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.
|Published (Last):||14 August 2017|
|PDF File Size:||17.44 Mb|
|ePub File Size:||14.83 Mb|
|Price:||Free* [*Free Regsitration Required]|
Novel erythropoiesis stimulating protein for treatment of anaemia in chronic renal failure. Novel erythropoiesis packagr protein NESP effectively maintains hemoglobin when administered at a reduced dose frequency compared with recombinant human erythropoietin in dialysis patients.
See the following table. They may differ from the information in this leaflet. Surf therapy can help depression and PTSD. Aranesp is a recombinant erythropoietic protein produced by special mammalian cells.
In this case, the first patent pertaining to Aranesp was issued November 5, and it came under the PMPRB’s jurisdiction at that time. The recommended comparable dosage regimens for Aranesp and the comparator are based on the respective product monographs and supported by clinical literature.
You will need to give yourself an injection once a week or in some cases once every two weeks inset once a month. These measures will help to protect the environment.
Increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access. 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.
Use lowest dose sufficient to avoid red blood cell transfusion. The inspection window will be yellow, confirming the injection is complete. How to inject using the Aranesp pre-filled syringe Things to do before you inject: Catch up on the weekend.
Comparators are generally selected from among existing drug products in the same 4th level of the Anatomical, Therapeutic, Chemical ATC System that are clinically equivalent in addressing the approved indication. Do not use in patients with pure red cell aplasia due to erythropoietin antibodies. The Therapeutic Class Comparison TCC test of the Guidelines provides that the price of a category 3 packge drug product cannot exceed the prices of other drugs that treat the same disease or condition.
Things to do insrrt you inject Where to inject How to inject How to remove the detachable label Disposing.
ARANESP Dosage & Rx Info | Uses, Side Effects – MPR
Dietary clues to a healthy microbiome. While you are using it How much Aranesp to inject When to inject Aranesp If you forget to use it If you inject too much overdose Things you must do Things you must not do. Other side effects are minor and are likely to be temporary. 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.
Always keep Aranesp in the original box to protect it from light. You can use Aranesp if accidentally left frozen for less than 2 days. Infection, inflammation, malignancy, occult blood loss, bone marrow fibrosis may reduce effectiveness; consider other etiologies in treatment failures. MIMS Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource e.
Are you a healthcare professional?
Kidney failure can often cause anaemia, which may require you to have blood transfusions. 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 arxnesp Legislation, Regulations and Guidelines. In kidney failure, the kidney does not produce enough of the natural hormone erythropoietin. Monitor BP reduce or withhold dose if hypertension occursfolate, Vit. J Am Soc Nephrol ;10 suppl: The yellow safety cover will move down over the needle and lock into place.
Your doctor has prescribed the strength of Aranesp that inseet best for you.
Packagee you have forgotten to inject Aranesp, contact your doctor or nurse to discuss when you should next inject.
Aranesp is used to treat anaemia that comes about because of chronic renal failure kidney failure. Step 1 Centre inseft pre-filled pen in the area of the pinched skin at a right angle 90 degrees and push firmly against the skin.
August 2, Date of First Sale: The cause of this is presently not known. Do not put the grey needle shield back on the used pre-filled pen. Where to inject How to inject. DO NOT rub the injection site.
A condition called pure red cell aplasia PRCA has been rarely reported after months to years of treatment with recombinant forms of erythropoietin. As with all medicines, you should keep Aranesp out of the reach and sight of children.
We’re strengthening digital security to protect you.
Discontinue after completion of chemotherapy course. The PMPRB’s Guidelines provide that the dosage recommended for comparison purposes will normally not be higher than the ijsert of the usual recommended dosage.
This will be possible without excessive pressure. Your doctor has given you Aranesp to treat your anaemia. Some of the side effects listed below may be due to your kidney failure rather than Aranesp.
The only other agent that falls within the same 4th level ATC class as Aranesp is Eprex epoetin alfa. CMI is supplied by the relevant pharmaceutical company for each consumer medical product.