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.

Author: Akinojas Tejar
Country: Pakistan
Language: English (Spanish)
Genre: Travel
Published (Last): 15 June 2006
Pages: 279
PDF File Size: 15.36 Mb
ePub File Size: 2.8 Mb
ISBN: 517-2-39501-722-4
Downloads: 91952
Price: Free* [*Free Regsitration Required]
Uploader: Mizuru

Single-dose vials 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. 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. See Privacy Policy and Disclaimer. DO NOT rub the injection site. Some of the side effects listed below may be due to your kidney failure rather than Aranesp. For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting.

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. If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.

The recommended comparable dosage regimens for Aranesp and the comparator are based on the respective product monographs and supported by clinical literature. Change the place that you inject each time so you do not become sore in one area.

Aranesp is used to treat anaemia that comes about because of chronic renal failure kidney failure. Grasp the pre-filled pen in your hand, ensuring that you are holding it towards the upper half of the pen see picture. Tell your doctor, nurse or pharmacist if you are taking any other medicines, including any medicines you buy without a prescription from your pharmacy, supermarket or health food shop.


CRFincluding patients on dialysis and patients not on dialysis.

Report on New Patented Drugs – Aranesp

The needle shield on the pre-filled pen and the needle cover on the pre-filled syringe contain a derivative of latex. Your Aranesp has now been fully injected. Lift the SureClick pen from the injection site. If there is blood, press a cotton ball or gauze pad on your injection site.

Aranesp Solution for injection –

Novel erythropoiesis stimulating protein NESP effectively maintains hemoglobin when administered at a reduced dose frequency compared with recombinant human erythropoietin in dialysis patients. A condition called pure red cell aplasia PRCA has been rarely reported after months to years of treatment with recombinant forms of erythropoietin.

Kidneys and aranep they work. Dispose of the full puncture-resistant sharps container as instructed by arabesp doctor, nurse or pharmacist. 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 aranes; as an 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.

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. You may also like.

We’re strengthening digital security to protect you.

Surf therapy can help depression and PTSD. As shown in the table below, the prices of Aranesp were considered within the Guidelines relative to the TCC test as they did not exceed the prices of the other drugs in the therapeutic class or did not do so by an amount that triggered the investigation criteria.


This condition is found mostly in patients with chronic kidney disease and means the absence of very young red blood cells in the bone marrow. Infection, inflammation, malignancy, occult blood loss, bone marrow fibrosis may reduce effectiveness; consider other etiologies in treatment failures. Am J Kidney Diseases ; Increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access.

These measures will help to protect aeanesp environment.

All copyright paackage responsibility for CMI is that of the relevant pharmaceutical company. Outback nurse treats his own heart attack. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. Hold down see picture. In compliance with the Guidelines, the prices in Canada did not exceed the range of prices in those countries; the prices in Canada were lower than the prices in those countries.

If you use Aranesp after the expiry date has passed, it may not work as well. It will reduce your need for blood transfusions. If there are any problems with administering the product, place the product back into original packaging and contact a pharmacy.

If you are on dialysis, your normal dialysis routine will not affect the ability of Aranesp to treat your anaemia. 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.

Date of First Sale: Medicines should be disposed of in accordance with local requirements. If you have forgotten to inject Aranesp, contact your doctor or nurse to discuss when you should next inject. J Am Soc Nephrol ;11 suppl: Packahe put the used pre-filled pens or used pre-filled syringes into your normal household rubbish bin.

If someone else is injecting for you, they can also use the back of your arms.