What ADVATE contains
- The active substance is octocog alfa (human coagulation Factor VIII produced by recombinant DNA technology). Each powder vial contains 2000 IU octocog alfa.
- The other ingredients are mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, and glutathione (reduced).
Solvent vial: 5 ml sterilised water for injections
What ADVATE looks like and contents of the pack
ADVATE is a white to off-white friable powder. After reconstitution, the solution is clear, colourless and free from foreign particles.
Each pack also contains a device for reconstitution (BAXJECT II).
Marketing Authorisation Holder
Baxter AG
Industriestrasse 67
A-1221 Vienna
Manufacturer
Baxter SA
Boulevard René Branquart 80
B-7860 Lessines
Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Baxter Belgium SPRL Bd. de la PlainePleinlaan 5 B-1050 BrusselBruxellesBrüssel TélTel 32 2 650 1711 LuxembourgLuxemburg Baxter Belgium SPRL Bd. de la PlainePleinlaan 5 B-1050 BruxellesBrüssel TélTel 32 2 650 1711
. 4 1000 . 359 2 9808482 Magyarország Baxter Hungary Kft Népfürd u. 22. H-1138 Budapest Tel. 361 202 19 80
eská republika Baxter Czech spol.s.r.o. Opletalova 55 CZ-110 00 Praha 1 Tel. 420 225774111 Malta Baxter Healthcare Ltd Wallingford Road, Compton Newbury Berkshire RG20 7QW - UK Tel. 44 1635 206345
Danmark Baxter AS Gydevang 43 DK-3450 Allerød Tlf 45 48 16 64 00 Nederland Baxter B.V. Kobaltweg 49 NL-3542 CE Utrecht Tel 31 30 2488911
Deutschland Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Tel 49 89 31 701-0 Norge Baxter AS Gjerdrumsvei 11 N-0486 Oslo Tlf 47 22 58 4800
Eesti AS Oriola Kungla 2 EE-76505 Saue Tel. 372 6 515 100 Österreich Baxter Vertriebs GmbH Landstraer Hauptstrae 99 Top 2A A-1031 Wien Tel. 43 1 71120 0
Polska Baxter Polska Sp. z o.o. ul. Kruczkowskiego 8 PL-00-380 Warszawa Tel. 48 22 4883 777 Baxter Hellas ... 34 GR-163 41 . 30-210-99 87 000
España Baxter S.L. Pouet de Camilo, 2 E- 46394 Ribarroja del Turia Valencia Tel 34 96 2722800 Portugal Baxter Médico Farmacêutica Lda Sintra Business Park Zona Industrial da Abrunheira, Edifício 10 P-2710-089 Sintra Tel 351 21 925 25 00
France Baxter SAS 6 Avenue Louis Pasteur F-78310 Maurepas Tél 33 1 3461 5050 România FARMACEUTICA REMEDIA SA B-dul Metalurgiei nr. 78 sector 4 Bucureti 041836-RO Tel. 40-21-321 16 40
Ireland Baxter Healthcare Ltd Unit 7 Deansgrange Industrial Estate IRL-Blackrock, Dublin Tel 353 1 2065500 Slovenija Baxter d.o.o. elezna cesta 14 SI-1000 Ljubljana Tel. 386 1 420 16 80
Ísland Lyfjaver ehf. Suðurlandsbraut 22 IS-108 Reykjavík Sími 354 533 6100 Slovenská republika Baxter AG, o. z. Dúbravská cesta 2 SK-841 04 Bratislava Tel 421 2 59418455
Italia Baxter S.p.A. Piazzale dellIndustria, 20 I-00144 Roma Tel 39 06 324911 SuomiFinland Baxter Oy Valimotie 15 A FIN-00380 Helsinki PuhTel 358 9 8621111
Baxter Hellas ... 34 GR-163 41 . 30-210-99 87 000 Sverige Baxter Medical AB Box 63 Torshamnsgatan 35 S-164 94 Kista Tel 46 8 6326400
Latvija BAXTER AG Latvijas filile Dzelzavas iela 117 Rga, LV 1021 Tel. 371 67 784 784 United Kingdom Baxter Healthcare Ltd Wallingford Road, Compton Newbury Berkshire RG20 7QW - UK Tel 44 1635 206345
Lietuva
UAB TAMRO atstovyb-
S. -ukausko g. 29-1
LT-09129 Vilnius
Tel: +370 5 269 16 91
This leaflet was last approved in
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INSTRUCTIONS FOR PREPARATION AND ADMINISTRATION
Aseptic technique is required during preparation of the solution and administration.
Use only the sterilised water for injections and the reconstitution device for preparation of the solution that are provided with each package of ADVATE. ADVATE must not be mixed with other medicinal products or solvents.
Instructions for reconstitution Do not use after the expiry date stated on the labels and carton. Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration as indicated by the symbol . Do not refrigerate the solution after preparation.
1. If the product is still stored in a refrigerator, take both the ADVATE powder and solvent vials from the refrigerator and let them reach room temperature (between 15°C and 25°C).
2. Wash your hands thoroughly using soap and warm water.
3. Remove caps from powder and solvent vials.
4. Cleanse stoppers with alcohol swabs. Place the vials on a flat clean surface.
5. Open the package of BAXJECT II device by peeling away the paper lid without touching the inside (Fig. a). Do not remove the device from the package. Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
6. Turn the package over and insert the clear plastic spike through the solvent stopper. Grip the package at its edge and pull the package off BAXJECT II (Fig. b). Do not remove the blue cap from the BAXJECT II device.
7. For reconstitution only the water for injections and the reconstitution device provided in the pack should be used. With BAXJECT II attached to the solvent vial, invert the system so that the solvent vial is on top of the device. Insert the white plastic spike through the ADVATE stopper. The vacuum will draw the solvent into the ADVATE vial (Fig. c).
8. Swirl gently until all material is dissolved. Be sure that ADVATE is completely dissolved, otherwise not all reconstituted solution will pass through the device filter. The product dissolves rapidly (usually in less than 1 minute). After reconstitution the solution should be clear, colourless and free from foreign particles.
Fig. a Fig. b Fig. c
Instructions for injection
For administration the use of a luer-lock syringe is required.
Important note:
- Do not try to administer the injection unless you have received special training from your doctor or nurse.
- Inspect the prepared solution for particulate matter and discoloration prior to administration (the solution should be clear, colourless and free from foreign particles). Do not use ADVATE if the solution is not fully clear or not completely dissolved.
1. Remove the blue cap from BAXJECT II. DO NOT DRAW AIR INTO THE SYRINGE. Connect the syringe to BAXJECT II (Fig. d).
2. Invert the system (the vial with the reconstituted solution has to be on top). Draw the reconstituted solution into the syringe by pulling the plunger back slowly (Fig. e).
3. Disconnect the syringe.
4. Attach a butterfly needle to the syringe. and inject the reconstituted solution into a vein. The solution should be administered slowly, at a rate as determined by the patient?s comfort level, not to exceed 10 ml per minute. (See Section 4 ?Possible side effects?).
5. Discard any unused solution appropriately.
Fig. d Fig. e
------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
In case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period. The following table can be used to guide dosing in bleeding episodes and surgery.
The dose and frequency of administration should be adapted to the clinical response in the individual case. Under certain circumstances (e.g. presence of a low-titre inhibitor), doses larger than those calculated using the formula may be necessary.
Degree of haemorrhagetype of surgical procedure Factor VIII level required or IUdl Frequency of doses hoursduration of therapy days Haemorrhage 20 40 Early haemarthrosis, muscle bleeding or oral bleeding. Repeat injections every 12 to 24 hours 8 to 24 hours for patients under the age of 6 for at least 1 day, until the bleeding episode, as indicated by pain, is resolved or healing is achieved. 30 60 More extensive haemarthrosis, muscle bleeding or haematoma. Repeat injections every 12 to 24 hours 8 to 24 hours for patients under the age of 6 for 3 4 days or more until pain and acute disability are resolved. Life-threatening haemorrhages. 60 100 Repeat injections every 8 to 24 hours 6 to 12 hours for patients under the age of 6 until threat is resolved. Surgery 30 60 Minor Including tooth extraction. Every 24 hours 12 to 24 hours for patients under the age of 6, at least 1 day, until healing is achieved. Major 80 100 pre- and postoperative Repeat injections every 8 to 24 hours 6 to 24 hours for patients under the age of 6 until adequate wound healing, then continue therapy for at least another 7 days to maintain a factor VIII activity of 30 to 60 IUdl.