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Self-injection procedure: The following instructions explain how to prepare Betaferon for injection and how to inject Betaferon yourself. Please read the instructions carefully and follow them step by step. Your doctor or nurse will help you to learn the process of self-administration. Do not attempt to inject yourself until you are sure that you understand how to prepare the injection solution and give the injection to yourself.
STEP BY STEP INSTRUCTIONS: A) General advice: Get a good start. You will find that within a few weeks your therapy will become a natural part of your routine. As you get started, you may find the following helpful: Set up a permanent storage area in a convenient location out of the sight and reach of children so your Betaferon and other supplies are always easy to find.
For details on storage conditions, see Storage.
Try to give your injection at the same time of day. This makes it easier to remember and easier to plan a block of time when you will not be interrupted.
Prepare each dose only when you are ready for an injection. After mixing Betaferon, you should give the injection immediately (if Betaferon is not used immediately, see Shelf life under Storage).
Important tips to keep in mind: Be consistent - use Betaferon as described in Dosage & Administration. Always double-check your dosage.
Keep your syringes and syringe disposal unit out of the sight and reach of children; lock the supplies away if possible.
Never re-use syringes or needles.
Always use a sterile (aseptic) technique as described.
Always place the used syringes in the proper disposal unit.
B) Getting ready to inject: Choosing an injection site: Before preparing your injection, decide where you are going to inject. You should inject Betaferon into the fatty layer between the skin and muscle (that is, subcutaneously, about 8 to 12 mm under the skin). The best places for injections are where the skin is loose and soft, and away from joints, nerves, or bones, for example the abdomen, arm, thigh or buttocks.
Important: Do not use any area where you can feel lumps, bumps, firm knots, pain or an area that is discoloured, indented, scabbed, or where the skin is broken. Talk to your doctor or nurse about these or any other unusual conditions you may find.
You should rotate the injection site at every injection. If some areas are too difficult for you to reach, you may need a family member or friend to help you with these injections. Follow the sequence described in the schedule (see Rotating injection sites as follows) and you will come back to your first injection site area after 8 injections (16 days). This will give each injection site a chance to fully recover before receiving another injection.
Please refer to the rotation schedule to learn how to choose an injection site. An example of a medication record is also included (see as follows). This should give you an idea of how you can keep track of your injection sites and dates.
Checking the content of the pack: In the Betaferon pack you will find: 1 Betaferon vial (with powder for solution for injection), 1 pre-filled syringe of solvent for Betaferon (sodium chloride solution 5.4 mg/ml (0.54% w/v)), 1 vial adapter with a pre-attached needle, 2 alcohol swabs to clean the skin and vial.
In addition you will need a disposal unit for used syringes and needles.
For skin disinfection use an appropriate disinfectant.
C) Reconstituting the solution, step by step: 1 - Wash your hands thoroughly with soap and water before beginning this process.
2 - Open the Betaferon vial and put it on the table. It is best to use your thumb rather than your nail as it could break.
3 - Clean the top of the vial with an alcohol wipe, moving the wipe in one direction only. Leave the wipe on top of the vial.
4 - Open the blister pack containing the vial adapter, but leave the vial adapter inside.
Do not remove the vial adapter from the blister pack at this stage.
Do not touch the vial adapter. This is to keep it sterile.
5 - Before attaching the adapter, remove and discard the alcohol wipe and rest the vial on a flat surface.
6 - Hold the blister pack on the outside and place it on top of the vial. Push it down firmly until you feel it snap into place on the vial.
7 - Remove the blister pack from the vial adapter, holding the blister edges. Now you are ready to attach the pre-filled solvent syringe to the vial adapter.
8 - Pick up the syringe. Be sure that the orange tip cap is firmly attached to the solvent syringe.
Remove the tip cap by twisting it off. Throw away the tip cap.
9 - Connect the syringe to the opening on the side of the vial adapter by inserting the end of the syringe and tightening carefully by a clockwise "push and twist" motion. This will form the syringe assembly.
10 - Hold the syringe assembly at the bottom of the vial. Slowly push the plunger of the syringe in all the way to transfer all of the solvent into the vial. Release the plunger, which may go back to its original position.
11 - With the syringe assembly still attached, swirl the vial around gently to completely dissolve the dry Betaferon powder.
Do not shake the vial.
12 - Examine the solution carefully. It should be clear and contain no particles. If the solution is discoloured or contains particles, discard it and start again with a new single pack of supplies. If foam is present - which can happen if the vial is shaken or swirled too much - let the vial sit undisturbed until the foam settles.
D) Drawing up the injection: 13 - If the plunger has moved back to its original position, push it in again and hold it in place. To prepare your injection, turn the assembly over so that the vial is on top, cap side pointing down. Doing this allows the solution to flow down into the syringe.
Keep the syringe horizontal.
Slowly pull the plunger back to withdraw all the solution out of the vial and into the syringe.
14 - After drawing up the solution, turn the syringe assembly so that the needle is pointing up. This allows any air bubbles to rise to the top of the solution.
15 - Remove any air bubbles by gently tapping the syringe and pushing the plunger to the 1-ml mark, or to the volume prescribed by your doctor.
If too much solution enters the vial along with the air bubbles, get back into the horizontal position and pull the plunger back a little to withdraw the solution back into the syringe.
16 - Next, hold the blue vial adapter with the attached vial and remove it from the syringe by twisting it and then pulling it down, away from the syringe.
Only hold the blue plastic adapter when removing. Keep the syringe in a horizontal position and the vial below the syringe.
Removing the vial and adapter from the syringe ensures that the solution will flow out from the needle when injected.
17 - Dispose of the vial and any unused portion of the solution in the disposal unit.
18 - You are now ready to inject.
If, for some reason, you are not able to inject the Betaferon immediately, you can keep the reconstituted solution in the syringe in a refrigerator for up to 3 hours before using. Do not freeze the solution, and do not wait longer than 3 hours to inject it. If more than 3 hours pass, discard the reconstituted Betaferon solution and prepare a new injection. When you use the solution, warm it up in your hands before injecting to avoid pain.
E) Making the injection: 1 - Choose an area for the injection, and make a note of it in your medication record.
2 - Use an alcohol wipe to clean the skin at the injection site. Let the skin air-dry. Throw the wipe away.
For skin disinfection use an appropriate disinfectant.
3 - Remove the cap from the needle by pulling not twisting it.
4 - Gently pinch the skin together around the disinfected injection site (to raise it up a little).
5 - Holding the syringe like a pencil or a dart, push the needle straight into the skin at a 90° angle with a quick, firm motion. Please note: Betaferon can also be administered with an auto-injector.
6 - Inject the medicine using a slow, steady push on the plunger. (Push the plunger all the way in until the syringe is empty.)
7 - Discard the syringe in the disposal unit.
F) Quick review of the process: Take out the required content for one injection; Attach vial adapter to the vial; Connect the syringe to the vial adapter; Push syringe plunger to transfer all the solvent into the vial; Turn the syringe assembly over and draw up the prescribed amount of the solution; Remove vial from syringe - you are now ready to inject.
NOTE: The injection should be administered immediately after mixing (if the injection is delayed, refrigerate the solution and inject it within 3 hours). Do not freeze.
ROTATING INJECTION SITES: You need to choose a new site for each injection to allow the area time to recover and help prevent infection. Advice on which areas to choose is given previously. It is a good idea to know where you plan to inject before you prepare your syringe. The schedule as follows will help you to vary the sites appropriately. For example, give the first injection into the right side of the abdomen, choose the left side for the second injection, then move to the right thigh for the third, and so on until all suitable areas of the body have been used. Keep a record of where and when you last gave yourself an injection. One way to do that is to note the injection site on the enclosed medication record card.
By following this schedule, you will come back to your first area (e.g. the right side of the abdomen) after 8 injections (16 days). This is called a Rotation Cycle. On our example schedule each area is split again into 6 injection sites (which adds up to 48 injection sites all together), left and right, upper, middle and lower part of each area. If you come back to an area after one Rotation Cycle, choose the most distant injection site within this area. If an area becomes sore, talk to your doctor or nurse about choosing other injection sites.
Rotation Schedule: To help you rotate the injection sites appropriately, we recommend that you keep a record of the date and location of your injection. You can use the following rotation schedule.
Work through each rotation cycle in turn. Each cycle will be 8 injections (16 days), given in area 1 through to area 8 in turn. By following this sequence, you will give each area a chance to recover before receiving another injection.
Rotation Cycle 1: Upper left section of each area.
Rotation Cycle 2: Lower right section of each area.
Rotation Cycle 3: Middle left section of each area.
Rotation Cycle 4: Upper right section of each area.
Rotation Cycle 5: Lower left section of each area.
Rotation Cycle 6: Middle right section of each area.
Area 1: Right Arm (upper back portion); 10-15 cm from shoulder, 10-15 cm from elbow.
Area 2: Left Arm (upper back portion); 10-15 cm from shoulder, 10-15 cm from elbow.
Area 3: Right Abdomen (leave about 5 cm on right side of navel).
Area 4: Left Abdomen (leave about 5 cm on left side of navel).
Area 5: Right Thigh; 10-15 cm from groin, 10-15 cm from knee.
Area 6: Left Thigh; 10-15 cm from groin, 10-15 cm from knee.
Area 7: Right Buttock.
Area 8: Left Buttock.
BETAFERON MEDICATION RECORD: Instructions for keeping track of your injection sites and dates: Select an injection site for your first injection.
Clean the injection site with an alcohol wipe and let it air-dry.
After your injection, fill in the used injection site and date on the table in your injection record.
