“We use cookies on this website to enhance your user experience and to personalise content. By clicking any link or continuing to use our Website you agree to our cookies as per our Privacy Policy. Read More” Ok, I agree

Infliximab-Dyyb (Inflectra)

Trade Name : INFLECTRA

Pfizer Laboratories Div Pfizer Inc

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 100 mg/10mL

INFLIXIMAB Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 Infliximab-Dyyb (Inflectra) which is also known as INFLECTRA and Manufactured by Pfizer Laboratories Div Pfizer Inc. It is available in strength of 100 mg/10mL per ml. Read more

Infliximab-Dyyb (Inflectra) 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

Validated Cold Chain Shipment

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.

Inquire directly from our website and get 5% off on any medicine!

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.

Read more

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.

Read more
  • No data
  • WARNING: SERIOUS INFECTIONS and MALIGNANCY
  • See full prescribing information for complete boxed warning
  • Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens.
  • Discontinue INFLECTRA if a patient develops a serious infection.
  • Perform test for latent TB; if positive, start treatment for TB prior to starting INFLECTRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. ()
  • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products.
  • Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers, including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males. ()
  • No data
  • INFLECTRA is a tumor necrosis factor (TNF) blocker indicated for:
  • Crohn's Disease ():
  • Pediatric Crohn's Disease ():
  • Ulcerative Colitis ():
  • Pediatric Ulcerative Colitis ():
  • Rheumatoid Arthritis () in combination with methotrexate:
  • Ankylosing Spondylitis ():
  • Psoriatic Arthritis ():
  • Plaque Psoriasis ():
  • INFLECTRA is administered by intravenous infusion over a period of not less than 2 hours.
  • Crohn's Disease ()
  • Pediatric Crohn's Disease ()
  • Ulcerative Colitis ()
  • Pediatric Ulcerative Colitis ()
  • Rheumatoid Arthritis ()
  • Ankylosing Spondylitis ()
  • Psoriatic Arthritis () and Plaque Psoriasis ()
  • For injection: 100 mg vial: 100 mg lyophilized infliximab-dyyb in a 20 mL vial for injection, for intravenous use.
  • For injection: 100 mg of lyophilized infliximab-dyyb in a 20 mL vial for intravenous infusion. ()
  • INFLECTRA at doses >5 mg/kg should not be administered to patients with moderate to severe heart failure. In a randomized study evaluating infliximab in patients with moderate to severe heart failure (New York Heart Association [NYHA] Functional Class III/IV), infliximab treatment at 10 mg/kg was associated with an increased incidence of death and hospitalization due to worsening heart failure .
  • INFLECTRA should not be readministered to patients who have experienced a severe hypersensitivity reaction to infliximab products. Additionally, INFLECTRA should not be administered to patients with known hypersensitivity to inactive components of the product or to any murine proteins.
  • INFLECTRA doses >5 mg/kg in moderate to severe heart failure. ()
  • Previous severe hypersensitivity reaction to infliximab products or known hypersensitivity to inactive components of INFLECTRA or to any murine proteins. ()
  • No data
  • Serious infections
  • Invasive fungal infections
  • Malignancies
  • Hepatitis B virus (HBV) reactivation
  • Hepatotoxicity
  • Heart failure
  • Cytopenias
  • Hypersensitivity
  • Cardiovascular and Cerebrovascular Reactions
  • Demyelinating disease
  • Lupus-like syndrome
  • Live vaccines or therapeutic infectious agents
  • Most common adverse reactions (>10%) u2013 infections (e.g. upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact CELLTRION, Inc. at 1-800-383-7504 or FDA at 1-800-FDA-1088 or n
  • Use with anakinra or abataceptu2013 increased risk of serious infections ()
  • Pediatric Use
  • 8.4
  • Single doses up to 20 mg/kg of infliximab have been administered without any direct toxic effect. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
  • Infliximab-dyyb, the active ingredient in INFLECTRA, is a chimeric IgG1u03ba monoclonal antibody (composed of human constant and murine variable regions) specific for human tumor necrosis factor-alpha (TNFu03b1). It has a molecular weight of approximately 149.1 kilodaltons. Infliximab-dyyb is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses.
  • INFLECTRA for injection is supplied as a sterile, white, lyophilized powder for intravenous infusion. Following reconstitution with 10 mL of Sterile Water for Injection, USP, the resulting pH is approximately 7.2. Each single-use vial contains 100 mg infliximab-dyyb, 500 mg sucrose, 0.5 mg polysorbate 80, 2.2 mg sodium dihydrogen phosphate monohydrate, and 6.1 mg di-Sodium hydrogen phosphate dihydrate. No preservatives are present.
  • No data
  • The significance of the results of nonclinical studies for human risk is unknown. A repeat dose toxicity study was conducted with mice given cV1q anti-mouse TNFu03b1 to evaluate tumorigenicity. CV1q is an analogous antibody that inhibits the function of TNFu03b1 in mice. Animals were assigned to 1 of 3 dose groups: control, 10 mg/kg or 40 mg/kg cV1q given weekly for 6 months. The weekly doses of 10 mg/kg and 40 mg/kg are 2 and 8 times, respectively, the human dose of 5 mg/kg for Crohn's disease. Results indicated that cV1q did not cause tumorigenicity in mice. No clastogenic or mutagenic effects of infliximab were observed in the mouse micronucleus test or the (Ames) assay, respectively. Chromosomal aberrations were not observed in an assay performed using human lymphocytes. It is not known whether infliximab products can impair fertility in humans. No impairment of fertility was observed in a fertility and general reproduction toxicity study with the analogous mouse antibody used in the 6-month chronic toxicity study.
  • No data
  • No data
  • Each INFLECTRA (infliximab-dyyb) for Injection 20 mL vial is individually packaged in a carton.
  • NDC 0069-0809-01 100 mg vial
  • Each single use vial contains 100 mg of infliximab-dyyb for final reconstitution volume of 10 mL.
  • Storage and Stability
  • INFLECTRA must be refrigerated at 2u00baC to 8u00baC (36u00baF to 46u00baF). Do not use INFLECTRA beyond the expiration date (Exp) located on the carton and the vial. This product contains no preservative.
  • Advise the patient to read the FDA-Approved Patient Labeling (Medication Guide).
  • Patients or their caregivers should be advised of the potential benefits and risks of INFLECTRA. Physicians should instruct their patients to read the Medication Guide before starting INFLECTRA therapy and to reread it each time they receive an infusion. It is important that the patient's overall health be assessed at each treatment visit and that any questions resulting from the patient's or their caregiver's reading of the Medication Guide be discussed.
  • Manufactured by:CELLTRION, Inc.23, Academy-ro,Yeonsu-gu, Incheon22014, Republic of KoreaU.S. License No. 1996
  • Distributed byPfizer LabsDivision of Pfizer IncNew York, NY 10017
  • No data
  • NDC 0069-0809-01
  • Inflectran (infliximab-dyyb)For Injection
  • 100 mg per vial
  • For IntravenousInfusion Only
  • Single-use vial u2013 Discardunused portion
  • NDC 0069-0809-01
  • Inflectran (infliximab-dyyb) For Injection
  • 100 mg per vial
  • For Intravenous Infusion Only ttttttSingle-use vial u2013Discard unused portion ttttttDispense the enclosedMedication Guide to each patient. ttttttReconstitute and Dilute BeforeIntravenous Infusion.Infuse over at least 2 hours with anin-line filter.
  • Rx only
  • Pfizer Biosimilars

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Desogestrel And Ethinyl Estradiol (Emoquette)

Manufacturer: REMEDYREPACK INC.

Presentation: KIT

Strength:

Pack Size:

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

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

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET

Strength: 2.5; .025 mg/1; mg/1

Pack Size:

Fluoxetine Hydrochloride (Fluoxetine)

Fluoxetine Hydrochloride (Fluoxetine)

Manufacturer: REMEDYREPACK INC.

Presentation: CAPSULE

Strength: 40 mg/1

Pack Size:

Metoprolol Succinate (Metoprolol Succinate)

Metoprolol Succinate (Metoprolol Succinate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, EXTENDED RELEASE

Strength: 25 mg/1

Pack Size:

Losartan Potassium (Losartan Potassium)

Losartan Potassium (Losartan Potassium)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, FILM COATED

Strength: 25 mg/1

Pack Size:

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Get Price

Are you an existing customer or a vendor of GNH India? Log in here to

View your Transaction
COMPANY
SERVICES
QUICK LINKS
CONTACT US
Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

US Office Address:

GNH Pharmaceuticals USA LLC,
Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
TEL: +1 704 557 0412

Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.