KINEVAC

02 mcg/kg as a single dose over 30 to 60 seconds via intravenous injection. 04 mcg/kg over 30 to 60 seconds. 9% Sodium Chloride Injection USP and infused over 50 minutes at a rate of 2 mL per minute. 9% Sodium Chloride Injection USP and infused over 30 minutes at a rate of 1 mL per minute.

04 mcg/kg over 30 to 60 seconds via intravenous injection. 04 mcg/kg over 30 to 60 seconds. 9% Sodium Chloride Injection USP and infused over 30 minutes. 1 Recommended Dosage and Administration Instructions The recommended dosage and administration of Kinevac by indication is shown in Table 1.

2 ) . 02 mcg/kg as a single dose over 30 to 60 seconds via intravenous injection. 04 mcg/kg over 30 to 60 seconds. 9% Sodium Chloride Injection USP and infused over 50 minutes at a rate of 2 mL per minute. 9% Sodium Chloride Injection USP and infused over 30 minutes at a rate of 1 mL per minute.

04 mcg/kg over 30 to 60 seconds via intravenous injection. 04 mcg/kg over 30 to 60 seconds. 9% Sodium Chloride Injection USP and infused over 30 minutes. 2 Preparation Instructions For Intravenous Injection Reconstitute Kinevac aseptically by adding 5 mL of Sterile Water for Injection USP to the vial.

Inspect the reconstituted solution visually for particulate matter and discoloration after reconstitution and prior to administration. Withdraw the prescribed dose of the reconstituted solution from the vial and administer as an intravenous injection over 30 to 60 seconds, as shown in Table 1.

Discard the unused portion. Store the reconstituted solution at room temperature. Discard after 8 hours. For single use only; discard unused portion. For Intravenous Infusion Reconstitute Kinevac aseptically by adding 5 mL of Sterile Water for Injection USP to the vial.

After reconstitution, withdraw the prescribed dose of the solution from the vial. Discard unused portion. 9% Sodium Chloride Injection USP, depending on the indication, as described in Table 1. Inspect the Kinevac solutions visually for particulate matter and discoloration after reconstitution, dilution and prior to administration.

Store the diluted solution at room temperature. Discard after 1 hour .

4 )] 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 size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.

The most frequent adverse reactions (20% or greater) are gastrointestinal: abdominal discomfort or pain, and nausea; these may not necessarily indicate an abnormality of the biliary tract unless there is other clinical or radiologic evidence of disease.

1 )] . Neurological reactions : seizures, headache. Vasovagal reactions : dizziness, loss of consciousness, nausea, diaphoresis, syncope and hypotension (generally self-limiting). Other: nausea, vomiting, flushing, hypertension, urge to defecate, diarrhea, sneezing.

Most common adverse reactions (≥20%) are: abdominal discomfort or pain, and nausea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc. gov/medwatch .

5 WARNINGS AND PRECAUTIONS Anaphylaxis, Anaphylactic Shock and Other Serious Hypersensitivity Reactions : Contains sodium metabisulfite. Serious reactions may occur during or soon after administration. If symptoms occur, discontinue the drug.

1 ) Evacuation of Gallstones : Stimulation of gallbladder contraction in patients with small gallbladder stones could lead to the evacuation of the stones from the gallbladder, resulting in their lodging in the cystic duct or in the common bile duct.

2 ) Gastrointestinal Adverse Reactions with Intravenous Injection : Administration as an intravenous injection may cause transient nausea, vomiting, abdominal pain or cramping, dizziness or flushing. To reduce the risk of adverse reactions when used to stimulate contraction of the gallbladder or accelerate transit of a barium meal through the small intestine, administer as an intravenous infusion over 50 or 30 minutes, respectively.

3 ) Preterm Labor or Spontaneous Abortion : Advise pregnant women of the potential risk for preterm labor and spontaneous abortion. 1 Anaphylaxis, Anaphylactic Shock and Other Serious Hypersensitivity Reactions Contains sodium metabisulfite [see Description ( 11 )] , a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.

The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. In postmarketing experience, anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported during and within one hour following administration of Kinevac [see Adverse Reactions ( 6 )] .

Kinevac is contraindicated in patients with a history of hypersensitivity to sulfites. Due to the potential for anaphylaxis, appropriate medical support should be readily available when Kinevac is administered. If anaphylaxis or other hypersensitivity reactions occur, immediately discontinue the infusion and initiate appropriate medical treatment.

4 CONTRAINDICATIONS KINEVAC is contraindicated in patients with: a history of hypersensitivity to sulfites or sincalide. 1 ), Adverse Reactions ( 6 )] . intestinal obstruction. History of hypersensitivity to sulfites or sincalide. 1 ) Intestinal obstruction.

( 4 )