NDC 0264-1915 Procalamine

Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite

NDC Product Code 0264-1915

NDC CODE: 0264-1915

Proprietary Name: Procalamine What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.
  • Drug uses not available
  • Calcium acetate is used to prevent high blood phosphate levels in patients who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and possibly decrease the risk of heart disease and strokes that can result from high phosphate levels. Calcium acetate is a natural mineral that works by holding onto phosphate from the diet so that it can pass out of your body.
  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.
  • This medication is a mineral supplement used to treat or prevent low amounts of potassium in the blood. A normal level of potassium in the blood is important. Potassium helps your cells, kidneys, heart, muscles, and nerves work properly. Most people get enough potassium by eating a well-balanced diet. Some conditions that can lower your body's potassium level include severe prolonged diarrhea and vomiting, hormone problems such as hyperaldosteronism, or treatment with water pills/diuretics.

NDC Code Structure

  • 0264 - B. Braun Medical Inc.

NDC 0264-1915-07

Package Description: 6 CARTON in 1 CASE > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER

NDC Product Information

Procalamine with NDC 0264-1915 is a a human prescription drug product labeled by B. Braun Medical Inc.. The generic name of Procalamine is glycerin, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, alanine, glycine, arginine, histidine, proline, serine, cysteine, sodium acetate, magnesium acetate, calcium acetate, sodium chloride, potassium chloride, phosphoric acid, and potassium metabisulfite. The product's dosage form is injection and is administered via intravenous form.

Labeler Name: B. Braun Medical Inc.

Dosage Form: Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Procalamine Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • GLYCERIN 3 g/100mL
  • ISOLEUCINE .21 g/100mL
  • LEUCINE .27 g/100mL
  • LYSINE ACETATE .22 g/100mL
  • METHIONINE .16 g/100mL
  • PHENYLALANINE .17 g/100mL
  • THREONINE .12 g/100mL
  • TRYPTOPHAN .046 g/100mL
  • VALINE .2 g/100mL
  • ALANINE .21 g/100mL
  • GLYCINE .42 g/100mL
  • ARGININE .29 g/100mL
  • HISTIDINE .085 g/100mL
  • PROLINE .34 g/100mL
  • SERINE .18 g/100mL
  • CYSTEINE HYDROCHLORIDE .014 g/100mL
  • SODIUM ACETATE .2 g/100mL
  • MAGNESIUM ACETATE .054 g/100mL
  • CALCIUM ACETATE .026 g/100mL
  • SODIUM CHLORIDE .12 g/100mL
  • POTASSIUM CHLORIDE .15 g/100mL
  • PHOSPHORIC ACID .041 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • POTASSIUM METABISULFITE (UNII: 65OE787Q7W)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Non-Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Glycerol - [CS]
  • Amino Acid - [EPC] (Established Pharmacologic Class)
  • Amino Acids - [CS]
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium - [CS]
  • Cations -
  • Divalent - [CS]
  • Potassium Compounds - [CS]
  • Potassium Salt - [EPC] (Established Pharmacologic Class)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: B. Braun Medical Inc.
Labeler Code: 0264
FDA Application Number: NDA018582 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-06-1982 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Procalamine Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

ProcalAmine® (3% Amino Acid and 3% Glycerin Injection with Electrolytes) is a sterile, nonpyrogenic, moderately hypertonic intravenous injection containing crystalline amino acids, a nonprotein energy substrate and maintenance electrolytes. A 1000 mL unit provides a total of 29 g of protein equivalent (4.6 g N) and 130 nonprotein calories.All amino acids designated USP are the "L"-isomer with the exception of Glycine USP which does not have an isomer.Each 100 mL contains:Nonprotein energy source:Glycerin USP (glycerol) ..............................................................................  3.0 gEssential amino acidsIsoleucine USP ..........................................................................................  0.21 gLeucine USP .............................................................................................  0.27 gLysine .......................................................................................................  0.22 g  (added as Lysine Acetate USP ................................................................  0.31 g)Methionine USP ........................................................................................  0.16 gPhenylalanine USP ....................................................................................  0.17 gThreonine USP ..........................................................................................  0.12 gTryptophan USP ......................................................................................  0.046 gValine USP ................................................................................................  0.20 gNonessential amino acidsAlanine USP ..............................................................................................  0.21 gGlycine USP ..............................................................................................  0.42 gArginine USP .............................................................................................  0.29 gHistidine USP............................................................................................  0.085 gProline USP ...............................................................................................  0.34 gSerine USP ................................................................................................  0.18 gCysteine ...................................................................................................<0.014 g  (as Cysteine HCl•H2O USP ...................................................................<0.020 g)Sodium Acetate•3H2O USP........................................................................  0.20 gMagnesium Acetate•4H2O.........................................................................  0.054 gCalcium Acetate•H2O ...............................................................................  0.026 gSodium Chloride USP .................................................................................  0.12 gPotassium Chloride USP..............................................................................  0.15 gPhosphoric Acid NF .................................................................................  0.041 gPotassium Metabisulfite NF (as an antioxidant) ............................................<0.05 gWater for Injection USP ....................................................................................  qspH adjusted with Glacial Acetic Acid USPpH: 6.8 (6.5–7.0), Calculated Osmolarity: 735 mOsmol/literConcentration of Electrolytes (mEq/liter): Sodium 35; Potassium 24.5; Calcium 3Magnesium 5; Chloride 41; Phosphate (HPO ) 73.5 mmole/liter; 10.9 mg% P; Acetate 47Acetate is provided as inorganic acetate salts (23 mEq/liter), acetic acid (9 mEq/liter), and lysine acetate (15 mEq/liter). It is thought that acetate from lysine acetate and acetic acid, under the conditions of parenteral nutrition does not impact net acid/base balance when renal and respiratory functions are normal. Clinical experience seems to support this thinking, although confirmatory experimental evidence is not available.

Clinical Pharmacology

ProcalAmine® provides a physiological ratio of biologically utilizable essential and nonessential amino acids, a nonprotein energy source, and a balanced pattern of maintenance electrolytes.The amino acids provide substrates for protein synthesis as well as sparing body protein and muscle mass. Glycerin USP (glycerol), a utilizable energy substrate, is also provided which serves to preserve body protein. Glycerol participates as an active energy substrate through its phosphorylation to α-glycerophosphate and subsequent conversion to dihydroxyacetone phosphate, one of the two key trioses in the metabolism of glucose for energy generation.The metabolism of glycerol has been investigated in both animals and humans. The liver is chiefly responsible for the high potential of glycerol utilization for gluconeogenesis, accounting for at least three-fourths of the total capacity of the body to utilize glycerol. Further, the kidney accounts for up to one-fifth of this total capacity. Among other kinds of cells and tissues shown to utilize glycerol at various rates are the brain, intestine, muscle, leukocytes, lungs and spermatozoa.In a multicenter clinical study, mildly catabolic post-surgical patients receiving ProcalAmine® (3% Amino Acid and 3% Glycerin Injection with Electrolytes) showed a significant improvement in nitrogen balance when compared with patients receiving isonitrogenous amino acids.

Indications And Usage

ProcalAmine® is indicated for peripheral administration in adults to preserve body protein and improve nitrogen balance in well-nourished, mildly catabolic patients who require short-term parenteral nutrition.

Contraindications

Renal failure.Severe liver disease and hepatic coma.Metabolic disorders associated with impaired nitrogen utilization.Hypersensitivity to one or more amino acids.

Warnings

  • This product contains potassium metabisulfite, 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 nonasthmatic people.WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.Peripheral intravenous infusion of amino acids may cause a normal, modest rise in blood urea nitrogen (BUN) as a result of increased protein intake. The BUN may become elevated in patients with impaired renal or hepatic function. If the BUN levels exceed post-prandial limits and continue to rise, further use of ProcalAmine® should be reevaluated.Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient's clinical status reevaluated.Undesirable side effects of glycerol reported in the literature include hemolysis, hemoglobinuria and renal damage. None of these side effects was observed in clinical trials with ProcalAmine®. The manifestation of these side effects is highly dependent on dose and route of administration as well as on formulation. In general, high concentrations of glycerol (up to 40%) are not hemolytic, provided solution is prepared with isotonic saline. Subcutaneous injection of low doses of glycerol alone, e.g., 3% without other solutes, can cause hemolysis. Much higher doses, up to 20 times that of subcutaneous injection are required to obtain similar effects intravenously. Subcutaneous injection of glycerol at low doses can produce hemoglobinuria. Therefore, there should be frequent monitoring to ensure early detection of infiltrations.Administration of solutions containing electrolytes should be undertaken with extreme caution in the following circumstances:Solutions containing sodium ions should be used with care in patients with congestive heart failure, renal insufficiency and in clinical states in which there exists edema with sodium retention.
  • Solutions containing potassium ions should be used with care in patients with hyperkalemia, renal insufficiency and in conditions in which potassium retention is present.
  • Solutions containing acetate ions from inorganic salts should be used with care in patients with metabolic or respiratory alkalosis.
  • Solutions containing calcium ions should not be administered through the same administration set as blood because of the likelihood of coagulation.Care should be taken to avoid circulatory overload, particularly in patients with cardiac insufficiency.Blood sugar levels should be monitored frequently in diabetic patients.

General

Safe, effective use of parenteral nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of complications which can occur. Frequent evaluation and laboratory determinations are necessary for proper monitoring of parenteral nutrition. Peripheral infusion therapy is intended to provide nutritional support for a limited period of time. If a patient requires an extended period of nutritional support, enteral or parenteral regimens should include nonprotein calories adequate for weight maintenance.The electrolyte pattern of ProcalAmine® is designed for maintenance only during peripheral infusion therapy in adults. Abnormal losses should be monitored and replaced as required.During peripheral vein infusion of ProcalAmine®, care should be taken to assure proper placement of the needle or catheter.The utilization of hypertonic solutions has been associated with an increased incidence of phlebitis. The incidence of phlebitis with ProcalAmine® was marginally higher than that observed with a less hypertonic solution. Phlebitis can be minimized by using an in-line filter and/or by changing the site of infusion.To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.Use only if solution is clear and vacuum is present.Drug product contains no more than 25 µg/L of aluminum.

Laboratory Tests

Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration.Laboratory tests should include measurement of blood sugar, electrolyte, and serum protein concentrations; kidney and liver function tests; and evaluation of acid-base balance and fluid balance. Other laboratory tests may be suggested by the patient's condition.

Drug Interactions

Administration of barbiturates, narcotics, hypnotics or systemic anesthetics should be adjusted with caution in patients also receiving magnesium-containing solutions because of an additive central depressive effect.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No in vitro or in vivo carcinogenesis, mutagenesis, or fertility studies have been conducted with ProcalAmine® (3% Amino Acid and 3% Glycerin Injection with Electrolytes).

Pregnancy Category C

Animal reproduction studies have not been conducted with ProcalAmine® (3% Amino Acid and 3% Glycerin Injection with Electrolytes). It is also not known whether ProcalAmine® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ProcalAmine® should be given to a pregnant woman only if clearly needed.

Labor And Delivery

Information is unknown.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised with ProcalAmine® if administered to a nursing woman.

Pediatric Use

Safety and effectiveness of amino acid injections in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acid injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is well established in the medical literature. See WARNINGS and DOSAGE AND ADMINISTRATION.

ProcalAmine® is intended for use in adults. Use of ProcalAmine® in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).Venous irritation at an infusion site can be minimized by the selection of a large peripheral vein as well as by slowing the rate of infusion. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).Parenteral drug products should be inspected visually for particulate matter and discoloration, prior to administration, whenever solution and container permit.

Geriatric Use

Clinical studies of ProcalAmine® did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.See WARNINGS.

Adverse Reactions

Local reactions of the infusion site consisting of a warm sensation, erythema, phlebitis and thrombosis have been reported in the literature with peripheral amino acid infusions. Generalized flushing, fever and nausea have been reported in the literature during the peripheral administration of amino acids.

Overdosage

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment.

Dosage And Administration

ProcalAmine® is a convenient source of nonprotein calories to preserve lean body mass, amino acids, maintenance electrolytes, and water for adult patients.Determination of nitrogen balance and accurate daily body weights (corrected for fluid balance) are probably the best means of assessing individual protein requirements.Approximately three liters per day of ProcalAmine® will provide a total of 90 grams of amino acids, 390 nonprotein calories and the recommended daily intake of principal intra- and extracellular electrolytes for the stable patient. Therapy can begin with three liters of ProcalAmine® on the first day with close monitoring of the patient.As with all intravenous fluid therapy, the goal is to provide adequate water to compensate for insensible, urinary and other losses, and electrolytes for replacement and maintenance. These requirements should be determined frequently and appropriately administered.Additional electrolytes should be administered evenly throughout the day, and irritating medications should be injected at an alternate infusion site.

How Supplied

ProcalAmine® (3% Amino Acid and 3% Glycerin Injection with Electrolytes) is supplied sterile and nonpyrogenic in 1000 mL intravenous infusion bottles, packaged six per case.NDCREFSize ProcalAmine® (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 0264-1915-07 S9050 (Solid Stopper) 1000 mL

Directions For Use Of B. Braun Glass Containers With Solid Stoppers

  • Designed for use with a vented set.  Use 18 to 22 gauge needle size for admixing or withdrawing solutions from the glass bottle. Before use, perform the following checks: Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.
  • Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter; check the bottle for cracks or other damage. In checking for cracks, do not be confused by normal surface marks and seams on the bottom and sides of the bottle. These are not flaws. Look for bright reflections that have depth and penetrate into the wall of the bottle. Reject any such bottle.
  • To remove the outer closure, lift the tear tab and pull up, over, and down until it is below the stopper (see Figure 1). Use a circular pulling motion on the tab until it breaks away.
  • Grasp and remove the metal disk, exercising caution not to touch the exposed sterile stopper surface.Warning: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.When adding medication to the container prior to administration, swab the target area of the rubber stopper, inject medication and mix thoroughly by gentle agitation. Refer to Directions for Use of the set being used. Insert the set spike into the bottle through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before administration begins. Hang the container.
  • After admixture and during administration, re-inspect the solution frequently. If any evidence of solution contamination or instability is found or if the patient exhibits any signs of fever, chills or other reactions not readily explainable, discontinue administration immediately and notify the physician.
  • Spiking, additions, or transfers should be made immediately after exposing the sterile stopper surface. Check for vacuum at first puncture of stopper. Admixture by needle or syringe should be made through the target area of the rubber stopper; contents should be drawn by vacuum into the bottle. Admixture by spiked vial should also be through the target area of the rubber stopper (see Figure 2). If contents of initial addition are not drawn into the bottle, vacuum is not present and the unit should be discarded. Each addition/transfer will reduce the vacuum remaining in the bottle.
  • If the first puncture of the stopper is the administration set spike, insert the spike fully into the target area of the rubber stopper and promptly invert the bottle. Verify vacuum by observing rising air bubbles. Do not use the bottle if vacuum is not present.
  • If admixture or set insertion is not performed immediately following removal of protective metal disk, swab stopper surface.

* Please review the disclaimer below.