ENTERO VU 24% Oral suspension (2022)
Βιβλιογραφική αναφορά
Συγγραφείς
E-Z-EM Canada Inc
Λέξεις κλειδιά
32909-145 32909-146
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1. Indications and Usage
ENTERO VU 24% is indicated for use in small bowel radiographic examinations to visualize the gastrointestinal (GI) tract in adult patients.
2. Dosage and Administration
2.1 Recommended Dosing The recommended oral dose of ENTERO VU 24% is:Adults: 600 mL 2.2 Administration Instructions For oral use only Shake bottle vigorously prior to oral administration to fully suspend ...
3. Dosage Forms and Strengths
<u>Oral suspension:</u> barium sulfate (24% w/v) supplied in a single-dose white HDPE plastic bottle as a ready-to-use suspension for oral administration. Each bottle contains 600 mL of suspension.
4. Contraindications
ENTERO VU 24% is contraindicated in patients with the following conditions: known or suspected perforation of the GI tract known obstruction of the GI tract high risk of GI perforation such as those with ...
5. Warnings and Precautions
5.1 Hypersensitivity Reactions Barium sulfate preparations contain a number of excipients, including natural and artificial flavors and may induce serious hypersensitivity reactions. The manifestations ...
6. Adverse Reactions
The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally. Because the reactions are reported voluntarily from a population ...
8.1. Pregnancy
Risk Summary ENTERO VU 24% is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug.
8.2. Lactation
Risk Summary ENTERO VU 24% is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to the drug.
8.4. Pediatric Use
ENTERO VU 24% is not indicated for pediatric use.
8.5. Geriatric Use
Clinical studies of ENTERO VU 24% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience ...
11. Description
ENTERO VU 24% (barium sulfate) is a radiographic contrast agent that is supplied as a suspension (24% w/v) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO ...
12.1. Mechanism of Action
Due to its high atomic number, barium (the active ingredient in ENTERO VU 24%) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies.
12.2. Pharmacodynamics
Barium sulfate is biologically inert and has no known pharmacological effects.
12.3. Pharmacokinetics
Under physiological conditions, barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in small, pharmacologically insignificant amounts.
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
No animal studies have been performed to evaluate the carcinogenic potential of barium sulfate or potential effects on fertility.
16.1. How Supplied
ENTERO VU 24% (barium sulfate) is supplied as a suspension (24% w/v) in a single-dose HDPE plastic bottle containing 600 mL of barium sulfate suspension (24% w/v). <u>Provided as:</u> 6 600 mL bottles ...
16.2. Storage and Handling
Store at USP controlled room temperature 20°C to 25°C (68°F to 77° F). Protect from freezing.
17. Patient Counseling Information
After administration, advise patients to: Maintain adequate hydration <em>[see Dosage and Administration (2.2) and Warnings and Precautions (5.3)]</em>. Seek medical attention for worsening of constipation ...