Arbor Pharmaceuticals

Arbor Pharmaceuticals Drugs

• Bidil
  

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  Bidil

  

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  Treatment with BiDil should be initiated at a dose of one BiDil Tablet, 3 times a day. BiDil may be titrated to a maximum tolerated dose, not to exceed two BiDil Tablets, 3 times a day.

  There is no adequate experience in heart failure with doses of BiDil other than those recommended and no experience with use of individual components.

  Although titration of BiDil can be rapid (3-5 days), some patients may experience side effects and may take longer to reach their maximum tolerated dose. The dosage may be decreased to as little as one-half BiDil Tablet 3 times a day if intolerable side effects occur. Efforts should be made to titrate up as soon as side effects subside.

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• Nymalize
  

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  Nymalize

  

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  2.1 Administration Instructions

  Administer only enterally (e.g., oral, nasogastric tube, or gastric tube route). Do not administer intravenously or by other parenteral routes. For all routes of administration, begin NYMALIZE within 96 hours of the onset of SAH. Administer one hour before a meal or two hours after a meal for all routes of administration [see Clinical Pharmacology (12.3)].

  2.2 Administration by Oral Route

  The recommended oral dosage is 20 mL (60 mg) every 4 hours for 21 consecutive days.

  2.3 Administration Via Nasogastric or Gastric Tube

  Using the supplied oral syringe labeled "ORAL USE ONLY", administer 20 mL (60 mg) every 4 hours into a nasogastric or gastric tube for 21 consecutive days. For each dose, refill the syringe with 20 mL of 0.9% saline solution and then flush any remaining contents from nasogastric or gastric tube into the stomach.

  2.4 Dosage Adjustments in Patients with Cirrhosis

  In patients with cirrhosis, reduce the dosage to 10 mL (30 mg) every 4 hours [see Warnings and Precautions (5.2), Clinical Pharmacology (12.3)].

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• Buspirone Hydrochloride...
  

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  Buspirone Hydrochloride

  

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  2.1 Recommended Dose

  The recommended dose of GLIADEL Wafer is eight 7.7 mg wafers for a total of 61.6 mg implanted intracranially. The safety and effectiveness of repeat administration have not been studied.

  2.2 Insertion Instructions

  Following maximal tumor resection, confirmation of tumor pathology and establishment of hemostasis, place up to a maximum of eight GLIADEL Wafers to cover as much of the resection cavity as possible. Should the size and shape of the resected cavity not accommodate eight wafers, place the maximum number of wafers feasible within the cavity. Slight overlapping of the wafers is acceptable. Wafers broken in half may be used, but discard wafers broken in more than two pieces. Oxidized regenerated cellulose (Surgicel®) may be placed over the wafers to secure them against the cavity surface. After placement of the wafers, irrigate the resection cavity and close the dura in a water-tight fashion.

  2.3 Preparation and Safe Handling

  GLIADEL Wafers contain a cytotoxic drug. Follow applicable special handling and disposal procedures.1

  Each wafer is packaged within two nested aluminum foil laminate pouches. The inner pouch is sterile and is designed to maintain product sterility and protect the product from moisture. The outside surface of the outer laminated aluminum foil pouch is a peelable overwrap and is not sterile.

  Deliver GLIADEL Wafers to the operating room in their outer aluminum foil pouch, unopened. Do not open the pouch until the wafers are ready to be implanted. GLIADEL Wafers in unopened outer foil pouches are stable at room temperature for six hours at a time for up to three cycles within a 30-day period.

  Exposure to carmustine can cause severe burning and hyperpigmentation of the skin. Use double gloves when handling GLIADEL Wafers. Discard the outer gloves into a biohazard waste container after use. Use a dedicated surgical instrument for wafer implantation. If repeat neurosurgical intervention is indicated, handle residual wafers or wafer remnants as potential cytotoxic agents.

  Instructions for Opening Pouch Containing GLIADEL Wafer

  Read all steps of the instructions prior to opening the pouch.

  Instructions for opening the pouch containing GLIADEL Wafer can be viewed at the following website: http://gliadel.com/hcp/pouch-opening-instructions. Illustrations are also pictured below.

  Figure 1: To remove the sterile inner pouch from the outer pouch, locate the folded corner and slowly pull in an outward motion.

   

  Figure 2: Do NOT pull in a downward motion rolling knuckles over the pouch. This may exert pressure on the wafer and cause it to break.

   

  Figure 3: The inner pouch is a multi-layered, silver colored, foil laminate. Remove the inner pouch by grabbing hold of the crimped edge of the inner pouch using a sterile instrument and pulling upward.

   

  Figure 4: To open the inner pouch, gently hold the crimped edge and cut in an arc-like fashion around the wafer.

   

  Figure 5: To remove the GLIADEL Wafer, gently grasp the wafer with the aid of forceps and place it onto a designated sterile field.

   

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