Leuprolide Acetate (Page 4 of 5)

INSTRUCTIONS FOR USE

Leuprolide Acetate (loo’ proe lide as’ e tate) Injection

Read the Instructions for Use before you start using leuprolide acetate injection and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. Your doctor should show you how to draw up leuprolide acetate injection and give the injection the right way before you inject the first time.

Do not share your syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

Supplies you will need for the Leuprolide Acetate Injection:

  • 1 vial of leuprolide acetate injection
  • a sterile 0.5 mL rigid pack syringe with permanently attached needle (28 gauge, ½ inch) (see Figure A).
  • 1 cotton gauze
  • 2 alcohol swabs
  • 1 puncture resistant sharps container (see “Disposal of used syringes, needles, and vials”)
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Figure A

Preparing the Leuprolide Acetate Injection

Step 1.

Wash hands thoroughly (see Figure B) and dry them with a clean towel.

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Figure B

Step 2.

  • Check the liquid in the container. It should look clear. Do not use if it is not clear or if it has particles in it.
  • If using a new vial, flip off the plastic cover to expose the grey rubber stopper.
  • Use an alcohol swab to clean the metal ring and the grey rubber stopper on the medicine vial every day, just before you use it (see Figure C).
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Figure C

Step 3.

Remove outer wrapping from one syringe (See Figure D).

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Figure D

Step 4.

Pull the syringe plunger back until the tip is at the proper mark for the prescribed dose (see Figure E).

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Figure E

Step 5.

Uncover needle by pulling the cap straight off (see Figure F). Do not touch the needle.

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Figure F

Step 6.

  • Place the vial on a clean flat surface.
  • Push the needle through the center of the rubber stopper on the vial (see Figure G).
  • Push the plunger all the way in to inject air into the vial.
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Figure G

Step 7.

  • Keep the needle in the vial.
  • Lift the vial and turn it straight upside down.
  • Check to see that the needle tip is in the liquid (see Figure H).

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Figure H

Step 8.

  • With the needle tip still in the liquid, slowly pull back the plunger until syringe fills to the proper mark (see Figure I).
  • If any bubbles appear in the syringe, remove them by pushing the plunger up slowly.

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Figure I

Giving Leuprolide Acetate Injection

Step 9.

  • Choose a different injection site each day.
  • Clean the injection site with a new alcohol swab.
  • Hold the skin fold between your thumb and your index finger or as you were instructed by your doctor.
  • Insert the needle straight into the skin quickly, as shown by your doctor in a 90° angle (see Figure J).
  • Push the plunger to inject the medicine.
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Figure J

Step 10.

  • Remove the needle at the same angle it was inserted (90°) (see Figure K).
  • Wipe the skin with a cotton gauze.
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Figure K

Disposal of used needles, syringes, and vials

Step 11.

  • Put the used needles, syringes, and vials in a FDA-cleared sharps disposal container right away after use (see Figure L). Do not throw away (dispose of) loose needles, syringes, or vials in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles, syringes, and vials. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
  • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
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Figure L

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Amneal Pharmaceuticals Private Limited

Parenteral Unit

Ahmedabad 382213, INDIA

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 11-2022-00

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