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CONTRACEPTION AND ENDOMETRIOSIS INDICATIONS

Route of Administration
depo-subQ provera 104^™ must be given by subcutaneous injection into the anterior thigh or abdomen, once every 3 months (12 to 14 weeks). depo-subQ provera 104^™ is not formulated for intramuscular injection. Dosage does not need to be adjusted for body weight. The pre-filled syringe of depo-subQ provera 104^™ must be vigorously shaken just before use to create a uniform suspension.

First Injection
Ensure that the patient is not pregnant at the time of the first injection. For women who are sexually active and having regular menses, the first injection should be given only during the first 5 days of a normal menstrual period. Women who are breast-feeding may have their first injection during or after their sixth postpartum week.

Second and Subsequent Injections
Dosing is every 12 to 14 weeks. If more than 14 weeks elapse between injections, pregnancy should be ruled out before the next injection.

IF USING FOR CONTRACEPTION AND SWITCHING FROM ANOTHER METHOD
When switching from other contraceptive methods, depo-subQ provera 104^™ should be given in a manner that ensures continuous contraceptive coverage. For example, patients switching from combined (estrogen plus progestin) contraceptives should have their first injection of depo-subQ provera 104^™ within 7 days after the last day of using that method (7 days after taking the last active pill, removing the patch or ring). Similarly, contraceptive coverage will be maintained in switching from Depo-Provera CI (150 mg) to depo-subQ provera 104^™, provided the next injection is given within the prescribed dosing period for Depo-Provera CI (150 mg).

IF USING FOR TREATMENT OF ENDOMETRIOSIS
Treatment for longer than two years is not recommended, due to the impact of long-term depo-subQ provera 104^™ on bone mineral density. If symptoms return after discontinuation of treatment, bone mineral density should be evaluated prior to retreatment.

Instructions for Administration of depo-subQ provera 104^™ for Subcutaneous Use

Getting ready
Ensure that the medication is at room temperature. Make sure the following components (Diagrams 1, 2, and 3) are available.

depo-subQ provera 104^™, as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.

Step 1: Choosing and preparing the injection area.
Choose the injection area. Avoid boney areas and the umbilicus. See shaded areas (Diagram 4).

Use an alcohol pad to wipe the skin in the injection area you have chosen. Allow the skin to dry.

Step 2: Syringe preparation
Gently twist off the protective end cap from the needle to break the seal (Diagram 5). Set aside.

While holding the syringe firmly by the barrel pointing upward, shake it forcefully for at least 1 minute to thoroughly mix the medication (Diagram 6).

Hold the syringe barrel firmly, remove the protective tip cap from the syringe and attach the needle by pushing it onto the barrel tip (Diagram 7).

While continuing to hold the syringe barrel firmly, remove the clear protective plastic cover from the needle, making sure the needle is still firmly attached to the syringe (Diagram 8).

While holding the syringe with the needle pointing upward, gently push in the plunger until the medicine is up to the top of the syringe (Diagram 9).

Step 3: Injecting the dose.
Gently grasp and squeeze a large area of skin in the chosen injection area between the thumb and fore-finger (Diagram 10) pulling it away from the body.

Insert the needle at a 45 degree angle so that most of the needle is in the fatty tissue. The plastic hub of the needle should be nearly or almost touching the skin (Diagram 11).

Inject the medication slowly until the syringe is empty (Diagram 12). This should take about 5-7 seconds.

The entire dose must be given to activate the needle guard. When the entire dose is completely injected, gently pull the needle out of the skin. Remove your finger from the plunger, allowing the syringe to move up inside the device until the needle guard completely covers the exposed needle. You will hear a 'click' when the needle guard is fully activated. It is very important that the entire dose of depo-subQ provera 104^™ is given.

Use a clean cotton pad to press lightly on the injection area for a few seconds. Do NOT rub the area.

Following the administration of each dose, the used syringe should be discarded in a safe and proper manner.

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