Ferring ZOMA-Jet 10 Instructions For Use Manual

For use with zomacton

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Instructions for Use

For use with

10 mg vial

Table of Contents

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Summary of Contents for Ferring ZOMA-Jet 10

Page 1 Instructions for Use For use with 10 mg vial...
Page 2: Table Of Contents
Table of Contents Parts of the ZOMA-Jet 10 ................1 ® Supplies you will need to mix a ZOMACTON 10 mg Vial ......2 ® Mix a ZOMACTON 10 mg vial ..............3 ® Reset the ZOMA-Jet 10 ................6 ®...
Page 3: Parts Of The Zoma-Jet ® 10
The ZOMA-Jet 10 is a device used to administer ZOMACTON human ® ® growth hormone of recombinant DNA (rDNA) origin. Do not share the ZOMA-Jet 10 device, the needle-free head, or the ® ZOMACTON 10 mg vial with anyone else. You may give an infection to them ®...
Page 4: Supplies You Will Need To Mix A Zomacton ® 10 Mg Vial
Supplies you will need to mix a ZOMACTON 10 mg Vial ® • Prefilled Syringe (liquid) • Vial Adapter • • ZOMACTON 10 mg Vial (powder) Alcohol Swab ® Plunger Prefilled Syringe Vial Adapter with Mating Alcohol Swab Piece ZOMACTON 10 mg Vial ®...
Page 5: Mix A Zomacton ® 10 Mg Vial
Mix a ZOMACTON 10 mg vial ® ZOMACTON 10 mg is not ready to be used right away. You must ® mix (reconstitute) the dry powder in the ZOMACTON 10 mg vial ® with the Prefilled Syringe using the Vial Adapter. Both the Prefilled Syringe and Vial Adapter come with your medicine.
Page 6 • Grasp the Vial Adapter just under the cap with 1 hand. Pull the cap up with your other hand to remove it. See Figure E. Do not hold the vial upside down. This may cause the vial to leak. Figure E •...
Page 7 Syringe Syringe Mating Piece • Firmly hold the Vial Adapter with 1 hand and remove the emptied Syringe (along with the already connected Syringe Mating Piece) with your other hand. See Figure H. Vial Adapter Vial Figure H • Hold the vial between your hands and gently roll it to dissolve the mixture until it is clear.
Page 8: Reset The Zoma-Jet ® 10
Reset the ZOMA-Jet ® • Hold the ZOMA-Jet 10 device so that you can see the Dosage Window. ® Turn the Winding Grip in the direction of “Reset” until you see the black bar in the Dosage Window. See Figure I. Injector Winding Grip Button Out...
Page 9: Attach A Needle-Free Head
• Must be used by only one person • Discard 7 days after opening size B or C, call the ZoGo Manufactured for: Ferring Pharmaceuticals Inc. 6815-02 Parsippany, NJ 07054 Patient Support Program at Figure J 844.944.ZOGO (9646). Write down the date of opening a new Needle- Important: Free Head in your Daily Planner.
Page 10: Prime The Zoma-Jet ® 10
Prime the ZOMA-Jet ® You must prime your ZOMA-Jet 10 with ZOMACTON 10 mg each time ® ® you use a new Needle-Free Head and to make sure you get the right dose. Priming also removes most of the air bubbles inside the Needle-Free Head. Important: Make sure that the Injector Button is popped out and that 0.0 is showing in the Dosage Window of the ZOMA-Jet 10 before you begin the...
Page 11 • Turn the ZOMA-Jet 10 back over so that ® the vial can be placed on a flat surface. Hold on to the Vial Adapter and pull the 10 straight off. See Figure O. ZOMA-Jet ® Figure O • Unlock the safety switch and point your ZOMA-Jet 10 so that it is facing down.
Page 12: Inject With The Zoma-Jet ® 10
Inject with the ZOMA-Jet ® You are now ready for your injection. Step 1. Turn the Winding Grip in the direction of “Reset” until you see the black bar in the Dosage Window. You should be able to see the green band on the Injector Button.
Page 13 Step 4. Turn the ZOMA-Jet 10 over so that ® the vial is upside down. Step 5. Turn the Winding Grip in the direction of “Fill” until you see your prescribed dose in the Dosage Window. If you go beyond the dose your doctor prescribed, turn the Winding Grip in the opposite direction to your prescribed dose.
Page 14 Step 7. Sit or lie down so that the injection site can be seen clearly and your muscles are relaxed. Step 8. Choose an injection site with fatty tissue from the following places. See Figure V. Choose a different site each time you inject ZOMACTON ®...
Page 15: Evaluate Your Injections
844.944.ZOGO (9646). If you experience an adverse event, please discuss it with your doctor. You are encouraged to report adverse events of prescription drugs to Ferring Pharmaceuticals at 1-888-FERRING (1-888-337-7464). You can also call FDA at 1-800-FDA-1088 or visit the FDA website www.fda.gov/medwatch.
Page 16: Remove A Needle-Free Head
Step 14. Place the cap on the Needle-Free Head, and put the ZOMA-Jet 10 in ® its carrying case until the next injection. Important: Do not store your ZOMA-Jet 10 in the refrigerator. ® Step 15. Place the cap on the mixed ZOMACTON 10 mg ®...
Page 17: Disposal Of Your Zoma-Jet ® 10, Needle-Free Head
Disposal of Your ZOMA-Jet 10, Needle-Free Head, ® and ZOMACTON 10 mg Vial: ® • Put your used ZOMA 10, needle-free head, and ZOMACTON vial in ® ® a FDA-cleared sharps disposal container after use. Do not throw away (dispose of) your ZOMA-Jet 10, needle-free head, and ZOMACTON 10mg ®...
Page 18: Maintenance And Storage
Maintenance and Storage ZOMACTON 10 mg Vial [medicine] ® • 10 mg vial upright in a refrigerator at 36°F to 46°F Store your ZOMACTON ® (2°C to 8°C) for up to 28 days after mixing. ZOMA-Jet 10 Device ® • 10 device with a damp cloth.