Micosona may be available in the countries listed below.
Naftifine hydrochloride (a derivative of Naftifine) is reported as an ingredient of Micosona in the following countries:
International Drug Name Search
Elazor may be available in the countries listed below.
Fluconazole is reported as an ingredient of Elazor in the following countries:
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Rec.INN
0130636-43-0
C19-H27-N5-O5
405
Antiarrhythmic agent
Potassium channel blocker
6-[[2-[(2-hydroxyethyl)[3-(p-nitrophenyl)propyl]amino]ethyl]amino]-1,3-dimethyluracil (WHO)
6-[[2-[(2-hydroxyethyl)[3-(4-nitrophenyl)propyl]amino]ethyl]amino]-1,3-dimethyl-2,4-(1H,3H)-pyrimidinedione
International Drug Name Search
Glossary
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| WHO | World Health Organization |
Bebulin (Factor IX Complex), Nanofiltered and Vapor Heated, is a purified, sterile, stable, freeze-dried concentrate of the Coagulation Factor IX (Christmas Factor) as well as Factor II (Prothrombin) and Factor X (Stuart Prower Factor) and low amounts of Factor VII. In addition, the product contains small amounts of heparin (≤ 0.15 IU heparin per IU Factor IX).
Bebulin is standardized in terms of Factor IX content and each vial is labeled for the Factor IX content indicated in International Units (IU). One International Unit of Factor IX (according to the current International Standard for Human Blood Coagulation Factors II, IX, and X in Concentrates) corresponds to the activity of Factor IX in 1 mL of fresh normal human plasma.
Bebulin is manufactured from large plasma pools of human plasma. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of Bebulin is collected only at FDA approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, mini-pools of the plasma are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found negative. In addition, two dedicated and independent virus removal/inactivation steps have been integrated into the manufacturing process, namely 35 nm nanofiltration1 and a vapor heat treatment process2 [10 hours at 60°C and subsequent 1 hour at 80°C under the condition of 7-8% (w/v) residual moisture]. In addition, the DEAE-Sephadex adsorption contributes to the virus safety profile of Bebulin. Despite these measures, such products can still potentially transmit disease (see WARNINGS).
In vitro spiking studies have been used to validate the capability of the manufacturing process to remove and inactivate viruses. To establish virus clearance capacity of the manufacturing process, these virus clearance studies were performed in accordance with good laboratory practices under extreme conditions (e.g. at minimum incubation times and temperatures below specifications for vapor –heat treatment). The in vitro viral reduction studies performed on nanofiltered Bebulin are summarized in Table 1 .
| |||||
| Virus Type | Enveloped RNA | Enveloped DNA | Non-enveloped RNA | Non-enveloped DNA | |
| Virus Family | Retroviridae | Flaviviridae | Herpesviridae | Picornaviridae | Parvoviridae† |
| Virus‡ | HIV-1 | BVDV | PRV | HAV | MMV |
| DEAE Sephadex Adsorption | n.d§ | n.d | n.d | 1.4 | 1.3 |
| 35 nm Nanofiltration¶ | > 6.4 | 2.0 | > 6.0 | 1.7 | ≤1.0 |
| Vapor-Heat Treatment | > 6.8 | > 7.1 | > 7.4 | > 4.5 | ≤1.0 |
| Overall log reduction factor (ORF) | > 13.2 | > 9.1 | > 13.4 | > 7.6 | 1.3 |
Bebulin is a combination of vitamin K-dependent clotting factors found in normal plasma. The administration of Bebulin provides an increase in plasma levels of Factor IX and can temporarily correct the coagulation defect of patients with Factor IX deficiency. Plasma levels of Factors II and X will also be increased. However, no clinical studies have been conducted to show benefit from this product for treating deficiencies other than Factor IX deficiency.
In vivo recovery of Bebulin was determined by investigators in Germany, Japan, and the United States using the former International Standard, WHO 72/32 and was found to be 53.3% ±9.6%, 57.5% ±21.8%, and 53.24% ±16.95%, respectively. In the same studies, using different methodologies, half-lives were determined to be 19.4 hrs ±3.8 hrs, 24.6 hrs ±3.2 hrs, and 19.97 hrs ±8.24 hrs, respectively1.
In the context of two prospective clinical studies and a retrospective survey, Bebulin was followed up for the risk of transfusion-transmitted viral infections. All patients received blood products for the first time. Using criteria established by the ICTH, 16 patients were followed up for non-A, non-B hepatitis, 9 for HCV seroconversion, 3 for hepatitis B, and 24 for HIV seroconversion. None tested positive for any of these infections. Additional 3 patients with 2 or more consecutive test samples missing tested negative for non-A, non-B hepatitis for all samples available.
Bebulin is indicated for the prevention and control of hemorrhagic episodes in hemophilia B patients.
Bebulin is not indicated for use in the treatment of Factor VII deficiency. No clinical studies have been conducted to show benefit from this product for treating deficiencies other than Factor IX deficiency.
None known.
The risk of thromboembolic complications including disseminated intravascular coagulation (DIC) and hyperfibrinolysis is present with the administration of Factor IX Complex, particularly in the postoperative period and in patients with risk factors predisposing to thrombosis.
Bebulin is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by effective donor screening, testing for the presence of certain current virus infections, by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jacob disease (CJD) agent. ALL adverse reactions including infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Baxter Healthcare Corporation at
1-800-423-2862 (in the U.S) and FDA Med Watch (1-800-FDA-1088 or www.fda.gov/medwatch). The physician should discuss the risks and benefits of this product with the patient.
Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly non-A, non-B hepatitis. Hepatitis B vaccination is essential for patients with hemophilia and it is recommended that this be done at birth or diagnosis.
Severe hypotensive reaction, such as anaphylactic shock, requires immediate intervention using current principles of shock therapy. Have epinephrine available for immediate administration, if appropriate, in the event of an anaphylactic reaction to Bebulin.
In patients with risk factors predisposing to thrombosis, do not raise the Factor IX level to more than approximately 60% of normal4. The risk factor for thromboembolic complications include, but are not limited to, patients with a history of coronary heart disease, liver disease, disseminated intravascular coagulation, post-operative immobilization, elderly patients and neonates. Monitor such patients, as well as patients who require high doses of Factor IX because of major surgical interventions, for the possible development of DIC and/or thrombosis. Stop treatment immediately in case changes occur in blood pressure or pulse rate or symptoms such as respiratory distress, chest pain or cough.
Some viruses, such as parvovirus B19, are particularly difficult to remove or inactivate at this time. Parvovirus B19 most seriously affects pregnant women or immune-compromised individuals. Symptoms of parvovirus B19 infection include fever, drowsiness, chills, and runny nose followed about two weeks later by a rash, and joint pain.
Inform patients of all signs and symptoms of immediate hypersensitivity reactions such as fever, urticaria/hives, rashes, nausea, retching, angioedema/swelling of face or other body areas, laryngeal edema, stridor, dysphonia, bronchospasm/wheezing, hypotension, dizziness, lightheadedness, or loss of consciousness. Advise patients to discontinue use of the product and contact their physician if these symptoms occur. Patients should seek emergency care immediately for serious symptoms.
Animal reproduction studies have not been conducted with Bebulin It is also not known whether Bebulin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bebulin should be given to a pregnant woman only if clearly needed.
Anaphylactoid or anaphylactic reactions may occur following infusion of Bebulin. The occurrence of these reactions (e.g. fever, urticarial rashes, nausea, retching, dyspnea, anaphylactic shock) necessitates the interruption of replacement therapy. Mild reactions (transient discomfort that resolves spontaneously or with minimal intervention), such as rash, can be managed with antihistamines.
For intravenous administration only.
As a general rule, 1 International Unit of Factor IX activity/kg will increase the plasma level of Factor IX by 0.8%.
Accordingly, the following formula is provided for dosage calculations
| Number of Factor IX IU required | = | bodyweight (kg) | x | desired Factor IX increase (% of normal) | x | 1.2 |
It must, however, be emphasized that the response to treatment will vary from patient to patient. Larger doses than those derived from the above formula may be required; particularly if treatment is delayed. Exact dosage determination should be based on localization and extent of hemorrhage, and the level of Factor IX to be achieved. It must be emphasized that particularly with severe hemorrhage and major surgery, close laboratory monitoring of the Factor IX level is required to determine proper dosage.
Approximate Factor IX levels, typical initial doses, and the average duration of treatment are suggested in the table below. For minor bleeding a single dose will usually be sufficient, otherwise a second dose may be given after 24 hours. More severe hemorrhage will require the administration of several doses at approximately 24 hours intervals. For maintenance therapy, usually two thirds of the initial dose is infused.
| |||
| Type of Bleeding | ApproximateFactor IX Level (% Normal) | Typical InitialDose (IU/kg) | Average Durationof Treatment (Days) |
Minor Early hemarthrosis, and gingival bleeding, mild hematuria | 20 | 25-35 | 1 |
Moderate Severe joint bleeding, hematemesis, and melena, major hematuria | 40 | 40-55 | 2 or until adequate wound healing |
Major Hematemesis, and melena | ≥60* | 60-70 | 2-3 or until adequate wound healing |
Dosage guidelines for surgical procedures are suggested below. The preoperative loading dose should be administered one hour prior to surgery. Depending on the type of surgery, replacement therapy has to be continued over one to several weeks until adequate wound healing is achieved. The average treatment interval will initially be 12 hours, while in the later postoperative period 24 hours is adequate.
| ||||||
Type ofSurgery | Day of Operation | Init. Postop. Period (1st to 2nd Week) | Late Postop. Period(from 3rd Week Onwards) | |||
Approx. Level F IX (% Normal) | Dose (IU/kg) | Approx. Level F IX (% Normal) | Dose (IU/kg) | Approx. Level F IX (% Normal) | Dose (IU/kg) | |
| Major | ≥60* | 70-95 | 60-20 | 70-35 | 20 | 35-25 |
| Minor | 40-60 | 50-60 | 40-20 | 55-25 | N/A† | N/A† |
For tooth extraction the same initial dose as for minor surgery is recommended.
One infusion should be sufficient. In case of extraction of several teeth, replacement therapy for up to one week may be necessary using the same doses as for minor surgery 4-6
Bebulin should be administered within 3 hours after reconstitution. The solution does not contain a preservative.
For reconstitution proceed as follows:
Do not refrigerate after reconstitution!
Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
Bebulin is supplied in single dose vials (NDC 64193-445-02) with Sterile Water for Injection, U.S.P., double-ended needle, and filter needle for reconstitution and withdrawal.
The vial stopper of the 20 mL Sterile Water for Injection may contain Dry Natural Rubber Latex.
Factor IX activity in International Units is stated on the label of each vial.
When stored at refrigerated temperature (2°C-8°C, 35°F-46°F), Bebulin is stable for the period indicated by the expiration date on its label. Avoid freezing, which may damage the diluent vial.
To enroll in the confidential, Industry-wide Patient Notification System, call 1 888-873-2838.
Baxter and Bebulin are trademarks of Baxter International Inc, its subsidiaries or affiliates..
Baxter Healthcare Corporation
Westlake Village, CA-91362
USA
U.S. License No. 140 Revised: April 2011
Bebulin unit carton for 200-1200 potency ranges
20 mL size, dried
NDC 64193-244-02
Factor IX Complex
Bebulin
Nanofiltered and Vapor Heated
BAXTER
For Intravenous Use Only
WARNING: Human plasma product. Human blood and its components may transmit infectious agents. The physician and patient should discuss the risks and benefits of this product.
Some components of the packaging material contain Dry Natural Rubber Latex.
Rx Only
Bebulin is a trademark of Baxter AG, Vienna, Austria: Baxter is a trademark of Baxter International Inc., registered in the U.S. Patent and Trademark Office.
Bebulin vial label for 200-1200 potency ranges
20 mL size, dried
NDC 64193-244-03
Factor IX Complex
Bebulin
Nanofiltered and Vapor Heated
BAXTER
For Intravenous Use Only
Rx Only
Directions for use: see package insert
Store between 2º and 8ºC (35º and 46ºF).
Reconstitute with 20 mL of Sterile Water for Injection
Bebulin is a trademark of Baxter AG, Vienna, Austria: Baxter is a trademark of Baxter International Inc., registered in the U.S. Patent and Trademark Office.
Baxter Healthcare Corporation
Westlake Village, CA 91362 USA
U.S. License No. 140
20 mL Sterile Water for Injection
NDC 0338-0764-62
20 mL
Single-Dose Container
Nonpyrogenic
Sterile Water for Injection, USP for reconstitution of accompanying product
Do not use unless clear. No antimicrobial agent or other substances has been added. Do not use for intravascular injection without making approximately isotonic by addition of suitable solute. Discard unused portion. Rx Only. This Product Contains Dry Natural Rubber.
BAXTER
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| BLA | BLA103112 | 06/06/2011 | |
| Labeler - Baxter Healthcare Corporation (085206634) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Baxter Healthcare Corporation | 001728059 | MANUFACTURE | |
Entocort CIR may be available in the countries listed below.
Budesonide is reported as an ingredient of Entocort CIR in the following countries:
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Levallorphan Tartrate may be available in the countries listed below.
Levallorphan Tartrate (BANM, JAN) is also known as Levallorphan (Rec.INN)
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Glossary
| BANM | British Approved Name (Modified) |
| JAN | Japanese Accepted Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Enalapril HCT Atid may be available in the countries listed below.
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Enalapril HCT Atid in the following countries:
Hydrochlorothiazide is reported as an ingredient of Enalapril HCT Atid in the following countries:
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Kinloft may be available in the countries listed below.
Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Kinloft in the following countries:
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In the US, Eldoquin (hydroquinone topical) is a member of the drug class topical depigmenting agents and is used to treat Dermatological Disorders.
US matches:
Hydroquinone is reported as an ingredient of Eldoquin in the following countries:
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Tioconazolo may be available in the countries listed below.
Tioconazolo (DCIT) is known as Tioconazole in the US.
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Glossary
| DCIT | Denominazione Comune Italiana |
Dezolam may be available in the countries listed below.
Etizolam is reported as an ingredient of Dezolam in the following countries:
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Elcrit may be available in the countries listed below.
Clozapine is reported as an ingredient of Elcrit in the following countries:
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Soaves may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Piperonyl Butoxide is reported as an ingredient of Soaves in the following countries:
Pyrethrin I is reported as an ingredient of Soaves in the following countries:
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