Basalog One

Basalog One Patient Counseling Information

insulin glargine

Manufacturer:

Biocon

Distributor:

Duopharma
Full Prescribing Info
Patient Counseling Information
INSTRUCTIONS FOR USE: Insulin Glargine Injection (rDNA Origin) 3 mL Prefilled Pen (100 IU/mL).
Basalog One is a prefilled, disposable pen injector containing 300 units of insulin glargine (rDNA Origin). Read all the instructions carefully before using Basalog One (hereafter "pen"). If you are unable to read or follow all of the instructions completely on your own, seek the help of someone who has been trained to use the pen.
Follow these instructions every time you use the pen. If you do not follow these instructions each time you use the pen, you may either get too much or too little insulin. This may affect your blood glucose level.
Before You Use the Pen for the First Time: Check that the carton is sealed with an intact gum tape. After opening the carton check that the pen looks new and undamaged.
Storage: Before first use, store the cartons containing the pen in the refrigerator at 2°C - 8°C (36°F - 46°F). DO NOT freeze.
Once you take a pen out of the refrigerator, allow it to reach room temperature (around 25°C) naturally before first use. Cold insulin is painful to inject.
Always store the pen with the cap on, to avoid any contamination.
After first use, store the pen at room temperature up to 30°C (86°F).
Use the pen within 28 days from first use. Dispose of the pen after 28 days.
DO NOT refrigerate the pen after first use. Store at room temperature between uses.
NEVER leave the needle attached to the pen during storage. This could lead to contamination or needle blockage.
Each Time You Use the Pen: 1. Wash your hands with soap and water before you handle the pen.
2. Check the pen's label to ensure that you are taking the correct type of insulin. The pen has a purple label and a purple injection button.
3. Check the expiration date given on the pen's label.
4. Check the appearance of the drug in the cartridge. This is important especially if you take more than one type of insulin.
5. DO NOT use the pen if the drug in the cartridge appears cloudy, colored or has visible particles.
6. ALWAYS use a new Sterile disposable Hypodermic needle for each injection.
7. Select the injection location as recommended by your Health Care Professional (HCP).
8. ALWAYS put the pen cap back on the pen after use, and store the pen at room temperature in a cool, dry place.
Required Supplies: Make sure you have the following items: Pen, Sterile disposable hypodermic needle*, 2 Alcohol Wipes*.
*Not provided with the pen.
Needles Compatible with this Pen: BD UltraFine 31G, 5mm; BD UltraFine 32G, 4mm; Novofine 32G, 6mm; Terumo Nanopass 33G, 5mm.
Step-By-Step Instructions: Preparing the Pen: A. 1. Inspect the pen: Check the purple-colored label present on the pen for: a. Correct insulin type; b. Expiration date.
Check the Insulin through the cartridge holder for: a. Clear and colourless appearance of the solution; b. Absence of cracks, breakage, or solution leakage.
B. 1. Hold the pen body with one hand.
2. With the other hand, pull off the pen cap.
3. Keep the pen cap aside for later use (in Step Q).
C. 1. Remove an alcohol wipe from its package.
2. Wipe the rubber seal at the front end of the cartridge with the alcohol wipe.
Note: Use of an alcohol wipe reduces chances of infection.
Attaching a New Needle: D. 1. Take a new sterile disposable hypodermic needle.
2. Hold the outer needle cap with one hand.
3. With the other hand, pull off the protective tab from the outer needle cap.
Caution: DO NOT use the needle if the protective tab is damaged or missing. The needle may not be sterile.
E. 1. Hold the pen body facing upwards with one hand.
2. With the other hand, attach the outer needle cap straight on to the cartridge holder.
Caution: DO NOT try to attach the outer needle cap in a tilted manner. This can bend or damage the needle.
3. Screw the outer needle cap in the clockwise direction, till it feels securely fixed on the pen.
F. 1. With a gentle pull, remove the outer needle cap.
2. Keep the outer needle cap. It is required to safely remove the needle later (in Step P).
G. 1. Carefully pull off and throw away the inner needle cap.
Caution: DO NOT re-use the inner needle cap to cover the needle. You may accidentally injure yourself. Only use the outer needle cap to cover the needle (in Step P).
Priming the Pen Needle with 2 Units: H. 1. Turn the white-colored dose knob to set 2 units.
"2" must be visible in the dose window, and align with the pointer on the pen body.
You will hear a "CLICK" for each unit dialed.
Note: If you turn past 2 units, then simply turn back the dose knob in the opposite direction to correct the dose.
I: 1. Hold the pen body facing upwards with one hand.
2. Tap the cartridge holder gently with your finger. This helps any large air bubbles present to rise to the top of the cartridge.
Note: Small bubbles may still be visible, and will not pose any problem.
J: 1. Hold the pen body facing upwards with one hand.
2. With your thumb, press the injection button in until it stops moving and the dose window shows "0".
3. Keep the injection button pressed down.
4. Priming is complete when you observe drops of insulin at the tip of the needle.
Note: If you do not see drops at the needle tip, repeat Steps H to J for a maximum of 4 times.
After 4 attempts, if insulin drops are still not visible at the needle-tip, it is likely that the needle is clogged.
Proceed directly to Step P to remove the needle. Then, return to Step D to attach the new needle and repeat priming (Step H).
Important: Always prime the pen needle before each injection to check insulin flow and avoid incomplete dose.
Setting the Dose: K. 1. Check that the dose window shows "0".
2. Look at the cartridge holder scale to estimate the insulin units left in the cartridge. If enough medication is not available in the cartridge, use a new pen to inject your required dose.
3. Turn the dose knob to set the required dose. The number in the dose window must align with the pointer on the pen body.
Note: Ensure that you hear "CLICK" as you set the desired dose.
The pen does not allow you to dial a dose beyond the units available within the cartridge.
Do not force the dose knob to turn beyond 80 units. 80 units is the maximum dose that you can inject in a single injection.
Caution: DO NOT push the injection button when turning the dose knob (during dose setting).
L. 1. Select the injection location as recommended by your Health Care Professional.
Note: Preferred injection locations on your body are both your arms, hips, thighs, and lower abdomen. It is advised to rotate your injection site for each injection.
M. 1. Clean the skin with an alcohol wipe, at the spot where you want to inject.
Injecting the Dose: N. 1. Insert the needle in a single continuous motion, as instructed by your Health Care Professional.
Caution: DO NOT inject with the needle at an angle.
O. 1. Place your thumb or finger on the injection button.
2. Press the injection button all the way in. The white dose-knob will turn and you will hear "Clicks" as you press down.
3. WAIT. Hold the injection button pressed in for an additional 10 seconds after the dose window shows "0". This pause ensures that all of the medication is delivered.
Caution: DO NOT press the injection button sideways or block the white dose-knob with your fingers. This will prevent you from injecting the medication.
If you don't keep the injection button pressed for 10 seconds after "0" is displayed in the dose window, it could result in an inaccurate dose and you may see drops of insulin at the injection site or at the needle tip.
Needle Removal and Disposal: P. 1. Take the outer needle cap that you had saved in Step F.
2. Hold the outer needle cap from its base and carefully cover the needle without touching it.
3. Squeeze the base of the outer needle cap while unscrewing the needle in a counter clockwise (left) direction. Keep twisting until the needle can be separated from the pen.
4. Discard this needle safely, as instructed by your Health Care Professional or as per local regulations in your country.
Note: It may take several twists to release the needle.
Q. 1. Replace the pen cap and store the pen at room temperature (under 86°F or 30°C) for next use. NEVER store with a used needle attached.
Required Storage: Always store the pen with the cap on, to avoid any contamination.
After first use, store the pen at room temperature up to 86°F (30°C).
Use the pen within 28 days from first use. Dispose of the pen after 28 days.
DO NOT refrigerate the pen after first use. Store at room temperature between uses.
NEVER leave the needle attached to the pen during storage. This could lead to contamination or needle blockage.
Care and Disposal: Always carry a spare insulin prefilled pen injector as recommended by your Health Care Professional, as a precautionary measure, in case your pen is lost or damaged.
Always use a new sterile disposable hypodermic needle for each injection.
Keep the pen away from moisture, dust, direct sunlight and places where the temperature may get too high or too low.
Discard an empty pen without the needle attached, as instructed by your Health Care Professional.
You can clean the outside of your pen by wiping it with a damp cloth.
DO NOT soak or wash your pen as this may damage it. Do not use alcohol, hydrogen peroxide, bleach or any other solvent to clean the pen. Also, do not apply lubricants such as oil, as this could damage the pen.
DO NOT share your pen with others. This pen is intended and recommended for use by one person only.
Keep your pen and needles out of sight and reach of children.
DO NOT attempt to repair the pen by yourself. Remove the needle as described in Step P, make a note of the problem, and return the pen to the manufacturer. Use a new pen instead.
Your pen is designed to work accurately and safely. It must be handled with care. Avoid dropping the pen, as this can cause cartridge breakage or can damage the pen.
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