|
GONAL-f®
Desription:
Gonal-f (follitropin alpha) is a highly purified form of human follicle stimulating hormone (FSH). Gonal-f is manufactured using recombinant human DNA technology. Gonal-f is packaged in monodose vials of 75 IU (international units) and Multi-Dose vials containing 450 IU. Each vial of Gonal-f contains powdered medication with prefilled syringes of diluent. Gonal-f Multi-Dose vials use specifically marked syringes to draw up the correct dose of medication, and inject subcutaneously. The Gonal-f RFF Pen is a disposable, premixed prefilled pen-like medication delivery system. Gonal-f RFF Pen is supplied in 3 strengths, 300 IU, 450 IU and 900 IU. It is indicated for the induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. It is also indicated for the development of multiple follicles in the ovulatory patient participating in an assisted reproductive technology (ART) program.
How It Works:
Gonal-f is administered as an injection subcutaneously. Gonal-f acts directly on the ovaries to help stimulate the development of follicles. Gonal-f is also used to stimulate the development of multiple eggs with assisted reproductive technologies.
Potential Side Effects:
Side effects that may occur include: nausea, vomiting, diarrhea, fever, breast tenderness, spotting or menstrual changes, ovarian enlargement, and injection site reaction (pain, swelling or irritation). Treatment with Gonal-f may increase the likelihood of multiple births. The risk of ovarian hyperstimulation syndrome (OHSS) should be discussed with your physician prior to treatment. Early warning signs include severe pelvic pain, nausea, vomiting and weight gain.
If you experience an allergic reaction: difficulty breathing; closing of the throat; swelling of the lips, tongue or face; or hives; seek emergency medical attention immediately. And if any time you experience: pain, warmth, redness, numbness, or tingling in an arm or leg; confusion, severe dizziness or severe headache, seek medical attention immediately.
PLEASE NOTE: If these or any other side effects occur, contact your physician.
Storage:
Store Gonal-f RFF 75 IU vial at room temperature. Gonal-f RFF 75 IU cannot be mixed in advance. Once it is mixed, it must be used immediately. Store Gonal-f 450 IU Multi-Dose at room temperature. Once mixed, it must be used within 28 days. Store Gonal-f RFF Pen 300 IU, 450 IU, 900 IU at room temperature for 28 days or refrigerate until expiration date. After initial use, store pen refrigerated or unrefrigerated for a maximum of 28 days.
GONAL-f® RFF 75 IU Vial
Supplies: |
75 IU Gonal-f® RFF vial of powdered medication, prefilled syringe of diluent, injection needle, alcohol wipes and Sharps container |
Mixing: |
Pop off the plastic top of powdered medication vial.
Swab the top of the vial with an alcohol pad to prevent contamination.
Hold the barrel of the prefilled syringe of diluent in one hand. Firmly hold the plastic cap between the thumb and forefinger of the other hand and with a downward motion, gently snap and pull off the cap. If the gray cap remains, simply remove it.
Attach the 18 gauge 1 ½” needle to syringe by pushing until tightened and remove needle cap.
NOTE Hold the base of the needle while removing needle cap.
Inject all of the contents of the prefilled diluent syringe into the vial of powdered medication.
Invert, or turn upside down, the syringe as one complete unit. Make sure the tip of the needle is BELOW the liquid level and pull the plunger to withdraw the entire contents of the vial.
NOTE: Withdraw liquid slowly and cautiously to prevent plunger from separating from syringe.• If you are mixing a single vial, you are now ready for your injection. Withdraw the needle from the vial and carefully recap and replace the mixing needle with the smaller subcutaneous injection needle (usually a ½” needle) and prepare for your injection. Invert the syringe so the needle is pointing upwards and tap the syringe to force any air bubbles to the top. Depress the plunger to expel the air.PROCEED TO SUBCUTANEOUS INJECTION INSTRUCTIONS |
If Mixing More than One Vial of
GONAL-f® RFF 75 IU
- Inject the contents of the syringe (powdered medication mixed with diluent) directly into the next vial of powdered medication, slowly and cautiously. (Do not use more diluent for additional vials of Gonal-f®RFF 75 IU). This will increase the dosage without increasing the liquid volume. Rotate the vial between your thumb and index finger until the solution is clear.
- Withdraw the newly mixed Gonal-f® RFF 75 IU from the second vial back into the syringe.
- Invert the syringe so the needle is pointing upwards and tap the syringe to force any air bubbles to the top. Depress the plunger to expel the air. Repeat until you have reached your prescribed vial dosage. Withdraw the medication mixture from the final vial into the syringe and prepare for your injection.
When you are ready for your injection, recap and remove the mixing needle and replace it with a smaller subcutaneous injection needle (usually ½” needle). PROCEED TO SUBCUTANEOUS INJECTION INSTRUCTIONS
Supplies: |
Prefilled syringe, Multi-Dose vial of medication, injection needle, alcohol wipes and Sharps container |
Mixing: |
op off the top of powdered medication of Gonal-f® Multi-Dose.
Swab the top of the vial with an alcohol pad to prevent contamination.
Remove the cap from the needle and inject all of the contents of the prefilled diluent syringe into the vial of powdered medication. DO NOT SHAKE VIAL.
After injecting the diluent into the Multi-Dose vial of Gonal-f, dispose of the syringe into the Sharps waste container. It is unnecessary to recap the needleas this could cause injury.Use the specifically marked syringes packaged with the medication. DO NOT USE THIS SYRINGE TO INJECT YOUR DOSE.
Swab the top of the vial with an alcohol pad to prevent contamination.
Firmly insert the needle through the rubber stopper into the vial. Invert, or turn upside down, the syringe as one complete unit. Make sure the tip of the needleis BELOW the liquid level and pull the plunger to withdraw the prescribed dose.
Withdraw the needle and prepare for your subcutaneous injection.
PROCEED TO SUBCUTANEOUS INJECTION INSTRUCTIONS |
Subcutaneous Administration
of Gonal-f
|
Cleanse your selected SUBCUTANEOUS injection site with an alcohol wipe and allow to dry.
Remove cover from needle and invert the syringe so the needle is pointing upwards and tap the syringe to force any air bubbles to the top. Depress the plunger to expel the air.
While holding the syringe with your dominant hand between your thumb and finger (as you would a pencil), pinch the skin (with your other hand) at the site you have selected.Cleanse your selected SUBCUTANEOUS injection site with an alcohol wipe and allow to dry.
While holding the syringe with your dominant hand between your thumb and finger (as you would a pencil), pinch the skin (with your other hand) at the site you have selected.
With a quick, dart-like motion, insert the entire needle (up to the hub of the syringe) at a 90° or a 45° angle and depress the plunger slowly and carefully.
After the injection is complete, quickly pull out the needle. If bleeding, apply pressure to the injection site with a sterile gauze pad. If stinging occurs after your injection, you may gently massage the injection site to alleviate your discomfort.
After injecting the medication dispose of the syringe into the Sharps waste container.
It is unnecessary to recap the needle as this could cause injury.
With a quick, dart-like motion, insert the entire needle (up to the hub of the syringe) at a 90° or a 45° angle and depress the plunger slowly and carefully.
After the injection is complete, quickly pull out the needle. If bleeding, apply pressure to the injection site with a sterile gauze pad. If discomfort occurs after your injection, you may gently massage the injection site to alleviate your discomfort.
After injecting the medication dispose of the syringe into the Sharps waste container.
It is unnecessary to recap the needle as this could cause injury. |
| |
|
|
