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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Kidney failure can often cause anaemia, which may require you to have blood transfusions. Ask your pharmacist how to dispose of medicines no longer required.

Do not use in patients with pure red cell aplasia packags to erythropoietin antibodies. Some side effects may be serious and need medical attention. Novel erythropoiesis stimulating protein for managing the anaemia of chronic kidney disease. Grab the pre-filled syringe safety guard to remove the pre-filled syringe from the tray.

The needle shield on the pre-filled pen and the needle cover on the pre-filled syringe contain a derivative of latex. Always keep Aranesp in the original box to protect it from light. The information contained in the PMPRB’s Summary Reports should not be relied upon for any purpose other than its stated purpose and is not to be interpreted as arannesp endorsement, recommendation or approval of any drug nor is it intended to be relied upon as a substitute for seeking appropriate advice from a qualified health care practitioner.

Consult your doctor, nurse or pharmacist if you have any questions. It does not contain all the available information. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose.

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Put used pre-filled pens and pre-filled syringes into the puncture-resistant sharps container and keep it out of the reach and sight of children. Before you use it When you must not use Aranesp Before you start to use it Taking other medicines. Medicines should be disposed of in accordance with local requirements.

Following blood tests, your doctor has decided you need Aranesp.

If someone else is injecting you, they can also use the back of your arms. The yellow safety cover will move down over the needle and lock into packxge. Wash your hands thoroughly with soap and water. Ask your doctor if you have any questions about why Aranesp has been prescribed for you.


Aranesp® (darbepoetin alfa)

Tell your doctor as soon as possible if you have any problems while using Aranesp, even if you do not think the problems are connected with Aranesp or are not listed in this leaflet. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. The introductory prices of Aranesp at date of first sale were found to be within the Guidelines because the cost of therapy did not exceed the 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.

See the following table. DO NOT rub the injection site. Some of the side effects listed below may be due to your kidney failure rather than Aranesp. If you are on dialysis, your normal dialysis routine will not affect the ability of Aranesp to treat your anaemia.

Further, the accuracy, currency and completeness of the information available on this Web site cannot be guaranteed. Indication as per For the treatment of anaemia associated with chronic renal failure product monograph: Use lowest dose sufficient to avoid red blood cell transfusion.

If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help. Under the Guidelines, the introductory price of a new category 3 drug product will be presumed to be excessive 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. Things to do before you inject Where to inject How to inject How to remove the detachable label Disposing.

In this case, the first patent pertaining to Aranesp was issued November 5, and it came under the PMPRB’s jurisdiction at that time. Carefully follow all directions given to you by your doctor, pharmacist or nurse.

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.

  IEC 1131-3 PDF

Lift the SureClick pen from the injection site. This will be possible without excessive pressure. If you have forgotten to inject Aranesp, contact your doctor or nurse to discuss when you should next inject. Where to inject How to inject.

MIMS Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource e. Anemia of chronic kidney disease CKDincluding patients on and not on dialysis.

Single-dose pqckage 25, 40, 60,mcg —4; Single-dose vialmcg —1; Single-dose prefilled syringes 10, 25, 40, 60,mcg —4; Single-dose prefilled syringes, mcg —1.

You will need to give yourself an injection once a week or in some cases once every two weeks or once a month. Consumers should be aware that the information provided by the Consumer Medicines Information CMI search CMI Search is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition isert which they have searched for CMI.

After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle. Step 2 While holding the pre-filled pen in place, use your thumb to 1 press – you will hear a “click” – and 2 release the red button on top. B 12renal function, electrolytes, fluid balance, and for premonitory neurological symptoms. Your doctor will work out the correct amount of Aranesp for you and tell you how much you must take.

Report on New Patented Drugs – Aranesp

An overview of the efficacy and safety of novel erythropoiesis stimulating protein Aranes. 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. It will take your body a short time to make red blood cells, so it will be about 4 weeks before you notice any effect.

DO NOT put the grey needle cover back on the used pre-filled syringe. Where to inject How to inject into the abdomen using Aranesp SureClick pre-filled pen How to inject into the thigh or back of the arm using Aranesp SureClick pre-filled pen.