What ZYPADHERA contains
The active substance is olanzapine. Each vial contains olanzapine pamoate monohydrate equivalent to 210 mg olanzapine. Each vial contains olanzapine pamoate monohydrate equivalent to 300 mg olanzapine. Each vial contains olanzapine pamoate monohydrate equivalent to 405 mg olanzapine. After reconstitution: 1ml suspension contains 150 mg/ml olanzapine.
The solvent ingredients are croscarmellose sodium, mannitol, polysorbate 80, water for injections, hydrochloric acid and sodium hydroxide.
What ZYPADHERA looks like and contents of the pack
ZYPADHERA is a powder and solvent for prolonged release suspension for injection. One carton contains one vial of powder for prolonged release suspension for injection, one vial of 3 ml solvent one syringe with safety needle attached and two separate safety needles.
ZYPADHERA powder for prolonged release suspension for injection comes as a yellow powder in a clear glass vial. Your doctor or nurse will make it into a suspension that will be given as an injection using the vial of solvent for ZYPADHERA that comes as a clear, colourless to slightly yellow solution in a clear glass vial.
Marketing Authorisation Holder and Manufacturer
Eli Lilly Nederland BV, Grootslag 1 ? 5, NL-3991 RA, Houten, The Netherlands.
Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Teichweg 3, D-35396 Giessen, Germany.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Eli Lilly Benelux S.A.N.V. TélTel 32 0 2 548 84 84 .. - 359 2 491 41 40 eská republika Eli Lilly R, s.r.o. Tel 420 234 664 111 Danmark Eli Lilly Danmark AS Tlf 45 45 26 60 00 Deutschland Lilly Deutschland GmbH Tel 49 0 6172 273 2222 Eesti Eli Lilly Holdings Limited Eesti filiaal Tel 372 6817 280 a - .... 30 210 629 4600 España Lilly S.A. Tel 34 91 663 50 00 France Lilly France SAS Tél 33 0 1 55 49 34 34 Ireland Eli Lilly and Company Ireland Limited Tel 353 0 1 661 4377 Ísland Icepharma hf. Sími 354 540 8000 Italia Eli Lilly Italia S.p.A. Tel 39 055 42571 Phadisco Ltd 357 22 715000 Latvija LuxembourgLuxemburg Eli Lilly Benelux S.A.N.V. TélTel 32 0 2 548 84 84 Magyarország Lilly Hungária Kft. Tel 36 1 328 5100 Malta Charles de Giorgio Ltd. Tel 356 25600 500 Nederland Eli Lilly Nederland B.V. Tel 310 30 6025800 Norge Eli Lilly Norge A.S Tlf 47 22 88 18 00 Österreich Eli Lilly Ges. m.b.H. Tel 43 0 1 711 780 Polska Eli Lilly Polska Sp. z o.o. Tel 48 0 22 440 33 00 Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel 351 21 412 66 00 România Eli Lilly România S.R.L. Tel 40 21 4023000 Slovenija Eli Lilly farmacevtska druba, d.o.o. Tel 386 0 1 580 00 10 Slovenská republika Eli Lilly Slovakia, s.r.o. Tel 421 220 663 111 SuomiFinland Oy Eli Lilly Finland Ab PuhTel 358 0 9 8545 250 Sverige Eli Lilly Sweden AB Tel 46 0 8 7378800 United Kingdom Eli Lilly Holdings Limited, prstvniecba Latvij Eli Lilly and Company Limited Tel 371 67364000 Tel 44 0 1256 315000 Lietuva Eli Lilly Holdings Limited atstovyb Tel 370 5 2649600
This leaflet was last approved in September 2010
(Perforation to allow health care provider information to be detached)
INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS
RECONSTITUTION AND ADMINISTRATION INSTRUCTIONS
ZYPADHERA olanzapine powder and solvent for prolonged release suspension for injection
FOR DEEP INTRAMUSCULAR GLUTEAL INJECTION ONLY.
DO NOT ADMINISTER INTRAVENOUSLY OR SUBCUTANEOUSLY.
STEP 1: Preparing materials
- Vial of ZYPADHERA powder for prolonged release suspension for injection
- Vial of solvent for ZYPADHERA
- One Hypodermic Needle-Pro syringe and safety needle (Hypodermic Needle-Pro Device)
- One 19-gauge, 38 mm Hypodermic Needle-Pro safety needle
- One 19-gauge, 50 mm Hypodermic Needle-Pro safety needle
- Patient Information Leaflet
- Reconstitution and Administration card (this leaflet)
- Hypodermic Needle-Pro Device Safety Information and Instructions for Use leaflet
It is recommended that gloves are used as ZYPADHERA may irritate the skin.
Reconstitute ZYPADHERA powder for prolonged release suspension for injection only with the solvent provided in the pack using standard aseptic techniques for reconstitution of parenteral products.
STEP 2: Determining solvent volume for reconstitution
This table provides the amount of solvent required to reconstitute ZYPADHERA powder for prolonged release suspension for injection.
ZYPADHERA vial strength mg Volume of solvent to add ml 210 1.3 300 1.8 405 2.3
It is important to note that there is more solvent in the vial than is needed to reconstitute.
STEP 3: Reconstituting ZYPADHERA
1. Loosen the powder by lightly tapping the vial.
2. Open the pre-packaged Hypodermic Needle-Prosyringe and needle with needle protection device. Peel blister pouch and remove device. Insure needle is firmly seated on the Needle-Pro device with a push and a clockwise twist, then pull the needle cap straight away from the needle. Failure to follow these instructions may result in a needle stick injury.
3. Withdraw the pre-determined solvent volume (Step 2) into the syringe.
4. Inject the solvent volume into the powder vial.
5. Withdraw air to equalize the pressure in the vial.
6. Remove the needle, holding the vial upright to prevent any loss of solvent.
7. Engage the needle safety device. Press the needle into the sheath using a one-handed technique. Perform a one-handed technique by GENTLY pressing the sheath against a flat surface. AS THE SHEATH IS PRESSED, THE NEEDLE IS FIRMLY ENGAGED INTO THE SHEATH (Figure 1 and 2)
8. Visually confirm that the needle is fully engaged into the needle protection sheath. (Figure 3) Only remove the Needle-Pro device with the engaged needle from the syringe when required by a specific medical procedure. Remove by grasping the Luer hub of the needle protection device with thumb and forefinger, keeping the free fingers clear of the end of the device containing the needle point.
Figure 1 Figure 2 Figure 3 9. Tap the vial firmly and repeatedly on a hard surface until no powder is visible. Protect the surface to cushion impact. See Figure A Figure A Tap firmly to mix
10. Visually check the vial for clumps. Unsuspended powder appears as yellow, dry clumps clinging to the vial. Additional tapping may be required if clumps remain. See Figure B Unsuspended visible clumps Suspended no clumps Figure B Check for unsuspended powder and repeat tapping if needed.
11. Shake the vial vigorously until the suspension appears smooth and is consistent in color and texture. The suspended product will be yellow and opaque. (See Figure C)
Figure C: Vigorously shake vial
If foam forms, let vial stand to allow foam to dissipate. If the product is not used immediately, it should be shaken vigorously to re-suspend. Reconstituted ZYPADHERA remains stable for up to 24 hours in the vial.
Administration STEP 1 Injecting ZYPADHERA This table confirms the final ZYPADHERA suspension volume to inject. Suspension concentration is 150 mgml olanzapine. Dose mg Final volume to inject ml 150 1.0 210 1.4 300 2.0 405 2.7
1. Determine which needle will be used to administer the injection to the patient. For obese patients, the 50 mm needle is recommended for injection: If the 50 mm needle is to be used for injection, attach the 38 mm safety needle to the syringe to withdraw the required suspension volume. If the 38 mm needle is to be used for the injection, attach the 50 mm safety needle to withdraw the required suspension volume.
2. Slowly withdraw the desired amount. Some excess product will remain in the vial.
3. Engage the needle safety device and remove needle from syringe.
4. Attach the remaining safety needle to the syringe prior to injection. Once the suspension has been removed from the vial, it should be injected immediately.
5. Select and prepare a site for injection in the gluteal area. DO NOT INJECT INTRAVENOUSLY OR SUBCUTANEOUSLY.
6. After insertion of the needle, aspirate for several seconds to ensure no blood appears. If any blood is drawn into the syringe, discard the syringe and the dose and begin reconstitution and administration procedure again. The injection should be performed with steady, continuous pressure. DO NOT MASSAGE THE INJECTION SITE.
7. Engage the needle safety device. (Figure 1 and 2)
8. Discard the vials, syringe, needles and any unused solvent in accordance with appropriate clinical procedures. The vial is for single use only.