Patient information: uses, side effects, how to take - Camcevi
Instructions for Use
 | You must read these complete instructions before you administer CAMCEVI for the first time. CAMCEVI must be administered by a healthcare provider. |
What is CAMCEVI?
CAMCEVI is a subcutaneous injection that provides long-acting gonadotropin releasing hormone (GnRH) agonist to patients. CAMCEVI contains a biodegradable polymer formulation dissolved in a biocompatible solvent that provides sustained release of leuprolide.
CAMCEVI is supplied as a kit containing one sterile, pre-filled syringe for subcutaneous injection, one sterile 18-gauge needle, one Point-Lok® needle protection device, and Instructions for Use.
Dosage
The recommended dosing is 1 subcutaneous injection (42 mg leuprolide) every 6 months.
Before you begin to prepare CAMCEVI Injection
Read these critical instructions.
Do not substitute any of the components from the kit for administration.
CAMCEVI is packaged in a blister in the kit. Check to make sure the kit contains:
- One sterile, single-dose prefilled syringe with plunger rod and backstop
- One sterile 18-gauge, 5/8-inch needle
- One Point-Lok® needle protection device
- Instructions for Use and Prescribing Information
Bring CAMCEVI to room temperature
STEP
To bring CAMCEVI to room temperature:
1
Remove CAMCEVI kit from refrigerator. Open carton and remove blister.
Allow prefilled syringe to sit at room temperature for 30 minutes prior to subcutaneous injection.
Prepare the syringe
STEP
Follow these steps to prepare CAMCEVI for use:
1
Examine all contents of the package. Do not use if any component is damaged.
2
Check the expiration date on the syringe. Do not use if the expiration date has passed.
3
The use of gloves is recommended during syringe assembly and administration.
4
On a clean, dry surface, remove pre-filled syringe (A) and needle cartridge (B) from the blister carton. Visually inspect the contents prior to use.
5
Remove the gray cap from the syringe (A). Twist the clear cap off the bottom of the needle cartridge (B).
6
Attach the needle (B) to the end of the syringe (A) by pushing and turning the needle until firmly connected to the syringe. Do not over twist the needle and strip the threading.
Assembled Pre-Filled Syringe
Select an injection site
STEP
To select an injection site, use these guidelines:
1
Choose an injection site on the upper- or mid-abdominal area with sufficient soft or loose subcutaneous tissue that has not recently been used. Clean the injection site with an alcohol swab.
Do NOT inject in areas with brawny or fibrous subcutaneous tissue or locations that can be rubbed or compressed (i.e., with a belt or clothing waistband). In addition, avoid applying heat directly to the site of Camcevi injection.
Inject CAMCEVI
STEP
Follow these steps to inject CAMCEVI:
1
Pull the blue cover off the needle (B). Use standard sharps safety techniques to avoid needle sticks.
2
Use standard aseptic technique when performing the injection.
Grab and bunch the skin around the injection site with one hand. Insert the needle at a 90° angle to the skin surface, and then release the bunched skin.
3
Inject the full contents of the syringe with a slow and steady push on the plunger, and then withdraw the needle at the same 90° angle used for insertion.
4
Do not remove the needle from the syringe. Use the enclosed Point-Lok® device to prevent needle sticks.
Retrieve the Point-Lok® needle protection device from the Camcevi kit and place it on a secured, flat surface with its largest surface base touching the surface as shown in the diagram below.
Immediately after use of the needle, gently insert the exposed needle into the Point-Lok® device opening at the top of the Point-Lok® device. (see Figure 1 below)
Push the needle into the top opening until it is fully inserted into the Point-Lok® device. This action will seal the needle tip and lock the needle firmly into the Point-Lok® device. (see Figure 2 below)
After use, place the used syringe with needle protected in a suitable sharps container. Dispose of contaminated product in a safe manner according to Centers for Disease Control and Prevention, USA and Federal/State/Local regulations (EPA, OSHA) and health care facility guidelines or local equivalent.
Manufactured for:
Foresee Pharmaceuticals Co. Ltd.
9F-2, No. 19-3, Sanchong Rd., Nangang Dist., Taipei City 115, Taiwan
By:
Fareva Pau 1
Avenue du Bearn, 64320 Idron, France