What XEPLION contains
The active substance is paliperidone.
Each pre-filled syringe contains 78 mg paliperidone palmitate equivalent to 50 mg paliperidone.
The other ingredients are:
Polysorbate 20
Polyethylene glycol 4000
Citric acid monohydrate
Disodium hydrogen phosphate anhydrous
Sodium dihydrogen phosphate monohydrate
Sodium hydroxide (for pH adjustment)
Water for injection
What XEPLION looks like and contents of the pack
XEPLION is a white to off-white prolonged release suspension for injection in a pre-filled syringe that is provided by your doctor?s office or clinic.
Each pack contains 1 pre-filled syringe and 2 needles.
Marketing Authorisation Holder and Manufacturer
Janssen-Cilag International NV,
Turnhoutseweg 30,
B-2340 Beerse,
Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
BelgiëBelgiqueBelgien JANSSEN-CILAG N.V.S.A. TelTél 32 14 64 94 11 LuxembourgLuxemburg JANSSEN-CILAG N.V.S.A. TelTél 32 14 64 94 11
Johnson Johnson, .359 2 489 9400 Magyarország JANSSEN-CILAG Kft. Tel. 36 23 513 800
eská republika JANSSEN-CILAG s.r.o. Tel420 227 012 222 Malta AM MANGION LTD Tel 356 2397 6000
Danmark JANSSEN-CILAG AS Tlf 45 45 94 82 82 Nederland JANSSEN-CILAG B.V. Tel 31 13 583 73 73
Deutschland JANSSEN-CILAG GmbH Tel 49 2137-955-955 Norge JANSSEN-CILAG AS Tlf 47 24 12 65 00
Eesti JANSSEN-CILAG Tel. 372 617 7410 Österreich JANSSEN-CILAG PHARMA GmbH Tel 43 1 610 300
JANSSEN-CILAG T 30 210 80 90 000 Polska JANSSENCILAG Polska Sp. z o.o. Tel. 48 22 237 6000
España JANSSEN-CILAG, S.A. Tel 34 91 722 81 00 Portugal JANSSEN-CILAG FARMACEUTICA, LDA Tel 351 21-4368835
France JANSSEN-CILAG Tel 0800 25 50 75 33 1 55 00 44 44 România Johnson Johnson d.o.o. Tel 40 21 207 1800
Ireland JANSSEN-CILAG Ltd. Tel 44 1 494 567 567 Slovenija Johnson Johnson d.o.o. Tel 386 1401 18 30
Slovenská republika JOHNSON JOHNSON S.R.O, Tel 421 233 552 600 Ísland JANSSEN-CILAG Co Vistor hf Sími 354 535 7000
Italia JANSSEN-CILAG SpA Tel 39 022510.1 SuomiFinland JANSSEN-CILAG OY PuhTel 358 207 531 300
T 357 22 755 214 Sverige JANSSEN-CILAG AB Tel 46 8 626 50 00
United Kingdom JANSSEN-CILAG Ltd. Tel 44 1494 567 567 Latvija JANSSEN-CILAG Polska Sp. z.o.o. filile Latvij Talr. 371 6789 3561
Lietuva
Johnson & Johnson UAB
Tel.: +370 5 278 68 88
This leaflet was last approved in
The following information is intended for medical or healthcare professionals only:
The suspension for injection is for single use only. It should be inspected visually for foreign matter before administration. Do not use if the syringe is not visually free of foreign matter.
The pack contains a pre-filled syringe and 2 safety needles (a 1½-inch 22 gauge needle [38.1 mm x 0.72 mm] and a 1-inch 23 gauge needle [25.4 mm x 0.64 mm]) for intramuscular injection.
1. Shake the syringe vigorously for a minimum of 10 seconds to ensure a homogeneous suspension.
2. Select the appropriate needle.
For DELTOID injection, if the patient weighs < 90 kg, use the 1-inch, 23 gauge needle (25.4 mm x 0.64 mm) (needle with blue colored hub); if the patient weighs ? 90 kg, use the 1½-inch, 22 gauge needle (38.1 mm x 0.72 mm) (needle with grey coloured hub).
For GLUTEAL injection, use the 1½-inch, 22 gauge needle (38.1 mm x 0.72 mm) (needle with grey coloured hub).
3. While holding the syringe upright, remove the rubber tip cap with a twisting motion.
4. Peel the safety needle blister pouch half way open. Grasp the needle sheath using the plastic peel pouch. Attach the safety needle to the luer connection of the syringe with an easy clockwise twisting motion.
5. Pull the needle sheath away from the needle with a straight pull. Do not twist the sheath as the needle may be loosened from the syringe.
6. Bring the syringe with the attached needle in upright position to de-aerate. De-aerate the syringe by moving the plunger rod carefully forward.
7. Inject the entire contents intramuscularly into the selected deltoid or gluteal muscle of the patient. Do not administer intravascularly or subcutaneously.
8. After the injection is complete, use either thumb or finger of one hand (8a, 8b) or a flat surface (8c) to activate the needle protection system. The system is fully activated when a ?click? is heard. Discard the syringe with needle appropriately.
8a
8b
8c
Any unused product or waste material should be disposed of in accordance with local requirements.