Antihemophilic Factor Recombinant (Recombinate)

Trade Name : RECOMBINATE

Baxalta US Inc.

KIT, PLASMA DERIVATIVE

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Antihemophilic Factor Recombinant (Recombinate) which is also known as RECOMBINATE and Manufactured by Baxalta US Inc.. It is available in strength of per ml. Read more

Antihemophilic Factor Recombinant (Recombinate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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u00a0Lyophilized Powder for Reconstitution for injection
Reconstitute with 5 mL of Sterile Water for Injection using BAXJECT II

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, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 u00b5g/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.
Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.

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 u00b1 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 u00b1 5.1 hours (n=61). The actual baseline recovery observed with RECOMBINATE was 123.9 u00b1 47.7 IU/dL (n=23), which is significantly higher than the actual HEMOFIL M baseline recovery of 101.7 u00b1 31.6 IU/dL (n=61). However, the calculated ratio of actual to expected recovery withu00a0RECOMBINATE (121.2 u00b1 48.9%) is not different on average from HEMOFIL M (123.4 u00b1 16.4%).
The clinical study ofu00a0 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.

The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. 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.u00a0 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 as well as the clinical status of the patient.
RECOMBINATE is not indicated in von Willebrand's disease.

RECOMBINATE is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including bovine, mouse or hamster proteins.

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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 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 n 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%):

RECOMBINATE is available in five different strengths in single-dose vials. The strength is designated on the outer box and on the vial label using the following color codes:
RECOMBINATE is packaged with 5 mL of Sterile Water for Injection, USP, a BAXJECT II Needleless Transfer Device, one physician insert and one patient insert.

RECOMBINATE can be refrigerated [2u00b0 - 8u00b0C (36u00b0 - 46u00b0F)] or stored at room temperature, not to exceed 30u00b0C (86u00b0F). Avoid freezing to prevent damage to the diluent vial. Do not use beyond the expiration date printed on the box.

Over the investigational period of the original safety and efficacy study of RECOMBINATE, none of the 69 subjects without an inhibitor at entry into the study, developed an inhibitor. In the previously untreated patient group there were 73 eligible subjects 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 (32%) developed a detectable inhibitor (median days on treatment at time of detection 10, range 3-69) and of these, 8 subjects (11%) showed a titer greater than 10 B.U.

To enroll in the confidential, industry-wide Patient Notification System, call 1-888-873-2838.
BAXALTA, BAXJECT and RECOMBINATE are trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.
SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
Manufactured by:n n Lexington, MA 02421 USAU.S. License No. 2020
Printed in USA
Issued: 06/2018

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.
Do not attempt to self-infuse unless you have been taught how by your doctor or hemophilia center.

Do not attempt to do an infusion to yourself unless you have been taught how by your doctor or hemophilia center.n n
1. u00a0u00a0 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. u00a0u00a0 Remove caps from the RECOMBINATE concentrate and diluent vials to expose the centers of the rubber stoppers.
3. u00a0u00a0 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. u00a0u00a0 Open the BAXJECT II device package by peeling away the lid, without touching the inside of the package. n
5. u00a0u00a0 Turn the package with the BAXJECT II device upside down, and place it over the top of the diluent vial. Fully insert the clear plastic spike of the device into the center of the diluent vial's stopper by pushing straight down. Grip the package at its edge and lift it off the device. Be careful not to touch the white plastic spike. The diluent vial now has the BAXJECT II device connected to it and is ready to be connected to the RECOMBINATE vial.
6. u00a0u00a0 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. u00a0u00a0 Swirl the connected vials gently and continuously until the RECOMBINATE is completely dissolved. . The RECOMBINATE solution should be colorless to light-yellow in appearance. If not, do not use it and notify Baxalta immediately.
8. u00a0 Take off the blue cap from the BAXJECT II device and connect the syringe. .
9. u00a0u00a0 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. u00a0u00a0 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. u00a0 Insert the needle into the vein, and remove the tourniquet. Slowly infuse the RECOMBINATE. . u00a0 Redness of the skin or irritation may be seen when infusing RECOMBINATE dissolved with 5 mL diluent.
12. u00a0 Take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes. . n
13. u00a0 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 any household disinfecting solution.
14. u00a0 Dispose of the used vials and BAXJECT II system in your hard-walled 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
BAXALTA, BAXJECT and RECOMBINATE are trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.
SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
Manufactured by:
Baxalta US Inc.n
Issued: 06/2018
Printed in USA

5 mL NDC 52919-003-08Shire
Sterile Water for Injection, USPfor reconstitution of accompanying product
Do not use unless clear. No antimicrobial agent or other substancehas been added. Do not use for intravascular injection without makingapproximately isotonic by additon of suitable solute.
Rx Only
0742003
Single dose containerNonpyrogenic

NDC 0944-2831-01
RECOMBINATE
[Antihemophilic Factor (Recombinant)]
For Intravenous Administration Only
Store in refrigerator at 36u00b0 to 46u00b0F (2u00b0 to 8u00b0C)or Store at room temperature up to 86u00b0F (30u00b0C)After reconstitution do not refrigerate
Contains no preservative
Direction for Use: Read package insert
Baxalta US Inc.Lexington, MA 02421 USAU.S. License No. 2020
Rx Only

RECOMBINATE[Antihemophilic Factor (Recombinant)]
NDC 0944-2841-10
Rx Only
Single-use vial
Includes BAXJECT II Needleless Transfer DeviceStore in refrigerator at 36u00b0 to 46u00b0F (2u00b0 to 8u00b0C) orStore at room temperature up to 86u00b0F (30u00b0C)Do not freeze
Baxalta US Inc., Lexington, MA 02421 USAU.S. License No. 2020
Recombinate, double-ended needle and filter spikeproducts of USA; Sterile water product of Germany.
Shire

NDC 0944-2832-01
RECOMBINATE
[Antihemophilic Factor (Recombinant)]
For Intravenous Administration Only
Store in refrigerator at 36u00b0 to 46u00b0F (2u00b0 to 8u00b0C)or Store at room temperature up to 86u00b0F (30u00b0C)After reconstitution do not refrigerate
Contains no preservative
Direction for Use: Read package insert
Baxalta US Inc.Lexington, MA 02421 USAU.S. License No. 2020
Rx Only

RECOMBINATE[Antihemophilic Factor (Recombinant)]
NDC 0944-2842-10
Rx Only
Single-use vial
Includes BAXJECT II Needleless Transfer DeviceStore in refrigerator at 36u00b0 to 46u00b0F (2u00b0 to 8u00b0C) orStore at room temperature up to 86u00b0F (30u00b0C)Do not freeze
Baxalta US Inc., Lexington, MA 02421 USAU.S. License No. 2020
Recombinate, double-ended needle and filter spikeproducts of USA; Sterile water product of Germany.
Shire

NDC 0944-2833-01
RECOMBINATE
[Antihemophilic Factor (Recombinant)]
For Intravenous Administration Only
Store in refrigerator at 36u00b0 to 46u00b0F (2u00b0 to 8u00b0C)or Store at room temperature up to 86u00b0F (30u00b0C)After reconstitution do not refrigerate
Contains no preservative
Direction for Use: Read package insert
Baxalta US Inc.Lexington, MA 02421 USAU.S. License No. 2020
Rx Only

RECOMBINATE[Antihemophilic Factor (Recombinant)]
NDC 0944-2843-10
Rx Only
Single-use vial
Includes BAXJECT II Needleless Transfer DeviceStore in refrigerator at 36u00b0 to 46u00b0F (2u00b0 to 8u00b0C) orStore at room temperature up to 86u00b0F (30u00b0C)Do not freeze
Baxalta US Inc., Lexington, MA 02421 USAU.S. License No. 2020
Recombinate, double-ended needle and filter spikeproducts of USA; Sterile water product of Germany.
Shire

NDC 0944-2834-01
RECOMBINATE
[Antihemophilic Factor (Recombinant)]
For Intravenous Administration Only
Store in refrigerator at 36u00b0 to 46u00b0F (2u00b0 to 8u00b0C)or Store at room temperature up to 86u00b0F (30u00b0C)After reconstitution do not refrigerate
Contains no preservative
Direction for Use: Read package insert
Baxalta US Inc.Lexington, MA 02421 USAU.S. License No. 2020
Rx Only

RECOMBINATE[Antihemophilic Factor (Recombinant)]
NDC 0944-2844-10
Rx Only
Single-use vial
Includes BAXJECT II Needleless Transfer DeviceStore in refrigerator at 36u00b0 to 46u00b0F (2u00b0 to 8u00b0C) orStore at room temperature up to 86u00b0F (30u00b0C)Do not freeze
Baxalta US Inc., Lexington, MA 02421 USAU.S. License No. 2020
Recombinate, double-ended needle and filter spikeproducts of USA; Sterile water product of Germany.
Shire

NDC 0944-2835-01
RECOMBINATE
[Antihemophilic Factor (Recombinant)]
For Intravenous Administration Only
Store in refrigerator at 36u00b0 to 46u00b0F (2u00b0 to 8u00b0C)or Store at room temperature up to 86u00b0F (30u00b0C)After reconstitution do not refrigerate
Contains no preservative
Direction for Use: Read package insert
Baxalta US Inc.Lexington, MA 02421 USAU.S. License No. 2020
Rx Only

RECOMBINATE[Antihemophilic Factor (Recombinant)]
NDC 0944-2845-10
Rx Only
Single-use vial
Includes BAXJECT II Needleless Transfer DeviceStore in refrigerator at 36u00b0 to 46u00b0F (2u00b0 to 8u00b0C) orStore at room temperature up to 86u00b0F (30u00b0C)Do not freeze
Baxalta US Inc., Lexington, MA 02421 USAU.S. License No. 2020
Recombinate, double-ended needle and filter spikeproducts of USA; Sterile water product of Germany.
Shire

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Antihemophilic Factor Recombinant (Recombinate)

Trade Name : RECOMBINATE

KIT, PLASMA DERIVATIVE

Delivery Process

Product information is meant for

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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Antihemophilic Factor Recombinant (Recombinate)

Trade Name : RECOMBINATE

KIT, PLASMA DERIVATIVE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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