Enantone L.P. Caution For Usage

Incompatibilities: No other fluid other than the sterile vehicle provided for ENANTONE L.P. 3.75 mg/11.25 mg/30 mg can be used for the reconstitution of ENANTONE L.P. 3.75 mg/11.25 mg/30 mg powder.
Special precautions for disposal and other handling: Instructions for use: ENANTONE is supplied as a dual-chamber prefilled syringe for injection.
This Instructions for Use contains information on how to reconstitute and inject ENANTONE.
Important Information: Do not use if syringe or packaging appears damaged.
Do not use the syringe if the powder appears clumped or caked.
Do not use the syringe if the powder or diluent appears discolored.
Storage Conditions: Keep the dual-chamber syringe in the outer carton in order to protect from light.
Hold the syringe upright (with the needle side up) throughout entire preparation to prevent leakage. If leaking occurs, the dose should not be administered.
Use immediately after mixing as the suspension settles out very quickly following reconstitution.
This medication may be injected intramuscularly, subcutaneously.
Parts Overview: The device may have the plunger already attached to the syringe.
Preparation: 1. Wash hands before opening the syringe package.
2. Open package and remove the syringe.
3. Check the expiration date printed on the syringe, and the powder and diluent in the syringe barrel. The powder should be white and dry, and the diluent should be clear.
4. Inspect the syringe for any damage.
a. Do not use the syringe if the powder appears clumped or caked.
b. Do not use the syringe if powder or diluent appear discolored.
c. Do not use the syringe if any part of it is damaged.
5. Gently tap the syringe to remove any lumps and release any powder stuck on the syringe walls.
6. Remove the plunger from the package.
7. Screw the plunger rod into the bottom of the syringe until the end stopper begins to rotate.
a. Do not twist or pull the plunger rod back once it has been attached.
8. Without removing the needle cap, twist the needle to the right (clockwise) to ensure it is secured tightly.
a. Do not remove needle cap until the patient is ready to inject.
9. Holding the syringe upright, release the diluents by slowly pushing the plunger until the middle stopper reaches the blue line in the middle of the syringe. See the diluent flowing into the interior chamber above the blue line.
a. Do not remove the needle cap before releasing the diluent.
b. Do not push the plunger too quickly or push past the blue line as these actions may cause leaking.
c. Do not withdraw plunger again.
10. Gently tap the syringe against the palm of the hand to mix the powder and diluent until it forms a uniform suspension. When properly mixed, the suspension should appear milky with no visible lumps.
a. If particles stick to the stopper during mixing, dislodge them by gently tapping the syringe with the finger.
b. Avoid hard tapping or shaking to prevent the generation of bubbles.
c. Use immediately after mixing as the suspension settles out very quickly following reconstitution.
11. Remove the needle cap by pulling it straight upwards.
a. Do not twist the needle cap.
12. Prime the syringe by pushing the plunger upward until all air has been expelled from the syringe.
13. The syringe is now ready for injection. Use immediately as the suspension settles out very quickly following reconstitution.
Intramuscular Administration: 1. Choose the injection site. Intramuscular injection sites include shoulder (deltoid), upper buttock (ventrogluteal), and thigh.
2. Clean the skin at the injection site with an alcohol swab and allow to air-dry.
a. Do not inject at a location where the skin is red, swollen, scarred, or damaged.
b. Do not use the same injection site for more than one injection consecutively.
3. Gently pull the skin at the injection site taut and insert needle at a 90° or 180° angle. Before inserting the needle, check the orientation of the safety device. The arrow on the safety device should be pointed towards the patient, with the round mark directed upward.
4. Once the needle has been inserted, aspirate the needle by pulling the plunger backward for 5-10 seconds. Care should be taken to avoid inadvertent injection into a blood vessel. If blood is visible in the needle barrel, stop the injection and withdraw the needle immediately.
5. Push the plunger all the way down slowly until entire contents of the syringe have been injected. Pull needle straight out at the same angle it was inserted, then use clean gauze to apply gentle pressure.
a. Do not rub the injection site.
b. Do not recap the needle after injection.
6. When injection is complete, withdraw the needle from the patient. Immediately activate the safety device by pressing upward from just below the arrow until a "CLICK" is heard or felt and the needle is fully covered.
Subcutaneous Administration: 1. Choose the injection site. Subcutaneous injection sites include stomach area (abdomen), thighs, upper arms, and buttock.
2. Clean the skin at the injection site with an alcohol swab and allow to air-dry.
a. Do not inject at a location where the skin is red, swollen, scarred, or damaged.
b. Do not use the same injection site for more than one injection consecutively.
3. Pinch a 2.5 cm section of skin between the fingers and insert needle at a 30°-90° angle. Before inserting the needle, check the orientation of the safety device. The arrow on the safety device should be pointed towards the patient, with the round mark directed upward.
4. Push the plunger all the way down slowly until the entire contents of the syringe have been injected. Pull needle straight out at the same angle it was inserted, then use clean gauze to apply gentle pressure.
a. Do not rub the injection site.
b. Do not recap the needle after injection.
5. When the injection is complete, withdraw the needle from the patient. Immediately activate the safety device by pressing upward from just below the arrow until a "CLICK" is heard or felt and the needle is fully covered.
Intramuscular and Subcutaneous Administration: 1. Choose the injection site. Intramuscular injection sites include shoulder (deltoid), upper buttock (ventrogluteal), and thigh. Subcutaneous injection sites include stomach area (abdomen), thighs, upper arms, and buttock.
2. Clean the skin at the injection site with an alcohol swab and allow to air-dry.
a. Do not inject at a location where the skin is red, swollen, scarred, or damaged.
b. Do not use the same injection site for more than one injection consecutively.
3. For intramuscular injection: a. Gently pull the skin at the injection site taut and insert needle at a 90° or 180° angle to the skin. Before inserting the needle, check the orientation of the safety device. The arrow on the safety device should be pointed towards the patient, with the round mark directed upward.
b. Once the needle has been inserted, aspirate the needle by pulling the plunger backward for 5-10 seconds. Care should be taken to avoid inadvertent injection into a blood vessel. If blood is visible in the needle barrel, stop the injection and withdraw the needle immediately.
c. Push the plunger all the way down slowly until entire contents of the syringe have been injected. Pull needle straight out at the same angle it was inserted, then use clean gauze to apply gentle pressure.
i. Do not rub the injection site.
ii. Do not recap the needle after injection.
d. When injection is complete, withdraw the needle from the patient. Immediately activate the safety device by pressing upward from just below the arrow until a "CLICK" is heard or felt and the needle is fully covered.
4. For Subcutaneous Injection: a. Pinch a 2.5 cm section of skin between the fingers and insert needle at a 30°-90° angle. Before inserting the needle, check the orientation of the safety device. The arrow on the safety device should be pointed towards the patient, with the round mark directed upward.
b. Push the plunger all the way down slowly until the entire contents of the syringe have been injected. Pull needle straight out at the same angle it was inserted, then use clean gauze to apply gentle pressure.
i. Do not rub the injection site.
ii. Do not recap the needle after injection.
c. When the injection is complete, withdraw the needle from the patient. Immediately activate the safety device by pressing upward from just below the arrow until a "CLICK" is heard or felt and the needle is fully covered.
Disposing of ENANTONE: Dispose of the used device in the appropriate sharp's container in accordance with the local standard procedure.