Disclaimer:

Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.

Coagadex

×

Overview

What is Coagadex?

COAGADEX is a plasma-derived, sterile, purified concentrate of human coagulation Factor X that contains sucrose as a stabilizer. It is formulated as a lyophilized powder for solution for intravenous administration. When reconstituted with Sterile Water for Injection, COAGADEX contains nominally (approximately) 100 IU/mL of coagulation Factor X and the following inactive ingredients: chloride, phosphate, citrate, sucrose and sodium. Each vial of COAGADEX is labeled with the actual Factor X activity/content expressed in IU per vial. Factor X activity in IU is determined using an chromogenic assay and a Factor X concentrate reference standard calibrated against the WHO 3 International Standard for Blood Coagulation Factors II and X, Concentrate.

COAGADEX contains no added biological components such as heparin, albumin or anti-thrombin. The content of Factor II and Factor IX are ≤ 1 IU/mL of the reconstituted product. Factor Xa and Factor IIa were not detectable by Non-activated Partial Thromboplastin Time (NaPTT) or Fibrinogen Clotting Time (FCT) tests for potential thrombogenicity, and comprised < 10 parts per million by weight when tested by more sensitive analytical methods. The specific activity of COAGADEX is typically 80-137 IU per mg protein. The product contains no preservatives.

COAGADEX is manufactured from plasma, obtained from healthy US donors, who have passed viral screening tests. All donors are subjected to medical examinations, laboratory tests, and a review of their medical history before being allowed to donate blood or plasma.

All plasma donations are screened for antibody to human immunodeficiency virus (HIV)-1/2, hepatitis C virus (HCV), and hepatitis B surface antigen (HBsAg). Additional testing of donations is carried out in plasma mini-pools (512 donations per pool) with nucleic acid amplification testing (NAT) for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis A virus (HAV) and human parvovirus B19. Furthermore, each manufacturing pool is tested to be negative for HBsAg and anti-HIV-1/2 antibodies. Also, manufacturing pools are non-reactive by nucleic acid test for HAV, HBV, HCV, and HIV-1. The limit for human parvovirus B19 in the manufacturing pools is set not to exceed 10 IU/mL.

Three processing steps specifically designed to remove or inactivate viruses are:

The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled-down process model. Overall virus reduction was calculated only from steps that were mechanistically independent from each other. Table 2 presents the contribution of each process step to virus reduction and the overall process reduction.



What does Coagadex look like?



What are the available doses of Coagadex?

COAGADEX is available as a lyophilized powder for reconstitution in single-use vials containing nominally (approximately) 250 IU or 500 IU of Factor X activity. When reconstituted using the Sterile Water for Injection supplied with the kit, the final concentration is approximately 100 IU/mL ().

What should I talk to my health care provider before I take Coagadex?

How should I use Coagadex?

COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation Factor indicated in adults and children (aged 12 years and above) with hereditary Factor X deficiency for:

For intravenous use after reconstitution only.


What interacts with Coagadex?

Sorry No Records found


What are the warnings of Coagadex?

Sorry No Records found


What are the precautions of Coagadex?

Sorry No Records found


What are the side effects of Coagadex?

Sorry No records found


What should I look out for while using Coagadex?

COAGADEX is contraindicated in patients who have had life-threatening hypersensitivity reactions to COAGADEX or any of the components [].


What might happen if I take too much Coagadex?

One case of accidental overdosage was reported in the clinical trials, in which a subject received approximately 80 IU/kg Factor X to treat a bleed. No adverse events were reported relating to this overdose.


How should I store and handle Coagadex?

Storage and Handling CLOBEX Shampoo, 0.05%, is a translucent, colorless to pale yellow viscous liquid, supplied in 4 fl. oz. (118 mL) bottles.NDCStorage:CLOBEX Shampoo, 0.05%, is a translucent, colorless to pale yellow viscous liquid, supplied in 4 fl. oz. (118 mL) bottles.NDCStorage:CLOBEX Shampoo, 0.05%, is a translucent, colorless to pale yellow viscous liquid, supplied in 4 fl. oz. (118 mL) bottles.NDCStorage:


×

Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

COAGADEX temporarily replaces the missing Factor X needed for effective hemostasis. Factor X is an inactive zymogen, which can be activated by Factor IXa (via the intrinsic pathway) or by Factor VIIa (via the extrinsic pathway). Factor X is converted from its inactive form to the active form (Factor Xa) by the cleavage of a 52-residue peptide from the heavy chain. Factor Xa associates with Factor Va on a phospholipid surface to form the prothrombinase complex, which activates prothrombin to thrombin in the presence of calcium ions. Thrombin then acts upon soluble fibrinogen and Factor XIII to generate a cross-linked fibrin clot.

Non-Clinical Toxicology
COAGADEX is contraindicated in patients who have had life-threatening hypersensitivity reactions to COAGADEX or any of the components [].

Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibacterial drugs or potent diuretics such as furosemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials.

Chloramphenicol has been shown to be antagonistic to beta-lactam antibacterial drugs, including ceftazidime, based on in vitro studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism in vivo, particularly when bactericidal activity is desired, this drug combination should be avoided.

In common with other antibacterial drugs, ceftazidime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

Allergic type hypersensitivity reactions, including anaphylaxis, are possible. Early signs of hypersensitivity reactions including angioedema, infusion site inflammation (e.g. burning, stinging, erythema), chills, cough, dizziness, fever, flushing, generalized urticaria, headache, hives, hypotension, lethargy, musculoskeletal pains, nausea, pruritus, rash, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing. If hypersensitivity symptoms occur, discontinue use of the product immediately and administer appropriate emergency treatment.

COAGADEX contains traces of human proteins other than Factor X.

The most common adverse drug reactions (frequency ≥ 5% of subjects) observed in clinical trials were infusion site erythema, infusion site pain, fatigue, and back pain.

×

Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

×

Review

Rate this treatment and share your opinion


Learn about User Reviews

Helpful tips to write a good review:

  1. Only share your first hand experience as a consumer or a care giver.
  2. Describe your experience in the Comments area including the benefits, side effects and how it has worked for you. Do not provide personal information like email addresses or telephone numbers.
  3. Fill in the optional information to help other users benefit from your review.

Reason for Taking This Treatment

(required)

Click the stars to rate this treatment

Effectiveness (required)

This medication has worked for me.




Ease of Use (required)

This medication has been easy for me to use.




Satisfaction (required)

Overall, I have been satisfied with my experience.




Write a brief description of your experience with this treatment:

2000 characters remaining

Optional Information

Help others benefit from your review by filling in the information below.
I am a:
Gender:
×

Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
×

Tips

Tips

×

Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).