Mallinckrodt Hemostat SolutionsMallinckrodt Hemostat Solutions

Mallinckrodt Hemostat Solutions

Mallinckrodt Hemostat Solutions

Providing products to address a range of surgical bleeding challenges.

Indications and Usage

RAPLIXA® (Fibrin sealant (human)) for topical use is a fibrin sealant indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. RAPLIXA is used in conjunction with an absorbable gelatin sponge (USP) and may be applied directly or using the RaplixaSprayTM device.

Important Risk Information

Contraindications

  • Do not apply intravascularly.
  • Do not use for the treatment of severe or brisk arterial bleeding.
  • Do not use in patients known to have anaphylactic or severe systemic reactions to human blood products.

Warnings and Precautions

  • For topical use only.
  • Life-threatening thromboembolic events may result from intravascular application of RAPLIXA.
  • Air or gas embolism has occurred with the use of spray devices employing pressure regulators to administer fibrin sealants.
  • Because the biological components of this product are made of human plasma, RAPLIXA may carry a risk of transmitting infectious agents, such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite manufacturing steps designed to reduce the risk of infectious agent transmission.
  • Allergic type hypersensitivity reactions may occur. Signs of hypersensitivity reactions may include hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.

Adverse Reactions

  • The most commonly reported adverse reactions (>5% subjects) were procedural pain, nausea, constipation, pyrexia, and hypotension.

Use In Specific Populations

  • Pregnancy: Animal reproduction studies have not been conducted with RAPLIXA. It is also not known whether RAPLIXA can cause fetal harm when administered to pregnant women or can affect reproductive capacity. RAPLIXA should be given to a pregnant woman only if clearly needed.
  • Breastfeeding: It is not known whether RAPLIXA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when administering to a nursing woman.
  • Pediatric Use: Safety and effectiveness of RAPLIXA in pediatric patients has not been established.
  • Geriatric Use: Clinical trials included 207/566 subjects of 65 years of age or older who were treated with RAPLIXA. No differences in safety and efficacy were observed between elderly and younger patients.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the Full Prescribing Information here.

RaplixaSpray device

Intended Use

RaplixaSpray™ device is intended for the topical application of the hemostatic agent RAPLIXA via spraying with propellant gas to control delivery of powder onto the wound surface. The accessory, the flexible nozzle, is intended to enable the RaplixaSpray device to be used in difficult to reach areas.

Important Risk Information

Contraindications

  • Do not administer RAPLIXA intravascularly.
  • Do not use for the treatment of severe or brisk arterial bleeding.

WARNINGS

  • Only use the RaplixaSpray device with the RAPLIXA powder.
  • Only use the RaplixaSpray device with a RaplixaReg CO2 regulator.
  • Only use RaplixaSpray accessories. The use of accessories of other manufacturers is not permitted.
  • A RaplixaSpray device can be used with at most two vials. To administer a third vial, a new device must be opened. The maximum total dose per patient is 3 grams.
  • The RaplixaSpray device and accessory must be used within 1 hour of opening the device package.
  • RAPLIXA powder must be used within 1 hour of opening the vial.
  • Air or gas embolism can occur using air- or gas-pressurized sprayers to administer fibrin sealants. Operate the device according to the manufacturer’s instructions. Be sure to take appropriate measures to exclude these risks, by control of maximum pressure of 1.5 bar (22 psi) and at a minimum distance of 5 cm (2 inches). Do not touch the tip against the bleeding site. Do not bend the flexible nozzle more than 90 degrees.
  • Ensure the vial is kept within 45° of vertical at all times.
  • Do not cut the nozzle to length.
  • Be careful not to push the RaplixaSpray device operating button when handing the device to the surgeon.
  • Do not re-use the device. The RAPLIXA powder contains human blood-derived materials and might remain in the device after use. To prevent contamination the device or its accessory must not be reused.
  • Caution: There is the potential for powder loss from the nozzle tip during or after usage. Minor leakage/drop of powder from the nozzle tip can occur when transferring the device back to the table. After the blue button is released and application of RAPLIXA powder is stopped some minor powder is still present in the nozzle. A single occurrence of powder leakage during transfer of device after use during Phase 3 clinical trial was noticed. The hazard is trivial and the user may not even be aware of it.

Please see complete Instructions for Use here.

Indications and Usage

RECOTHROM® Thrombin topical (Recombinant) is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP.

Important Risk Information

Contraindications

  • Do not inject directly into the circulatory system.
  • Do not use for the treatment of massive or brisk arterial bleeding.
  • Do not administer to patients with a history of hypersensitivity to RECOTHROM or any components of RECOTHROM.
  • Do not use in patients with known hypersensitivity to hamster proteins.

Warnings and Precautions

  • For topical use only. DO NOT INJECT.
  • RECOTHROM may cause thrombosis if it enters the circulatory system.
  • Hypersensitivity reactions, including anaphylaxis, may occur. RECOTHROM is produced in a genetically modified Chinese Hamster Ovary (CHO) cell line and may contain hamster or snake proteins.

Adverse Reactions

  • Thromboembolic adverse reactions were reported in 6% of surgical patients treated with RECOTHROM in all completed clinical trials.
  • Antibody formation to RECOTHROM occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin.

Use In Specific Populations

  • Pregnancy Category C. RECOTHROM should be given to a pregnant woman only if clearly needed.
  • Pediatric Use: Safety and efficacy have not been established in neonates.
  • Geriatric Use: Of 644 patients in clinical studies of RECOTHROM, 36% (n=232/644) were ≥65 years old and 15% (n=95/644) were ≥75 years old. No differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the Full Prescribing Information here.

Indications

PREVELEAK® Surgical sealant is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

Important Risk Information

Contraindications

  • Not for use in patients with known allergies to materials of bovine or shellfish origin.
  • Not for intravascular use.
  • Not for cerebrovascular repair or cerebrospinal leak repair.

Warnings and Precautions

  • Do not use as a substitute for sutures or staples.
  • Avoid exposure to nerves.
  • Do not use in the presence of obvious infection and use with caution in contaminated areas of the body.
  • Do not allow either the uncured or polymerized form to contact circulating blood.
  • PREVELEAK contains a material of animal origin that may be capable of transmitting infectious agents.
  • Repeated use of PREVELEAK in subsequent surgeries has not been studied.
  • Hypersensitivity reactions were not seen using PREVELEAK, but hypersensitivity of BSA has been reported.
  • Avoid contact with skin or other tissue not intended for application.
  • Safety and effectiveness of PREVELEAK in minimally invasive procedures or coronary artery bypass grafting (CABG) have not been established.
  • Do not use blood saving devices when suctioning excess PREVELEAK from the surgical field.
  • PREVELEAK syringe and delivery tips are for single patient use only. Do not resterilize.
  • Do not use if packages have been opened or damaged.
  • Take care not to spill contents of syringe. Avoid tissue contact with material expelled from delivery tip during priming.
  • Avoid pausing more than 10-15 seconds between priming and application to prevent polymerization within the delivery tip.
  • Minimize use in patients with abnormal calcium metabolism (e.g. chronic renal failure, hyperparathyroidism). Polyaldehyde treated tissue can have an enhanced propensity for mineralization.
  • Evidence of cytotoxicity was observed during cell culture-based laboratory assays and is believed to be due to the polyaldehyde component of the product. No evidence of cytotoxicity was observed in animal or clinical studies.

Adverse Reactions

  • Potential adverse effects associated with the use of this class of surgical sealants include application of the sealant to tissue not targeted for the procedure, failure of the sealant to adhere to the tissue, hypersensitivity reaction such as swelling or edema at the application site, possible transmission of infectious agents from materials of animal origin, thrombosis and thromboembolism.
  • Serious adverse events that occurred in clinical studies included death, hypotension, thrombosis/thromboembolism, ischemia, respiratory failure/dysfunction, steal syndrome, and myocardial infarction.

Use In Specific Populations

  • Use of PREVELEAK in pediatric or pregnant patients has not been studied.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the complete Instructions for Use here.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.