CLINIMIX And CLINIMIX E Injections

1 CLINIMIX And CLINIMIX E InjectionsNutrient ProfileINDICATIONS CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections and CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections are indicated as a caloric component in a parenteral nutrition regimen and as the protein (nitrogen) source for offsetting nitrogen loss or for the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive see Important Risk Information on inside page Please see accompanying Package Inserts for Full Prescribing Information To Mix Solutions1 Grasp the container firmly on each side of the top of the bag (hanger end).

2 2 Roll the bag to open seal between chambers as Mix solutions Check for IMPORTANT RISK INFORMATIONB ecause of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture. With Vertical Peel Seal CLARITY Dual Chamber Container in 1 L and 2 L sizes* without additivesPlease see accompanying Package Insert for full Prescribing InformationClinimix sulfite-free (Amino Acid in Dextrose) and CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections Nutritional Profile: Nutrients per 1-Liter Container1 ProductCLINIMIX Inj.

3 CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX E E E E Inj. CLINIMIX E E E E Volume (without lipids)1-Liter1-Liter1-Liter1-Liter1-Lit er1-Liter1-Liter1-Liter1-Liter1-Liter1-L iter1-Liter1-Liter1-Liter1-Liter1-LiterA mino Acid Concentration5%5%10%20%25%15%20%25%5%10% 5%10%25%15%20%25%gm Dextrose/L505010020025015020025050100501 00250150200250gm Amino Acids/L (mEq/L)----------------3535353535353535 Potassium (mEq/L)----------------3030303030303030 Magnesium (mEq/L)----------------55555555 Calcium (mEq/L) (mEq/L)24373737374242425151707070808080 Chloride (mEq/L)11171717172020203939393939393939 Phosphate (as HPO4=) (mmol/L)----------------1515151515151515 pH* (mOsmol/L)

4 5256759301435168512551505176066592081510 701825139516501900 Kcal from Amino Acids/L110170170170170200200200110110170 170170200200200 Kcal from Dextrose/L170170340680850510680850170340 170340850510680850 Total Kcal/L2803405108501020710880105028045034 051010207108801050 Total Kcal with IV Fat Emulsion added**+ 20% 500 mL (1000 Kcal) 1280134015101850202017101880205012801450 134015102020171018802050+ 20% 250 mL (500 Kcal)78084010101350152012101380155078095 084010101520121013801550+ 10% 500 mL (550 Kcal)83089010601400157012601430160083010 0089010601570126014301600+ 10% 250 mL (275 Kcal)55561578511251295985115513255557256 15785129598511551325 Final concentrations AFTER mixing.

5 * pH Range = ** Data on file, Baxter Healthcare see accompanying Package Insert for full Prescribing InformationClinimix sulfite-free (Amino Acid in Dextrose) and CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections Nutritional Profile: Nutrients per 1-Liter Container1 ProductCLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX E E E E Inj. CLINIMIX E E E E Volume (without lipids)1-Liter1-Liter1-Liter1-Liter1-Lit er1-Liter1-Liter1-Liter1-Liter1-Liter1-L iter1-Liter1-Liter1-Liter1-Liter1-LiterA mino Acid Concentration5%5%10%20%25%15%20%25%5%10% 5%10%25%15%20%25%gm Dextrose/L505010020025015020025050100501 00250150200250gm Amino Acids/L (mEq/L)----------------3535353535353535 Potassium (mEq/L)----------------3030303030303030 Magnesium (mEq/L)----------------55555555 Calcium (mEq/L) (mEq/L)24373737374242425151707070808080 Chloride (mEq/L)11171717172020203939393939393939 Phosphate (as HPO4=) (mmol/L)----------------1515151515151515 pH* (mOsmol/L)

6 5256759301435168512551505176066592081510 701825139516501900 Kcal from Amino Acids/L110170170170170200200200110110170 170170200200200 Kcal from Dextrose/L170170340680850510680850170340 170340850510680850 Total Kcal/L2803405108501020710880105028045034 051010207108801050 Total Kcal with IV Fat Emulsion added**+ 20% 500 mL (1000 Kcal) 1280134015101850202017101880205012801450 134015102020171018802050+ 20% 250 mL (500 Kcal)78084010101350152012101380155078095 084010101520121013801550+ 10% 500 mL (550 Kcal)83089010601400157012601430160083010 0089010601570126014301600+ 10% 250 mL (275 Kcal)55561578511251295985115513255557256 15785129598511551325 CLINIMIX SULFITE-FREE (AMINO ACID IN DEXTROSE) AND CLINIMIX E SULFITE-FREE (AMINO ACID WITH ELECTROLYTES IN DEXTROSE WITH CALCIUM) INJECTIONSIMPORTANT RISK INFORMATION It is essential that a carefully prepared protocol based on current medical practices be followed, preferably by an experienced team.

7 Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration. CLINIMIX and CLINIMIX E Injections are contraindicated in patients having intracranial or intraspinal hemorrhage, in patients who are severely dehydrated, in patients hypersensitive to one or more amino acids and in patients with severe liver disease or hepatic coma. Solutions containing corn-derived dextrose may be contraindicated in patients with known allergy to corn or corn products. Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture.

8 Use with caution when administering to patients with anuria or renal insufficiency, pulmonary insufficiency, or heart disease. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. Metabolic complications have been reported, such as acid-base, electrolyte, and blood glucose imbalances, elevated liver enzymes, and osmotic diuresis and dehydration. Other adverse reactions that may occur include febrile response, infection at the site of injection, extravasation, and hypervolemia.

9 The infusion of hypertonic nutrient Injections into a peripheral vein may result in vein irritation, vein damage, and thrombosis. This product contains aluminum that may be toxic with prolonged parenteral administration if kidney function is impaired. CLINIMIX and CLINIMIX E Injections must be admixed prior to see accompanying Package Insert for full Prescribing InformationTotal Volume (without lipids)2-Liter2-Liter2-Liter2-Liter2-Lit er2-Liter2-Liter2-Liter2-Liter2-Liter2-L iter2-Liter2-Liter2-Liter2-LiterAmino Acid Concentration5%10%20%25%15%20%25%5%10%5% 10%25%15%20%25%gm Dextrose/2 L100200400500300400500100200100200500300 400500gm Amino Acids/2 L858585851001001005555858585100100100gm Nitrogen/2 (mEq/2 L)--------------7070707070707070 Potassium (mEq/2 L)--------------6060606060606060 Magnesium (mEq/2 L)--------------1010101010101010 Calcium (mEq/2 L)

10 --------------99999999 Acetate (mEq/2 L)74747474848484102102140140140160160160 Chloride (mEq/2 L)343434344040407878787878787878 Phosphate (as HPO4=) (mmol/2 L)--------------3030303030303030pH* (mOsmol/L)675930143516851255150517606659 2081510701825139516501900 Kcal from Amino Acids/2 L340340340340400400400220220340340340400 400400 Kcal from Dextrose/2 L340680136017001020136017003406803406801 700102013601700 Total Kcal/2 L680102017002040142017602100560900680102 02040142017602100 Total Kcal with IV Fat Emulsion added**+ 20% 500 mL (1000 Kcal)16802020270030402420276031001560190 0168020203040242027603100+ 20% 250 mL (500 Kcal)11801520220025401920226026001060140 0118015202540192022602600+ 10% 500 mL (550 Kcal)12301570225025901970231026501110145 0123015702590197023102650+ 10% 250 mL (275 Kcal)95512951975231516952035237583511759 5512952315169520352375* pH Range = ** Data on file, Baxter Healthcare see accompanying Package Insert for full Prescribing Information2 ProductCLINIMIX E E E E E E E E sulfite-free (Amino Acid in Dextrose) and CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium)