRAPHY
R ONLY
DESCRIPTION
HYPAQUE-CYSTO, brand of diatrizoate meglumine, is a water-soluble
radiopaque diagnostic medium.
It is a triiodinated benzoic acid derivative. It is constituted as a
radiopaque iodinated anion (diatrizoate)
and a radiolucent cation (meglumine). It is a colorless,
microcrystalline solid which is readily soluble in
water.
HYPAQUE-CYSTO is a sterile aqueous solution containing 30 g (w/v) of
the meglumine salt of
diatrizoic acid per 100 mL aqueous solution. The sterile solution is
clear and colorless to pale yellow.
The pH is adjusted between 6.5 and 7.7 with hydrochloric acid, or
diatrizoic acid, or meglumine. It does
not contain an antibacterial preservative. It is relatively
thermostable and may be autoclaved. Edetate
calcium disodium 1:10,000 has been added as a sequestering stabilizing
agent. Each 1 mL contains
approximately 141 mg of organically bound iodine.
It has an osmolality of 633 mosm/kg (determined by VPO) and is
hypertonic to blood.
The viscosity of the solution is 1.94 cp at 25°C and 1.42 cp at
37°C.
HYPAQUE-CYSTO is a 30 percent solution of 1-Deoxy-l
(methylamino)-D-glucitol 3,5-diacetamido-
2,4,6-triiodobenzoate (C
H I N O • C H NO ) with a molecular weight of 809.13, and has the
following structural formula:
CLINICAL PHARMACOLOGY
Retrograde introduction of HYPAQUE-CYSTO solution provides radiopacity
of the contents of the
urinary bladder. When used during micturation as a function test, it
also opacifies the bladder neck and
lower urinary tract. Continuous fluoroscopic and monitoring of urinary
bladder contractions will
demonstrate cystoureteric reflux and its extent, if present.
X
11
9 3
2
4
7
17
5
HYPAQUE-CYSTO is not absorbed from the urinary tract to any extent (<
2°), therefore, systemic
effects are rare. However,