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204508S000lbl.Pdf HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ____________________CONTRAINDICATIONS____________________ CLINOLIPID injection safely and effectively. See full prescribing • Known hypersensitivity to egg and soybean proteins, the lipid emulsion information for CLINOLIPID injection. and/or excipients. (4) • Severe hyperlipidemia or severe disorders of lipid metabolism. (4) CLINOLIPID (Lipid Injectable Emulsion) for intravenous use Initial U.S. Approval: 1975 ________________WARNINGS AND PRECAUTIONS_______________ • Preterm infants have poor clearance of intravenous lipid emulsion. (5.1) WARNING: DEATH IN PRETERM INFANTS • Monitor for signs or symptoms of hypersensitivity reactions. (5.2) See full prescribing information for complete boxed warning • Monitor for signs and symptoms of infection, fat overload, and refeeding • Deaths in preterm infants have been reported in literature. (5.1, complications. (5.3, 5.4, 5.5) 8.4) • Frequent clinical and laboratory determinations are necessary. (5.6) • Autopsy findings included intravascular fat accumulation in the lungs. (5.1, 8.4) __________________ADVERSE REACTIONS__________________ • Preterm and low birth weight infants have poor clearance of The most common (5%) adverse drug reactions from clinical trials were intravenous lipid emulsion and increased free fatty acid plasma nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and levels following lipid emulsion infusion. (5.1, 8.4) abnormal liver function tests. (6.1) __________________INDICATIONS AND USAGE___________________ To report SUSPECTED ADVERSE REACTIONS, contact Baxter CLINOLIPID injection is a lipid emulsion indicated in adults for parenteral Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or nutrition providing a source of calories and essential fatty acids when oral or www.fda.gov/medwatch enteral nutrition is not possible, insufficient, or contraindicated. (1) ____________________DRUG INTERACTIONS____________________ _______________DOSAGE AND ADMINISTRATION_______________ The anticoagulant activity of coumarin derivatives, including warfarin, may CLINOLIPID injection is intended for intravenous infusion. The be counteracted. (7) recommended dose depends on energy expenditure, clinical status, body weight, tolerance, ability to metabolize and consideration of additional energy ________________USE IN SPECIFIC POPULATIONS_______________ given to the patient. The usual daily lipid dosage in adults is 1 to 1.5 g/kg/day • Hepatic Impaired: Use with caution in patients with preexisting liver and should not exceed 2.5 g/kg/day. (2) disease or liver insufficiency. (8.5) ______________DOSAGE FORMS AND STRENGTHS_______________ See 17 for PATIENT COUNSELING INFORMATION CLINOLIPID 20% is a lipid injectable emulsion for intravenous infusion. The lipid content is 0.20 g/mL. (3) Revised: October 2013 FULL PRESCRIBING INFORMATION: CONTENTS* 8 USE IN SPECIFIC POPULATIONS WARNING: DEATH IN PRETERM INFANTS 8.1 Pregnancy 1 INDICATIONS AND USAGE 8.3 Nursing Mothers 2 DOSAGE AND ADMINISTRATION 8.4 Pediatric Use 2.1 Use of an Inline Filter 8.5 Geriatric Use 2.2 Important Administration Instructions 8.6 Hepatic Impairment 2.3 Mixing Guidelines 10 OVERDOSAGE 2.4 Dosing Considerations 11 DESCRIPTION 3 DOSAGE FORMS AND STRENGTHS 12 CLINICAL PHARMACOLOGY 4 CONTRAINDICATIONS 12.1 Mechanism of Action 5 WARNINGS AND PRECAUTIONS 12.2 Pharmacodynamics 5.1 Death in Preterm Infants 12.3 Pharmacokinetics 5.2 Hypersensitivity Reactions 13 NONCLINICAL TOXICOLOGY 5.3 Infections 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.4 Fat Overload Syndrome 13.2 Animal Toxicology and/or Pharmacology 5.5 Refeeding Syndrome 14 CLINICAL STUDIES 5.6 Monitoring/Laboratory Tests 15 REFERENCES 5.7 Interference with Laboratory Tests 16 HOW SUPPLIED/STORAGE AND HANDLING 5.8 Aluminum Toxicity 17 PATIENT COUNSELING INFORMATION 5.9 Risk of Parenteral Nutrition Associated Liver Disease 5.10 Hypertriglyceridemia 6 ADVERSE REACTIONS * Sections or subsections omitted from the full prescribing information 6.1 Clinical Trials Experience are not listed. 6.2 Post-marketing Experience 7 DRUG INTERACTIONS Reference ID: 3384122 66 FULL PRESCRIBING INFORMATION 67 68 WARNING: DEATH IN PRETERM INFANTS 69 70 Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported in the 71 medical literature. 72 Autopsy findings included intravascular fat accumulation in the lungs. 73 Preterm infants and low birth weight infants have poor clearance of intravenous lipid emulsion and 74 increased free fatty acid plasma levels following lipid emulsion infusion. 75 [See Warnings and Precautions (5.1) and Use in Specific Populations (8.4)] 76 1 INDICATIONS AND USAGE 77 CLINOLIPID injection is indicated in adults for providing a source of calories and essential fatty acids for 78 parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. 79 Limitations of Use 80 CLINOLIPID injection is not indicated for use in pediatric patients because there is insufficient data to 81 demonstrate that CLINOLIPID injection provides sufficient amounts of essential fatty acids in this 82 population. [See Use in Specific Populations (8.4)] 83 The omega-3: omega-6 fatty acid ratio in CLINOLIPID injection has not been shown to improve clinical 84 outcomes compared to other intravenous lipid emulsions. [See Clinical Studies (14)] 85 2 DOSAGE AND ADMINISTRATION 86 2.1 Use of an Inline Filter 87 Fragments of the administration port membrane could be dislodged into the bag after spiking. Use a 1.2 88 micron inline filter during administration of CLINOLIPID injection (alone or as part of an admixture) to 89 remove particulate matter or micro-precipitate contamination during administration of CLINOLIPID 90 injection (alone or as part of an admixture). Particulate matter > 5 microns has the capability of obstructing 91 blood flow through capillaries, which could lead to embolism and vascular occlusion. Do not use filters of 92 less than 1.2 micron pore size with lipid emulsions. 93 2.2 Important Administration Instructions 94 Before opening the overwrap, check the color of the oxygen indicator. Compare color of the indicator to the 95 reference color printed next to the OK symbol depicted in the printed area of the indicator label. Do not use 96 the product if the color of the oxygen absorber/indicator does not correspond to the reference color printed 97 next to the OK symbol. 98 After opening the bag, use the contents immediately and do not store for a subsequent infusion. 2 Reference ID: 3384122 99 Visually inspect that the emulsion is a homogeneous liquid with a milky appearance. Inspect for particulate 100 matter and discoloration prior to administration, whenever solution and container permit. 101 Do not connect flexible bags in series to avoid air embolism due to possible residual gas contained in the 102 primary bag. 103 Air embolism can result if residual gas in the bag is not fully evacuated prior to administration if the flexible 104 bag is pressurized to increase flow rates. 105 Use of a vented intravenous administration set with the vent in the open position could result in air 106 embolism. 107 If CLINOLIPID injection is mixed with dextrose and/or amino acid solutions, check the compatibility 108 before administration by inspecting the mixture closely for the presence of precipitates. Formation of 109 precipitates could result in vascular occlusion. 110 When infused alone, CLINOLIPID injection can be administered via central or peripheral vein. When 111 administered with dextrose and amino acids, the choice of a central or peripheral venous route should 112 depending on the osmolarity of the final infusate. 113 Do not use administration sets and lines that contain di-2-ehtylhexyl phthalate (DEHP). 114 2.3 Mixing Guidelines 115 Prepare the admixture using strict aseptic techniques to avoid microbial contamination. 116 Do not add additives directly to CLINOLIPID injection. Do not add CLINOLIPID injection to the total 117 parenteral nutrition container first; destabilization of the lipid may occur from such an admixture. 118 Do not use the EXACTAMIX Inlet H938173 with an EXACTAMIX compounder to transfer CLINOLIPID 119 injection. This inlet spike has been associated with dislodgement of the administration port membrane into 120 the CLINOLIPID injection bag. 121 The following proper mixing sequence must be followed to minimize pH related problems by ensuring that 122 typically acidic Dextrose Injections are not mixed with lipid emulsions alone: 123 1. Transfer Dextrose Injection to the Total Parenteral Nutrition Admixture Container 124 2. Transfer Amino Acid Injection 125 3. Transfer Lipid Emulsion 126 127 Amino Acid Injection, Dextrose Injection and Lipid Emulsions may be simultaneously transferred to the 128 admixture container. Use gentle agitation during admixing to minimize localized concentration effects; 129 shake bags gently after each addition. 3 Reference ID: 3384122 130 The prime destabilizers of emulsions are excessive acidity (such as a pH below 5) and inappropriate ++ ++ 131 electrolyte content. Give careful consideration to additions of divalent cations (Ca and Mg ), which have 132 been shown to cause emulsion instability. Amino acid solutions exert buffering effects that protect the 133 emulsion. 134 Inspect the admixture closely for separation of the emulsion. This can be visibly identified by a yellowish 135 streaking or the accumulation of yellowish
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