What Ceplene contains
- The active substance is histamine dihydrochloride. One vial contains 0.5 mg histamine dihydrochloride in 0.5 ml solution.
- The other ingredients are water for injections and sodium chloride, and it may also contain sodium hydroxide and/or hydrochloric acid for pH adjustment.
What Ceplene looks like and contents of the pack
Ceplene is a clear, colourless liquid. It is provided in a glass vial with a grey rubber stopper and a blue peel flip off aluminium tamper evident over seal.
Ceplene is available in pack sizes of 14 single-use vials.
Marketing Authorisation Holder
EpiCept GmbH, Goethestrasse 4, D-80336 München, Germany.
Catalent UK Packaging Ltd, Lancaster Way, Wingates Industrial Park, Westhoughton, Bolton, Lancashire, BL5 3XX, United Kingdom
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Meda Pharma S.A.N.V. Chaussée de la Hulpe 166 Terhulpsesteenweg 166 1170 Brussels TélTel 32 02 5 04 08 11 LuxembourgLuxemburg Meda Pharma S.A.N.V. Chaussée de la Hulpe 166 Terhulpsesteenweg 166 B-1170 Brussels Belgique Belgien TélTel 32 02 5 04 08 11
. 14 .3. 1421 . 359 2 950 44 10 Magyarország MEDA Pharma Hungary Kereskedelmi Kft. 1139 Budapest Váci ut 91 Tel 36 1 236 3410
eská republika Malta
MEDA Pharma s.r.o. Kodaská 1441 46 100 10 Praha 10 Tel 420 234 064 201 Alfred Gera Sons Ltd. 10 Triq Il Masgar Qormi Qrm 3217 Tel 356 21 446205
Danmark Meda AS Solvang 8 3450 Allerød Tlf 45 44 52 88 88 Nederland MEDA Pharma B.V. Krijgsman 20 1186 DM Amstelveen Tel 31 020 751 65 00
Deutschland MEDA Pharma GmbH Co. KG Benzstraße 1 61352 Bad Homburg Tel 49 0 6172 888 01 Norge Meda AS Askerveien 61 1384 Asker Tlf 47 66 75 33 00
Eesti Meda Pharma SIA Narva mnt. 11D EE10151 Tallinn Tel 372 62 61 025 Österreich MEDA Pharma GmbH Guglgasse 15 1110 Wien Tel 43 01 86 390 0
MEDA Pharmaceuticals A.E. , 3 GR-15231 - 30 210 6 77 5690 Polska Meda Pharmaceuticals Sp.z.o.o. Al. Jana Pawla II 15 00-828 Warszawa Tel 48 22 697 7100
Portugal MEDA Pharma - Produtos Farmacêuticos, S.A. Rua do Centro Cultural, 13 1749-066 Lisboa Tel 351 21 842 0300 España Meda Pharma S.A.U. Avenida de Castilla, 2 Parque Empresarial San Fernando Edificio Berlín 28830 San Fernando de Henares Madrid Tel 34 91 669 93 00
France MEDA Pharma SAS 25 Boulevard de lAmiral Bruix F-75016 Paris Tél 33 01 56 64 10 70 România SODIMED SRL B-dul Timioara, nr. 100G, sector 6 Bucureti Tel. 40 0 21 408 63 34
Slovenija Medical Intertrade d.o.o. Karlovka cesta 1 1000 Ljubljana Tel 386 1 2529 113 Ireland Meda Health Sales Ireland Ltd. Office 10 Dunboyne Business Park Dunboyne Co Meath Tel 353 1 802 66 24
Ísland Meda AB Box 906 170 09 Solna Svíjóð Slovenská republika MEDA Pharma spol. s. r.o. Trnavská cesta 50 821 02 Bratislava Tel 421 2 4914 0172
Sími: +46 8 630 1900
Italia Meda Pharma S.p.A. Viale Brenta, 18 20139 Milano Tel 39 02 57 416 1 SuomiFinland Meda Oy Vaisalantie 4Vaisalavägen 4 FI-02130 EspooEsbo PuhTel 358 20 720 9550
Sverige Meda AB Box 906 170 09 Solna Tel 46 08 630 1900 MEDA Pharmaceuticals A.E. , 3 GR-15231 - 30 210 6 77 5690
Latvija Meda Pharma SIA Ojra Vciea iela 13 LV-1004 Rga Tlr 371 7 805 140 United Kingdom Meda Pharmaceuticals Ltd. Skyway House Parsonage Road Takeley Bishops Stortford CM22 6PU Tel. 44 845 460 0000 Lietuva Meda Pharma SIA Veiveri g. 134 LT-46352 Kaunas Tel. 370 37330509
This leaflet was last approved in
This medicine has been authorised ?Exceptional circumstances?. This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicine. The European Medicines Agency will review any new information on this medicine every year and this package leaflet will be updated as necessary. Detailed information on this medicine is available on the European Medicine Agency website: http//:www.ema.europa.eu They are also links to other websites about rare diseases and treatments.
INSTRUCTIONS FOR SELF-INJECTION OF CEPLENE
This section contains information on how to give yourself an injection of Ceplene.
For general information about the dosage and how to use Ceplene and IL-2, please see Section 3, ?HOW TO USE CEPLENE?.
Read the following instructions carefully. It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. If you are not sure about how to give yourself the injection or you have any questions, please ask your doctor or nurse for help.
If you feel faint or dizzy during or after the injections, tell your doctor before injecting your next dose. Your doctor may want to increase the time you take to complete your injection, or change your dose.
You will have to inject Ceplene and IL-2 twice a day by subcutaneous injection (in the layer of tissue just under the skin), according to the directions provided by your doctor.
Always inject IL-2 first. Ceplene must be injected 1 to 3 minutes later.
Ceplene must not be mixed with any other products and must not be diluted.
Your doctor will explain to you how to prepare and inject IL-2.
It is recommended that you always have someone with you when injecting Ceplene, such as an adult family member, friend, or other care provider to help you if you feel light-headed or faint.
PREPARATION FOR INJECTION OF CEPLENE
To prepare a dose of Ceplene you will need the following:
- 1 vial of Ceplene solution (0.5 ml)
- 1 sterile syringe with needle
- 1 alcohol wipe
1 Take 1 vial out of the carton. Check the expiry date (EXP) on the vial label.
2. Do not use if the date has passed the last day of the month shown.
3. Wash your hands thoroughly with soap and water.
4. Double check the vial label to make sure you are using the correct medicine. The solution must be clear and colourless. If not, use another vial and inform your doctor or pharmacist.
5. Remove the plastic cap from the vial, exposing the stopper with the inner rubber circle.
6. Use an alcohol wipe to clean the rubber part of the stopper. Do not touch the stopper with your hands.
7. Pick up the sterile syringe. Notice the numbered marks on it. Each mark (0.1, 0.2, 0.3, etc) represents one-tenth of a millilitre (0.1 ml). With the needle cover on, pull back the plunger and draw air into the syringe to the level (number of millilitres) instructed by your doctor. See Figure 1.
8. Pull the needle cover straight off. With the vial standing on a flat surface, insert the needle straight through the rubber stopper into the vial.
9. Push the plunger of the syringe down to inject air into the vial. See Figure 2.
10 Holding both the vial and the syringe, turn the vial upside down. Adjust the syringe so that the tip of the needle is slightly above the rubber stopper but still within the solution. See Figure 3.
11. Slowly pull back the plunger to draw the solution into the syringe, filling it to the level (number of millilitres) instructed by your doctor. If bubbles appear in the syringe, push the solution slowly back into the vial and withdraw the solution again. 12 Take the needle out of the vial. Do not lay the syringe down or let the needle touch anything.
13. Replace the cover on the needle. Place the syringe on a clean flat surface.
14. There may be a small amount of solution left in the vial. This is to be returned to the pharmacist for disposal.
15. Double check the syringe to make sure that you have withdrawn the correct amount.
16. Take the syringe and follow the ?INSTRUCTIONS FOR INJECTION? information below.
INSTRUCTIONS FOR INJECTION
You will usually inject two doses of 0.5 ml in a day, unless your doctor has prescribed a lower dose for you.
For the injection you will need the following:
- 1 prepared syringe for your IL-2 injection (refer to the IL-2 package leaflet and your doctor?s dose instructions).
- 1 prepared syringe containing Ceplene.
- Alcohol wipe(s).
- A timer, clock or watch with a second hand.
- A puncture-proof container so you can dispose of used syringes safely.
1. Find a comfortable, well-lit place to sit and where you can lie back. Place the pre-prepared syringes containing IL-2, Ceplene and an opened alcohol wipe where you can reach them. For your safety it is very important that you are sitting where you can lean back or lie flat when you perform the injections.
2. Inject IL-2 as you have been instructed.
3. Wait 1 to 3 minutes.
4. Decide where you will inject Ceplene. You may choose the inner or outer thighs, arms or stomach. Ceplene and IL-2 must not be injected into the same region. For example, if you inject IL-2 in the left arm, you could inject Ceplene into the left or right thigh, the stomach, or the right arm. Always vary the site that you inject. For possible injection sites, see Figure 4.
5. Make sure that the area of the skin you selected is exposed. Use an alcohol wipe to clean it. Allow the area to dry for 10 seconds.
6. Pinch up a section of the cleaned skin between your thumb and forefinger, without squeezing it. See Figure 5.
7 Hold needle either vertically (90°) or at a 45° angle to the skin and insert it under the skin as far as it will go in one quick motion. The needle must be inserted under the skin, but not into any blood vessels below the skin. See Figure 6.
8. Slightly pull back the plunger. If blood appears, do not inject Ceplene because the needle has entered a blood vessel.
Withdraw and discard the syringe as instructed. Obtain new supplies and start the procedure over again, even if 3 minutes have passed after injection of IL-2.
9. Notice the numbered marks on each syringe. Each mark (0.1, 0.2, 0.3, etc.) represents one-tenth of a millilitre (0.1 ml).
10. Push down the syringe plunger and inject one-tenth of a millilitre (0.1 ml) every minute, or more slowly if instructed to do so by your doctor. See Figure 7.
11 12 13 14 15 Never inject Ceplene any faster or all at once. When the syringe is empty, remove the needle from your skin. Apply gentle pressure with the alcohol wipe over the injection site without rubbing it. Remain seated or lying down for 20 minutes after injecting Ceplene. Dispose of the syringe in the puncture-proof container as instructed.