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Enantone 1-Month DPS 3.75 mg: Precautions Concerning Use: Route of Administration: ENANTONE should be used only by the subcutaneous route. Intravenous injection of ENANTONE may induce thrombosis.
Method of Administration: A needle for injection of 25 gauge or not finer should be used.
For subcutaneous injection, the following cautions should be exercised.
1. The site for subcutaneous injection should be the brachial, abdominal or gluteal region.
2. The injection site should be changed each time. The repeated injection should not be given at the same site.
3. The check should be made to see that the needle is not piecing a blood vessel.
4. The patients should be instructed not to massage the injection site.
Preparation: The injectable solution should be prepared at the time of use and be used immediately after suspending.
If any sedimentation is noticed in the suspension of vial product, such suspension should be used after swirling gently, avoiding formation of bubbles, to re-suspend the particles uniformly.
Mode of administration: Screw the plunger rod into the end stopper until the end stopper begins to turn.
Check if the needle is tight by twisting the needle cap clockwise. Do not overtighten.
While holding the syringe upright, depress the plunger SLOWLY by pushing the plunger rod until the middle stopper is at the blue line in the middle of the barrel. NOTE: pushing the plunger rod quickly or over the blue line will cause leakage of the suspension from the needle.
Gently tap the syringe on the palm keeping the syringe upright to thoroughly mix the particles to form a uniform suspension. The suspension will appear milky. NOTE: Avoid hard tapping to prevent the generation of bubbles.
If the microspheres adhere to the stopper, tap the syringe by the finger.
Remove the needle cap and advance the plunger to expel the air from the syringe.
At the time of injection, check the direction of the safety device (with round mark face up).
Inject the entire contents of the syringe subcutaneously as it would be for a normal injection.
AFTER INJECTION, withdraw the needle from the patient and immediately activate the safety device to cover the needle by pushing the arrow forward with a finger, until a CLICK is heard and the device is fully extended and the needle is covered.
Enantone 3-Month DPS 11.25 mg: Special precautions for handling and disposal: Any unused medicinal product or waste should be disposed of in accordance with local requirements.
Incompatibilities: Not applicable.
Enantone 6-Month DPS 30 mg: Special precautions for disposal and other instructions for handling: Prepare the injectable suspension only at the time of administration, and use immediately. Any
unused medicinal product or waste material should be disposed in accordance with local
requirements. Do not dispose medicinal products into the drain water.
Instructions for the preparation of the ENANTONE 6 MONTH DPS suspension: 1) Insert plunger rod by turning it in.
2) Hold dual chamber syringe vertically with the top (cannula) upright.
3) By means of the plunger rod push the stopper system carefully to reach the blue marking. In this way the vehicle is enabled to enter the front chamber via the bypass.
4) At this stage the plunger rod must not be pulled back any more.
5) Continue to hold the dual chamber syringe vertically with the injection needle upright and move it to right and left to shake it or knock it at the hand joint to produce a milky suspension of the microcapsules in the vehicle. (Do not hold the syringe horizontally or downwards because in that case vehicle might escape.)
6) Prior to injection remove the needle sheath by pulling it off, not by turning it off. Subsequently, carefully remove the remaining air above the suspension by pressing it off the syringe.
The syringe is now ready for injection.
An aspiration is possible with subcutaneously applied cannula.
Handling after injection: 7) Slide the safety device of the needle according the arrow marks forward until it audibly/noticeable engages.
8) Dispose syringe properly.
Incompatibilities: Not applicable. ENANTONE 6 MONTH DPS should not be injected at the same time as other medicinal products.
