Monoclate-P ® is indicated for treatment of classical hemophilia (Hemophilia A). Affected individuals frequently require therapy following minor accidents. Surgery, when required in such individuals, must be preceded by temporary corrections of the clotting abnormality. Surgical prophylaxis in severe AHF deficiency can be accomplished with an appropriately-dosed pre-surgical IV bolus of Monoclate-P ® followed by i...
Monoclate-P ® is for intravenous administration only. As a general rule 1 unit of AHF activity per kg will increase the circulating AHF level by 2%. 10 The following formula 10 provides a guide of dosage calculations for both adult and pediatric patients: Number of AHF = Body weight × desired Factor VIII × 0.5 IU Required (in kg) increase (% normal) Although dosage must be individualized according to the needs of ...
When stored at refrigerator temperature, 2-8°C (36-46°F), Monoclate-P ® is stable for the period indicated by the expiration date on its label. Within this period, Monoclate-P ® may be stored at room temperature not to exceed 25°C (77°F), for up to 6 months. Avoid freezing which may damage container for the diluent.
Rx only
Antihemophilic Factor (Human), Monoclate-P®, Factor VIII:C Pasteurized, Monoclonal Antibody Purified, is a sterile, stable, lyophilized concentrate of Factor VIII:C with reduced amounts of VWF:Ag and purified of extraneous plasma-derived protein by use of affinity chromatography. A murine monoclonal antibody to VWF:Ag is used as an affinity ligand to first isolate the Factor VIII Complex. Factor VIII:C is then dissociated from VWF:Ag, recovered, formulated and provided as a sterile lyophilized powder.1,2,3 The concentrate as formulated contains Albumin (Human) as a stabilizer, resulting in a concentrate with a specific activity between 4 and 10 units/mg of total protein. In the absence of this added Albumin (Human) stabilizer, specific activity has been determined to exceed 3000 units/mg of protein.4 Monoclate-P® has been prepared from pooled human plasma and is intended for use in therapy of classical hemophilia (Hemophilia A).
All Source Plasma used in the manufacture of this product was tested by FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV, and HIV-1 and found to be nonreactive (negative).
This concentrate has been pasteurized by heating at 60°C for 10 hours in aqueous solution form during its manufacture in order to further reduce the risk of viral transmission.5 However, no procedure has been shown to be totally effective in removing viral infectivity from coagulant factor concentrates (see CLINICAL PHARMACOLOGY and WARNINGS).
Monoclate-P® is a highly purified preparation of Factor VIII:C. When stored as directed, it will maintain its labeled potency for the period indicated on the container and package labels.6,7
Upon reconstitution of the 250, 500 and 1000 IU concentrates, a clear, colorless solution is obtained, containing 50 to 150 times as much Factor VIII:C as does an equal volume of plasma.
Upon reconstitution of the 1500 IU concentrate, a clear, colorless solution is obtained, containing 120 to 180 times as much Factor VIII:C as does an equal volume of plasma.
Each vial contains the labeled amount of antihemophilic factor (AHF) activity as expressed in terms of International Units (IU) of antihemophilic activity. One unit of antihemophilic activity is equivalent to that quantity of AHF present in one mL of normal human plasma. When reconstituted as recommended, the resulting solution contains approximately 300 to 450 millimoles of sodium ions per liter and has 2 to 3 times the tonicity of saline. It contains approximately 2-5 millimoles of calcium ions per liter, contributed as calcium chloride, approximately 1 to 2% Albumin (Human), 0.8% mannitol, and 1.2 mM histidine. The pH is adjusted with hydrochloric acid and/or sodium hydroxide. Monoclate-P® also contains trace amounts (≤50 ng per 100 IU of AHF) of the murine monoclonal antibody used in its purification (see CLINICAL PHARMACOLOGY).
Monoclate-P® is to be administered only intravenously.
Factor VIII:C is the coagulant portion of the Factor VIII complex circulating in plasma. It is noncovalently associated with the von Willebrand protein responsible for von Willebrand factor activity. These two proteins have distinct biochemical and immunological properties and are under separate genetic control. Factor VIII:C acts as a cofactor for Factor IX to activate Factor X in the intrinsic pathway of blood coagulation.8 Hemophilia A, a hereditary disorder of blood coagulation due to decreased levels of Factor VIII:C, results in profuse bleeding into joints, muscles or internal organs as a result of a trauma. Monoclate-P® provides an increase in plasma levels of AHF, thereby enabling temporary correction of Hemophilia A bleeding.
Clinical evaluation of Monoclate-P® concentrate for its half-life characteristics in hemophilic patients showed it to be comparable to other commercially available Antihemophilic Factor (Human) concentrates. The mean half-life obtained from six patients was 17.5 hours with a mean recovery of 1.9 units/dl rise/U/kg.
The pasteurization process used in the manufacture of this concentrate has demonstrated in vitro inactivation of human immunodeficiency virus (HIV) and several model viruses. In two separate studies, HIV was reduced by ≥7.0 log10 to an undetectable level and by 10.5 log10, respectively. In addition to HIV, studies were also performed using three lipid containing model viruses and one non-lipid, encapsulated model virus. Vesicular stomatitis (VSV) was reduced by ≥6.79 log10 to undetectable, Sindbis was reduced by ≥6.48 log10 to undetectable and Vaccinia was reduced by ≥5.36 log10 to undetectable. Murine encephalomyocarditis (EMC), a non-lipid, encapsulated model virus, was reduced by ≥7.1 log10 to undetectable.
Evidence of the capability of the purification and preparative steps used in the production of Monoclate-P® to reduce viral bioburden was obtained in studies involving the addition of known quantities of virus to cryoprecipitate. These studies were conducted using an earlier form of the concentrate which had not undergone liquid pasteurization (Antihemophilic Factor (Human), Monoclate®, Monoclonal Antibody Purified, Factor VIII:C, Heat-Treated). These studies provide evidence of the viral removal potential of the purification and preparative steps of the manufacturing process (exclusive of heat treatment) which are common to both concentrates. In one study, the viruses used were human immunodeficiency virus (HIV), Sindbis virus, vesicular stomatitis virus (VSV) and pseudorabies virus (PsRV). A comparison of the cumulative mean reductions for all viruses tested with the individual values obtained in each experiment indicates that the combined effects of the manufacturing steps, which purify the Factor VIII:C and prepare the concentrate in a final sterile container as a lyophilized powder, contribute viral reduction capabilities of approximately 5 to 6 logs. In a separate study, aluminum hydroxide treatment followed by antibody affinity chromatography reduced vaccinia virus infectivity by 4.81 logs. These studies indicate that the purification and preparative steps of the manufacturing process are capable of providing a non-specific, viral reduction of approximately 5 to 6 logs, independent of the pasteurization process.
Monoclate-P® contains trace amounts of mouse protein9 (≤50 ng per 100 IU of AHF). In a study using an earlier form of the concentrate which had not undergone pasteurization (Monoclate®), a number of patients seronegative for Anti-HIV-1 were monitored to determine whether they would develop antibody or experience adverse reactions as a result of repeated exposure. These patients were treated on multiple occasions. Pre-study serum measurements of 27 patients for human anti-mouse IgG showed that, prior to treatment, 6 of them had either detectable antibody to mouse proteins or cross-reactive proteins. These patients continued to demonstrate similar or lower antibody levels during the study. Of the remaining 21 patients, 6 were shown to have low antibody levels on one or more occasions. In no case was observance of low antibody level associated with an anamnestic response or with any clinical adverse reaction. Patients were observed for time periods ranging from 2 to 30 months.
The viral safety of Monoclate-P® has been evaluated in two open-label studies using patients (aged 1 day to 20 years) with moderate to severe hemophilia A previously unexposed to blood or blood products. Thirty patients received Monoclate-P® therapy for 5 to 34 months as necessary according to the normal practices of the treatment center. These patients were followed for serum ALT elevations and a range of viral serologies. Six patients received another blood product prior to or during the study. Twenty-four patients were evaluable for assessment of viral safety of Monoclate-P®. No patients seroconverted to HIV, hepatitis nonA/nonB, or hepatitis B. Factor VIII:C inhibitors developed in 7 patients (23%) with 3 being high (>10 BU) titer.
Monoclate-P® is indicated for treatment of classical hemophilia (Hemophilia A). Affected individuals frequently require therapy following minor accidents. Surgery, when required in such individuals, must be preceded by temporary corrections of the clotting abnormality. Surgical prophylaxis in severe AHF deficiency can be accomplished with an appropriately-dosed pre-surgical IV bolus of Monoclate-P® followed by intermittent maintenance doses (see DOSAGE AND ADMINISTRATION).
Monoclate-P® is not effective in controlling the bleeding of patients with von Willebrand's disease.
Known hypersensitivity to mouse protein is a contraindication to Monoclate-P®.
Monoclate-P® is made from human blood. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Because Monoclate-P® is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current viral infections and inactivating and/or removing certain viruses during manufacture (see DESCRIPTION section for viral reduction measures). The manufacturing procedure for Monoclate-P® includes processing steps designed to reduce further the risk of viral transmission. Stringent procedures utilized at plasma collection centers, plasma testing laboratories, and fractionation facilities are designed to reduce the risk of viral transmission. The primary viral reduction step of the Monoclate-P® manufacturing process is the heat treatment of the purified, stabilized aqueous solution at 60°C for 10 hours. In addition, the purification procedure (several precipitation steps) used in the manufacture of Monoclate-P® also provides viral reduction capacity. Despite these measures, such products may still potentially contain human pathogenic agents, including those not yet known or identified. Thus the risk of transmission of infectious agents can not be totally eliminated. Any infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CSL Behring at 1-866-915-6958 (in the U.S. or Canada).
Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections (see Information For Patients).
Most Antihemophilic Factor (Human) concentrates contain naturally occurring blood group specific antibodies. However, the processing of Monoclate-P® significantly reduces the presence of blood group specific antibodies in the final product. Nevertheless, when large or frequently repeated doses of product are needed, patients should be monitored by means of hematocrit and direct Coombs tests for signs of progressive anemia.
Although no hypersensitivity reactions have been observed, because Monoclate-P® contains trace amounts of mouse protein (≤50 ng per 100 IU of AHF), the possibility exists that patients treated with Monoclate-P® may develop hypersensitivity to the mouse proteins.
Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis, and should be advised to discontinue use of the concentrate and contact their physician if these symptoms occur.
Some viruses, such as parvovirus B19 or hepatitis A, are particularly difficult to remove or inactivate at this time. Parvovirus B19 most seriously affects pregnant women, or immune-compromised individuals.
Although the overwhelming number of hepatitis A and parvovirus B19 cases are community acquired, there have been reports of these infections associated with the use of some plasma-derived products. Therefore, physicians should be alert to the potential symptoms of parvovirus B19 and hepatitis A infections and inform patients under their supervision receiving plasma derived products to report potential symptoms promptly.
Symptoms of parvovirus B19 include fever, drowsiness, chills and runny nose followed two weeks later by a rash and joint pain. Evidence of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting and pain in the belly. Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physicians if such symptoms occur.
Animal reproduction studies have not been conducted with Monoclate-P®. It is also not known whether Monoclate-P® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Monoclate-P® should be given to a pregnant woman only if clearly needed.
The safety and effectiveness of Monoclate-P® for the treatment of hemophilia A has been demonstrated in 33 pediatric patients. As in adults, pediatric patients should be dosed based upon weight (see DOSAGE AND ADMINISTRATION).
Clinical studies of Monoclate-P® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Dosing should be appropriate to the clinical situation.
Products of this type are known to cause allergic reactions, mild chills, nausea or stinging at the infusion site. In some cases, inhibitors of FVIII may occur.
Monoclate-P® is for intravenous administration only. As a general rule 1 unit of AHF activity per kg will increase the circulating AHF level by 2%.10 The following formula10 provides a guide of dosage calculations for both adult and pediatric patients:
| Number of AHF | = | Body weight | × | desired Factor VIII | × | 0.5 |
| IU Required | (in kg) | increase (% normal) |
Although dosage must be individualized according to the needs of the patient (weight, severity of hemorrhage, presence of inhibitors), the following general dosages are suggested.11
(This item is individually packaged in a separate, labeled blister pack.)
Intravenous Injection
Plastic disposable syringes are recommended with Monoclate-P® solution. The ground glass surfaces of all-glass syringes tend to stick with solutions of this type.
(This spike is supplied in the four-item Administration Components pack.)
Intravenous Injection
Plastic disposable syringes are recommended with Monoclate-P® solution. The ground glass surfaces of all-glass syringes tend to stick with solutions of this type.
When stored at refrigerator temperature, 2-8°C (36-46°F), Monoclate-P® is stable for the period indicated by the expiration date on its label. Within this period, Monoclate-P® may be stored at room temperature not to exceed 25°C (77°F), for up to 6 months.
Avoid freezing which may damage container for the diluent.
Monoclate-P® is supplied in a single dose vial with Sterile Water for Injection, USP, double-ended needle for reconstitution, vented filter spike for withdrawal, filter needle for withdrawal, winged infusion set and alcohol swabs. Factor VIII activity in IU is stated on the label of each vial.
Each product package consists of the following:
| NDC Number | Component | Approximate FVIII Activity (IU) |
|---|---|---|
| 0053-7631-02 | Carton (kit) containing one vial of Monoclate-P® [NDC 0053-7641-01], one 2.5 mL vial of Sterile Water for Injection, USP (diluent) [NDC 0053-7653-02], one double-ended needle for reconstitution, one vented filter spike for withdrawal, one filter needle for withdrawal, one winged infusion set, and alcohol swabs. | 250 (LOW) |
| 0053-7632-02 | Carton (kit) containing one vial of Monoclate-P® [NDC 0053-7642-01], one 5 mL vial of Sterile Water for Injection, USP (diluent) [NDC 0053-7653-05], one double-ended needle for reconstitution, one vented filter spike for withdrawal, one filter needle for withdrawal, one winged infusion set, and alcohol swabs. | 500 (MID) |
| 0053-7633-02 | Carton (kit) containing one vial of Monoclate-P® [NDC 0053-7643-01], one 10 mL vial of Sterile Water for Injection, USP (diluent) [NDC 0053-7653-10], one double-ended needle for reconstitution, one vented filter spike for withdrawal, one filter needle for withdrawal, one winged infusion set, and alcohol swabs. | 1000 (HIGH) |
| 0053-7634-02 | Carton (kit) containing one vial of Monoclate-P® [NDC 0053-7644-01], one 10 mL vial of Sterile Water for Injection, USP (diluent) [NDC 0053-7653-10], one double-ended needle for reconstitution, one vented filter spike for withdrawal, one filter needle for withdrawal, one winged infusion set, and alcohol swabs. | 1500 (SUPER HIGH) |
Hershman, R.J., Naconti, S.B., and Shulman, N.R. Prophylactic Treatment of Factor VIII Deficiency. Blood 35, (1970), p. 189.
Kasper, C.K. Dietrich, S.I. and Rapaport, S.K. Hemophilia Prophylaxis in Factor VIII Concentrate. Arch Int Med 125, (1970), p. 1004.
Biggs, R. ed. The Treatment of Hemophilia A and B and von Willebrands Disease. Oxford: Blackwell, 1978.
Fulcher, C.A., Zimmerman, T.S., Characterization of the Human Factor VIII Procoagulant Protein With A Heterologous Precipitating Antibody. Proc Natl Acad Sci 79 (1982), pp. 1648-1652.
Levine, P.H., Factor VIII C Purified from Plasma Via Monoclonal Antibodies Human Studies. Semin Hematol 25 (2 Suppl. 1), 1988, pp. 38-41.
Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA
US License No. 1767
Revised February, 2014
12810-08
NDC 0053-7631-02
One vial with diluent
LOW
Antihemophilic Factor
(Human)
Monoclate-P®
Factor VIII:C Pasteurized
Monoclonal Antibody Purified
For Intravenous Administration Only.
Rx only
Storage: Monoclate-P® stored in a refrigerator at 2-8°C (36-46°F) is
stable for the period indicated by the expiration date on the label.
Within this period Monoclate-P® may be stored at room temperature
not to exceed 25°C (77°F), for up to 6 months. Avoid freezing.
Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA
US License No. 1767
CSL Behring
NDC 0053-7632-02
One vial with diluent
MID
Antihemophilic Factor
(Human)
Monoclate-P®
Factor VIII:C Pasteurized
Monoclonal Antibody Purified
For Intravenous Administration Only.
Rx only
Storage: Monoclate-P® stored in a refrigerator at 2-8°C (36-46°F) is
stable for the period indicated by the expiration date on the label.
Within this period Monoclate-P® may be stored at room temperature
not to exceed 25°C (77°F), for up to 6 months. Avoid freezing.
Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA
US License No. 1767
CSL Behring
NDC 0053-7633-02
One vial with diluent
HIGH
Antihemophilic Factor
(Human)
Monoclate-P®
Factor VIII:C Pasteurized
Monoclonal Antibody Purified
For Intravenous Administration Only.
Rx only
Storage: Monoclate-P® stored in a refrigerator at 2-8°C (36-46°F)
is stable for the period indicated by the expiration date on the
label. Within this period Monoclate-P® may be stored at room
temperature not to exceed 25°C (77°F), for up to 6 months.
Avoid freezing.
Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA
US License No. 1767
CSL Behring
NDC 0053-7634-02
One vial with diluent
SUPER HIGH
Antihemophilic Factor
(Human)
Monoclate-P®
Factor VIII:C Pasteurized
Monoclonal Antibody Purified
For Intravenous Administration Only.
Rx only
Storage: Monoclate-P® stored in a refrigerator at 2-8°C (36-46°F) is
stable for the period indicated by the expiration date on the label.
Within this period Monoclate-P® may be stored at room temperature
not to exceed 25°C (77°F), for up to 6 months. Avoid freezing.
Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA
US License No. 1767
CSL Behring
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0053-7633-02 | EA - Each | 0053-7633 | 7d8ac57b-0be7-4ae2-89bc-e2b96a1a6c9d | 1 | 2012-07-24 |
| 0053-7634-02 | EA - Each | 0053-7634 | 49bedaca-d823-476a-baae-ef3dd27958e9 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ANTIHEMOPHILIC FACTOR HUMAN | ACTIVE INGREDIENT | 839MOZ74GK | 7 | |
| ANTIHEMOPHILIC FACTOR HUMAN | ACTIVE MOIETY | 839MOZ74GK | 7 | |
| albumin (human) | INACTIVE INGREDIENT | ZIF514RVZR | 7 | |
| Histidine | INACTIVE INGREDIENT | 4QD397987E | 7 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | 7 | |
| Mannitol | INACTIVE INGREDIENT | 3OWL53L36A | 7 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 7 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0053-7631 | 0053-7631-02 |
| 0053-7641 | 0053-7641-01 |
| 0053-7632 | 0053-7632-02 |
| 0053-7642 | 0053-7642-01 |
| 0053-7633 | 0053-7633-02 |
| 0053-7643 | 0053-7643-01 |
| 0053-7634 | 0053-7634-02 |
| 0053-7644 | 0053-7644-01 |
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 103953 | Monoclate, Monoclate-P | Antihemophilic Factor (Human) | 351(a) | Disc | 2026-09-01 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRADISCAL | ADJ PH | ||
| Mannitol | MANNITOL | 3OWL53L36A | GRANULE, FOR SUSPENSION / ORAL | 6000 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRAPERITONEAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRAVENOUS | 1037 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / OPHTHALMIC | 0.31 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | MOUTHWASH / BUCCAL | 2 mg/1ml | ||
| Mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS | 180 mg | ||
| Mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 980.4 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | TABLET / ORAL | 2.32 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / EPIDURAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | EMULSION / TOPICAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / SUBCUTANEOUS | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SHAMPOO / TOPICAL | 3 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SUSPENSION / INTRALESIONAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | DISC / TOPICAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRATHECAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRADERMAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / INTRAVASCULAR | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SUSPENSION / INTRAVENOUS | ADJ PH | ||
| Mannitol | MANNITOL | 3OWL53L36A | SOLUTION / SUBCUTANEOUS | 4.54 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / RETROBULBAR | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / RECTAL | NA | ||
| Mannitol | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / SUBCUTANEOUS | 99 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | LOTION, AUGMENTED / TOPICAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRA-AMNIOTIC | ADJ PH | ||
| Mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 35 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION, EXTENDED RELEASE / ORAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION / AURICULAR (OTIC) | 0.04 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| Mannitol | MANNITOL | 3OWL53L36A | GEL / OPHTHALMIC | 25 mg | ||
| Mannitol | MANNITOL | 3OWL53L36A | SOLUTION, CONCENTRATE / INTRAVENOUS | 220 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRALESIONAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | SYRUP / ORAL | 2.03 mg/1ml | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | TABLET, FILM COATED / ORAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| Mannitol | MANNITOL | 3OWL53L36A | SOLUTION / OPHTHALMIC | 4.7 %w/v | ||
| Mannitol | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION / INTRAVENOUS | 2.5 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, COATED PELLETS / ORAL | 0.01 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETERAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETHRAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTERSTITIAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CREAM / TOPICAL | 69 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / INTRAOCULAR | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRABURSAL | ADJ PH | ||
| Mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 658 mg | ||
| Mannitol | MANNITOL | 3OWL53L36A | SOLUTION, GEL FORMING / DROPS / OPHTHALMIC | 4 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / ORAL | 223 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRAVITREAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, FOR SOLUTION / INTRATUMOR | ADJ PH | ||
| Mannitol | MANNITOL | 3OWL53L36A | WAFER / ORAL | 642 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | AEROSOL, FOAM / TOPICAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SUSPENSION / SUBCUTANEOUS | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SYRUP / ORAL | 71 mg/5ml | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / NASAL | 20 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE / ORAL | 60 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 5 mg |
Adverse event summaries are temporarily unavailable. Other product information remains available.