Method of Administration. Patients will receive two intradermal injections of approximately 0.5 mL volume on the anterior or medial side of the same thigh. The general area of vaccination will be at a location midway between the inguinal ligament and the knee and will be administered in the same lymph node draining area. The vaccinations will be given every 21 days for 5 doses total. Intradermal vaccinations should be given in a method similar to the “PPD Skin Test” through a 26- or 27-gauge needle (3/8 inch) in the anterior thigh midway between the inguinal ligament and the knee. The whole 1 mL vaccination volume will be administered in 2 different sites approximately 5 cm (about 2 inches) apart from each other, by carefully injecting 500 μL (0.5 cc) at each vaccination site by intradermal injection per the diagram shown below. The vaccinations will be administered using sterile technique by a well-trained research nurse or trained study staff. The patient must be monitored for 1 hour after the vaccination for signs of any adverse reaction. • Cleanse the area by swabbing the skin (an approximately 4 to 5 inch circle) with alcohol pads. • Hold the skin taut before injecting. Place the 2 intradermal vaccinations in 2 quadrants of the cleansed circle. • As depicted below keep the syringe low and flat along the skin surface (inject with needle bevel side up). Inject 500 μL forming a nice “bleb” under the skin. • Slowly retract the needle and allow the “bleb” to resorb. Repeat 1 more time to completely administer the full 1.0 mL volume. Observe the patient and injection sites for 1 hour. • Place a 4x6 sterile gauze bandage over the site on the thigh to protect from irritation for 12 to 24 hours. • Any leakage of the dose onto the skin or inability to deliver the full 1 mL volume to the 2 sites should be noted in the eCRF. • Patients must be observed immediately after vaccinations for signs of an acute allergic reaction. If symptoms such as difficulty breathing, angioedema, diffuse and significant urticaria, and/or hypotension are observed, immediate emergency medical attention will be provided.
Method of Administration. The Ceding Company will report to AUL all risks reinsured hereunder by the preparation and submission to AUL of a monthly Statement. The statement shall include, but not be limited to, the information shown in Attachment 1. The Ceding Company may request facultative consideration on any risk written by the Ceding Company on the plans of insurance set out in Exhibit B, by mailing to AUL a Reinsurance Application Form (Attachment 3) properly completed as facultative. Along with reinsurance application, the Ceding Company shall forward copies of its application, medical examination, inspection report, and all other pertinent information. AUL will give the application for reinsurance its prompt consideration and communicate its decision on the risk to the Ceding Company. For risks facultatively reinsured hereunder, the Ceding Company shall also mail to AUL a completed Formal Reinsurance Cession, (Attachment 3), along with copies of all pertinent papers which have not previously been submitted to AUL.
Method of Administration. The capsules containing the gastro-resistant granules should be taken before meals, swallowed whole with plenty of fluid (e.g. a glass of water). The duration of treatment in active Crohn’s Disease and in collagenous colitis should be limited to 8 weeks. The treatment with Budenofalk 3 mg should not be stopped abruptly, but withdrawn gradually (tapering doses). In the first week, the dosage should be reduced to two capsules daily, one in the morning, one in the evening. In the second week, only one capsule should be taken in the morning. Afterwards treatment can be stopped.
Method of Administration. Budenofalk® 2mg rectal foam can be applied in the morning or evening. The canister is first fitted with an applicator and then shaken for about 15 seconds before the applicator is inserted into the rectum as far as comfortable. Note that the dose is only sufficiently accurate when the pump dome is held downwards as vertically as possible. To administer a dose of Budenofalk® 2mg rectal foam, the pump dome is fully pushed down and very slowly released. Following the activation the applicator should be held in position for 10-15 seconds before being withdrawn from the rectum. The best results are obtained when the intestine is evacuated prior to administration of Budenofalk® 2mg rectal foam.