Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Powder
None

Solvent
Carmellose sodium
Mannitol
Polysorbate 80
Water for injections
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
6.2   Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

2 years.
Chemical and physical stability of the suspension in the vials has been demonstrated for 24 hours at 20°C-25°C. From a microbiological point of view, the product should be used immediately.

6.4   Special precautions for storage

Do not refrigerate or freeze. Before reconstitution do not store above 30°C.
6.5   Nature and contents of container

300 mg powder: Type I glass vial. Bromobutyl stopper with olive colour seal.
405 mg powder: Type I glass vial. Bromobutyl stopper with steel blue colour seal.

3 ml solvent: Type I glass vial. Butyl stopper with purple seal.
One carton contains one vial of powder and one vial of solvent, one Hypodermic 3 ml syringe with pre-attached 19-gauge, 38 mm safety needle, one 19-gauge, 38 mm Hypodermic safety needle and two 19-gauge, 50 mm Hypodermic safety needles.

6.6   Special precautions for disposal and other handling

FOR DEEP INTRAMUSCULAR GLUTEAL INJECTION ONLY. DO NOT ADMINISTER
INTRAVENOUSLY OR SUBCUTANEOUSLY.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Description:
The Jelco Hypodermic Needle-Pro® device is a sterile, single use device. It includes a needle and needle safety sheath. The Needle-Pro® device can be used with Luer slip or Luer lock syringe.

Indications for use:
This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.

Contraindications:
None known.

Warnings:
A needle stick with a contaminated needle may cause infectious diseases.
Intentional disengagement of the Needle-Pro® device may result in a needle stick with a contaminated needle.
Bent or damaged needles can result in breakage or damage to the tissue or accidental needle puncture.
If the needle is bent or damaged, no attempt should be made to straighten the needle or engage the Needle-Pro® device. The Needle-Pro® device may not properly contain a bent needle and/or the needle could puncture the needle protection device which may result in the needle stick with a contaminated needle.
Mishandling of the needle protection device may cause needles, especially short or small gauge needles, to bend whereby they protrude from the needle protector sheath which may result in a contaminated needle stick.
Do not use with Paraldehyde.

Caution:
Do Not Reuse: Medical devices require specific material characteristics to perform as intended. These characteristics have been verified for single use only. Any attempt to re-process the device for subsequent re-use may adversely affect the integrity of the device or lead to deterioration in performance.
Not made with natural rubber latex. Do not use if package is damaged.
Sterilized using ethylene oxide. Non-pyrogenic fluid path.

Needle-Pro and the color orange applied to the needle protection device, Jelco design mark and Smiths Medical design mark are trademarks of Smiths Medical. The symbol ® indicated the trademark is registered in the U.S. Patent and Trademark Office and certain other countries.


Reconstitution
STEP 1: Preparing materials
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             Volume of solvent to add vial strength (mg)               (ml)
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 syringe and needle with needle protection device. Peel blister pouch and remove device. Attach a syringe (if not already attached) to the Luer connection of the device with an easy twisting motion. Seat the needle firmly on the 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 needlestick 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 (Fig. 1), THE NEEDLE IS FIRMLY ENGAGED INTO THE SHEATH (Fig. 2).
8. Visually confirm that the needle is fully engaged into the needle protection sheath. Only remove the 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 (Fig.
3). After use, place sharps in a suitable sharps container. Dispose the contaminated product in a safe manner according to local regulations.



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 mg/ml olanzapine.
Dose      Final volume to inject
(mg)               (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 selected 50 mm or 38 mm 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 (Fig. 1 and 2).


8. Discard the vials, syringe, used needles, extra needle and any unused solvent in accordance with appropriate clinical procedures. The vial is for single use only.