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Antihemophilic Factor (Recombinant), Glycopegylated-Exei (Esperoct)

Trade Name : ESPEROCT

Novo Nordisk

KIT, PLASMA DERIVATIVE

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

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Antihemophilic Factor (Recombinant), Glycopegylated-Exei (Esperoct) which is also known as ESPEROCT and Manufactured by Novo Nordisk. It is available in strength of per ml. Read more

Antihemophilic Factor (Recombinant), Glycopegylated-Exei (Esperoct) 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

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for:
  • Limitation of Use:
  • ESPEROCT is not indicated for the treatment of von Willebrand disease. n
  • ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for:
  • ESPEROCT is not indicated for the treatment of von Willebrand disease. ()
  • For intravenous infusion after reconstitution only.
  • For intravenous infusion after reconstitution only
  • Array
  • ESPEROCT is available as a sterile white to off-white lyophilized powder supplied in single-dose vials containing nominally 500, 1000, 1500, 2000 or 3000 IU. The actual FVIII activity is printed on each ESPEROCT vial and carton.
  • After reconstitution with 4 mL of saline diluent, the reconstituted solution contains approximately 125, 250, 375, 500 or 750 IU per mL of ESPEROCT, respectively.
  • ESPEROCT is available as a lyophilized powder in single-dose vials of dosage strengths at 500, 1000, 1500, 2000 and 3000 IU per vial. ()
  • ESPEROCT is contraindicated in patients who have known hypersensitivity to ESPEROCT or its components (including hamster proteins) [].
  • Do not use in patients who have known hypersensitivity to ESPEROCT or its components, including hamster proteins. ()
  • No data
  • 5.2n- 5.3
  • The most frequently reported adverse reactions (incidence u22651%) in clinical trials were rash, redness, itching (pruritus), and injection site reactions.
  • The most frequently reported adverse reactions (u2265 1%) were rash, redness, itching and injection site reactions. ()
  • Pediatric Use: Higher clearance (based on kg body weight), a shorter half-life and lower incremental recovery are seen in children. Higher and more frequent dosing may be needed. ()
  • ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride.
  • FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, or 3000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), eachu00a0mL of the solution contains approximately 125, 250, 375, 500, or 750 IU of FVIII, respectively.
  • The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent (Triton X-100) treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT.
  • In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa.
  • No data
  • No data
  • The safety and efficacy of ESPEROCT have been evaluated in five multinational, open-label trials in male subjects with severe hemophilia A (<1% endogenous Factor VIII activity). One trial was subsequently partially randomized to evaluate two different prophylaxis regimens. All subjects were previously treated, which was defined as having received other Factor VIII products for u2265150 exposure days for adolescents and adults, and u226550 exposure days for pediatric subjects. The key exclusion criteria across trials included known or suspected hypersensitivity to trial or related products and known history of Factor VIII inhibitors or current inhibitor u22650.6 Bethesda units (BU).
  • The efficacy evaluation included 254 subjects, who received at least one dose of ESPEROCT, in the following trials:
  • On-demand Treatment and Control of Bleeding Episodes
  • There were 1506 bleeds reported in 171 of 254 subjects across the completed clinical trials, and the most common bleed types were joint (65.2%), muscle (14.5%), and subcutaneous (8.9%). Table 6 summarizes the efficacy in control of bleeding episodes by age.
  • Doses used for treatment of bleeding episodes depended on age, treatment regimen and the severity of the bleed.
  • Of the 1407 mild and moderate bleeding episodes in all subjects in the adolescent/adult study, the median dose used was 42u00a0IU/kg. For subjects who were on the on-demand arm the median initial dose was 28 IU/kg and 88.4% of the bleeds were treated successfully with a single dose. In subjects receiving routine prophylaxis, the median initial dose was 52 IU/kg, and 76.4% of the bleeds were successfully treated with a single dose. Of the 15 severe bleeds, 12 (80%) required more than one dose with a total median dose of 111 IU/kg.
  • In the pediatric study, 70 mild/moderate bleeds in children < 12 years old receiving routine prophylaxis were treated with a median initial dose of 64 IU/kg per injection, with 63% treated with a single injection. When needed, additional median doses of 62 IU/kg were used at approximately 24 hour intervals. The median total dose was 70 IU/kg per bleed.
  • Table 6: Summary of efficacy in control of bleeding episodes by age
  • Definition of Hemostatic Response:
  • Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single injection.
  • Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after one injection, but possibly requiring more than one injection for complete resolution.
  • Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection; usually requiring more than one injection.
  • Perioperative Management
  • The efficacy analysis of ESPEROCT in perioperative management included 45 major surgical procedures performed in 33 adolescent and adult subjects. The procedures included 15 joint replacements, 9 arthroscopic orthopedic interventions, 17 other orthopedic interventions, and 4 non-orthopedic surgeries.
  • The clinical evaluation of hemostatic response during major surgery was assessed using a 4-point scale of excellent, good, moderate, or none. The hemostatic effect of ESPEROCT was rated as u201cexcellentu201d or u201cgoodu201d in 43 of 45 surgeries (95.6%), while the effect was rated as u201cmoderateu201d in 2 surgeries (4.4%). No surgery had an outcome rated as u201cnoneu201d or u201cmissing.u201d
  • The median pre-operative dose for adults and adolescents undergoing major surgeries was 52 IU/kg, and the median total dose was 702 IU/kg. During post-operative days 1-6, the median dose was 32 IU/kg at approximately 24 hour intervals. During post-operative days 7-14, the median dose was 36 IU/kg at approximately 28 hour intervals. The number of doses and duration of treatment varied by procedure.
  • Routine Prophylaxis in Adolescents/Adults
  • The efficacy of ESPEROCT in routine prophylaxis with Q4D dosing was demonstrated for the adult/adolescent population (see Table 7). In the extension part of the study, treatment success of the Q7D arm was not established. During the Main Phase of the adolescent/adult trial, 186 subjects had a total of 159 exposure years. The median annualized bleeding rate (ABR) for treated bleeds in adults and adolescents treated every 4u00a0days was 1.2 (IQR: 0.0:4.3), and mean ABR was 3.0 (SD: 4.7). When including all bleeds (treated and non-treated), the median ABR was 1.2 (IQR: 0.0; 4.7) and the mean ABR was 3.3 (SD: 4.9).
  • Table 7: Efficacy in adolescent/adult prophylaxis, median and mean ABRs by age, treatment regimen, and bleed type
  • ABR = annualized bleed rate; IQR = interquartile range, 25th percentile to 75th percentile; SD = standard deviation; AsBR = annualized spontaneous bleed rate; AtBR = annualized traumatic bleed rate; AjBR = annualized joint bleed rate.
  • *Reflects all bleeds reported by patients including those where no ESPEROCT was administered
  • Routine Prophylaxis in Children <12 Years of Age
  • Overall, 68 children below 12 years received prophylactic treatment with ESPEROCT at an average dose of approximately 65 IU/kg twice weekly. The prophylactic effect of ESPEROCT was demonstrated with a median ABR rate of 2.0 (IQR: 0.0; 2.8) and 2.0 (IQR: 0.0; 4.2) for treated bleeds and all bleeds respectively (see Table 8). The mean ABR (SD) for treated bleeds and all bleeds were 3.1 (7.1) and 4.4 (8.7), respectively. Of the 68 children, 22 (32%) did not experience any bleeding episodes and 29 (43%) did not experience any bleeding episodes that required treatment during the Main Phase of the trial. Of the 13 subjects with 17 documented target joints at baseline, 10 subjects (77%) and 14 target joints (82%) did not have any bleeds during the Main Phase of the trial.
  • Table 8: Efficacy in pediatric prophylaxis, median and mean ABR by age and bleed type
  • ABR = annualized bleed rate; IQR = interquartile range, 25th percentile to 75th percentile; SD = standard deviation; AsBR = annualized spontaneous bleed rate; AtBR = annualized traumatic bleed rate; AjBR = annualized joint bleed rate
  • *Reflects all bleeds reported by patients including those where no ESPEROCT was administered
  • **Elevated mean ABRs are due to subjects who withdrew from the study, whose bleeding rates were extrapolated to one year
  • How Supplied
  • Table 9: ESPEROCT Presentations
  • IU = International Units
  • Storage and Handling
  • Advise patients:
  • Version: 2
  • License Number: 1261
  • ESPEROCTand MixPro are registered trademarks of Novo Nordisk Health Care AG.
  • Patent Information: n
  • Clave and MicroClave are registered trademarks of ICU Medical Inc.
  • InVision-Plus, InVision-Plus CS, Invision-Plus Junior are registered trademarks of RyMed Technologies, Inc. Bionector is a registered trademark of Vygon.
  • u00a9 2019 Novo Nordisk
  • For information contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, NJ 08536, USA
  • 1-800-727-6500
  • Manufactured by:
  • Novo Nordisk A/S
  • Novo Allu00e9, DK-2880 Bagsvaerd
  • Patient Information
  • ESPEROCTn
  • [antihemophilic factor (recombinant), glycopegylated-exei]
  • Read the Patient Information and the Instructions For Use that come with ESPEROCT before you start taking this medicine and each time you get a refill. There may be new information.
  • This Patient Information does not take the place of talking with your healthcare provider about your medical condition or treatment. If you have questions about ESPEROCT after reading this information, ask your healthcare provider.
  • Arrayn- What is the most important information I need to know about ESPEROCT?
  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center.
  • You must carefully follow your healthcare provider's instructions regarding the dose and schedule for infusing ESPEROCT so that your treatment will work best for you.
  • Arrayn- What is ESPEROCT?
  • ESPEROCT is an injectable medicine used to replace clotting Factor VIII that is missing in patients with hemophilia A. Hemophilia A is an inherited bleeding disorder in all age groups that prevents blood from clotting normally.
  • ESPEROCT is used to treat and prevent or reduce the number of bleeding episodes in people with hemophilia A.
  • Your healthcare provider may give you ESPEROCT when you have surgery.
  • Arrayn- Who should not use ESPEROCT?
  • You should not use ESPEROCT if you
  • If you are not sure, talk to your healthcare provider before using this medicine.
  • Tell your healthcare provider if you are pregnant or nursing because ESPEROCT might not be right for you.
  • Arrayn- What should I tell my healthcare provider before I use ESPEROCT?
  • You should tell your healthcare provider if you:
  • Arrayn- How should I use ESPEROCT?
  • Treatment with ESPEROCT should be started by a healthcare provider who is experienced in the care of patients with hemophilia A.
  • ESPEROCT is given as an infusion into the vein.
  • You may infuse ESPEROCT 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 the medicine by themselves or with the help of a family member.
  • Your healthcare provider will tell you how much ESPEROCT to use based on your weight, the severity of your hemophilia A, and where you are bleeding. Your dose will be calculated in international units, IU.
  • Call your healthcare provider right away if your bleeding does not stop after taking ESPEROCT.
  • If your bleeding is not adequately controlled, it could be due to the development of Factor VIII inhibitors. This should be checked by your healthcare provider. You might need a higher dose of ESPEROCT or even a different product to control bleeding. Do not increase the total dose of ESPEROCT to control your bleeding without consulting your healthcare provider.
  • Arrayn- Use in children
  • ESPEROCT can be used in children. Your healthcare provider will decide the dose of ESPEROCT you will receive.
  • Arrayn- If you forget to use ESPEROCT
  • If you forget a dose, infuse the missed dose when you discover the mistake. Do not infuse a double dose to make up for a forgotten dose. Proceed with the next infusions as scheduled and continue as advised by your healthcare provider.
  • Arrayn- If you stop using ESPEROCT
  • Do not stop using ESPEROCT without consulting your healthcare provider.
  • If you have any further questions on the use of this product, ask your healthcare provider.
  • Arrayn- What if I take too much ESPEROCT?
  • Always take ESPEROCT exactly as your healthcare provider has told you. You should check with your healthcare provider if you are not sure. If you infuse more ESPEROCT than recommended, tell your healthcare provider as soon as possible.
  • Arrayn- What are the possible side effects of ESPEROCT?
  • Common Side Effects Include:
  • Other Possible Side Effects:
  • You could have an allergic reaction to coagulation Factor VIII products. n : hives, chest tightness, wheezing, dizziness, difficulty breathing, and/or swelling of the face.
  • Your body can also make antibodies called u201cinhibitorsu201d against ESPEROCT, which may stop ESPEROCT from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time.
  • These are not all of the possible side effects from ESPEROCT. Ask your healthcare provider for more information. You are encouraged to report side effects to FDA at 1-800-FDA-1088.
  • Tell your healthcare provider about any side effect that bothers you or that does not go away.
  • Arrayn- What are the ESPEROCT dosage strengths?
  • ESPEROCT comes in five different dosage strengths. The actual number of international units (IU) of Factor VIII in the vial will be imprinted on the label and on the box. The five different strengths are as follows:
  • Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider.
  • Arrayn- How should I store ESPEROCT?
  • Prior to Reconstitution
  • Protect from light. Do not freeze ESPEROCT.
  • ESPEROCT can be stored in refrigeration at 36u00b0F to 46u00b0F (2u00b0C to 8u00b0C) for up to 30 months until the expiration date stated on the label. During the 30 month shelf life, ESPEROCT may be kept at room temperature (not to exceed 86u00b0F/30u00b0C) for up to 12 months, up to 104u00b0F (40u00b0C) for no longer than 3 months.
  • If you choose to store ESPEROCT at room temperature:
  • Do not use this medicine after the expiration date which is on the outer carton and the vial. The expiration date refers to the last day of that month.
  • After Reconstitution
  • The reconstituted (the final product once the powder is mixed with the diluent) ESPEROCT should appear clear and colorless without visible particles.
  • The reconstituted ESPEROCT should be used immediately.
  • If you cannot use the reconstituted ESPEROCT immediately, it must be used within 4 hours when stored at or below 86u00baF (30u00b0C) or within 24 hours when stored in a refrigerator at 36u00b0F to 46u00b0F (2u00b0C to 8u00b0C). Store the reconstituted product in the vial.
  • Keep this medicine out of the sight and out of reach of children.
  • Arrayn- What else should I know about ESPEROCT and hemophilia A?
  • Medicines are sometimes prescribed for purposes other than those listed here. Do not use ESPEROCT for a condition for which it is not prescribed. Do not share ESPEROCT with other people, even if they have the same symptoms that you have.
  • For more information about ESPEROCT, please call Novo Nordisk at 1-800-727-6500.
  • Revised: 10/2019
  • ESPEROCT is a trademark of Novo Nordisk Health Care AG.
  • For Patent Information, refer to: http://novonordisk-us.com/patients/products/product-patents.html
  • u00a9 2019 Novo Nordisk
  • Manufactured by:
  • Novo Nordisk A/S
  • Novo Allu00e9
  • DK-2880 Bagsvu00e6rd, Denmark
  • For information about ESPEROCT contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, NJ 08536, USA
  • Instructions for Use
  • Instructions on how to use ESPEROCT[antihemophilic factor (recombinant), glycopegylated-exei] MixPron
  • READ THESE INSTRUCTIONS CAREFULLY BEFORE USING ESPEROCT.
  • ESPEROCT is supplied as a powder. Before infusion (administration) it must be mixed (reconstituted) with the liquid diluent supplied in the syringe. The liquid diluent is a sodium chloride solution. The mixed ESPEROCT must be infused into your vein (intravenous infusion). The equipment in this package is designed to mix and infuse ESPEROCT.
  • You will also need an infusion set (butterfly needle with tubing), sterile alcohol swabs, gauze pads, and bandages.
  • Donu2019t use the equipment without proper training from your doctor or nurse.
  • Always wash your hands and ensure that the area around you is clean.
  • When you prepare and infuse medication directly into the veins, it is important to Improper technique can introduce germs that can infect the blood.
  • Donu2019t open the equipment until you are ready to use it.
  • Donu2019t use the equipment if it has been dropped, or if it is damaged.
  • Donu2019t use the equipment if it is expired. n- Array
  • Donu2019t use the equipment if you suspect it is contaminated.
  • Donu2019t dispose of any of the items until after you have infused the mixed solution.
  • The equipment is for single use only.
  • Single-dose container. Discard unused portion.
  • Content
  • The package contains:
  • u2022 Vial with ESPEROCT powder
  • u2022 Vial adapter
  • u2022 Pre-filled syringe with diluent
  • u2022 Plunger rod (placed under the syringe)
  • 1. Prepare the vial and the syringe
  • 2. Attach the vial adapter
  • 3. Attach the plunger rod and the syringe
  • 4. Mix the powder with the diluent
  • ESPEROCT is recommended to be used immediately after it is mixed.
  • If you cannot use the mixed ESPEROCT solution immediately,
  • Do not freeze mixed ESPEROCT solution or store it in syringes.
  • Keep reconstituted ESPEROCT solution out of direct light.
  • If your dose requires more than one vial, repeat step to with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.
  • Donu2019t touch the syringe tip.
  • Caution: The pre-filled diluent syringe is made of glass with an internal tip diameter of 0.037 inches, and is compatible with a standard Luer-lock connector.
  • Some needleless connectors for intravenous catheters are incompatible with the glass diluent syringes (for example, certain connectors with an internal spike, such as Clave /MicroClave, InVision-Plus, InVision-Plus CS, Invision-Plus Junior, Bionector).
  • To administer ESPEROCT through incompatible needleless connectors, withdraw reconstituted product into a standard 10 mL sterile Luer-lock plastic syringe.
  • If you have encountered any problems with attaching the pre-filled sodium chloride syringe to any Lueru2010lock compatible device, please contact Novo Nordisk at (800) 727-6500.
  • 5. Infuse the mixed solution
  • ESPEROCT is now ready to infuse into your vein.
  • Infusing the solution via a central venous access device (CVAD) such as a central venous catheter or subcutaneous port:
  • The peel-off label found on the ESPEROCT vial can be used to record the lot number.
  • Disposal
  • Donu2019t throw it out with the ordinary household trash.
  • Donu2019t disassemble the vial and vial adapter before disposal.
  • Donu2019t reuse the equipment.
  • Important information
  • Contact your healthcare provider or local hemophilia treatment center if you experience any problems.
  • For full Prescribing Information please read the other insert included in this package.
  • ESPEROCT and MixPro are trademarks of Novo Nordisk Health Care AG.
  • For Patent Information, refer to: http://novonordisk-us.com/patients/products/product-patents.html
  • u00a9 2019 Novo Nordiskn
  • Manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvaerd, Denmark
  • For information about ESPEROCT contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, NJ 08536, USA
  • License No: 1261
  • Revised: 10/2019
  • 500 IU Carton
  • NDC 0169 8500 01 List: 850001
  • [antihemophilic factor (recombinant), glycopegylated-exei]
  • 500 IU
  • Intravenous use, after reconstitution.
  • Single-dose. Discard unused portion
  • Contains no preservatives.
  • Rx Only
  • Includes MixPron
  • a vial adapter and pre-filled diluent syringe
  • NDC 0169 8100 01 List: 810001
  • [antihemophilic factor (recombinant), glycopegylated-exei]
  • 1000 IU
  • Intravenous use, after reconstitution.
  • Single-dose. Discard unused portion
  • Contains no preservatives.
  • Rx Only
  • Includes MixPron
  • a vial adapter and pre-filled diluent syringe
  • NDC 0169 8150 01 List: 815001
  • [antihemophilic factor (recombinant), glycopegylated-exei]
  • 1500 IU
  • Intravenous use, after reconstitution.
  • Single-dose. Discard unused portion
  • Contains no preservatives.
  • Rx Only
  • Includes MixPron
  • a vial adapter and pre-filled diluent syringe
  • NDC 0169 8200 01
  • List: 820001
  • [antihemophilic factor (recombinant), glycopegylated-exei]
  • 2000 IU
  • Intravenous use, after reconstitution.
  • Single-dose. Discard unused portion
  • Contains no preservatives.
  • Rx Only
  • Includes MixPron
  • a vial adapter and pre-filled diluent syringe
  • NDC 0169 8300 01
  • List: 830001
  • [antihemophilic factor (recombinant), glycopegylated-exei]
  • 3000 IU
  • Intravenous use, after reconstitution.
  • Single-dose. Discard unused portion
  • Contains no preservatives.
  • Rx Only
  • Includes MixPron
  • a vial adapter and pre-filled diluent syringe
  • NDC 0169 800898
  • Sodium chloride 4 mL
  • For reconstitution of ESPEROCTn
  • Store in a refrigerator 36u00b0F to 46u00b0F (2u00b0C to 8u00b0C)
  • Do not freeze
  • Rx Only
  • Single-dose
  • Novo Nordisk Inc.
  • 1-800-727-6500
  • Expiry Date/Lot:
  • NDC 0169 8501 11
  • [antihemophilic factor (recombinant), glycopegylated-exei]
  • Store in a refrigerator 36u00b0F - 46u00b0F (2u00b0C - 8u00b0C)
  • Rx Only
  • Reconstitution with 4 mL sodium chloride solution only
  • Do not freeze
  • Novo Nordisk Inc.
  • 1-800-727-6500
  • NDC 0169 8101 11
  • [antihemophilic factor (recombinant), glycopegylated-exei]
  • Store in a refrigerator 36u00b0F - 46u00b0F (2u00b0C - 8u00b0C)
  • Rx Only
  • Reconstitution with 4 mL sodium chloride solution only
  • Do not freeze
  • Novo Nordisk Inc.
  • 1-800-727-6500
  • NDC 0169 8151 11
  • [antihemophilic factor (recombinant), glycopegylated-exei]
  • Store in a refrigerator 36u00b0F - 46u00b0F (2u00b0C - 8u00b0C)
  • Rx Only
  • Reconstitution with 4 mL sodium chloride solution only
  • Do not freeze
  • Novo Nordisk Inc.
  • 1-800-727-6500
  • NDC 0169 8201 11
  • [antihemophilic factor (recombinant), glycopegylated-exei]
  • Store in a refrigerator 36u00b0F - 46u00b0F (2u00b0C - 8u00b0C)
  • Rx Only
  • Reconstitution with 4 mL sodium chloride solution only
  • Do not freeze
  • Novo Nordisk Inc.
  • 1-800-727-6500
  • NDC 0169 8301 11
  • [antihemophilic factor (recombinant), glycopegylated-exei]
  • Store in a refrigerator 36u00b0F - 46u00b0F (2u00b0C - 8u00b0C)
  • Rx Only
  • Reconstitution with 4 mL sodium chloride solution only
  • Do not freeze
  • Novo Nordisk Inc.
  • 1-800-727-6500

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Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, FILM COATED

Strength: 25 mg/1

Pack Size:

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