Omnipaque

OMNIPAQUE- iohexol injection, solution
GE Healthcare

WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION

FOR INTRAVENOUS USE ONLY. Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions (5.1)] .

1 INDICATIONS AND USAGE

OMNIPAQUE Imaging Bulk Package is indicated for

  • Computed tomographic (CT) imaging of the head and body by intravenous administration in:
    • adults (300 and 350 mg iodine/mL)
    • pediatric patients (300 mg iodine/mL)

For use only with an automated contrast injection system, contrast management system, or contrast media transfer set cleared for use with OMNIPAQUE Imaging Bulk Package.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

  • OMNIPAQUE is for intravenous use only [see Boxed Warning, Contraindications (4), and Warnings and Precautions (5.1)]
  • OMNIPAQUE may be administered at body (37°C) or room temperature. Do not warm the container beyond 37°C.
  • Inspect OMNIPAQUE for particulate matter or discoloration before administration, whenever solution and container permit. Do not administer if OMNIPAQUE contains particulate matter or is discolored.
  • Do not mix OMNIPAQUE with, or inject in intravenous lines containing, other drugs or total nutritional admixtures.
  • Use sterile technique for all handling and administration of OMNIPAQUE.
  • Hydrate patients before and after OMNIPAQUE administration [see Warnings and Precautions (5.3)].
  • Avoid extravasation when injecting OMNIPAQUE, especially in patients with severe arterial or venous disease [see Warnings and Precautions (5.5)]

2.2 Recommended Dosage

  • The dosing recommendations for OMNIPAQUE Imaging Bulk Package are summarized below for adult (Table 1) and pediatric (Table 2) patients.
  • The maximum recommended total dose of iodine for adults is 60 grams.
  • Use the lowest dose necessary to obtain adequate visualization.
  • Individualize the volume, strength, and rate of administration of OMNIPAQUE Imaging Bulk Package. Consider factors such as age, body weight, vessel size, blood flow rate within the vessel, anticipated pathology, degree and extent of opacification required, structures or area to be examined, disease processes affecting the patient, and equipment and technique to be employed.
Table 1
Adult Dosing Recommendations: Intravenous Administration
STUDY TYPE 300 mg iodine/mL 350 mg iodine/mL
CT Imaging – Head 70 to 150 mL (21 to 45 grams iodine) 80 mL (28 grams iodine)
CT Imaging – Body 50 to 200 mL (15 to 60 grams iodine) 60 to 100 mL (21 to 35 grams iodine)
Table 2
Pediatric Patients * Dosing Recommendations: Intravenous Administration
STUDY TYPE 300 mg iodine/mL
*
The concentration and volume required will depend on the equipment and imaging technique used.
Dosage for infants and children should be administered in proportion to age and body weight. CT Imaging – Head and Body 1 to 2 mL/kg Maximum single dose = 3mL/kg 35 grams iodine (116 mL)

2.3 Imaging Bulk Package Preparation Instructions

  • OMNIPAQUE Imaging Bulk Package is for use only with an automated contrast injection system, contrast management system, or contrast media transfer set cleared for use with this contrast agent in this Imaging Bulk Package. See device labeling for information on devices indicated for use with this Imaging Bulk Package and techniques to help assure safe use.
  • Use OMNIPAQUE Imaging Bulk Package and 0.9% Sodium Chloride Injection only in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
  • Utilize sterile technique for penetrating the container closure of the OMNIPAQUE Imaging Bulk Package and transferring OMNIPAQUE solution. The container closure may be penetrated only one time with a suitable sterile component of the automated contrast injection system, contrast management system, or contrast media transfer set cleared for use with this Imaging Bulk Package. Do not use if tamper-evident ring is broken or missing.
  • If 0.9% Sodium Chloride Injection USP is used, prepare the 0.9% Sodium Chloride Injection USP sterile port in accordance with the dosage and administration section of its approved prescribing information. The intravenous administration port of the 0.9% Sodium Chloride Injection USP container may be penetrated only one time with a suitable sterile component of the contrast management system approved for use with the OMNIPAQUE Imaging Bulk Package.
  • Affix the saline tag provided with the OMNIPAQUE Imaging Bulk Package on the 0.9% Sodium Chloride Injection USP container.
  • Once the OMNIPAQUE Imaging Bulk Package and 0.9% Sodium Chloride Injection are punctured do not remove them from the work area during the entire period of use. Maintain the OMNIPAQUE Imaging Bulk Package bottle in an inverted position such that container contents are in continuous contact with the dispensing set.
  • After the container closure is punctured, if the integrity of the OMNIPAQUE Imaging Bulk Package, the 0.9% Sodium Chloride, and the delivery system cannot be assured through direct continuous supervision, discard the OMNIPAQUE Imaging Bulk Package, 0.9% Sodium Chloride, and all associated disposables for the iodinated contrast media transfer set.
  • A maximum time of 8 hours from initial puncture is permitted to complete fluid transfer. Discard any unused OMNIPAQUE solution and 0.9% Sodium Chloride 8 hours after initial puncture of the OMNIPAQUE Imaging Bulk Package.

3 DOSAGE FORMS AND STRENGTHS

Injection: Non-ionic, sterile, pyrogen-free, colorless to pale yellow solution in an imaging bulk package in the following strengths:

  • 300 mg of organically bound iodine per mL (647 mg of iohexol/mL)
  • 350 mg of organically bound iodine per mL (755 mg of iohexol/mL)

Imaging Bulk Package is available in the following format: 500 mL polymer bottle ( PLUS PAK™)

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Risks with Inadvertent Intrathecal Administration

OMNIPAQUE is for intravenous use only [see Dosage and Administration (2.1)]. Inadvertent Intrathecal administration can cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema.

5.2 Hypersensitivity Reactions

OMNIPAQUE, can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of the injection (within 3 minutes), but reactions can occur up to hours later. There is an increased risk in patients with a history of a previous reaction to contrast agent, and known allergies (i.e., bronchial asthma, drug, or food allergies) or other hypersensitivities. Premedication with antihistamines or corticosteroids does not prevent serious life-threatening reactions, but may reduce both their incidence and severity.

Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents and always have emergency resuscitation equipment and trained personnel available prior to OMNIPAQUE administration. Monitor all patients for hypersensitivity reactions.

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