`
`
`
`
`November 30, 2017
`
`Important Prescribing Information
`
`Subject: Temporary importation of intravenous drug products to address drug shortages
`
`Dear Healthcare Professional,
`
`In order to address shortages of critical drug products from the aftermath of Hurricane Maria,
`Baxter Healthcare Corporation (Baxter) is coordinating with the U.S. Food and Drug
`Administration (FDA) to increase the availability of products from Baxter’s manufacturing facility
`in Italy.
`
`Baxter has initiated temporary importation of Primene 10% Solution for Infusion, 250 mL,
`in glass container, which contains amino acids and is indicated for use in children, infants, and
`neonates. This product is manufactured by Baxter’s manufacturing facility in Italy and marketed in
`Europe. At this time, no other entity except Baxter is authorized by the FDA to import or distribute
`these products in the United States. FDA has not approved the product manufactured by Baxter’s
`manufacturing facility in Italy.
`
`Effective immediately, and during this temporary period, Baxter will offer the following:
`Product name and description
`Size
`Product code
`Pack factor
`NDC
`Primene 10% Solution for Infusion
`in glass container
`
`250 mL
`
`FCA3CG133R79D
`
`10
`
`0338-9577-10
`
`
`It is also important to note the following:
`
` Primene 10% Solution for Infusion contains a different amino acid composition than amino
`acid solutions for pediatric patients marketed in the U.S. Primene 10% Solution for Infusion is
`sulfite-free. Please refer to the product comparison table at the end of this letter. Primene 10%
`Solution for Infusion contains L-Cysteine 0.189 g/100 mL as compared to 10% Premasol
`Sulfite-free (Amino Acid) Injection (<0.016 g/100 mL) and 6% Premasol Sulfite-free (Amino
`Acid) Injection (<0.014 g/100 mL). Consider this difference when adding additional L-Cysteine
`to the final parenteral nutrition solution.
`
` Primene 10% Solution for Infusion is packaged in a Type II Glass Bottle with an elastomeric
`stopper. Prior to use, it is important to visually inspect the container. Only use if the container
`is undamaged and the solution is clear. Discard if the container is leaking or if the solution is
`discolored, cloudy or contains a precipitate. Aseptic conditions must be observed throughout
`the preparation and use of Primene 10% Solution for Infusion. For single use only. Protect from
`light
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` This product has not been tested for aluminum content and this should be taken into
`consideration, especially when administering to preterm infants, term infants less than 1
`month of age, or patients with renal impairment.
`
` Administration of solution: The use of a final filter is required during administration of all
`formulations containing Primene and trace elements (including copper, iron, or zinc) for
`removal of visible particulate matter which has been observed in the infusion line for some
`formulations.
`o For 2-in-1 (amino acid and carbohydrate) parenteral nutrition solutions, use a
`0.2 micron filter for removal of particulate matter that may be formed with the use of
`trace elements (e.g. copper).
`o For 3-in-1 (lipid, amino acid, and carbohydrate) parenteral nutrition solutions, use a
`1.2 micron filter for particulate matter removal.
`
`Perform visual inspections for cloudiness or precipitation of the TPN solution after
`compounding, prior to administration and periodically during administration. If discoloration or
`precipitation is noted in the filter, perform blood levels of copper (or other trace elements)
`where medically relevant.
`
` The barcode may not register accurately on the U.S. scanning systems. Institutions should
`manually input the product into their systems and confirm that barcode systems do not provide
`incorrect information when the product is scanned. Alternative procedures should be followed to
`assure that the correct drug product is being used and administered to individual patients.
`
`
`There are some key differences in the labeling between the US FDA approved product 6% and
`10% Premasol-Sulfite-free (Amino Acid) Injections and Primene 10% Solution for Infusion. Please
`see the product comparison table at the end of this letter.
`
`Please refer to the FDA-approved package insert for the full prescribing information of 6%
`and 10% Premasol-Sulfite-free (Amino Acid) Injections in VIAFLEX Plastic Container at:
`https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=9afdcc3e-0d06-47f4-86ca-
`40da48b2b02b&type=pdf&name=9afdcc3e-0d06-47f4-86ca-40da48b2b02b
`
`If you have any questions about the information contained in this letter or the use of the imported
`products, please contact Baxter’s Medical Information Service at 1-800-933-0303.
`
`To place an order, please contact Baxter’s Center for Service by calling 1-888-229-0001.
`
`To report product quality issues, please contact Baxter Product Surveillance at 1-800-437-5176. To
`report adverse events associated with these imported products, please call Baxter at 1-866-888-
`2472, or fax: 1-800-759-1801. Adverse events or quality problems experienced with the use of this
`product may also be reported to the FDA's MedWatch Adverse Event Reporting program either
`online, by regular mail or by fax:
` Complete and submit the report Online: www.fda.gov/medwatch/report.htm
` Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-
`800-332-1088 to request a reporting form, then complete and return to the address on the
`pre-addressed form, or submit by fax to 1-800-FDA-0178.
`
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`Sincerely,
`
`
`
`
`
`Dennis Vaughn
`Vice President, Marketing Operations
`
`Baxter Healthcare Corporation
`
`Baxter, PRIMENE, PREMASOL and VIAFLEX are trademarks of Baxter International Inc.
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`is impossible, insufficient or contraindicated.
`Primene 10% is indicated in 1) children and infants 2) neonates, at term or premature, of normal or low birth weight when oral or enteral nutrition
`
`container size of 250 mL
`Primene 10% Solution for Infusion is a Sterile solution which contains amino acids, packaged in type II glass bottle container with nominal
`Water For Injection QS 1000 mL
`Malic Acid QS pH 5.5 Osmolarity 780 mOsm/L
`
`(For monovalent ions, such as sodium and chloride, the numeric value of the millimole and milliequivalent are identical.)
`Chlorides 19 mmol/L
`Amino Acids 100 g/L
`Total Nitrogen 15 g/L
`Ph.Eur.= European Pharmacopoeia; D.A.B = German Pharmacopoeia
`
`
`
`L‐Ornithine Hydrochloride, D.A.B. 0.318 g
`Taurine, USP 0.06 g
`L‐Aspartic Acid, Ph. Eur. 0.60 g
`Glycine, Ph. Eur. 0.40 g
`L‐Serine, Ph. Eur. 0.40 g
`L‐Glutamic Acid, Ph. Eur. 1.00 g
`L‐Alanine, Ph. Eur. 0.80 g
`L‐Proline, Ph. Eur. 0.30 g
`L‐Arginine, Ph. Eur. 0.84 g
`L‐Cysteine, D.A.B. 0.189 g
`L‐Tryptophan, Ph. Eur. 0.20 g
`L‐Tyrosine, Ph. Eur. 0.045 g
`L‐Methionine, Ph. Eur. 0.24 g
`L‐Threonine, Ph. Eur. 0.37 g
`L‐Phenylalanine, Ph. Eur 0.42 g
`L‐Histidine, Ph. Eur. 0.38 g
`L‐Valine, Ph. Eur 0.76 g
`L‐Lysine, Ph. Eur. 1.10 g
`L‐Isoleucine, Ph. Eur. 0.67 g
`L‐Leucine, Ph. Eur. 1.00 g
`
`Each 100 mL contains:
`
`
`
`Osmolarity 865 (mOsmol/L) (Calc.)
`pH 5.5(5.0‐6.0) adjusted with glacial acetic acid
`contain no added phosphorus.
`PREMASOL ‐ sulfite‐free (Amino Acid) Injections
`94mEq/L; Chloride (Calc.) <3mEq/L
`Acetate (provided as acetic acid and lysine acetate)
`Total Nitrogen 1.55 (grams/100 mL) (Calc.)
`Total Amino Acids 10 (grams/100 mL) (Calc.)
`USP = United States Pharmacopoeia
`Taurine, USP 0.025 g
`L‐Aspartic Acid, USP 0.32 g
`Glycine, USP 0.36 g
`L‐Serine, USP 0.38 g
`L‐Glutamic Acid, USP 0.50 g
`L‐Alanine, USP 0.54 g
`L‐Proline, USP 0.68 g
`L‐Arginine, USP 1.2 g
`Nonessential Amino Acids
`(Added as Cysteine HCl.H2O, USP)
`L‐Cysteine <0.016 g
`L‐Tryptophan, USP 0.20 g
`(added as Tyrosine, and N‐Acetyl‐L‐Tyrosine, USP)
`L‐Tyrosine 0.24 g
`L‐Methionine, USP 0.34 g
`L‐Threonine, USP, 0.42 g
`L‐Phenylalanine, USP 0.48 g
`L‐Histidine, USP 0.48 g
`L‐Valine, USP 0.78 g
`L‐Lysine 0.82 g (as Lysine Acetate, USP)
`L‐Isoleucine, USP 0.82 g
`L‐Leucine, USP 1.4 g
`Essential Amino Acids
`Each 100 mL contains:
`
`requirements are substantially increased as with extensive burns.
`not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein
`by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is
`weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract,
`Parenteral nutrition with PREMASOL ‐ sulfite‐free (Amino Acid) Injections is indicated to prevent nitrogen and
`those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes.
`PREMASOL ‐ sulfite‐free (Amino Acid) Injections are indicated for the nutritional support of infants (including
`single port VIAFLEX (PL146) polyvinyl chloride (PVC) container closure system.
`crystalline amino acids provided in a Pharmacy Bulk Package.The finished drug product is packaged in the
`PREMASOL ‐ sulfite‐free (Amino Acid) Injections are sterile, non‐pyrogenic, hypertonic solutions containing
`Osmolarity 520 (mOsmol/L) (Calc.)
`pH 5.5(5.0‐6.0) adjusted with glacial acetic acid
`contain no added phosphorus.
`PREMASOL ‐ sulfite‐free (Amino Acid) Injections
`57mEq/L; Chloride (Calc.) <3mEq/L
`Acetate (provided as acetic acid and lysine acetate)
`Total Nitrogen 0.93 (grams/100 mL) (Calc.)
`Total Amino Acids 6 (grams/100 mL) (Calc.)
`USP = United States Pharmacopoeia
`Taurine, USP 0.015 g
`L‐Aspartic Acid, USP 0.19 g
`Glycine, USP 0.22 g
`L‐Serine, USP 0.23 g
`L‐Glutamic Acid, USP 0.30 g
`L‐Alanine, USP 0.32 g
`L‐Proline, USP 0.41 g
`L‐Arginine, USP 0.73 g
`Nonessential Amino Acids
`(Added as Cysteine HCl.H2O, USP)
`L‐Cysteine <0.014 g
`L‐Tryptophan, USP 0.12 g
`(added as Tyrosine, and N‐Acetyl Tyrosine, USP)
`L‐Tyrosine 0.14 g
`L‐Methionine, USP 0.20 g
`L‐Threonine, USP 0.25 g
`L‐Phenylalanine,USP 0.29 g
`L‐Histidine, USP 0.29 g
`L‐Valine, USP 0.47 g
`L‐Lysine 0.49 g (as Lysine Acetate, USP)
`L‐Isoleucine, USP 0.49 g
`L‐Leucine, USP 0.84 g
`Essential Amino Acids
`Each 100 mL contains:
`
`Primene 10% Solution for Infusion
`
`10% PREMASOL –sulfite‐free
`
`(Amino Acid) Injection
`
`6% PREMASOL – sulfite‐free
`
`(Amino Acid) Injection
`
`
`
`Primene 10% Solution for Infusion (glass bottle)
`
`Import Product
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`Please see page 8 for a larger image
`
`6% and 10% PREMASOL – sulfite‐free
`
`US FDA Approved Product
`
`(Amino Acid) Injection
`
`Use
`Indications for
`
`Description
`
`Information
`Additional
`
`Ingredients
`Composition and
`
`
`
`
`
`
`
`
`
`Product Comparison Table: Key differences in 6% and 10% Premasol – Sulfite-free Injection and Primene 10% Solution for Infusion
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`The addition of trace elements may cause formation of visible particulate matter.
`Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates.
`preparation.
`Do not add other medicinal products or substances without first confirming their compatibility and the stability of the resulting
`Additives may be incompatible.
`Attach administration set. Refer to ‘Instructions for Use’ accompanying the set
`Primene must not be infused through the same tubing with blood or blood components unless there is documentation that it is safe.
`Do not connect containers in series in order to avoid air embolism due to possible residual air in the primary container.
`Discard any unused contents. Do not reconnect any partially used container.
`perform blood levels of copper (or other trace elements) where medically relevant.
`compounding, prior to administration and periodically during administration. If discolouration or precipitation is noted in the filter,
`Perform visual inspections for cloudiness or precipitation of the TPN solution, infusion set, catheter and in‐line filter after
`solutions, use a 1.2 micron filter for particulate matter removal.
`may be formed with the use of trace elements (e.g. copper). For 3 in 1 (lipid, amino acid, and carbohydrate) parenteral nutrition
`For 2 in 1 (amino acid and carbohydrate) parenteral nutrition solutions, use a 0.2 micron filter for removal of particulate matter that
`iron, or zinc) for removal of visible particulate matter which has been observed in the infusion line for some formulations.
`The use of a final filter is required during administration of all formulations containing Primene and trace elements (including copper,
`Administration of the infusion: Allow the solution to reach room temperature before use.
`Ensure proper storage requirements of additives are followed.
`Any unused portion of Primene should be discarded and should not be used for subsequent admixing.
`Confirm the integrity of the container. Only use if the container is undamaged and the solution is clear.
`and particulate matter.
`device/transfer set, as appropriate. Mix content of the container and the additives thoroughly. Inspect final solution for discoloration
`site of the container as appropriate. Puncture the injection site and inject the additives using an injection needle or a reconstitution
`If additions are made to the container: Ensure stability and compatibility of additives. Consult with pharmacist. Prepare the injection
`For single use only.
`Aseptic conditions must be observed throughout the preparation and use of Primene 10%.
`Discard if the container is leaking or if the solution is discoloured, cloudy or contains a precipitate.
`Visually inspect the container. Only use if the container is undamaged and the solution is clear.
`of all ages if the osmolarity of the formulation is ≤ 900 mOsm/L
`vein. If deemed appropriate by the healthcare professional, parenteral nutrition solution may be administered peripherally in patients
`nutrition solutions (>900 mOsm/L) should be administered through a central venous catheter with the tip located in a large central
`specific infusion solution must be taken into account when peripheral administration is considered. Strongly hypertonic parenteral
`should be administered according to the final osmolarity of the solution infused, in a peripheral or central vein. The osmolarity of a
`stability are known. Primene 10% alone should be administered in a central vein. Primene 10% in co‐administration or as a mixture
`elements and vitamins to meet nutrient needs and prevent deficiencies and complications from developing, when compatibility and
`mixture. Primene 10% may be included in the composition of nutritive mixtures combining carbohydrates, lipids, electrolytes, trace
`Primene 10% is usually administered with a source of energy appropriate for the needs of the child, either by co‐administration or as a
`Method of administration: Primene is intended for intravenous use. Primene is not intended for fluid or volume replacement.
`hours and the infusion duration. The flow rate should be increased gradually during the first hour.
`The flow rate should be adjusted according to the dosage, the characteristics of the infusion solution, the total volume intake per 24
`
`Children: continuous infusion (over 24 hours) or cyclic infusion (over about 12 hours in 24).
`Neonates and Infants: continuous infusion (over 24 hours).
`
`The infusion rate should not exceed 0.05ml/kg/min. Recommended flow rates:
`
`15 – 35 ml of Primene 10%/kg/24 hours
`0.230 – 0.53 g nitrogen/kg/24 hours
`1.5 – 3.5 g amino‐acids/kg/24 hours
`
`The usual range is:
`
`• additional nutrition that may be provided parenterally and/or enterally.
`• ability to metabolize the constituents of Primene,
`• nitrogen requirements,
`• age, weight, clinical condition,
`
`Parenteral nutrition initiation and duration as well as dosage (dose and rate of administration) depends on a patient’s
`
`Primene 10% Solution for Infusion (glass bottle)
`
`Import Product
`
`be under refrigeration and limited to a brief period of time, preferably less than 24 hours.
`pharmacist. Parenteral nutrition solutions should be used promptly after mixing. Any storage should
`order to avoid precipitation. Care must be taken to avoid incompatible admixtures. Consult with
`magnesium ions in an additive solution should be considered when phosphate is also present, in
`phosphate or which have been supplemented with phosphate. The presence of calcium and
`PREMASOL ‐ sulfite‐free (Amino Acid) Injections may be admixed with solutions which contain
`permit. A slight yellow color does not alter the quality and efficacy of the product.
`for particulate matter and discoloration prior to administration, whenever solution and container
`be accompanied by adequate caloric intake. Parenteral drug products should be inspected visually
`isotonic or slightly hypertonic solutions for peripheral infusion. It is essential that peripheral infusion
`can be prepared by dilution with Sterile Water for Injection or 5% ‐10% Dextrose Injection to prepare
`be administered by peripheral vein with or without parenteral carbohydrate calories. Such infusates
`who can consume adequate calories enterally, PREMASOL ‐ sulfite‐free (Amino Acid) Injections may
`Peripheral Parenteral Nutrition. For patients in whom the central venous route is not indicated and
`glucose levels in blood and urine.
`increased gradually to the maximum required dose as indicated by frequent determinations of
`governed by the patient's glucose tolerance. Daily intake of amino acids and dextrose should be
`protein needs, the rate of administration, particularly during the first few days of therapy, is
`behind schedule, no attempt to “catch up” to planned intake should be made. In addition to meeting
`recommended 60‐125 mL per kilogram of body weight per day. If administration rate should fall
`superior vena cava. Initial infusion rates should be slow, and gradually increased to the
`administered by continuous infusion through a central venous catheter with the tip located in the
`Central Venous Nutrition. Hypertonic mixtures of amino acids and dextrose may be safely
`vitamins, minerals and trace elements should also be provided.
`electrolytes, including magnesium and phosphorus, should be monitored frequently. Appropriate
`free (Amino Acid) Injections must be considered when calculating daily electrolyte intake. Serum
`salts to provide bicarbonate precursor. The electrolyte content of 6% and 10% PREMASOL ‐ sulfite‐
`hyperchloremic or other metabolic acidoses, sodium and potassium may be added as the acetate
`major extracellular electrolytes sodium, calcium, and chloride, must be given. In patients with
`phosphate, is required for optimum utilization of amino acids. In addition, sufficient quantities of the
`The provision of sufficient intracellular electrolytes, principally potassium, magnesium, and
`monitored for evidence of EFAD in patients maintained on fat free TPN.
`nutrition is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be
`Fat emulsion co‐administration should be considered when prolonged (more than 5 days) parenteral
`solutions are abruptly discontinued.
`hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose
`administration of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound
`In many patients, provision of adequate calories in the form of hypertonic dextrose may require the
`weight per day.
`recommended dosage is 1.0 mmole of L‐cysteine hydrochloride monohydrate per kilogram of body
`hydrochloride to the TPN solution is therefore recommended. Based on clinical studies, the
`considered to be an essential amino acid in infants and young children. An admixture of cysteine
`nitrogen may not be possible due to fluid intake limits, nitrogen, or glucose intolerance. Cysteine is
`requirements may be higher in severely hypercatabolic or depleted patients, provision of additional
`per kilogram body weight per day is appropriate for most infants on TPN. Although nitrogen
`Total daily fluid intake should be appropriate for the patient's age and size. A fluid dose of 125 mL
`hour period.
`Injection USP supplemented with electrolytes and vitamins and administered continuously over a 24
`Typically, PREMASOL ‐ sulfite‐free (Amino Acid) Injections are admixed with 50% or 70% Dextrose
`kilograms.
`grams/day for the first 10 kg of body weight plus 1.0 to 1.25 g/day for each kg of body weight over 10
`children larger than 10 kilograms, the total dosage of amino acids should include the 20 to 25
`body weight per day (2.0 to 2.5 g/kg/day) for infants up to 10 kilograms. For infants and young
`PREMASOL ‐ sulfite‐free (Amino Acid) Injections is 2.0 to 2.5 grams of amino acids per kilogram of
`protein per kilogram of body weight per day (2.0 to 4.0 g/kg/day).4 The recommended dosage of
`Recommendations for allowances of protein in infant nutrition have ranged from 2 to 4 grams of
`nitrogen tolerances, as well as by metabolic and clinical response.
`requirements. Dosage should also be guided by the patient's fluid intake limits and glucose and
`body weights, corrected for fluid balance, are probably the best means of assessing individual protein
`patient's metabolic and clinical response. The determination of nitrogen balance and accurate daily
`PREMASOL ‐ sulfite‐free (Amino Acid) Injections depends on daily protein requirements and on the
`amino acid and caloric support for protein synthesis and growth. The total daily dose of 6% and 10%
`The objective of nutritional management of infants and young children is the provision of sufficient
`
`6% and 10% PREMASOL – sulfite‐free
`
`US FDA Approved Product
`
`(Amino Acid) Injection
`
`Administration
`Dosage and
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`
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`Nitrogen tolerance may be altered and dosage may have to be adjusted. Fluid and electrolyte status should be closely monitored in these patients.
`Use with caution in patients with renal insufficiency (with e.g., uraemia).
`renal impairment.
`Azotaemia has been reported with parenteral administration of solutions containing amino acids, and may occur in particular in the presence of
`Renal effects
`
`• Use with caution in patients with pulmonary oedema or heart failure. Fluid status should be closely monitored.
`infusion.
`• Severe water and electrolyte disorders, severe fluid overload states, and severe metabolic disorders should be corrected before starting the
`well as severe reactions (with, e.g., necrosis and blistering) when associated with extravasation. Patients should be monitored accordingly.
`• Infusion site reactions have occurred with the use of parenteral nutrition. They include infusion site thrombophlebitis and venous irritation, as
`Additional precautions
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`Depending on extent and etiology, hyperammonaemia may require immediate intervention.
`Blood ammonia should be measured frequently in newborns and infants to detect hyperammonaemia.
`the presence of a congenital disorder of amino acid metabolism or hepatic insufficiency.
`Increase in blood ammonia levels and hyperammonaemia may occur in patients receiving amino acid solutions. In some patients this may indicate
`hyperammonaemia.
`Liver function parameters should be closely monitored in these patients, and they should be monitored for possible symptoms of
`Amino acid solutions should be used with caution in patients with pre‐existing liver disease or liver insufficiency.
`possible therapeutic and prophylactic interventions.
`disorders should be assessed by a clinician knowledgeable in liver diseases in order to identify possible causative and contributory factors, and
`thought to be multifactorial and may differ between patients. Patients developing abnormal laboratory parameters or other signs of hepatobiliary
`leading to hepatic failure, as well as cholecystitis and cholelithiasis) and should be monitored accordingly. The etiology of these disorders is
`Patients on parenteral nutrition may experience hepatic complications (including cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly
`Hepatic function
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`
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`from administration of inadequate or excessive nutrients or from inappropriate composition of an admixture for a particular patient's needs.
`dietary component is not accurately assessed. Adverse metabolic effects may arise
`Metabolic complications may occur if the nutrient intake is not adapted to the patient's requirements, or the metabolic capacity of any given
`Metabolic Effects
`
`
`
`slowly increasing nutrient intakes while avoiding overfeeding can prevent these complications.
`magnesium intracellularly as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. Careful monitoring and
`Refeeding severely undernourished patients may result in the refeeding syndrome that is characterized by the shift of potassium, phosphorus, and
`Refeeding Syndrome in Patients Receiving Parenteral Nutrition
`
`In addition to inspection of the solution, the infusion set and catheter should also periodically be checked for precipitates.
`If signs of pulmonary distress occur, the infusion should be stopped and medical evaluation initiated.
`has also been reported.
`reported even in the absence of phosphate salt in the solution. Precipitation distal to the in line filter and suspected in vivo precipitate formation
`Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates. Precipitates have been
`Pulmonary vascular precipitates have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes have occurred.
`Precipitates in Patients Receiving Parenteral Nutrition
`a component of parenteral nutrition. The infusion must be stopped immediately if any signs or symptoms of a reaction develop.
`Anaphylactic/anaphylactoid reactions and other hypersensitivity/infusion reactions have been reported with amino acid solutions administered as
`Allergic Reactions / Hypersensitivity Reactions
`
`
`
`well as aseptic technique in nutritional formula preparation.
`The occurrence of septic complications can be decreased with heightened emphasis on aseptic technique in catheter placement, maintenance, as
`can help recognize early infections.
`Careful symptomatic and laboratory monitoring for fever/chills, leukocytosis, technical complications with the access device, and hyperglycaemia
`infectious complications.
`Immunosuppression and other factors such as hyperglycaemia, malnutrition and/or their underlying disease state may predispose patients to
`contaminated solutions.
`Infection and sepsis may occur as a result of intravenous catheters used to administer parenteral formulations, poor maintenance of catheters or
`Infectious complications
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`its osmolality, Primene 10% should not be infused alone into a peripheral vein.
`Hypertonic infusion solutions may cause irritation of the vein, vein damage, and thrombosis when administered into a peripheral vein. In view of
`Hypertonic solutions
`
`
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`balance, serum osmolarity, acid/base balance, blood glucose levels, blood ammonia levels, and liver and kidney function.
`Monitoring should be appropriate to the patient’s clinical situation and condition, and should include determinations of water and electrolyte
`General Monitoring
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`congenital abnormality of amino acid metabolism.
`hypersensitivity to any of the active substances or to any of the excipients .
`
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`
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`Primene is contraindicated in patients with:
`
`Primene 10% Solution for Infusion (glass bottle)
`
`Import Product
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`thrombosis, and air and catheter embolus.
`injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis,
`central venous catheters are pneumothorax, hemothorax, hydrothorax, artery puncture and transection,
`X‐ray is the best means of verifying catheter placement. Complications known to occur from the placement of
`of complications. For details of techniques and placement sites, consult the medical literature.
`should be fully acquainted with various techniques of catheter insertion as well as recognition and treatment
`Technical. The placement of a central venous catheter should be regarded as a surgical procedure. One
`lists those based on current literature.
`Although a detailed discussion of the complications is beyond the scope of this insert, the following summary
`followed, preferably by an experienced team.
`monitoring. It is essential that a carefully prepared protocol, based on current medical practices, be
`careful attention to all aspects of the procedure, including solution preparation, administration, and patient
`Central venous nutrition may be associated with complications which can be prevented or minimized by
`used only by those familiar with this technique and its complications.
`Special Precautions for Central Venous Nutrition: Administration by central venous catheter should be
`Injections can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
`sulfite‐free (Amino Acid) Injections. It is also not known whether PREMASOL ‐ sulfite‐free (Amino Acid)
`Pregnancy Category C. Animal reproduction studies have not been conducted with 6% and 10% PREMASOL ‐
`Usage in Pregnancy
`PREMASOL ‐ sulfite‐free (Amino Acid) Injections.
`No in vitro or in vivo carcinogenesis, mutagenesis, or fertility studies have been conducted with 6% and 10%
`Carcinogenesis, Mutagenesis, Impairment of Fertility
`Drug product contains no more than 25 μg/L of aluminum.
`Do not use unless solution is clear and seal is intact.
`mixing, prior to administration, and periodically during administration.
`may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after
`To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that
`levels should be monitored frequently.
`supplementation should always accompany phosphate administration. To assure adequate intake, serum
`hypophosphatemia, may require the addition of phosphate. To prevent hypocalcemia, calcium
`PREMASOL ‐ sulfite‐free (Amino Acid) Injections contain no added phosphorus. Patients, especially those with
`PREMASOL ‐ sulfite‐free (Amino Acid) Injections contain less than 3 mEq chloride per liter.
`treatment.
`venous thrombosis or phlebitis occurs, discontinue infusions or change infusion site and initiate appropriate
`within the lumen of the vein. The venipuncture site should be inspected frequently for signs of infiltration. If
`dilution and provision of adequate calories. Care should be taken to assure proper placement of the needle
`Peripheral administration of 6% and 10% PREMASOL ‐ sulfite‐free (Amino Acid) Injections require appropriate
`ketonemia may be achieved by the administration of carbohydrates.
`without carbohydrates may result in the accumulation of ketone bodies in the blood. Correction of this
`the patient's utilization rate may lead to hyperglycemia, coma, and death. Administration of amino acids
`severe hyperglycemia in such patients, insulin may be required. Administration of glucose at a rate exceeding
`Special care must be taken when giving hypertonic dextrose to a diabetic or pre‐diabetic patient.To prevent
`Care should be taken to avoid circulatory overload, particularly in patients with cardiac insufficiency.
`vena cava.
`solutions should be administered via an intravenous catheter placed in a central vein, preferably the superior
`therapy or wh