ZOMACTON

 

ZOMACTON™ 5mg

[somatropin (rDNA origin)] for Injection

ZOMACTON™ 5 mg is not ready for immediate use, you must first mix (or reconstitute) the dry powder with the liquid included with your medication. Mix the amount of liquid your physician has prescribed (between 1 mL and 5 mL) with your medication. Please note that the liquids are different for the 5-mg and 10-mg vials*—do not use the 10-mg liquid with 5-mg ZOMACTON™ or vice versa.

  • Remove the plastic cap from the vial of liquid and clean the rubber stopper with an alcohol swab. Remove the needle cap from the preparation syringe
  • Pull back on the plunger of the preparation syringe and stop when the amount of air is equal to the amount of liquid your physician has prescribed
  • Slowly insert the needle of the preparation syringe into the vial of liquid, gently push down on the plunger, and release the air into the vial
  • Keeping the tip of the needle in the liquid, turn the vial upside down and pull back on the plunger until the correct amount of liquid fills the syringe
  • Remove the needle from the vial and recap the needle
  • Only use the liquid that comes with the 5-mg ZOMACTON™ to mix. Remove the hard plastic cap of the ZOMACTON™ vial and clean the top of the vial with an alcohol swab
  • Remove the needle cap from the syringe filled with liquid and insert the needle into the center of the rubber stopper on the vial
  • Slowly inject the liquid against the side of the vial to avoid creating air bubbles. Do not squirt the liquid directly onto the powder. When all the liquid is in the vial, remove the needle
  • Recap the needle and throw away the syringe in a sharps disposal container
  • Hold the ZOMACTON™ vial between your hands and gently roll it (never shake it) until the mixture is clear. This may take a few seconds. Do not inject the medication if it is cloudy or has particles. If air bubbles appear, let the mixture sit until they disappear

Contact your child’s doctor if you notice any of the following:

  • Lump, bruise, or redness at the injection site that doesn’t go away
  • Any sign of infection at the injection site (pus, redness, heat, or persistent pain)
  • Severe, sharp pain or ache at injection site that does not go away
  • Rash at injection site

*5 mg contains benzyl alcohol as a preservative and 10 mg contains metacresol as a preservative.

Wash hands thoroughly with soap and water. Check that the ZOMACTON™ vial is clear and the date of mixing is within 14 days.

  • Remove the needle cap from the injection syringe
  • Slowly insert injection syringe into the ZOMACTON™ vial
  • Keeping the tip of the needle below the surface of the medication, turn the vial upside down
  • Gently pull back on the plunger until your prescribed amount of medication fills the syringe. (If you do not have enough medication for a full dose, reconstitute a new vial to make up the difference)
  • With the needle still in the upside down vial, gently tap the syringe to loosen any air bubbles
  • Remove the needle from the vial and carefully replace the needle cap until ready to inject
  • Clean the site of injection with an alcohol swab
  • Remove the needle cap and hold the syringe the way you hold a pencil
  • With your free hand, gently pinch your child’s skin around the injection site between your fingers
  • Quickly insert the needle into the tissue beneath the skin’s surface at a 45° to 90° angle to reduce discomfort
  • Holding the syringe in place, pull back (if there is blood, DO NOT INJECT ZOMACTON™; withdraw the needle, discard all supplies, and go back to step 1)
  • Slowly push the plunger until the syringe is empty. Quickly pull the needle straight out and apply pressure to the site of injection with a sterile gauze pad

For safety reasons, it is important to properly store your medication and correctly dispose of used needles and syringes. Remember, needles can only be used once

  • Write the date on the vial label. The 5-mg vial must be used within 14 days. Store the mixed ZOMACTON™ and all unopened vials in the refrigerator. Do not freeze
  • Dispose of needles, syringes, and vials in a sharps disposal container; never dispose of needles, syringes, and vials in your household trash
  • Keep your sharps disposal container out of the reach of children

Benzyl alcohol, a component used to reconstitute the ZOMACTON™ 5-mg vial, should not be used with newborns. Benzyl alcohol has been associated with serious adverse events and death. When administering ZOMACTON™ 5 mg to newborns, it should be reconstituted with sterile normal saline. Benzyl alcohol should not be used in patients with a known sensitivity.

 

ZOMACTON™ 10mg

[somatropin (rDNA origin)] for Injection

ZOMACTON™ 10 mg is not ready for immediate use, you must first mix (or reconstitute) the dry powder with the liquid included with your medication. Mix 1 mL of pre-filled liquid with your medication. Please note that the liquids are different for the 5-mg and 10-mg vials*—do not use the 5-mg liquid with 10-mg ZOMACTON™ or vice versa.

  • Remove the syringe tip cap from the top of the pre-filled liquid syringe and attach the included 25-gauge mixing needle with needle cap
  • Only use the liquid that comes with the 10-mg ZOMACTON™ to mix. Remove the hard plastic cap of the ZOMACTON™ vial and clean the top of the vial with an alcohol swab
  • Remove the needle cap from the pre-filled liquid syringe and insert the needle into the center of the rubber stopper on the vial
  • Slowly inject the liquid against the side of the vial to avoid creating air bubbles. Do not squirt the liquid directly onto the powder. When all the liquid is in the vial, remove the needle
  • Recap the needle and throw away the syringe in a sharps disposal container
  • Hold the ZOMACTON™ vial between your hands and gently roll it (never shake it) until the mixture is clear. This may take a few seconds. Do not inject the medication if it is cloudy or has particles. If air bubbles appear, let the mixture sit until they disappear

Contact your child’s doctor if you notice any of the following:

  • Lump, bruise, or redness at the injection site that doesn’t go away
  • Any sign of infection at the injection site (pus, redness, heat, or persistent pain)
  • Severe, sharp pain or ache at injection site that does not go away
  • Rash at injection site

*5 mg contains benzyl alcohol as a preservative and 10 mg contains metacresol as a preservative.

Wash hands thoroughly with soap and water. Check that the ZOMACTON™ vial is clear and the date of mixing is within 28 days.

  • Remove the needle cap from the injection syringe
  • Slowly insert injection syringe into the ZOMACTON™ vial
  • Keeping the tip of the needle below the surface of the medication, turn the vial upside down
  • Gently pull back on the plunger until your prescribed amount of medication fills the syringe. (If you do not have enough medication for a full dose, reconstitute a new vial to make up the difference)
  • With the needle still in the upside down vial, gently tap the syringe to loosen any air bubbles
  • Remove the needle from the vial and carefully replace the needle cap until ready to inject
  • Clean the site of injection with an alcohol swab
  • Remove the needle cap and hold the syringe the way you hold a pencil
  • With your free hand, gently pinch your child’s skin around the injection site between your fingers
  • Quickly insert the needle into the tissue beneath the skin’s surface at a 45° to 90° angle to reduce discomfort
  • Holding the syringe in place, pull back (if there is blood, DO NOT INJECT ZOMACTON™; withdraw the needle, discard all supplies, and go back to step 1)
  • Slowly push the plunger until the syringe is empty. Quickly pull the needle straight out and apply pressure to the site of injection with a sterile gauze pad

For safety reasons, it is important to properly store your medication and correctly dispose of used needles and syringes. Remember, needles can only be used once

  • Write the date on the vial label. The 10-mg vial must be used within 28 days. Store the mixed ZOMACTON™ and all unopened vials in the refrigerator. Do not freeze
  • Dispose of needles, syringes, and vials in a sharps disposal container; never dispose of needles, syringes, and vials in your household trash
  • Keep your sharps disposal container out of the reach of children
 
 

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