CATHFLO PACKAGE INSERT PDF

Cathflo Activase should not be administered to patients with known hypersensitivity to alteplase or any component of the formulation. Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase e. These types of conditions should be considered before treatment with Cathflo Activase. Excessive pressure should be avoided when Cathflo Activase is instilled into the catheter. Such force could cause rupture of the catheter or expulsion of the clot into the circulation. The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding.

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Slight foaming is not unusual; let the vial stand undisturbed to allow large bubbles to dissipate. Complete dissolution should occur within 3 minutes. The reconstituted preparation results in a colorless to pale yellow transparent solution at a pH of approximately 7.

If catheter function is not restored at minutes after 1 dose of Cathflo, a second dose may be instilled see Instructions for Administration. There is no efficacy or safety information on dosing in excess of 2 mg per dose for this indication. Studies have only evaluated up to two 2-mg doses. Cathflo should be reconstituted immediately before use.

The INS Infusion Therapy Standards of Practice state that the instillation of alteplase 2 mg Cathflo Activase is safe and effective in restoring catheter patency in patients. Cathflo Activase should not be administered to patients with known hypersensitivity to alteplase or any component of the formulation. Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase e.

These types of conditions should be considered before treatment with Cathflo Activase. Excessive pressure should be avoided when Cathflo Activase is instilled into the catheter. Such force could cause rupture of the catheter or expulsion of the clot into the circulation.

The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding. Cathflo Activase has not been studied in patients known to be at risk for bleeding events that may be associated with the use of thrombolytics. Caution should be exercised with patients who have any condition for which bleeding constitutes a significant hazard. Should serious bleeding in a critical location e. Cathflo Activase should be used with caution in the presence of known or suspected infection in the catheter.

Using Cathflo Activase in patients with infected catheters may release a localized infection into the systemic circulation. As with all catheterization procedures, care should be used to maintain aseptic technique. Hypersensitivity, including urticaria, angioedema and anaphylaxis, has been reported in association with use of Cathflo Activase.

Monitor patients treated with Cathflo Activase for signs of hypersensitivity and treat appropriately if necessary.

The interaction of Cathflo Activase with other drugs has not been formally studied. Long-term studies in animals have not been performed to evaluate the carcinogenic potential or the effect on fertility.

There are no adequate and well-controlled studies in pregnant women. Cathflo Activase should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis. You may also report side effects to Genentech at The information contained in this section of the site is intended for U. Click "OK" if you are a healthcare professional.

The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. Genentech, Inc. Genentech does not recommend and does not endorse the content on any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.

Submit the form below to share this with a friend or colleague. Genentech will not contact the individuals you share content with. All fields are required. FDA-approved dosing with Cathflo 8. No other medication should be added to solutions containing Cathflo. Contraindications Cathflo Activase should not be administered to patients with known hypersensitivity to alteplase or any component of the formulation.

General Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase e. Bleeding The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding.

Infections Cathflo Activase should be used with caution in the presence of known or suspected infection in the catheter. Hypersensitivity Hypersensitivity, including urticaria, angioedema and anaphylaxis, has been reported in association with use of Cathflo Activase. Potential interactions between Cathflo Activase and laboratory tests have not been studied.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential or the effect on fertility. Pregnancy There are no adequate and well-controlled studies in pregnant women. Adverse Reactions In clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis.

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Cathflo Activase

Slight foaming is not unusual; let the vial stand undisturbed to allow large bubbles to dissipate. Complete dissolution should occur within 3 minutes. The reconstituted preparation results in a colorless to pale yellow transparent solution at a pH of approximately 7. If catheter function is not restored at minutes after 1 dose of Cathflo, a second dose may be instilled see Instructions for Administration.

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Genentech Patient Resource Center Our center dedicated to getting patients and caregivers to the right resources. Genentech Patient Foundation Provides free medicine to patients without insurance coverage or who can't pay for their Genentech medicine. Medicine Information Support Ask about possible side effects and any other medical questions related to your prescribed Genentech medicine. Call a nurse at , Monday-Friday, 5am-5pm PT.

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