What Sebivo contains
- The active substance is telbivudine. 30 ml oral solution contain 600 mg telbivudine.
- The other ingredients are: benzoic acid, sodium saccharin, passion fruit flavouring, sodium hydroxide, citrc acid anhydrous, water.
What Sebivo looks like and contents of the pack
Sebivo 20 mg/ml oral solution is supplied as 300 ml of a clear, colourless to pale yellow solution in an brown glass bottle with a child-resistant white polypropylene closure, including a polyethylene sealing disc and a guarantee ring. The pack contains an oral dosing cup made of polypropylene with embossed graduations from 5 to 30 ml in 5 ml increments and a polypropylene oral syringe with graduations of 1 ml to 10 ml in 0.5 ml increments.
Marketing Authorisation Holder
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom
Manufacturer
Novartis Pharma S.A.S.
26, rue de la Chapelle
F-68330 Huningue
France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma GmbH Tel 49 911 273 0
Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00
eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217
Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111
Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00
Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570
Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888
España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600
France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01
Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 50
Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439
Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 010 6133 200
Novartis Pharma Services Inc. 357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00
Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370
Lietuva
Novartis Pharma Services Inc.
Tel: +370 5 269 16 50
This leaflet was last approved in
INSTRUCTIONS FOR USE
Please read these instructions carefully so that you know how to use the solution correctly.
1. Bottle containing the oral solution. 2. Child-resistant screw cap with a guarantee-ring. Always close the bottle with the cap after use. 3. Oral dosing cup for measuring out the dose. Always put the dosing cup back onto the cap after use and cleaning. 4. Oral syringe for measuring out doses that cannot be precisely measured using the cup.
Preparing a dose of medicine using the dosing cup
1. Remove the dosing cup. 2. Simultaneously press down 2a and turn the child-resistant cap 2b to open the bottle.
3. Before pouring any solution into the cup, please check the position of the appropriate graduation to avoid any potential waste or spillage. Holding the cup at eye level, carefully and slowly pour the prescribed amount of solution from the bottle into the dosing cup until the solution reaches the top of the appropriate graduation. Note If the amount poured into the cup exceeds the required dose, discard the excess in the sink. Do not pour it back into the bottle.
4. Drink the solution or administer it to the patient immediately. 5. Close the bottle by screwing the cap back on tightly.
6. Immediately rinse the dosing cup with water. 7. Remove the water from the dosing cup, wipe it with a clean tissue and place it back on top of the cap.
Preparing a 6 ml dose of medicine using the oral syringe
1. Remove the dosing cup. 2. Simultaneously press down 2a and turn the child-resistant cap 2b to open the bottle. 3. Before pouring any solution into the cup, please check the position of the 5 and 10 ml marks to avoid any potential waste or spillage. Holding the cup at eye level, carefully and slowly pour the solution from the bottle into the cup until it comes to about halfway between the 5 ml and 10 ml marks. 4. Withdraw all the solution from the cup into the syringe. 5. Turn the syringe to the upright position and incline it slightly so that the air bubbles rise to the top. 6. Push the plunger carefully and slowly to remove the air until a droplet of solution appears.
7. Hold the syringe above the cup. 8. Push the plunger slowly and carefully until the solution reaches the 6 ml mark. 9. Immediately swallow the solution direct from the syringe. 10. Discard the solution left in the cup into the sink. Do not pour it back into the bottle as this could cause contamination. 11. Close the bottle firmly. 12. Rinse the cup and syringe with clean water. 13. Dry the cup with a clean tissue and place it back over the cap of the bottle. 14. Allow the syringe to air-dry and store with the bottle.