Reviews Certolizumab Pegol


No reviews yet.

Cimzia Drug Description
CIMZIA
(certolizumab pegol) Lyophilzed Powder for Solution and Solution for Subcutaneous
Injection

WARNINGS
SERIOUS INFECTIONS
Patients treated with CIMZIA are at increased risk for developing serious
infections that may lead to hospitalization or death [see WARNINGS AND PRECAUTIONS
and ADVERSE REACTIONS]. Most patients who developed these infections were taking
concomitant immunosuppressants such as methotrexate or corticosteroids.
CIMZIA should be discontinued if a patient develops a serious infection
or sepsis.
Reported infections include:

Active tuberculosis, including reactivation of latent tuberculosis. Patients
with tuberculosis have frequently presented with disseminated or extrapulmonary
disease. Patients should be tested for latent tuberculosis before CIMZIA use
and during therapy. Treatment for latent infection should be initiated prior
to CIMZIA use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis,
candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with
histoplasmosis or other invasive fungal infections may present with disseminated,
rather than localized disease. Antigen and antibody testing for histoplasmosis
may be negative in some patients with active infection. Empiric anti-fungal
therapy should be considered in patients at risk for invasive fungal infections
who develop severe systemic illness.
Bacterial, viral and other infections due to opportunistic pathogens.


The risks and benefits of treatment with CIMZIA should be carefully considered
prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms
of infection during and after treatment with CIMZIA, including the possible
development of tuberculosis in patients who tested negative for latent tuberculosis
infection prior to initiating therapy. [see WARNINGS AND PRECAUTIONS and ADVERSE
REACTIONS].
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children
and adolescent patients treated with TNF blockers, of which CIMZIA is a member
[see WARNINGS AND PRECAUTIONS]. CIMZIA is not indicated for use in pediatric
patients.

DRUG DESCRIPTION



What are the possible side effects of certolizumab (Cimzia)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with certolizumab. Stop using certolizumab and call your doctor right away if you have signs of infection such as:

fever, sweating, chills, tired feeling;
feeling short of breath;
cough, sore throat; or
flu symptoms, weight...
Read All Potential Side Effects for Cimzia »




CIMZIA (certolizumab pegol) is a TNF blocker. CIMZIA is a recombinant, humanized
antibody Fab' fragment, with specificity for human tumor necrosis factor alpha
(TNFα), conjugated to an approximately 40kDa polyethylene glycol (PEG2MAL40K).
The Fab' fragment is manufactured in E. coli and is subsequently subjected
to purification and conjugation to PEG2MAL40K, to generate certolizumab pegol.
The Fab' fragment is composed of a light chain with 214 amino acids and a heavy
chain with 229 amino acids. The molecular weight of certolizumab pegol is approximately
91 kiloDaltons.
CIMZIA is supplied as either a sterile, white, lyophilized powder for solution
or as a sterile, solution in a single-use prefilled 1 mL glass syringe for subcutaneous
injection. After reconstitution of the lyophilized powder with 1 mL sterile
Water for Injection, USP, the resulting pH is approximately 5.2.
Each single-use vial provides approximately 200 mg certolizumab pegol, 100
mg sucrose, 0.9 mg lactic acid, and 0.1 mg polysorbate. Each prefilled syringe
delivers 1 mL (200 mg) of drug product with a pH of approximately 4.7. Each
1 mL syringe of CIMZIA contains 200 mg of certolizumab pegol, 1.36 mg of sodium
acetate, 7.31 mg sodium chloride, and Water for Injection, USP.
CIMZIA is a clear to opalescent solution that is colorless to pale yellow and
essentially free from particulates. No preservatives are present.
Last reviewed on RxList: 8/27/2010




Cimzia Drug Description
CIMZIA
(certolizumab pegol) Lyophilzed Powder for Solution and Solution for Subcutaneous
Injection

WARNINGS
SERIOUS INFECTIONS
Patients treated with CIMZIA are at increased risk for developing serious
infections that may lead to hospitalization or death [see WARNINGS AND PRECAUTIONS
and ADVERSE REACTIONS]. Most patients who developed these infections were taking
concomitant immunosuppressants such as methotrexate or corticosteroids.
CIMZIA should be discontinued if a patient develops a serious infection
or sepsis.
Reported infections include:

Active tuberculosis, including reactivation of latent tuberculosis. Patients
with tuberculosis have frequently presented with disseminated or extrapulmonary
disease. Patients should be tested for latent tuberculosis before CIMZIA use
and during therapy. Treatment for latent infection should be initiated prior
to CIMZIA use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis,
candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with
histoplasmosis or other invasive fungal infections may present with disseminated,
rather than localized disease. Antigen and antibody testing for histoplasmosis
may be negative in some patients with active infection. Empiric anti-fungal
therapy should be considered in patients at risk for invasive fungal infections
who develop severe systemic illness.
Bacterial, viral and other infections due to opportunistic pathogens.


The risks and benefits of treatment with CIMZIA should be carefully considered
prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms
of infection during and after treatment with CIMZIA, including the possible
development of tuberculosis in patients who tested negative for latent tuberculosis
infection prior to initiating therapy. [see WARNINGS AND PRECAUTIONS and ADVERSE
REACTIONS].
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children
and adolescent patients treated with TNF blockers, of which CIMZIA is a member
[see WARNINGS AND PRECAUTIONS]. CIMZIA is not indicated for use in pediatric
patients.

DRUG DESCRIPTION



What are the possible side effects of certolizumab (Cimzia)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with certolizumab. Stop using certolizumab and call your doctor right away if you have signs of infection such as:

fever, sweating, chills, tired feeling;
feeling short of breath;
cough, sore throat; or
flu symptoms, weight...
Read All Potential Side Effects for Cimzia »




CIMZIA (certolizumab pegol) is a TNF blocker. CIMZIA is a recombinant, humanized
antibody Fab' fragment, with specificity for human tumor necrosis factor alpha
(TNFα), conjugated to an approximately 40kDa polyethylene glycol (PEG2MAL40K).
The Fab' fragment is manufactured in E. coli and is subsequently subjected
to purification and conjugation to PEG2MAL40K, to generate certolizumab pegol.
The Fab' fragment is composed of a light chain with 214 amino acids and a heavy
chain with 229 amino acids. The molecular weight of certolizumab pegol is approximately
91 kiloDaltons.
CIMZIA is supplied as either a sterile, white, lyophilized powder for solution
or as a sterile, solution in a single-use prefilled 1 mL glass syringe for subcutaneous
injection. After reconstitution of the lyophilized powder with 1 mL sterile
Water for Injection, USP, the resulting pH is approximately 5.2.
Each single-use vial provides approximately 200 mg certolizumab pegol, 100
mg sucrose, 0.9 mg lactic acid, and 0.1 mg polysorbate. Each prefilled syringe
delivers 1 mL (200 mg) of drug product with a pH of approximately 4.7. Each
1 mL syringe of CIMZIA contains 200 mg of certolizumab pegol, 1.36 mg of sodium
acetate, 7.31 mg sodium chloride, and Water for Injection, USP.
CIMZIA is a clear to opalescent solution that is colorless to pale yellow and
essentially free from particulates. No preservatives are present.
Last reviewed on RxList: 8/27/2010




Cimzia Drug Description
CIMZIA
(certolizumab pegol) Lyophilzed Powder for Solution and Solution for Subcutaneous
Injection

WARNINGS
SERIOUS INFECTIONS
Patients treated with CIMZIA are at increased risk for developing serious
infections that may lead to hospitalization or death [see WARNINGS AND PRECAUTIONS
and ADVERSE REACTIONS]. Most patients who developed these infections were taking
concomitant immunosuppressants such as methotrexate or corticosteroids.
CIMZIA should be discontinued if a patient develops a serious infection
or sepsis.
Reported infections include:

Active tuberculosis, including reactivation of latent tuberculosis. Patients
with tuberculosis have frequently presented with disseminated or extrapulmonary
disease. Patients should be tested for latent tuberculosis before CIMZIA use
and during therapy. Treatment for latent infection should be initiated prior
to CIMZIA use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis,
candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with
histoplasmosis or other invasive fungal infections may present with disseminated,
rather than localized disease. Antigen and antibody testing for histoplasmosis
may be negative in some patients with active infection. Empiric anti-fungal
therapy should be considered in patients at risk for invasive fungal infections
who develop severe systemic illness.
Bacterial, viral and other infections due to opportunistic pathogens.


The risks and benefits of treatment with CIMZIA should be carefully considered
prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms
of infection during and after treatment with CIMZIA, including the possible
development of tuberculosis in patients who tested negative for latent tuberculosis
infection prior to initiating therapy. [see WARNINGS AND PRECAUTIONS and ADVERSE
REACTIONS].
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children
and adolescent patients treated with TNF blockers, of which CIMZIA is a member
[see WARNINGS AND PRECAUTIONS]. CIMZIA is not indicated for use in pediatric
patients.

DRUG DESCRIPTION



What are the possible side effects of certolizumab (Cimzia)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with certolizumab. Stop using certolizumab and call your doctor right away if you have signs of infection such as:

fever, sweating, chills, tired feeling;
feeling short of breath;
cough, sore throat; or
flu symptoms, weight...
Read All Potential Side Effects for Cimzia »




CIMZIA (certolizumab pegol) is a TNF blocker. CIMZIA is a recombinant, humanized
antibody Fab' fragment, with specificity for human tumor necrosis factor alpha
(TNFα), conjugated to an approximately 40kDa polyethylene glycol (PEG2MAL40K).
The Fab' fragment is manufactured in E. coli and is subsequently subjected
to purification and conjugation to PEG2MAL40K, to generate certolizumab pegol.
The Fab' fragment is composed of a light chain with 214 amino acids and a heavy
chain with 229 amino acids. The molecular weight of certolizumab pegol is approximately
91 kiloDaltons.
CIMZIA is supplied as either a sterile, white, lyophilized powder for solution
or as a sterile, solution in a single-use prefilled 1 mL glass syringe for subcutaneous
injection. After reconstitution of the lyophilized powder with 1 mL sterile
Water for Injection, USP, the resulting pH is approximately 5.2.
Each single-use vial provides approximately 200 mg certolizumab pegol, 100
mg sucrose, 0.9 mg lactic acid, and 0.1 mg polysorbate. Each prefilled syringe
delivers 1 mL (200 mg) of drug product with a pH of approximately 4.7. Each
1 mL syringe of CIMZIA contains 200 mg of certolizumab pegol, 1.36 mg of sodium
acetate, 7.31 mg sodium chloride, and Water for Injection, USP.
CIMZIA is a clear to opalescent solution that is colorless to pale yellow and
essentially free from particulates. No preservatives are present.
Last reviewed on RxList: 8/27/2010




Cimzia Drug Description
CIMZIA
(certolizumab pegol) Lyophilzed Powder for Solution and Solution for Subcutaneous
Injection

WARNINGS
SERIOUS INFECTIONS
Patients treated with CIMZIA are at increased risk for developing serious
infections that may lead to hospitalization or death [see WARNINGS AND PRECAUTIONS
and ADVERSE REACTIONS]. Most patients who developed these infections were taking
concomitant immunosuppressants such as methotrexate or corticosteroids.
CIMZIA should be discontinued if a patient develops a serious infection
or sepsis.
Reported infections include:

Active tuberculosis, including reactivation of latent tuberculosis. Patients
with tuberculosis have frequently presented with disseminated or extrapulmonary
disease. Patients should be tested for latent tuberculosis before CIMZIA use
and during therapy. Treatment for latent infection should be initiated prior
to CIMZIA use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis,
candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with
histoplasmosis or other invasive fungal infections may present with disseminated,
rather than localized disease. Antigen and antibody testing for histoplasmosis
may be negative in some patients with active infection. Empiric anti-fungal
therapy should be considered in patients at risk for invasive fungal infections
who develop severe systemic illness.
Bacterial, viral and other infections due to opportunistic pathogens.


The risks and benefits of treatment with CIMZIA should be carefully considered
prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms
of infection during and after treatment with CIMZIA, including the possible
development of tuberculosis in patients who tested negative for latent tuberculosis
infection prior to initiating therapy. [see WARNINGS AND PRECAUTIONS and ADVERSE
REACTIONS].
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children
and adolescent patients treated with TNF blockers, of which CIMZIA is a member
[see WARNINGS AND PRECAUTIONS]. CIMZIA is not indicated for use in pediatric
patients.

DRUG DESCRIPTION



What are the possible side effects of certolizumab (Cimzia)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with certolizumab. Stop using certolizumab and call your doctor right away if you have signs of infection such as:

fever, sweating, chills, tired feeling;
feeling short of breath;
cough, sore throat; or
flu symptoms, weight...
Read All Potential Side Effects for Cimzia »




CIMZIA (certolizumab pegol) is a TNF blocker. CIMZIA is a recombinant, humanized
antibody Fab' fragment, with specificity for human tumor necrosis factor alpha
(TNFα), conjugated to an approximately 40kDa polyethylene glycol (PEG2MAL40K).
The Fab' fragment is manufactured in E. coli and is subsequently subjected
to purification and conjugation to PEG2MAL40K, to generate certolizumab pegol.
The Fab' fragment is composed of a light chain with 214 amino acids and a heavy
chain with 229 amino acids. The molecular weight of certolizumab pegol is approximately
91 kiloDaltons.
CIMZIA is supplied as either a sterile, white, lyophilized powder for solution
or as a sterile, solution in a single-use prefilled 1 mL glass syringe for subcutaneous
injection. After reconstitution of the lyophilized powder with 1 mL sterile
Water for Injection, USP, the resulting pH is approximately 5.2.
Each single-use vial provides approximately 200 mg certolizumab pegol, 100
mg sucrose, 0.9 mg lactic acid, and 0.1 mg polysorbate. Each prefilled syringe
delivers 1 mL (200 mg) of drug product with a pH of approximately 4.7. Each
1 mL syringe of CIMZIA contains 200 mg of certolizumab pegol, 1.36 mg of sodium
acetate, 7.31 mg sodium chloride, and Water for Injection, USP.
CIMZIA is a clear to opalescent solution that is colorless to pale yellow and
essentially free from particulates. No preservatives are present.
Last reviewed on RxList: 8/27/2010




Cimzia Drug Description
CIMZIA
(certolizumab pegol) Lyophilzed Powder for Solution and Solution for Subcutaneous
Injection

WARNINGS
SERIOUS INFECTIONS
Patients treated with CIMZIA are at increased risk for developing serious
infections that may lead to hospitalization or death [see WARNINGS AND PRECAUTIONS
and ADVERSE REACTIONS]. Most patients who developed these infections were taking
concomitant immunosuppressants such as methotrexate or corticosteroids.
CIMZIA should be discontinued if a patient develops a serious infection
or sepsis.
Reported infections include:

Active tuberculosis, including reactivation of latent tuberculosis. Patients
with tuberculosis have frequently presented with disseminated or extrapulmonary
disease. Patients should be tested for latent tuberculosis before CIMZIA use
and during therapy. Treatment for latent infection should be initiated prior
to CIMZIA use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis,
candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with
histoplasmosis or other invasive fungal infections may present with disseminated,
rather than localized disease. Antigen and antibody testing for histoplasmosis
may be negative in some patients with active infection. Empiric anti-fungal
therapy should be considered in patients at risk for invasive fungal infections
who develop severe systemic illness.
Bacterial, viral and other infections due to opportunistic pathogens.


The risks and benefits of treatment with CIMZIA should be carefully considered
prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms
of infection during and after treatment with CIMZIA, including the possible
development of tuberculosis in patients who tested negative for latent tuberculosis
infection prior to initiating therapy. [see WARNINGS AND PRECAUTIONS and ADVERSE
REACTIONS].
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children
and adolescent patients treated with TNF blockers, of which CIMZIA is a member
[see WARNINGS AND PRECAUTIONS]. CIMZIA is not indicated for use in pediatric
patients.

DRUG DESCRIPTION



What are the possible side effects of certolizumab (Cimzia)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with certolizumab. Stop using certolizumab and call your doctor right away if you have signs of infection such as:

fever, sweating, chills, tired feeling;
feeling short of breath;
cough, sore throat; or
flu symptoms, weight...
Read All Potential Side Effects for Cimzia »




CIMZIA (certolizumab pegol) is a TNF blocker. CIMZIA is a recombinant, humanized
antibody Fab' fragment, with specificity for human tumor necrosis factor alpha
(TNFα), conjugated to an approximately 40kDa polyethylene glycol (PEG2MAL40K).
The Fab' fragment is manufactured in E. coli and is subsequently subjected
to purification and conjugation to PEG2MAL40K, to generate certolizumab pegol.
The Fab' fragment is composed of a light chain with 214 amino acids and a heavy
chain with 229 amino acids. The molecular weight of certolizumab pegol is approximately
91 kiloDaltons.
CIMZIA is supplied as either a sterile, white, lyophilized powder for solution
or as a sterile, solution in a single-use prefilled 1 mL glass syringe for subcutaneous
injection. After reconstitution of the lyophilized powder with 1 mL sterile
Water for Injection, USP, the resulting pH is approximately 5.2.
Each single-use vial provides approximately 200 mg certolizumab pegol, 100
mg sucrose, 0.9 mg lactic acid, and 0.1 mg polysorbate. Each prefilled syringe
delivers 1 mL (200 mg) of drug product with a pH of approximately 4.7. Each
1 mL syringe of CIMZIA contains 200 mg of certolizumab pegol, 1.36 mg of sodium
acetate, 7.31 mg sodium chloride, and Water for Injection, USP.
CIMZIA is a clear to opalescent solution that is colorless to pale yellow and
essentially free from particulates. No preservatives are present.
Last reviewed on RxList: 8/27/2010





Other reviews about Certolizumab Pegol on wordpress

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  by rsdscrpsnews
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CIMZIATM (Certolizumab Pegol) Maintained Response And Remission In Crohn's Patients Previously Treated With Infliximab
  by rognar
New data from a post hoc analysis of the PRECiSE clinical trial program demonstrated that the anti-TNF CIMZIATM (certolizumab pegol) maintained response and remission in patients with moderate […]


Significant Phase III Results with CIMZIA (TM) In RA-Radiographic Data Demonstrated Significant Reduction in Joint Damage
  by Moderator
Medical News Today-UCB today announced key results of a pivotal Phase III study (RAPID 1) involving nearly 1,000 patients on CIMZIA(TM) (certolizumab pegol), the first PEGylated, Fc-free anti-TNF, […]


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CIMZIATM (Certolizumab Pegol) Maintained Response And Remission In Crohn's Patients Previously Treated With Infliximab
  by rognar
New data from a post hoc analysis of the PRECiSE clinical trial program demonstrated that the anti-TNF CIMZIATM (certolizumab pegol) maintained response and remission in patients with moderate […]


UCB's Cimzia Approved for Crohn's Disease
  by heremias
The FDA approved Cimzia® (certolizumab pegol) for treatment of Crohn's disease, a chronic inflammatory disease of the digestive tract on April 22, 2008. Cimzia® […]


CIMZIA(R) (certolizumab pegol) Approved for Moderate to Severe Rheumatoid Arthritis
  by diplomatsp
Diplomat Specialty Pharmacy dispenses Cimzia - call us at 1.866.311.9966 for answers to your questions regarding accessing a prescription, prior authorization issues, and co-pay assistance. *Features* * Diplomat initiates and manages the […]


Another biologic makes the grade - but will NASTY sanction it?
  by pollyannapenguin
Cimzia (certolizumab pegol), a biologic produced by UCB and administered by injection under the skin, has got the OK from the European Commission for use in rheumatoid arthritis. […]


NICE reconsiders certolizumab pegol for rheumatoid arthritis
  by rcplondon
Final draft guidance published today by NICE will enable another therapy to be considered for some people in England, Wales and NI suffering with rheumatoid arthritis. In the […]


Rheumatoid Arthritis - final NICE guidance on use of certolizumab pegol
  by rcplondon
Final guidance published today by NICE means that another drug -certolizumab pegol (Cimzia) - can be considered for some people in England and Wales suffering with RA. NICE‟s […]



Other reviews about Certolizumab Pegol on web:

Certolizumab pegol (CDP870, tradename Cimzia) is a therapeutic monoclonal antibody produced by UCB for the treatment of Crohn's disease and rheumatoid arthritis. Certolizumab pegol - Wikipedia, the free encyclopedia


Learn about the prescription medication Cimzia (Certolizumab Pegol), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Cimzia (Certolizumab Pegol) Drug Information: Uses, Side Effects ...


Certolizumab Pegol professional patient advice. Specific and up to date information about Certolizumab Pegol. Complete Certolizumab Pegol information from Drugs.com


Mayo Clinic offers award-winning medical and health information and tools for healthy living. Certolizumab Pegol (Subcutaneous Route) - MayoClinic.com


Policy. Aetna considers certolizumab pegol (Cimzia®) medically necessary for adult members 18 years of age or older with moderately-to-severely active Crohn's disease as ... Certolizumab Pegol (Cimzia)


1. N Engl J Med. 2007 Jul 19;357(3):228-38. Certolizumab pegol for the treatment of Crohn's disease. Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, Mason D ... Certolizumab pegol for the treatment of Crohn's disease.


Home \ Reuters \ Certolizumab pegol appears effective for Crohn's disease Certolizumab pegol appears effective for Crohn's disease. Last Updated: July 18, 2007 CCFA.org: Certolizumab pegol appears effective for Crohn's disease


Certolizumab pegol - in the Clinical Immunology Society WEBbook of Biologic Therapies, a compendium of interventional biological therapies Certolizumab pegol - WEBbook of Biologic Therapies


BlueCross BlueShield of Tennessee Medical Policy Manual Certolizumab Pegol. DESCRIPTION. Certolizumab pegol, a tumor necrosis factor (TNF) inhibitor, binds and selectively ... Certolizumab Pegol


Follow Certolizumab pegol at Evri.com, your source for real time news, quotes, tweets, trends, photos and videos Certolizumab pegol - News - Evri





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