Basalin is a long-acting insulin used to treat adults with type 1 and type 2 diabetes for the control of high blood sugar. Before using Basalin for the treatment of diabetes, please read the instruction leaflet and follow your doctor’s advice.
Basalin®ElasPen® is a disposable single-patient-use prefilled insulin pen. Before using Basalin®ElasPen®, please talk to your healthcare provider about proper injection technique and follow instructions in the instruction leaflet.
The information below is solely for the purpose of addressing your inquiry and should not be used for promotional or advertising purposes. It is not intended to serve as a clinical medication guidance.
※ Injection and Use
● What is the ideal time for administering Basalin®? Should it be injected in the morning or evening? Is it advisable before or after meals?
The effect of Basalin® lasts for 24 hours without exhibiting a peak value. Consequently, there are no constraints on the injection timing. The glucose-lowering impact remains consistent regardless of whether the injection is administered in the morning, before bedtime, or before and after meals. It is perfectly acceptable to set a consistent injection time each day and repeat it the following day.
When insulin glargine is injected into the human body, it encounters body fluids with a pH value of approximately 7.4. This environment causes a decrease in the solubility of insulin glargine, resulting in the formation of tiny precipitates. These gradually dissolve into monomers, which are released at a controlled and steady rate. This mechanism produces a smooth and sustained glucose-lowering effect over 24 hours, similar to the body's natural basal insulin secretion. As a result, the injection can be given at a fixed time of the day. Given the variability in patients' blood glucose levels and lifestyles, the injection time can be adapted to individual circumstances in clinical practice.
● Can Basalin® (cartridge) be used in an insulin pump?
Basalin® (cartridge) cannot be used in insulin pumps.
● What is the best place to administer insulin? Is it necessary to rotate injection sites regularly?
Typical injection sites encompass the abdomen, upper and outer arms, front and outer thighs, as well as buttocks. Among these, the abdomen is generally preferred.
To maintain optimal results, it's recommended to rotate the subcutaneous injection site regularly. It's advisable to avoid using the same location for insulin injections within a two-week period. This practice prevents a decrease in the ability of the subcutaneous tissue to absorb insulin due to multiple injections in a concentrated area over a short period of time. Such repeated injections in the same area can lead to problems such as fat nodules, which can affect the absorption and use of insulin.
● What happens if you notice symptoms such as redness, itching, rash, or swelling at the injection site?
Pouching: If the injection is mistakenly placed on the surface of the skin (dermis 1.8 mm-2.5 mm) rather than in the subcutaneous fat layer, pouching will occur.
Pain, redness, and swelling: If the injection reaches the muscle layer and the fat at the injection site is thin, you may experience pain, redness, or swelling. To avoid this, consider changing the injection site or using a different type of needle next time. It's important to note that pinching the skin during the injection can help to ensure that the injection is properly angled.
Local allergic reactions: Symptoms such as redness, itching, rash, and swelling at the injection site are usually mild and local allergic reactions. These reactions are usually temporary and will gradually subside as treatment continues. If these symptoms persist or worsen, it's advisable to consult a healthcare professional immediately for appropriate advice.
● What causes ecchymosis when insulin is injected subcutaneously?
The emergence of this condition is not linked to the insulin medication itself. Potential triggers encompass repeated use of disposable needles, microvascular disease, brittle blood vessels, abnormal coagulation function, etc.; the human skin is divided into epidermis and dermis, and there are blood vessels in the dermis layer, which may also lead to rupture of blood vessels and formation of ecchymosis when injected in an improper manner.
Scientific studies have shown that finer needles correlate with a reduced incidence of discomfort and ecchymosis. Patients are therefore advised to switch to finer needles and establish a consistent injection technique. In cases of severe ecchymosis, patients are advised to seek immediate medical advice to determine the possible presence of underlying medical factors.
● What causes medication to leak from the injection site after administration?
Insufficient absorption and leakage of the medication may occur if the needle is withdrawn from the skin too quickly after a short time. To improve absorption and prevent leakage, it's advisable to keep the needle under the skin for more than 10 seconds.
Prolonged injection at the same site can lead to fat hyperplasia and the development of solid nodules, which may also lead to needle leakage. To mitigate these problems, it is advisable to consistently rotate the injection site for insulin administration. This practice will effectively prevent the above situations from occurring.
● After switching from abdominal to arm injections due to prolonged abdominal fat hyperplasia, the patient experienced an increase in fasting blood glucose of 1.5 mmol/L compared to her previous levels. This change in glucose levels could potentially be attributed to what underlying cause?
Typically, the fat layer in the arm is thinner than in the abdomen, which makes it easier for arm injections to reach the muscle layer. When injected into the muscle layer of the arm, there are distinct characteristics of insulin absorption that are different from those seen when injected into the subcutaneous fat layer. These include a rapid rise in insulin levels, earlier peak concentrations and a shorter duration of insulin action. This may result in an inadequate duration of action and an increase in fasting blood glucose levels. If this situation occurs and the patient wishes to continue with arm injections, it is advisable to consider switching to a shorter needle or using a pinch technique to ensure that insulin doesn't infiltrate the muscle layer. Choosing to inject into the buttock can also reduce the risk of injecting into the muscle layer.
If the above strategies fail to reduce blood glucose levels, it is plausible that the patient's condition has progressed, possibly involving escalated beta cell damage or increased insulin resistance. In such cases, it is recommended that the patient seek immediate medical attention by visiting a hospital and consulting with a healthcare professional.
※ Storage and Stability
● Why is used Basalin® stored at room temperature below 25°C, whereas other used insulins are stored at 30°C?
The information provided in this leaflet is derived from test data, with variations due to different test temperature standards. The post-opening stability/challenge test for Basalin® was performed at 25°C, whereas for other insulins, such as Rapilin®, the post-opening stability/challenge test was performed at 30°C.
● Why is the expiry date for Basalin® (cartridge) 36 months, but the expiry date for Basalin® (prefilled pen) is 24 months?
The expiry date is the period during which a pharmaceutical product maintains its registered quality standards under specific storage conditions. Determined by stability testing - which includes comprehensive accelerated, long-term, and impact studies - the expiry date is subject to regulatory approval. For Basalin® (cartridge), stability test data support a shelf life of 36 months, while the Basalin® (prefilled pen) is stable for 24 months. Initially set at 24 months, the expiry date for Basalin® (cartridge) was extended to 36 months following the submission of additional stability data.
● Can insulin be injected right after taking it out of the fridge?
No. Insulin needs to be taken out of the refrigerator and left at room temperature for a while, and then injected when it returns to room temperature. Immediate injection after taking insulin out of the fridge may result in a delayed onset of action due to the effect of cold temperatures on protein activity. This delay could potentially affect blood glucose control. In addition, cryogenic injection can cause increased discomfort for the patient.
● Can insulin still be used if it's accidentally frozen, and why?
No. Insulin that has been frozen must not be used anymore.
This is because insulin is a protein-based drug and freezing can cause denaturation of the protein, altering its activity and affecting its effectiveness in lowering glucose levels and potentially compromising safety. The optimum storage temperature for insulin is between 2°C and 8°C.
● Can insulin be taken onto an airplane or be part of a check-in?
Travelers with diabetes can carry sufficient supplies of insulin, as well as hypodermic syringes and needles, with a medical certificate. When traveling by air, insulin should be carried as hand luggage and not placed in checked baggage. This is because the temperature in the baggage compartment can often drop below 0°C and the extreme cold can make insulin ineffective.
Medicines and injections should be packed securely, with labels retained as proof of authenticity. Insulin should be separated from other carry-on items for security screening and presented to security personnel for inspection. Unopened insulin should be stored in a refrigerator between 2°C and 8°C. Occasionally, airport security may not allow small ice packs to be carried. In such cases, discussions with security management may lead to permission for 1~2 small ice packs. Alternatively, requesting ice from flight attendants after boarding can serve the same purpose.
● Can medicines that expire in a month still be used?
Yes. Medicines are safe to use as long as they are within their shelf life, and do not use them after their shelf life has expired.
● In cases where patients require a lower dose of insulin, how should patients address the situation if a medication is not fully utilized within a 28-day period?
A medicine should be used within 28 days of opening, and a new insulin cartridge should be replaced if it has not been used up for more than 28 days.
※ Quality and Safety
● Can I use an insulin cartridge that has small air bubbles in it?
When insulins are filled, it is inevitable that a small amount of air will enter the product, causing small bubbles to form. These cartridges are rigorously tested at the factory before distribution. The presence of air bubbles in unopened cartridges doesn't affect the quality of the medicine or the accuracy of the dose. However, it's important to remove the air properly before injecting.
Administer insulin injections correctly and be sure to remove the needle after each use. This will prevent the introduction of air, which can reduce the effectiveness of the medication.
● What if foreign bodies or red, brown, or white flocs appear in the liquid medicine during use?
Based on our company's previous blood return tests, the introduction of blood into the product results in the formation of foreign particles such as flakes, granules, and fibers. In addition, the color of the liquid may either remain a light yellow or show no significant change due to the presence of blood in the return. (Since 2019, Gan & Lee has received a total of 11 complaints related to blood return incidents. We have also observed similar complaints related to foreign bodies in 2019, 2020, and 2021. All of these cases were confirmed to be related to blood-return events. Possible factors contributing to the occurrence of foreign bodies in blood return incidents may include repeated needle use or improper handling during insulin administration. To mitigate these problems, we advise patients to use new disposable needles for each insulin injection, to remove needles from the product immediately after use, to follow the injection site recommendations in the instructions, and to observe the storage conditions specified in the instructions after use). If red flocculent material is visible, this may indicate a small amount of blood from the syringe returning to the vial. White particles are usually caused by the cartridge stopper, which can release rubber particles into the cartridge as a result of repeated needle punctures. In such cases, it is advisable to stop using that particular insulin cartridge.
● Does Basalin® exhibit a lower quality and efficacy compared to imported originator products?
In terms of product quality, Gan & Lee uses German-imported manufacturing equipment and employs molecular chaperone technology during production to ensure protein purity. The standards for "residual DNA" and "microbial limit" exceed those of the European and American Pharmacopoeia. The National Institute for the Control of Biological Products designates Gan & Lee as the supplier of "National Standard Insulin Glargine". The 36-month shelf life of Basalin® (cartridge) underlines the stability of the product.
In terms of product efficacy, numerous comparative clinical studies have confirmed that Basalin® matches the efficacy of imported glargine, with equivalent safety and dosage. Besides over 17 years of commercial experience in China, the product also has been successfully exported to numerous countries worldwide.
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