Throughout this section of the package insert, the Aranesp™ study numbers In 2 open-label studies, Aranesp™ or Epoetin alfa were administered for the. Package Insert Aranesp (Darbepoetin alfa) Amgen Inc. Table of Contents. Description Clinical Pharmacology Clinical Studies Indications and. This patient package insert contains information and directions for patients who will be receiving injections of Aranespä and their caregivers.
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These symptoms may be serious and could possibly become life-threatening if not treated promptly. Novel erythropoiesis stimulating protein NESP effectively maintains hemoglobin when administered at a reduced dose frequency compared with recombinant human erythropoietin in dialysis patients.
Monitor BP reduce or withhold dose if hypertension occursfolate, Vit. Information and interactions contained in this Web site are for information purposes only and are not intended to be used to diagnose, treat, cure or prevent any disease. For information on the Criteria for Commencing an Investigation, please see Schedule 5 of the Compendium of Guidelines Policies and Procedures, as posted on our website under Legislation, Regulations and Guidelines.
They may differ from the information in this leaflet. Practical guidelines for the use of NESP in treating renal anemia. Anaemia is when your blood does not contain enough red blood cells.
August 2, Date of First Sale: Following blood tests, your doctor has decided you need Aranesp. It should be yellow. The yellow safety cover will move down over the needle and lock into place. You can give yourself a subcutaneous injection after you have received training from your doctor or nurse.
Never put the used pre-filled pens or used pre-filled syringes into your normal household rubbish bin. CRFincluding patients on dialysis and patients not on dialysis. CMI is supplied by the relevant pharmaceutical company for each consumer medical product.
Aranesp will help your bone marrow to produce more red blood cells, like your natural erythropoietin. Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: The cause of this is presently not known. Although PRCA is rare, you should know that you would have to stop injecting Aranesp and would need to have regular blood transfusions to treat your anaemia.
If someone else is injecting you, they can also use the back of your arms. Under the Guidelines, the introductory price of a new category 3 drug product will be presumed to be atanesp if it exceeds the prices of all of the comparable drug products based on the TCC test, and if it exceeds the prices of the same medicine in the seven countries listed in the Patented Medicines Regulations.
This web site is intended for Australian residents and is not a substitute for independent professional advice. Always keep Aranesp in the original box to protect it from light. If there is blood, press a cotton ball or gauze pad on your injection site. The introductory prices of Aranesp at date of first sale were found to be within the Guidelines because pac,age cost of therapy did not exceed oackage cost of therapy of existing drugs in the therapeutic class comparison or did not do so by an amount sufficient to trigger the investigation criteria and the prices did not exceed the range of prices in other comparator countries where Aranesp was sold.
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Do not use in patients with pure red cell aplasia due to erythropoietin antibodies. Things to do araneap you inject Where to inject How to inject How to remove the detachable label Disposing. Chemotherapy-induced anemia in patients with non-myeloid malignancies.
It will take your body a short isnert to make red blood cells, so it will be about 4 weeks before you notice any effect. If any of the following happens, stop injecting Aranesp and go straight to the hospital, as you may need urgent medical attention: Further, the accuracy, currency and completeness of the information available on this Web site cannot be guaranteed.
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You will need to give yourself an injection once a week or in some cases once every two weeks or once a month. Place the pre-filled pen on the injection site at a right angle 90 degrees and push firmly against the skin.
A condition called pure red cell aplasia PRCA has been rarely reported after months to years of treatment with recombinant forms of erythropoietin.
DO NOT put the grey needle cover back on the used pre-filled syringe. Tell your doctor, nurse or pharmacist if you notice anything that worries you or that is making you feel unwell, even if it is not on this list. These measures will help to protect the environment. Grab the pre-filled syringe safety guard to remove the pre-filled syringe from the tray. Do not use Aranesp after the expiry date Exp.
Aranesp is a recombinant erythropoietic protein produced by special mammalian cells. Novel erythropoiesis stimulating protein NESP safely maintains hemoglobin concentration levels in hemodialysis patients as effectively as r-HuEPO when administered once weekly.