What Betaferon contains:
The active substance is Interferon beta-1b, 250 microgram per millilitre when reconstituted.
The other ingredients are
- in the powder: mannitol and human albumin,
- in the solvent (sodium chloride solution 5.4 mg/ml (0.54 % (w/v))): sodium chloride, water for injections.
The Betaferon powder is provided in a 3-millilitre vial, containing 300 microgram (9.6 million IU) Interferon beta-1b per vial. After reconstitution each millilitre contains 250 microgram (8 million IU) Interferon beta-1b.
The solvent for Betaferon is provided in a 2.25-millilitre pre-filled syringe and contains 1.2 ml sodium chloride solution 5.4 mg/ml (0.54%).
What Betaferon looks like and contents of the pack:
Betaferon is a sterile white to off-white powder for solution for injection.
Betaferon is available in pack sizes of:
- multipacks comprising 5 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
- multipacks comprising 12 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
- multipacks comprising 14 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
- multipacks comprising 15 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
- 2-month packs comprising 2x14 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
- 3-month packs comprising 3x15 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
- 3-month packs comprising 3x14 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
- titration pack for the first 12 injections comprising 4 triple packs, each containing 3 vials with powder, 3 pre-filled syringes with solvent, 3 vial adapters with needle, 6 alcohol wipes
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer:
Bayer Schering Pharma AG, D-13342 Berlin, Germany
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. The list of local representatives is located at the end of this leaflet/booklet.
BelgiëBelgiqueBelgien Bayer SA-NV Tel. 32-02-535 63 11 . 359-02-81 401 01 eská republika Bayer s.r.o. Tel 420-2-66 101 111 Danmark Bayer AS Tel.45-45 235 000 Deutschland Bayer Vital GmbH Tel. 49-0214-30 513 48 Eesti Bayer OÜ Tel. 372-655 85 65 Bayer . 30-210-618 75 00 España. Química Farmacéutica Bayer S.L. Tel. 34-93-495 65 00 France Bayer Santé Tel. 33-03-28 16 34 00 Ireland Bayer Limited Tel. 353-01-2999 313 Ísland Icepharma hf. Tel 354-540 8000 Italia Bayer S.p.A. Tel. 39-02-3978 1 NOVAGEM Limited 357-22-747 747 Latvija SIA Bayer Tel. 371-67 84 55 63 Lietuva UAB Bayer Tel. 370-5-233 68 68 LuxembourgLuxemburg TélTel. 32-02-535 63 11 see BelgiëBelgiqueBelgien Bayer SA-NVMagyarország Bayer Hungária KFT Tel. 36-1-487 4100 Malta Alfred Gera Sons Ltd Tel. 356-21 44 62 05 Nederland Bayer B.V., Bayer Schering Pharma Tel. 31-0297-28 06 66 Norge Bayer AS Tlf 47-24 11 18 00 Österreich Bayer Austria Ges.m.b.H. Tel. 43-01-711 460 Polska Bayer Sp. z o.o. Tel. 48-22-572 35 00 Portugal Bayer Portugal S.A. Tel. 351-21-416 42 00 România SC Bayer SRL Tel. 40-021-528 59 00 Slovenija Bayer d.o.o. Tel. 386-01-58 14 400 Slovenská republika Bayer, spol. s r.o. Tel. 421-02-59 21 31 11 SuomiFinland Bayer Oy, Bayer Schering Pharma Puh.Tel. 358-020-78521 Sverige Bayer AB Tel. 46-08-580 223 00 United Kingdom Bayer plc Tel. 44-01635-56 30 00
This leaflet was last approved in
Annex: SELF-INJECTION PROCEDURE
Your doctor has prescribed Betaferon to treat your MS. You will best tolerate Betaferon in the beginning if you start with a low dose and gradually increase to the full standard dose (see first part of this leaflet, section 3. ?How to use Betaferon?). To easily increase the dosage during the first 12 injections, you may be given a special titration pack, containing four differently coloured triple packs with special marked syringes and with detailed instructions on the separate introductory leaflet for titration pack. The syringes in this titration pack are marked accordingly with the appropriate doses (0.25; 0.5; 0.75 or 1.0 ml).
The following instructions and pictures 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 their assistant 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.
PART I:STEP BY STEP INSTRUCTIONS
The instructions include the following main steps:
A) General advice
B) Getting ready to inject
C) Reconstituting the solution, step by step
D) Drawing up the injection
E) Making the injection
F) Quick review of the process
A) General advice
Get a good start
You will find that within a few weeks your treatment 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 reach of children so your Betaferon and other supplies are always easy to find. For details on storage conditions see section 5. ?How to store Betaferon ? in the first part of this leaflet.
- 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 section 5. ?How to store Betaferon? in the first part of this leaflet).
Important tips to keep in mind
- Be consistent - use Betaferon as described in section 3. ?How to use Betaferon? in the first part of this leaflet. Always double-check your dosage.
- Keep your syringes and syringe disposal unit out of the reach of children; lock the supplies away if possible.
- Never re-use syringes or needles.
- Always use a sterile (aseptic) technique as described in here.
- 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 healthcare professional 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 at the end of the Annex (see Part II, ?Rotating injection sites?) 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 at the end of this Annex to learn how to choose an injection site. An example of a medication record is also included (see Annex Part III). 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%)),
- 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. If you have a Betaferon titration pack you will find 4 differently coloured and numbered triple packs, each containing:
- 3 Betaferon vials (with powder for solution for injection)
- 3 pre-filled syringes with solvent for the Betaferon powder (sodium chloride solution 5.4 mg/ml (0.54%))
- 3 vial adapters with a pre-attached needle
- 6 alcohol wipes for skin and vial cleaning In addition you will need a disposal unit for used syringes and needles. For skin disinfection use an appropriate disinfectant.
Start with the yellow triple pack 1 containing 3 syringes with a 0.25-ml marking, for treatment days 1, 3 and 5.
Use then the red triple pack 2 containing 3 syringes with a 0.5-ml marking, for treatment days 7, 9 and 11.
Continue with the green triple pack 3 containing 3 syringes with a 0.75-ml marking, for treatment days 13, 15 and 17.
Use the blue triple pack 4 containing 3 syringes with a 0.25; 0.5; 0.75 and 1.0-ml marking, for treatment days 19, 21 and 23.
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 with a clockwise push and twist motion see arrow. 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. This applies also to the titration pack.
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.
With the titration pack, withdraw solution only up to the mark on the syringe:
0.25 ml for first three injections(at day 1, 3, 5 of therapy), or
0.5 ml for the injectionsat day 7, 9, 11 of therapy, or
0.75 ml for the injectionsat day 13, 15, 17 of therapy.
Discard the vial with any remaining solution.
From day 19 you are injecting the full dose 1.0 ml.
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 you are injecting less than 1 ml with the titration pack there might not be any air bubbles, however for full dose injection some air bubbles might turn up. Remove them by gently tapping the syringe and pushing the plunger to the respective marking on the syringe.
If too much solution enters the vial along with the air bubbles, get back into the horizontal position (see pict. 13) 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 (see advice at the start and the diagrams at the end of this Annex), 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.
PART II 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 in the first part of this Annex. It is a good idea to know where you plan to inject before you prepare your syringe. The schedule shown in the diagram below 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 through the diagram 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, 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
ROTATION SCHEDULE:
AREA 1 AREA 2 AREA 3 AREA 4 10 15 cm from groin AREA 5 AREA 6
AREA 8 AREA 7
PART III: BETAFERONMedication 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 (see the example: ?Keeping track of your injection sites and dates?).
EXAMPLE OF A MEDICATION RECORD:
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Separate Annex: INTRODUCTORY LEAFLET FOR TITRATION PACK
Your doctor has prescribed Betaferon to treat your MS. You will best tolerate Betaferon in the beginning if you start with a low dose and gradually increase to the full standard dose (see first part of the package leaflet, section 3. ?How to use Betaferon?). The syringes in this titration pack are marked accordingly with the appropriate doses (0.25; 0.5; 0.75 or 1.0 ml).
Checking the content of the pack
You will find in the Betaferon titration pack 4 differently coloured and numbered triple packs, each containing:
- 3 Betaferon vials (with powder for solution for injection)
- 3 pre-filled syringes with solvent for the Betaferon powder (sodium chloride solution 5.4 mg/ml (0.54%))
- 3 vial adapters with a pre-attached needle
- 6 alcohol wipes for skin and vial cleaning Each triple pack contains the syringes you will require for preparing each dose. The syringes have special markings for this dose. Please follow in detail the instructions for use below. For each titration step use the complete amount of solvent for reconstitution of the Betaferon powder, then draw up the required dose into the syringe.
Start by using the yellow triple pack which is clearly marked with a ?1? on the top right hand side of the box.
This first triple pack should be used for treatment days 1, 3 and 5.
It contains specially marked syringes with 0.25 ml marking. This will help you to inject the required dose only.
After finishing with the yellow pack, start using the red triple pack which is clearly marked with a "2" on the top right hand side of the box.
This second triple pack should be used for treatment days 7, 9 and 11.
It contains specially marked syringes with 0.50 ml marking. This will help you to inject the required dose only.
After finishing with the red pack, start using the green triple pack which is clearly marked with a "3" on the top right hand side of the box
This third triple pack should be used for treatment days 13, 15 and 17.
It contains specially marked syringes with 0.75 ml marking. This will help you to inject the required dose only.
Finally, after finishing with the green pack, start using the blue triple pack which is clearly marked with a "4" on the top right hand side of the box. This last triple pack should be used for treatment days 19, 21 and 23.
It contains syringes with 0.25, 0.5, 0.75 and 1.0 ml markings. With triple pack ?4? you can inject the full dose 1.0 ml.
For a description of how to prepare and use the Betaferon powder, please refer to section 3. ?How to use Betaferon?in the first part of the package leaflet and to the Annex 'Self-injection procedure' in the second part of the package leaflet.
In addition you will need a disposal unit for used syringes and needles.