KINEVAC Powder for solution for injection (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

Bracco Diagnostics Inc.

Λέξεις κλειδιά

0270-0556

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1. Indications and Usage

Kinevac is indicated in adults to: to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for ...

2. Dosage and Administration

2.1 Recommended Dosage and Administration Instructions The recommended dosage and administration of Kinevac by indication is shown in Table 1. For preparation instructions see <em>Dosage and Administration ...

3. Dosage Forms and Strengths

For injection: 5 mcg of sincalide as a lyophilized white powder for reconstitution in a single-dose vial.

4. Contraindications

KINEVAC is contraindicated in patients with: a history of hypersensitivity to sincalide. Serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock <em>[see Warnings and Precautions ...

5. Warnings and Precautions

5.1 Anaphylaxis, Anaphylactic Shock and Other Hypersensitivity Reactions In postmarketing experience, anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported during ...

6. Adverse Reactions

The following adverse reactions associated with the use of Kinevac were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain ...

7. Drug Interactions

7.1 Drugs that Affect Gallbladder Motility or Contractile Response Drugs that may stimulate or inhibit gallbladder motility or contractile response may interfere with the response to sincalide. Consider ...

8.1. Pregnancy

Risk Summary Based on limited human data and mechanism of action, sincalide may cause preterm labor or spontaneous abortion <em>[see Warnings and Precautions (5.4)]</em>. Available data with sincalide ...

8.2. Lactation

Risk Summary There are no data regarding the presence of sincalide in human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits ...

8.4. Pediatric Use

The safety and effectiveness in pediatric patients have not been established.

8.5. Geriatric Use

Clinical studies of Kinevac did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

10. Overdosage

In the event of an overdose, symptoms related to vagal stimulation, such as gastrointestinal symptoms (abdominal cramps, nausea, vomiting and diarrhea), hypotension with dizziness or fainting may occur. ...

11. Description

Kinevac (sincalide for injection) is a cholecystopancreatic-gastrointestinal hormone for parenteral administration. The agent is a synthetically-prepared C-terminal octapeptide of cholecystokinin. Each ...

12.1. Mechanism of Action

When injected intravenously, sincalide stimulates gallbladder contraction and reduction in size. The evacuation of bile that results is similar to that which occurs physiologically in response to endogenous ...

12.2. Pharmacodynamics

Following an intravenous (bolus) injection of 0.02 mcg/kg of sincalide, maximal contraction of the gallbladder occurred in 5 to 15 minutes. Sincalide reduced gallbladder radiographic size by at least 40%, ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.

16.1. How Supplied

Kinevac (sincalide for injection) is supplied as 5 mcg of sincalide as a lyophilized white powder for reconstitution in a single-dose vial; in packages of 10 vials (NDC 0270-0556-15). Manufactured for: ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

17. Patient Counseling Information

Anaphylaxis, Anaphylactic Shock and Other Hypersensitivity Reactions Inform patients that hypersensitivity reactions, including anaphylaxis and anaphylactic shock have been reported during or following ...