4. CLINICAL PARTICULARS
4.2 Posology and method of administration
Re-Formatted:
Use of HUMALOG in an insulin infusion pump:
Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before infusing insulin lispro, the manufacturers instructions should be studied to ascertain the suitability or otherwise for the particular pump. Read and follow the instructions that accompany the infusion pump. Use the correct reservoir and catheter for the pump. Change the infusion set every 48 hours. Use aseptic technique when inserting the infusion set. In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. If repeated or severe low blood glucose levels occur, notify your health care professional and consider the need to reduce or stop your insulin infusion. A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels. If an interruption to insulin flow is suspected, follow the instructions in the product literature and if appropriate, notify your health care professional. When used with an insulin infusion pump, HUMALOG should not be mixed with any other insulin.
Intravenous administration of insulin:
Intravenous injection of insulin lispro should be carried out following normal clinical practise for intravenous injections, for example by an intravenous bolus or by an infusion system. Frequent monitoring of the blood glucose levels is required.
Infusion systems at concentrations from 0.1U/ml to 1.0U/ml insulin lispro in 0.9% sodium chloride or 5% dextrose are stable at room temperature for 48 hours. It is recommended that the system is primed before starting the infusion to the patient.
6. PHARMACEUTICAL PARTICULARS
6.6 Special precautions for disposal and other handling
Deleted from section 4.2 and inserted into section 6.6:
Instructions for Use and Handling
Humalog vials
The vial is to be used in conjunction with an appropriate syringe (100U markings).
a) Preparing a dose
Inspect the Humalog solution. It should be clear and colourless. Do not use Humalog if it appears cloudy, thickened, or slightly coloured, or if solid particles are visible.
i) Humalog
1. Wash your hands.
2. If using a new vial, flip off the plastic protective cap, but do not remove the stopper.
3. If the therapeutic regimen requires the injection of basal insulin and Humalog at the same time, the two can be mixed in the syringe. If mixing insulins, refer to the instructions for mixing that follow in section ii) and 6.2.
4. Draw air into the syringe equal to the prescribed Humalog dose. Wipe the top of the vial with an alcohol swab. Put the needle through the rubber top of the Humalog vial and inject the air into the vial.
5. Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand.
6. Making sure the tip of the needle is in the Humalog, withdraw the correct dose into the syringe.
7. Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount of Humalog in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.
8. Remove the needle from the vial and lay the syringe down so that the needle does not touch anything.
ii) Mixing Humalog with longer-acting human insulins (see section 6.2)
1. Humalog should be mixed with longer-acting human insulins only on the advice of a doctor.
2. Draw air into the syringe equal to the amount of longer-acting insulin being taken. Insert the needle into the longer-acting insulin vial and inject the air. Withdraw the needle.
3. Now inject air into the Humalog vial in the same manner, but do not withdraw the needle.
4. Turn the vial and syringe upside down.
5. Making sure the tip of the needle is in the Humalog, withdraw the correct dose of Humalog into the syringe.
6. Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount of Humalog in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.
7. Remove the needle from the vial of Humalog and insert it into the vial of the longer-acting insulin. Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand and shake gently. Making sure the tip of the needle is in the insulin, withdraw the dose of longer-acting insulin.
8. Withdraw the needle and lay the syringe down so that the needle does not touch anything.
b) Injecting a dose
1. Choose a site for injection.
2. Clean the skin as instructed.
3. Stabilise the skin by spreading it or pinching up a large area. Insert the needle and inject as instructed.
4. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
5. Dispose of the syringe and needle safely.
6. Use of the injection sites should be rotated so that the same is not used more than approximately once a month.
c) Mixing insulins
Do not mix insulin in vials with insulin in cartridges. See section 6.2.
Humalog cartridges
Humalog cartridges are to be used with a CE marked pen as recommended in the information provided by the device manufacturer.
a) Preparing a dose
Inspect the Humalog solution. It should be clear and colourless. Do not use Humalog if it appears cloudy, thickened, or slightly coloured, or if solid particles are visible.
The following is a general description. The manufacturer’s instructions with each individual pen must be followed for loading the cartridge, attaching the needle, and administering the insulin injection.
b) Injecting a dose
1. Wash your hands.
2. Choose a site for injection.
3. Clean the skin as instructed.
4. Remove outer needle cap.
5. Stabilise the skin by spreading it or pinching up a large area. Insert the needle as instructed.
6. Press the knob.
7. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
8. Using the outer needle cap, unscrew the needle and dispose of it safely.
9. Use of injection sites should be rotated so that the same site is not used more than approximately once a month.
c) Mixing insulins
Do not mix insulin in vials with insulin in cartridges. See section 6.2.
Humalog Pens
a) Preparing a dose
1. Inspect the Humalog Pen solution.
It should be clear and colourless. Do not use Humalog Pen if it appears cloudy, thickened, or slightly coloured, or if solid particles are visible.
2. Put on the needle.
Wipe the rubber seal with alcohol. Remove the paper tab from the capped needle. Screw the capped needle clockwise onto the pen until it is tight. Hold the pen with needle pointing up and remove the outer needle cap and inner needle cover.
3. Priming the pen (check insulin flow).
(a) The arrow should be visible in the dose window. If the arrow is not present, turn the dose knob clockwise until the arrow appears and notch is felt or visually aligned.
(b) Pull dose knob out (in direction of the arrow) until a ‘0’ appears in the dose window. A dose cannot be dialled until the dose knob is pulled out.
(c) Turn dose knob clockwise until a ‘2’ appears in the dose window.
(d) Hold the pen with needle pointing up and tap the clear cartridge holder gently with your finger so any air bubbles collect near the top. Depress the injection button fully until you feel or hear a click. You should see a drop of insulin at the tip of the needle. If insulin does not appear, repeat the procedure until insulin appears.
(e) Always prime the pen (check the insulin flow) before each injection. Failure to prime the pen may result in an inaccurate dose.
4. Setting the dose.
(a) Turn the dose knob clockwise until the arrow appears in the dose window and a notch is felt or visually aligned.
(b) Pull the dose knob out (in the direction of the arrow) until a ‘0’ appears in the dose window. A dose cannot be dialled until the dose knob is pulled out.
(c) Turn the dose knob clockwise until the dose appears in the dose window. If too high a dose is dialled, turn the dose knob backward (anti-clockwise) until the correct dose appears in the window. A dose greater than the number of units remaining in the cartridge cannot be dialled.
b) Injecting a dose
1. Wash your hands.
2. Choose a site for injection.
3. Clean the skin as instructed.
4. Remove outer needle cap.
5. Stabilise the skin by spreading it or pinching up a large area. Insert the needle as instructed.
6. Press the injection button down with the thumb (until you hear or feel a click); wait 5 seconds.
7. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
8. Immediately after an injection, use the outer needle cap to unscrew the needle. Remove the needle from the pen. This will ensure sterility, and prevent leakage, re-entry of air, and potential needle clogs. Do not reuse the needle. Dispose of the needle in a responsible manner. Needles and pens must not be shared.
The prefilled pen can be used until it is empty. Please properly discard or recycle.
9. Replace the cap on the pen.
10. Use of injection sites should be rotated so that the same site is not used more than approximately once a month.
11. The injection button should be fully depressed before using the pen again.
c) Mixing insulins
Do not mix insulin in vials with insulin in cartridges. See section 6.2.
10. DATE OF REVISION OF THE TEXT
31 January 2008
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