Recombinate
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Generic Name: antihemophilic factor, human recombinant
Dosage Form: injection, concentrate
Recombinate [Antihemophilic Factor (Recombinant)]
Recombinate Description
Recombinate [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII.
Recombinate is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. Recombinate is available in single-dose vials, which contain nominally 250, 500 and 1000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: 12.5 mg/mL Albumin (Human), 0.20 mg/mL calcium, 1.5 mg/mL polyethylene glycol (3350), 180 mEq/L sodium, 55 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand’s disease. The product contains no preservative.
Manufacturing of Recombinate is shared by Baxter Healthcare Corporation and Wyeth BioPharma. The recombinant Antihemophilic Factor Concentrate (For Further Manufacturing Use), is produced by Baxter Healthcare Corporation and Wyeth BioPharma (For Further Manufacturing Use) and subsequently formulated and packaged at Baxter Healthcare Corporation.
Each vial of Recombinate is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.
Recombinate - Clinical Pharmacology
Factor VIII is the specific clotting factor deficient in patients with hemophilia A (classical hemophilia). Hemophilia A is a genetic bleeding disorder characterized by hemorrhages, which may occur spontaneously or after minor trauma. The administration of Recombinate provides an increase in plasma levels of Factor VIII and can temporarily correct the coagulation defect in these patients. Pharmacokinetic studies on sixty-nine (69) patients revealed the circulating mean half-life for Recombinate to be 14.6 ± 4.9 hours (n=67), which was not statistically significantly different from plasma-derived HEMOFIL M, [Antihemophilic Factor (Human), Method M, Monoclonal Purified]. The mean half-life of HEMOFIL M was 14.7 ± 5.1 hours (n=61). The actual baseline recovery observed with Recombinate was 123.9 ± 47.7 IU/dL (n=23), which is significantly higher than the actual HEMOFIL M baseline recovery of 101.7 ± 31.6 IU/dL (n=61). However, the calculated ratio of actual to expected recovery with Recombinate (121.2 ± 48.9%) is not different on average from HEMOFIL M (123.4 ± 16.4%).
The clinical study of Recombinate in previously treated patients (individuals with hemophilia A who had been treated with plasma derived Factor VIII) was based on observations made on a study group of 69 patients. These individuals received cumulative amounts of Factor VIII ranging from 20,914 to 1,383,063 IU over the 48 month study. Patients were given a total of 17,700 infusions totaling 28,090,769 IU Recombinate.
These patients were successfully treated for bleeding episodes on a demand basis and also for the prevention of bleeds (prophylaxis). Spontaneous bleeding episodes successfully managed include hemarthroses, soft tissue and muscle bleeds. Management of hemostasis was also evaluated in surgeries. A total of 24 procedures on 13 patients were performed during this study. These included minor (e.g. tooth extraction) and major (e.g. bilateral osteotomies, thoracotomy and liver transplant) procedures. Hemostasis was maintained perioperatively and postoperatively with individualized Factor VIII replacement.
A study of Recombinate in previously untreated patients was also performed as part of an ongoing study. The study group was comprised of seventy-nine (79) patients, of whom seventy-six (76) had received at least one infusion of Recombinate. To date, this cohort has been given 12,209 infusions totaling over 11,277,043 IU of Recombinate. Hemostasis was appropriately managed in spontaneous bleeding episodes, intracranial hemorrhage and surgical procedures.
INDICATIONS and USAGE
The use of Recombinate [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.1 Recombinate is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia).
Recombinate can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.2 In clinical studies with Recombinate, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of Recombinate should be controlled by frequent laboratory determinations of circulating Factor VIII levels.
Recombinate is not indicated in von Willebrand’s disease.
Contraindications
Known hypersensitivity to mouse, hamster or bovine protein may be a contraindication to the use of Recombinate (see Precautions).
Warnings
None
Precautions
General
Certain components used in the packaging of this product contain natural rubber latex.
Identification of the clotting defect as a Factor VIII deficiency is essential before the administration of Recombinate [Antihemophilic Factor (Recombinant)] is initiated. No benefit may be expected from this product in treating other deficiencies.
The formation of neutralizing antibodies, inhibitors to Factor VIII, is a known complication in the management of individuals with hemophilia A. The reported prevalence of these antibodies in patients receiving plasma-derived Factor VIII is 10-20%.3-7, 10-12. These inhibitors are invariably IgG immunoglobulins, the Factor VIII procoagulant inhibitory activity of which is expressed as Bethesda Units (B.U.) per mL of plasma or serum.3-7 Over the investigational period, none of the 69 previously treated individuals, without an inhibitor at entry into the study, developed an inhibitor. In the previously untreated patient group there were 73 eligible patients with Factor VIII levels less than or equal to 2% who received at least one Recombinate treatment (median days 100, range 3-821) and who were tested for an inhibitor after treatment with Recombinate. Of this group, 23 individuals developed a detectable inhibitor (median days 10, range 3-69) and of these, 8 patients showed a titer greater than 10 B.U. Patients treated with Factor VIII should be carefully monitored for the development of antibodies to Factor VIII by appropriate clinical observations and laboratory tests.
Formation of Antibodies to Mouse, Hamster or Bovine Protein
As Recombinate contains trace amounts of mouse protein (maximum of 0.1 ng/IU Recombinate), hamster protein (maximum of 1.5 ng CHO protein/IU Recombinate), and bovine protein (maximum of 1 ng BSA/IU Recombinate), the remote possibility exists that patients treated with this product may develop hypersensitivity to these non-human mammalian proteins.
INFORMATION FOR PATIENTS
The patients and physician should discuss the risks and benefits of this product.
Allergic type hypersensitivity reactions have been observed with Recombinate. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physician if these symptoms occur.
LABORATORY TESTS
Although dosage can be estimated by the calculations that follow, it is strongly recommended that whenever possible, appropriate laboratory tests be performed on the patient’s plasma at suitable intervals to assure that adequate Factor VIII levels have been reached and are maintained.
If the patient’s plasma Factor VIII fails to reach expected levels or if bleeding is not controlled after adequate dosage, the presence of inhibitor should be suspected. By performing appropriate laboratory procedures, the presence of an inhibitor can be demonstrated and quantified in terms of Factor VIII International Units neutralized by each mL of plasma or by the total estimated plasma volume. If the inhibitor is present at levels less than 10 Bethesda Units per mL, administration of additional Factor VIII may neutralize the inhibitor. Thereafter, the administration of additional Factor VIII International Units should elicit the predicted response. The control of Factor VIII levels by laboratory assay is necessary in this situation.
Inhibitor titers above 10 Bethesda Units per mL may make hemostasis control with Factor VIII either impossible or impractical because of the very large dose required. In addition, the inhibitor titer may rise following Factor VIII infusion because of an anamnestic response to the Factor VIII antigen.CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT of FERTILITY
Recombinate was tested for mutagenicity at doses considerably exceeding plasma concentrations of Factor VIII in vitro and at doses up to ten times the expected maximum clinical dose in vivo, and did not cause reverse mutations, chromosomal aberrations, or an increase in micronuclei in bone marrow polychromatic erythrocytes. Long-term studies in animals have not been performed to evaluate carcinogenic potential.
PEDIATRIC USE
Recombinate is appropriate for use in children of all ages, including the newborn. Safety and efficacy studies have been performed in both previously treated (n=23) and previously untreated (n=75) children. (See Clinical Pharmacology and Precautions).
PREGNANCY
Pregnancy Category C. Animal reproduction studies have not been conducted with Recombinate. It is not known whether Recombinate can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Recombinate should be given to a pregnant woman only if clearly needed.Adverse Reactions
During the clinical studies conducted in the previously treated patient group, there were 13 infusion related minor adverse reactions reported out of 10,446 infusions (0.12%). One patient experienced flushing and nausea during his first infusion, which abated on decreasing the infusion rate. A second patient experienced mild fatigue during and following one infusion and a third patient had a series of eleven bleeds with a periodicity associated with the infusions.
The protein in greatest concentration in Recombinate is Albumin (Human). Reactions associated with intravenous administration of albumin are extremely rare, although nausea, fever, chills or urticaria have been reported. Other allergic reactions could be encountered in the use of this Factor VIII preparation. (See Information for Patients).
Recombinate Dosage and Administration
Each vial of Recombinate is labeled with the Factor VIII activity expressed in IU per vial. This potency assignment is referenced to the World Health Organization International Standard for Factor VIII:C Concentrate and is evaluated by appropriate methodology to ensure accuracy of the results.
The expected in vivo peak increase in Factor VIII level expressed as IU/dL of plasma or % (percent) of normal can be estimated by multiplying the dose administered per kg body weight (IU/kg) by two. This calculation is based on the clinical findings of Abildgaard et al8 and is supported by the data generated by 419 clinical pharmacokinetic studies with Recombinate in 67 patients over time. This pharmacokinetic data demonstrated a peak recovery point above the pre-infusion baseline of approximately 2.0 IU/dL per IU/kg body weight.
Examples (Assuming patient’s baseline Factor VIII level is at <1%):
(1) A dose of 1750 IU Recombinate administered to a 70 kg patient, i.e. 25 IU/kg (1750 IU/70 kg), should be expected to cause a peak post-infusion Factor VIII increase of 25 IU/kg x 2 (IU/dL)/(IU/kg) = 50 IU/dL (50% of normal).
(2) A peak level of 70% is required in a 40 kg child. In this situation, the dose would be 70 IU/dL/[2(IU/dL)/(IU/kg)] x 40 kg = 1400 IU.
Recommended Dosage Schedule
Physician supervision of the dosage is required. The following dosage schedule may be used as a guide.
| Hemorrhage | ||
| Degree of hemorrhage | Required peak post infusion Factor VIII activity in the blood (as % of normal or IU/dL plasma) | Frequency of Infusion |
| Early hemarthrosis or muscle bleed or oral bleed | 20-40 | Begin infusion every 12 to 24 hours for one-three days until the bleeding episode is resolved (as indicated by pain), or healing is achieved. |
| More extensive hemarthrosis, muscle bleed, or hematoma | 30-60 | Repeat infusion every 12 to 24 hours for (usually) three days or more until pain and disability are resolved. |
| Life threatening bleeds such as head injury, throat bleed, severe abdominal pain | 60-100 | Repeat infusion every 8 to 24 hours until threat is resolved |
| Surgery | ||
| Type of Operation | ||
| Minor surgery, including tooth extractions | 60-80 | A single infusion plus oral antifibrinolytic therapy within one hour is sufficient in approximately 70% of cases. |
| Major surgery | 80-100 (pre- and post-operative) |
Repeat infusion every 8 to 24 hours depending on state of healing. |
The careful control of the substitution therapy is especially important in cases of major surgery or life threatening hemorrhages.
Although dosage can be estimated by the calculations above, it is strongly recommended that whenever possible, appropriate laboratory tests including serial Factor VIII assays be performed on the patient’s plasma at suitable intervals to assure that adequate Factor VIII levels have been reached and are maintained.
Other dosage regimens have been proposed such as that of Schimpf, et al, which describes continuous maintenance therapy.9
Reconstitution using the BAXJEXT II Device: Use Aseptic Technique
- Bring Recombinate (dry factor concentrate) and Sterile Water for Injection, USP, (diluent) to room temperature.
- Remove caps from concentrate and diluent vials.
- Cleanse stoppers with germicidal solution and allow to dry prior to use. Place vials on a flat surface.
- Open the BAXJECT II device package by peeling away the lid, without touching the inside. Do not remove the device from the package.
- Turn the package over. Press straight down to fully insert the clear plastic spike through the diluent vial stopper.
- Grip the BAXJECT II package at its edge and pull the package off the device. Do not remove the blue cap from the BAXJECT II device.Do not touch the exposed white plastic spike.
- Turn the system over, so that the diluent vial is on top. Quickly insert the white plastic spike fully into the Recombinate vial stopper by pushing straight down. The vacuum will draw the diluent into the Recombinate vial.
- Swirl gently until Recombinate is completely dissolved.
NOTE: Do not refrigerate after reconstitution. (See Administration)
Administration: Use Aseptic Technique
Administer at room temperature.
Recombinate should be administered not more than 3 hours after reconstitution.
Intravenous Syringe Injection
Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be colorless to faint yellow in appearance. If not, do not use the solution and notify Baxter immediately.
Plastic syringes are recommended for use with this product since proteins such as Recombinate tend to stick to the surface of glass syringes.
- Remove the blue cap from the BAXJECT II device. Connect the syringe to the BAXJECT II device. DO NOT INJECT AIR.
- Turn over the connected vials so that the Recombinate vial is on top. Draw the factor concentrate into the syringe by pulling the plunger back slowly.
- Disconnect the syringe; attach a suitable needle and inject intravenously as instructed under Rate of Administration.
- If a patient is to receive more than one vial of Recombinate, the contents of multiple vials may be drawn into the same syringe. Please note that the BAXJECT II device is intended for use with a single vial of Recombinate and Sterile Water for Injection only, therefore reconstituting and withdrawing a second vial into the syringe requires a second BAXJECT II device.
Rate of Administration
Preparations of Recombinate can be administered at a rate of up to 10 mL per minute with no significant reactions.
The pulse rate should be determined before and during administration of Recombinate. Should a significant increase in pulse rate occur, reducing the rate of administration or temporarily halting the injection usually allows the symptoms to disappear promptly.
How is Recombinate Supplied
Recombinate is available in three different strengths in single-dose vials. The strength is designated on the outer box and on the vial label using the following color codes:
Light blue bar: For low potencies between 220-400 IU per vial (NDC 0944-2831-10)
Light pink bar: For medium potencies between 401-800 IU per vial (NDC 0944-2832-10)
Light green bar: For high potencies between 801-1240 IU per vial (NDC 0944-2833-10)
Recombinate is packaged with 10 mL of Sterile Water for Injection, USP, a BAXJECT II Needleless Transfer Device, one physician insert and one patient insert.
STORAGE
Recombinate can be refrigerated [2° - 8°C (36° - 46°F)] or stored at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the diluent vial. Do not use beyond the expiration date printed on the box.
REFERENCES
- White GC, McMillan CW, Kingdon HS, et al: Use of recombinant antihemophilic factor in the treatment of two patients with classic hemophilia. New Eng J Med 320:166-170, 1989
- Kessler CM: An Introduction to Factor VIII Inhibitors: The Detection and Quantitation. Am J Med 91 (Suppl 5A):1S-5S, 1991
- Schwarzinger I, Pabinger I, Korninger C, Haschke F, Kundi M, Niessner H, Lechner K: Incidence of inhibitors in patients with severe and moderate hemophilia A treated with factor VIII concentrates. Am J Hematology 24:241-245, 1987
- Penner JA, Kelly PE: Management of patients with factor VIII or IX inhibitors. Sem Thromb Hemostasis 1:386-399, 1975
- Ehrenforth S, Kreuz W, Scharrer I, et al: Incidence of development of factor VIII and factor IX inhibitors in haemophiliacs. Lancet 339:594-598, 1992
- McMillan CW, Shapiro SS, Whitehurst D, et al: The natural history of factor VIII inhibitors in patients with hemophilia A: a national cooperative study. II. Observations on the initial development of factor VIII:C inhibitors. Blood 71:344-348, 1988
- Addiego JE Jr., Gomperts E, Liu S, et al: Treatment of hemophilia A with a highly purified Factor VIII concentrate prepared by Anti-FVIIIc immunoaffinity chromatography. Thrombosis and Haemostasis 67:19-27, 1992
- Abildgaard CF, Simone JV, Corrigan JJ, et al: Treatment of hemophilia with glycine-precipitated Factor VIII. New Eng J Med 275:471-475, 1966
- Schimpf K, Rothman P, Zimmermann K: Factor VIII dosis in prophylaxis of hemophilia A; A further controlled study in Proc XIth Cong W.F.H. Kyoto, Japan, Academic Press, 1976, pp 363-366
- Gill FM: The Natural History of Factor VIII Inhibitors in Patients with Hemophilia A. Hoyer LW (ed), Factor VIII Inhibitors, N.Y. AR Liss, 1984, pp 19-29
- Rasi V, Ikkala E: Haemophiliacs with factor VIII inhibitors in Finland: prevalence, incidence and outcome. Br J Haematol 76:369-371, 1990
- Lusher JM, Salzman PM: Viral Safety and Inhibitor Development Associated with Factor VIIIC Ultra-Purified From Plasma in Hemophiliacs Previously Unexposed to Factor VIIIC Concentrates. Seminars in Hematology 27:1-7, 1990
Recombinate [Antihemophilic Factor (Recombinant)] Patient Information
This leaflet summarizes important information about Recombinate. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about Recombinate. If you have any questions after reading this, ask your healthcare provider.
What is the most important information I need to know about Recombinate [Antihemophilic Factor (Recombinant)]?
Do not attempt to do an infusion to yourself unless you have been taught how by your doctor or hemophilia center.
You must carefully follow your doctor's or other healthcare provider's instructions regarding the dose and schedule for infusing Recombinate so that your treatment will work best for you.
What is Recombinate [Antihemophilic Factor (Recombinant)]?
Recombinate is a medicine used to replace a clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia). Hemophilia A is an inherited bleeding disorder that prevents blood from clotting normally.
Recombinate is used to prevent and control bleeding in people with hemophilia A.
Recombinate is not used to treat von Willebrand’s Disease.
Who should not use Recombinate [Antihemophilic Factor (Recombinant)]?
You should not use Recombinate if you
- are allergic to mouse, hamster or bovine proteins.
- are allergic to any ingredients in Recombinate.
How should I use Recombinate [Antihemophilic Factor (Recombinant)] ?
Recombinate is given directly into the blood stream.
You may infuse Recombinate at a hemophilia treatment center, at your healthcare provider’s office or in your home. You should be trained on how to do infusions by your hemophilia treatment center or healthcare provider. Many people with hemophilia A learn to infuse their Recombinate by themselves or with the help of a family member.
Your healthcare provider will tell you how much Recombinate to use based on your weight, the severity of your hemophilia A, and where you are bleeding.
You may have to have blood tests done after getting Recombinate to be sure that your blood level of Factor VIII is high enough to clot your blood.
Call your healthcare provider right away if your bleeding does not stop after taking Recombinate.
What should I tell my healthcare provider before I use Recombinate [Antihemophilic Factor (Recombinant)]?
You should tell your healthcare provider if you
- have or have had any medical problems.
- take any medicines, including non-prescription medicines and dietary supplements.
- have any allergies, including allergies to mouse, hamster or bovine proteins.
- are nursing.
- are pregnant.
- have been told that you have inhibitors to Factor VIII (because Factor VIII may not work for you).
What are the possible side effects of Recombinate [Antihemophilic Factor (Recombinant)]?
You could have an allergic reaction to Recombinate.
Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, light-headed, dizziness, or fainting. The most common side effects are flushing, nausea, fever, chills, mild fatigue, nose bleeds, and hives.
What are the Recombinate [Antihemophilic Factor (Recombinant)] dosage strengths?
Recombinate comes in three different dosage strengths. The actual strength will be imprinted on the label and on the box. The three different strengths are coded, as follows:
Always check the potency printed on the label to make sure you are using the strength prescribed by your doctor. Always check the expiration date printed on the box. You should not use the product after the expiration date printed on the box.
How do I store Recombinate [Antihemophilic Factor (Recombinant)]?
Recombinate vials containing powdered product (without sterile diluent added) should be stored in a refrigerator (2° to 8°C [36° to 46°F]) or at room temperature (up to 30°C [86°F]).
If you choose to store Recombinate at room temperature:
- it should remain at room temperature until infused.
- do not put room temperature product back in the refrigerator.
Reconstituted product (after mixing dry product with wet diluent) must be used within 3 hours and cannot be stored or refrigerated. Any Recombinate left in the vial at the end of your infusion should be discarded.
What else should I know about Recombinate [Antihemophilic Factor (Recombinant)] and hemophilia A?
Your body may form inhibitors to Factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop Recombinate from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.
Resources at Baxter available to the patients:
Contact Baxter to receive more product information:
Baxter Customer Service 1-800-423-2090
Information on patient assistance programs:
Factor Assist (insurance gap program) 1-888-BAXTER9 (1-888-229-8379)
Hemophilia Galaxy (www.hemophiliagalaxy.com)
Recombinate [Antihemophilic Factor (Recombinant)] Instructions for Use
Do not attempt to do an infusion to yourself unless you have been taught how by your doctor or hemophilia center.1. In a quiet place, prepare a clean flat surface and gather all the materials you will need for the infusion. Check the expiration date, and let the vial with the Recombinate concentrate and the Sterile Water for Injection, USP (diluent) warm up to room temperature. Wash your hands and put on clean exam gloves. If infusing yourself at home, the use of gloves is optional.
2. Remove caps from the Recombinate concentrate and diluent vials to expose the centers of the rubber stoppers.
3. Disinfect the stoppers with an alcohol swab (or other suitable solution suggested by your doctor or hemophilia center) by rubbing the stoppers firmly for several seconds, and allow to dry prior to use. Place the vials on a flat surface.
4. Open the BAXJECT II device package by peeling away the lid, without touching the inside of the package. Do not remove the BAXJECT II device from the package.
The diluent vial now has the BAXJECT II device connected to it and is ready to be connected to the Recombinate vial.
6. To connect the diluent vial to the Recombinate vial, turn the diluent vial over and place it on top of the vial containing Recombinate concentrate. Fully insert the white plastic spike into the Recombinate vial’s stopper by pushing straight down. Diluent will flow into the Recombinate vial. This should be done right away to keep the liquid free of germs.
7. Swirl the connected vials gently and continuously until the Recombinate is completely dissolved. Do not shake. The Recombinate solution should be colorless to light yellow in appearance. If not, do not use it and notify Baxter immediately.
8. Take off the blue cap from the BAXJECT II device and connect the syringe. BE CAREFUL TO NOT INJECT AIR.
9. Turn over the connected vials so that the Recombinate vial is on top. Draw the Recombinate solution into the syringe by pulling back the plunger slowly. Disconnect the syringe from the vials. Attach the infusion needle to the syringe using a winged (butterfly) infusion set, if available. Point the needle up and remove any air bubbles by gently tapping the syringe with your finger and slowly and carefully pushing air out of the syringe and needle.
If you are using more than one vial of Recombinate, the contents of more than one vial may be drawn into the same syringe. However, you will need a separate diluent and BAXJECT II device to mix each additional vial of Recombinate.
10. Apply a tourniquet, and get the injection site ready by wiping the skin well with an alcohol swab (or other suitable solution suggested by your doctor or hemophilia center).
11. Insert the needle into the vein, and remove the tourniquet. Slowly infuse the Recombinate. Do not infuse any faster than 10 mL per minute.
12. Take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes.
Do not recap the needle. Place it with the used syringe in a hard-walled Sharps container for proper disposal.
13. Remove the peel-off label from the Recombinate vial and place it in your logbook. Clean any spilled blood with a freshly prepared mixture of 1 part bleach and 9 parts water, soap and water, or a any household disinfecting solution.
14. Dispose of the used vials and BAXJECT II system in your hard-wall Sharps container, without taking them apart. Do not dispose of these supplies in ordinary household trash.
Important: Contact your doctor or local Hemophilia Treatment Center if you experience any problems.
Baxter, Recombinate, Baxject, Hemophilia Galaxy and Factor Assist, are trademarks of Baxter International Inc.
| Recombinate antihemophilic factor, human recombinant kit |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| BLA | bla103375 | 12/10/1992 | |
| Recombinate antihemophilic factor, human recombinant kit |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| BLA | bla103375 | 12/10/1992 | |
| Recombinate antihemophilic factor, human recombinant kit |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| BLA | bla103375 | 12/10/1992 | |
| Labeler - Baxter Healthcare Corporation (123412376) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Baxter Healthcare Corporation | 009471603 | manufacture | |
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Recombinate - Includes detailed dosage instructions.
