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c1 esterase inhibitor recombinant
Overview
What is Ruconest?
RUCONEST is a recombinant analogue of human complement component 1 esterase inhibitor for intravenous injection. RUCONEST is purified from the milk of transgenic rabbits, and supplied as a sterile, preservative-free, white/off-white lyophilized powder for reconstitution for injection. One U of rhC1INH activity is defined as the equivalent of C1 esterase inhibiting activity present in 1 mL of pooled normal plasma.
RUCONEST is a soluble, single-chain glycoprotein containing 478 amino acids, with a molecular mass of 68 kDa, of which approximately 22% comprises oligosaccharide structures. The primary and secondary structures of the molecule and target protease selectivity are consistent with those of plasma-derived C1 esterase inhibitor.
Each vial of RUCONEST contains 2100 U of rhC1INH, 937 mg of sucrose, 83.3 mg of sodium citrate dihydrate and 1.0 mg of citric acid monohydrate. After reconstitution with 14 mL of sterile Water for Injection, each vial of RUCONEST contains 150 U of rhC1INH per 1 mL in a 20 mM sodium citrate buffer with a pH of 6.8. RUCONEST does not contain preservatives and each vial is for single use only.
RUCONEST is purified from the milk of transgenic rabbits. The rabbits are maintained in a closed colony that is controlled and routinely monitored for specific pathogens. The skimmed milk is screened for adventitious contaminants prior to further manufacture. The manufacturing process has been validated to demonstrate adequate capacity for removal and/or inactivation of viruses (
). RUCONEST contains less than 0.002% of host-related impurities.
What does Ruconest look like?
What are the available doses of Ruconest?
2100 U Lyophilized powder for reconstitution for injection in a single-use vial. (
)
What should I talk to my health care provider before I take Ruconest?
Pregnancy: Limited animal data. No human data. Use only if clearly needed. (
)
How should I use Ruconest?
RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks.
For intravenous use after reconstitution only.
What interacts with Ruconest?
Sorry No Records found
What are the warnings of Ruconest?
Sorry No Records found
What are the precautions of Ruconest?
Sorry No Records found
What are the side effects of Ruconest?
Sorry No records found
What should I look out for while using Ruconest?
Known or suspected allergy to rabbits and rabbit-derived products. (
)
History of immediate hypersensitivity reactions, including anaphylaxis, to C1 esterase inhibitor preparations. (
)
Drug Interactions
Array
WARNINGS
What might happen if I take too much Ruconest?
Sorry No Records found
How should I store and handle Ruconest?
The RadioGenixTM System is a Technetium Tc-99m Generator supplied and installed by NorthStar Medical Radioisotopes. It produces Sodium Pertechnetate Tc-99m injection from a non-uranium potassium molybdate Mo-99 source solution. The potassium molybdate Mo-99 source solution is shielded within a source container which completely encases a vial that contains 29mL of solution. NorthStar supplies potassium molybdate Mo-99 solution with the referenced calibration date and time specified on the container label, Table 12:The following kits, Tables 13- 17, are used in the operation of the RadioGenixTM System as described in the RadioGenix™ System Operator Guide, 94S05058.*Discarded Material, Type A Kit is designed to be used to ship the dicarded material container back to NorthStar for disposal. Both Discarded Material Kits contain the same components. The RadioGenixTM System is a Technetium Tc-99m Generator supplied and installed by NorthStar Medical Radioisotopes. It produces Sodium Pertechnetate Tc-99m injection from a non-uranium potassium molybdate Mo-99 source solution. The potassium molybdate Mo-99 source solution is shielded within a source container which completely encases a vial that contains 29mL of solution. NorthStar supplies potassium molybdate Mo-99 solution with the referenced calibration date and time specified on the container label, Table 12:The following kits, Tables 13- 17, are used in the operation of the RadioGenixTM System as described in the RadioGenix™ System Operator Guide, 94S05058.*Discarded Material, Type A Kit is designed to be used to ship the dicarded material container back to NorthStar for disposal. Both Discarded Material Kits contain the same components. The RadioGenixTM System is a Technetium Tc-99m Generator supplied and installed by NorthStar Medical Radioisotopes. It produces Sodium Pertechnetate Tc-99m injection from a non-uranium potassium molybdate Mo-99 source solution. The potassium molybdate Mo-99 source solution is shielded within a source container which completely encases a vial that contains 29mL of solution. NorthStar supplies potassium molybdate Mo-99 solution with the referenced calibration date and time specified on the container label, Table 12:The following kits, Tables 13- 17, are used in the operation of the RadioGenixTM System as described in the RadioGenix™ System Operator Guide, 94S05058.*Discarded Material, Type A Kit is designed to be used to ship the dicarded material container back to NorthStar for disposal. Both Discarded Material Kits contain the same components.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
C1 esterase inhibitor (C1INH) is a normal constituent of human blood and is one of the serine protease inhibitors (serpins). The primary function of C1INH is to regulate the activation of the complement and contact system pathways. Regulation of these systems is performed through the formation of complexes between the protease and the inhibitor, resulting in inactivation of both and consumption of the C1INH.
C1INH exerts its inhibitory effect by irreversibly binding several proteases (target proteases) of the contact and complement systems. The effect of RUCONEST on the following target proteases was assessed
: activated C1s, kallikrein, factor XIIa and factor XIa. Inhibition kinetics were found to be comparable with those observed for plasma-derived human C1INH.
HAE patients have low levels of endogenous or functional C1INH. Although the events that induce attacks of angioedema in HAE patients are not well defined, it is thought that contact system activation, and resulting increased vascular permeability lead to the clinical manifestation of HAE attacks. Suppression of contact system activation by C1INH through the inactivation of plasma kallikrein and factor XIIa is thought to modulate vascular permeability by preventing the generation of bradykinin.
Administration of RUCONEST increases plasma levels of functional C1INH activity.
Non-Clinical Toxicology
Known or suspected allergy to rabbits and rabbit-derived products. ( )History of immediate hypersensitivity reactions, including anaphylaxis, to C1 esterase inhibitor preparations. ( )
Array
Severe hypersensitivity reactions may occur The signs and symptoms of hypersensitivity reactions may include hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and/or anaphylaxis during or after injection of RUCONEST. Should symptoms occur, discontinue RUCONEST and institute appropriate treatment. Because hypersensitivity reactions may have symptoms similar to HAE attacks, treatment methods should be carefully considered.
The serious adverse reaction in clinical studies of RUCONEST was anaphylaxis.
The most common adverse reactions (≥ 2%) reported in all clinical trials were headache, nausea, and diarrhea.
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.
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