Perikabiven Dosage

​2.1 Administration

• ​PERIKABIVEN is for intravenous infusion into a peripheral or central vein [see Warnings and Precautions (5.11)].
• ​Use a 1.2 micron in-line filter.
• ​Use of a vented intravenous administration set with the vent in the open position could result in air embolism.
• ​Use a dedicated line without any connections. Multiple connections could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.
• ​Do not exceed the recommended maximum infusion rate of 3.7 mL/kg/hour [see Dosage and Administration (2.4) and Warnings and Precautions (5.1)].
• ​Ceftriaxone must not be administered simultaneously with calcium-containing intravenous solutions such as PERIKABIVEN via a Y-site due to precipitation. However, in patients other than neonates, ceftriaxone and PERIKABIVEN may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Contraindications (4), Warnings and Precautions (5.5)].
• ​Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Administration sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer.

Important Preparation Instructions

• Inspect the bag prior to activation. Discard the bag in the following situations:
  • Evidence of damage to the bag
  • More than one chamber is white
  • Solution is yellow
  • Any seal is already broken
• Activate the bag [see Dosage and Administration (2.3)].
• Once the bag is activated, ensure the vertical seals between chambers are broken at least from the bend in the seals and down to the ports. The upper sections of the vertical seals above the bend and the horizontal seal may remain closed.
• It is recommended to mix the contents thoroughly by inverting the bag upside down to ensure a homogenous admixture.
• Ensure the vertical seals between chambers are broken and the contents of all three chambers are mixed together prior to infusion [see Dosage and Administration (2.3)].
• Use PERIKABIVEN immediately after mixing and the introduction of additives. If not used immediately, the storage time and conditions prior to use should not be longer than 24 hours at 2° to 8°C (36° to 46°F). After removal from storage at 2° to 8°C (36° to 46°F), the admixture should be infused within 24 hours. Any mixture remaining must be discarded.
• For total parenteral nutrition add multivitamins and trace elements via the additive port. Any other additions to the bag should be evaluated by a pharmacist for compatibility. Questions about compatibility may be directed to Fresenius Kabi USA, LLC.
• When introducing additives, it is recommended to use 18 to 23 gauge needles with a maximum length of 1.5 inches (40 mm) and to mix thoroughly after each addition, use aseptic technique and add after the vertical seals have been broken (i.e., bag has been activated) and the three components are mixed [see Dosage and Administration (2.3)].
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect PERIKABIVEN to ensure:
  • Precipitates have not formed during the mixing or addition of additives.
  • The emulsion has not separated. Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the mixed emulsion.

  Discard the admixture if any of the above are observed.

Instructions for Use

	Overpouch Notch Handle Hole (For hanging the bag) Vertical Seals (Must break to activate) Bends in Vertical Seals Horizontal Seal (May remain unopened) Blind Port (NEVER use this port) WHITE Additive Port BLUE Infusion Port Oxygen Absorber (Present between bag and inside overpouch-position may vary) An instructional video is available at www.freseniuskabinutrition.com/products/kabiv en-perikabiven/.
	1. INSPECT BAG PRIOR TO ACTIVATION. PERIKABIVEN is a 3 chambered bag: - One chamber is WHITE. - Two chambers are CLEAR. a) Discard bag if: - Overpouch is OPENED OR DAMAGED. - More than one chamber is WHITE. - Solution is YELLOW. - Seals are already BROKEN. 2. REMOVE OVERPOUCH. a) Place bag on a clean, flat surface. b) Tear from Overpouch Notch, located close to the ports. c) Tear long sides open to access the inner bag. d) Discard Overpouch and Oxygen Absorber.
	3. ACTIVATE BAG. a) Place bag on a clean, flat surface with text side up and ports pointing away from you. b) Roll tightly from top of bag down toward ports. c) Apply pressure until both Vertical Seals break and entire contents are white. It may take up to 5 seconds of continued pressure to break Vertical Seals. NOTE: Both Vertical Seals must be broken from bends to ports. Upper section of Vertical Seals and Horizontal Seal may remain unbroken. d) After both Vertical Seals are broken, mix contents thoroughly by inverting the bag at least three times to ensure a homogenous mixture. 4. INSPECT BAG TO CONFIRM ACTIVATION. An activated bag has both Vertical Seals broken from bends to ports and entire contents are white. 5. IDENTIFY CORRECT PORT. Additive port is WHITE with arrow pointing toward bag. Infusion port is BLUE with arrow pointing away from bag.
	6. MAKE ADDITIONS (if prescribed). WARNING: Ensure additives are compatible. a) Immediately before injecting additives, break off WHITE Additive Port cap with the arrow pointing toward the bag. b) Hold base of Additive Port horizontally. c) Insert needle horizontally through the center of Additive Port's septum and inject additives. d) Repeat as necessary using aseptic technique. e) Mix thoroughly after each addition. NOTE: The membrane of Additive Port is sterile at first use. Use aseptic technique for subsequent additions. The septum can be pierced up to 10 times with the recommended needle size 18 to 23 G 1½ inches (40mm).
	7. SPIKE AND HANG BAG. a) Immediately before inserting the infusion set, break off BLUE Infusion Port cap with the arrow pointing away from the bag. b) Use a non-vented infusion set or close the air- inlet on a vented set. It is recommended to use 1.2 μm in-line filter. c) Close the roller clamp of the infusion set. d) Hold the base of Infusion Port. e) Insert spike through Infusion Port by rotating your wrist slightly until the spike is inserted. f) Lift and hold the bag with both hands. g) Hang the bag by Hole below Handle. NOTE: The membrane of Infusion Port is sterile at first use. Use infusion sets (according to ISO Number 8536-4) with an external spike diameter of 5.5 to 5.7 mm. 8. FOR SINGLE USE ONLY. - Discard unused portion.

Dosing Considerations

The dosage of PERIKABIVEN should be individualized based on the patient's clinical condition (ability to adequately metabolize amino acids, dextrose and lipids), body weight and nutritional/fluid requirements, as well as additional energy given orally/enterally to the patient.

PERIKABIVEN is a combination of amino acids, electrolytes, dextrose, and lipids in a fixed volume and concentration. The dosage selection is based upon fluid requirements which can be used in conjunction with the nutritional requirements to determine final dosage [see Table 1].

PERIKABIVEN meets the total nutritional requirements for protein, dextrose and lipids in stable patients, and can be individualized to meet specific needs with the addition of nutrients. The maximum infusion rate is based upon the dextrose component.

Prior to administration of PERIKABIVEN, correct severe fluid, electrolyte and acid-base disorders. Before starting the infusion, obtain serum triglyceride levels to establish the baseline value.