INTRODUCTION

HUMAN MIXTARD 50/50 40IU INJECTION contains Biphasic Isophane Insulin which belongs to the group of medicines called Antidiabetic agents. It is used to treat diabetes mellitus (both type I and type II).

Diabetes mellitus is a chronic disease characterized by abnormally high levels of glucose in the blood. It is caused either due to inadequate production of a hormone called insulin (produced by pancreas to metabolize glucose) in the body or due to inadequate sensitivity of body cells to the actions of insulin.

Biphasic Isophane Insulin is a pre-mixed combination of Regular (soluble) insulin and Isophane (NPH) insulin. It is a fast-acting medicine where it begins to lower blood sugar levels within 30 minutes. Therefore, inject the medicine 30 minutes before meal and make sure to have your meals within the next 30 minutes.

Talk to your doctor before starting therapy with HUMAN MIXTARD 50/50 40IU INJECTION if you have any liver, kidney or heart problems. You must also inform your doctor if you have any hormonal problems, made sudden changes to your diet or perform intense exercise as a precaution. Do not use this medicine if you have hypoglycemia (low blood sugar levels). Consult your doctor before using this medicine if you are pregnant or breastfeeding.

The most common side effects of receiving HUMAN MIXTARD 50/50 40IU INJECTION are low blood sugar levels, pain, redness, itching, swelling or thickening at the injection site, lump formation under the skin and swelling of body parts. Consult your doctor if any of these side effect troubles you.

USES OF HUMAN MIXTARD 50/50 40IU INJECTION

• Treats diabetes mellitus (both type I and type II)

HOW HUMAN MIXTARD 50/50 40IU INJECTION WORKS

HUMAN MIXTARD 50/50 40IU INJECTION helps your body to make utilize of the circulating blood glucose. It helps in the transport of glucose from the blood into the muscles and fat tissues. It also stops the production of glucose by the liver. As a result, it controls blood sugar levels and improve glycemic control in patients with diabetes mellitus.

DIRECTIONS FOR USE

Always inject this medicine into your thighs, buttocks, upper arm, or abdomen (i.e., subcutaneously). Do not administer this medicine into the vein or muscle directly. It should be administered 30 minutes before meals. Eat a meal or snack containing carbohydrates within 30 minutes of the injection to avoid low blood sugar.

Before administration, roll the vial/cartridge between your hands until the liquid becomes uniformly white and cloudy. While injecting, keep the needle under the skin for at least 6 seconds to make sure that the entire dose is injected.

Prior to the administration, visualize the cartridge/vial for any visible particulate matter and discoloration. Discard the needle and syringe after use and do not share your needles with others to avoid the risk of transmission of infections.

Avoid repeatedly injecting the medicine at the same site to prevent skin damage. Instead, rotate the injection site. Make sure to consult your doctor before changing the injection site as a precaution.

HUMAN MIXTARD 50/50 40IU INJECTION should not be mixed with any other insulins before use. Do not stop therapy with HUMAN MIXTARD 50/50 40IU INJECTION without consulting your doctor. Your doctor will decide correct dose and frequency of administration depending upon your age, body weight and health condition.

SIDE EFFECTS OF HUMAN MIXTARD 50/50 40IU INJECTION

HOW TO MANAGE SIDE EFFECTS

Hypoglycemia

Have foods rich in sugars such as fruit juices, glucose drinks, candies, honey or biscuits. Check your blood sugar after 10 minutes. If not gained optimum level, take another sugary snack, or a drink and check the blood sugar again. Consult your doctor if there is no improvement in your condition.

Injection Site Reactions

Place an ice pack on the injected site. Do not move the affected area frequently. If the symptom worsens, consult your doctor. Do not inject this medicine at the same site. Always rotate injection sites within the same region from one injection to the next to reduce skin damage.

WARNING & PRECAUTIONS

PREGNANCY

Monitoring required

HUMAN MIXTARD 50/50 40IU INJECTION can be used during pregnancy if prescribed by the physician. Therefore, consult your doctor before administration.

BREASTFEEDING

Safe

HUMAN MIXTARD 50/50 40IU INJECTION is considered safe for use during breastfeeding. However, consult your doctor before administration.

DRIVING AND USING MACHINES

Use with Caution

Do not drive or operate any heavy tools or machines if your ability is affected by HUMAN MIXTARD 50/50 40IU INJECTION.

ALCOHOL

Consult your doctor

Avoid consumption of alcohol while taking this medicine as it could aggravate your existing disease condition.

KIDNEY

Use with Caution

HUMAN MIXTARD 50/50 40IU INJECTION should be used with caution in patients with kidney problems. Therefore, consult your doctor before administration.

LIVER

Use with Caution

HUMAN MIXTARD 50/50 40IU INJECTION should be used with caution in patients with liver problems. Therefore, consult your doctor before administration.

ALLERGY

Contraindicated

Talk to your doctor before receiving HUMAN MIXTARD 50/50 40IU INJECTION if you are allergic to Regular insulin, Isophane insulin or to any other Human insulin (Ex. Lente, ultra-Lente).

HEART DISEASE

Use with Caution

HUMAN MIXTARD 50/50 40IU INJECTION should be taken with caution in patients with heart disease. Therefore, consult your doctor before administration.

USE IN PEDIATRICS

Monitoring required

HUMAN MIXTARD 50/50 40IU INJECTION can be used in children and adolescents (aged below 18 years) if prescribed by the physician. Therefore, consult your doctor before administration.

USE IN GERIATRICS

Use with Caution

HUMAN MIXTARD 50/50 40IU INJECTION should be used with caution in elderly patients (aged 65 years or above). Therefore, consult your doctor before administration. Proper dose adjustments and careful monitoring of blood glucose levels and kidney functions are required in such patients.

INTERACTIONS

A. Drug-Drug interactions:

Before HUMAN MIXTARD 50/50 40IU INJECTION is administered, inform your doctor if you are taking any of the following medicines such as:

• other medicines used to treat diabetes such as sulfonylureas (Ex. tolbutamide, glibenclamide, glipizide), biguanides (Ex. metformin, phenformin), thiazolidinediones (Ex. pioglitazone), DPP-4 inhibitors (Ex. sitagliptin, vildagliptin) or SGLT-2 inhibitors (Ex. remogliflozin)
• medicines used to treat depression such as monoamine oxidase inhibitors (Ex. rasagiline, selegiline, phenelzine)
• medicines used to treat high blood pressure and other heart problems such as beta-blockers (Ex. propranolol, atenolol, nebivolol) or ACE inhibitors (Ex. captopril, enalapril, lisinopril)
• salicylates (used to relieve pain or fever) Ex. aspirin
• anabolic steroids (used to build muscle and improve athlete performance) Ex. testosterone, nandrolone, oxandrolone
• sulfonamide antibiotics (used to treat bacterial infections) Ex. sulfasalazine, sulfadiazine, sulfamethoxazole
• oral contraceptives (birth control pills) Ex. mifepristone,
• thiazide diuretics (used to increase urine output and reduce blood pressure) Ex. chlorothiazide, hydrochlorothiazide
• glucocorticoids (used to treat inflammation) Ex. cortisone, betamethasone, beclomethasone, dexamethasone, budesonide, prednisone
• thyroid hormone (used to treat thyroid disorders) Ex. thyroxine, triiodothyronine
• sympathomimetic agents (used to treat asthma or other circulatory disorders) Ex. ephedrine, adrenaline, salbutamol, or terbutaline
• growth hormone (a hormone used to increase skeletal and somatic growth in the body)
• danazol (a medicine used to treat endometriosis)
• octreotide (used to treat diarrhea)
• lanreotide (a medicine used to treat abnormal body growth)

B. Interaction with food or drink:

HUMAN MIXTARD 50/50 40IU INJECTION should be administered 30 minutes before a meal.

Overdosage:

If you or anyone else took too much of this medicine, contact your doctor immediately or go to a hospital straight away as it may cause severe hypoglycemia. Symptoms of hypoglycemia might include fainting, feel unwell, sweating, vomiting, difficulty in breathing, fast heartbeat, and dizziness.

SYNOPSIS

MORE INFORMATION

• Keep out of reach of children
• Store the unopened pack in the refrigerator at 2°C – 8°C. Do not freeze
• During use or when carried as a spare, keep it at room temperature
• Always place the vial/cartridge in the outer carton to protect from light

FAQs ABOUT HUMAN MIXTARD 50/50 40IU INJECTION

Q: Should HUMAN MIXTARD 50/50 40IU INJECTION be refrigerated?

A: Yes. An unopened pack must be stored in the refrigerator (2°C – 8°C). During use or while carrying as a spare, keep it at room temperature to ensure uniform resuspension.

Q: Can HUMAN MIXTARD 50/50 40IU INJECTION be mixed with other insulins?

A: No. HUMAN MIXTARD 50/50 40IU INJECTION is already a pre-mixed combination of regular insulin and isophane insulin and therefore should not be mixed with other insulins. For more information regarding the direction of use contact your doctor.

Q: Is HUMAN MIXTARD 50/50 40IU INJECTION safe during pregnancy?

A: Yes. HUMAN MIXTARD 50/50 40IU INJECTION can be used during pregnancy if prescribed by the physician. Therefore, consult your doctor before administration.

Q: How long does it take for HUMAN MIXTARD 50/50 40IU INJECTION to start working?

A: HUMAN MIXTARD 50/50 40IU INJECTION is a fast-acting medicine where it begins to lower blood sugar levels about 30 minutes post administration and its effect would last for about 24 hours.

Q: Can HUMAN MIXTARD 50/50 40IU INJECTION be given intravenously?

A: No. HUMAN MIXTARD 50/50 40IU INJECTION is meant for subcutaneous use only (i.e., thighs, buttocks, abdomen, or upper arms). It should not be directly injected into the vein or muscle as it may cause severe hypoglycemia.

Q: What is the best area for injecting HUMAN MIXTARD 50/50 40IU INJECTION? Should I inject it only at the same site every day?

A: The best place for injecting this medicine is front of your thighs, buttocks, abdomen, or upper arms. The insulin would work more quickly if it were injected into the waist (abdomen). Do not repeatedly inject the medicine on the same site. Instead, rotate the injection sites within the same area to avoid the risk of developing lumps or skin pitting.

Q: What is HUMAN MIXTARD 50/50 40IU INJECTION used for?

A: HUMAN MIXTARD 50/50 40IU INJECTION is used to treat diabetes mellitus (both type I and II).

Q: What are the most common side effects of taking HUMAN MIXTARD 50/50 40IU INJECTION?

A: The most common side effects of receiving HUMAN MIXTARD 50/50 40IU INJECTION are low blood sugar levels, pain, redness, itching, swelling or thickening at the injection site, lump formation under the skin and swelling of body parts. Consult your doctor if any of these side effect troubles you.

Q: Can I stop therapy with HUMAN MIXTARD 50/50 40IU INJECTION without consulting your doctor?

A: No. You should not stop therapy with HUMAN MIXTARD 50/50 40IU INJECTION without consulting your doctor because it may lead to reversal of symptoms. If you feel better after using HUMAN MIXTARD 50/50 40IU INJECTION, consult your doctor for advice.

Q: Will taking a higher dose of HUMAN MIXTARD 50/50 40IU INJECTION be more effective?

A: No, taking a higher dose of HUMAN MIXTARD 50/50 40IU INJECTION will not be effective rather it can lead to toxicity. Always take the dose prescribed by your doctor. If the prescribed dose is not effective for you, consult your doctor for advice. Your doctor might increase the dose or suggest an alternative therapy.

Q: Can I take medication for high blood pressure along with HUMAN MIXTARD 50/50 40IU INJECTION?

A: It is not advisable to take medicines to control blood pressure while taking HUMAN MIXTARD 50/50 40IU INJECTION without consulting your doctor. Therefore, consult your doctor before taking any antihypertensive medications along with HUMAN MIXTARD 50/50 40IU INJECTION as they have known interactions with HUMAN MIXTARD 50/50 40IU INJECTION.

REFERENCES

1. KD. Tripathi. Insulin, Oral Hypoglycemic Drugs and Glucagon. Essentials of medical pharmacology. Seventh edition. 2013. Page – 263-264 & 266-269.

2. Jaime A. Davidson, Daniel Einhorn, Pamela Allweiss, Thomas M. Flood, Alan J. Garber, Mariano J. Garcia, Charles B. Kahn, Norman G. Soler, John R. White, William J. Huster. Effect of Premixed NPH and Regular Insulin on Glucose Control and Health-Related Quality of Life in Patients with Type 2 Diabetes Mellitus. AACE Endocrine practice. [Revised in August 1996]. [Accessed on 18th February 2023]. https://www.endocrinepractice.org/article/S1530-891X(20)43520-7/pdf

3. Biocon Ltd. Biphasic Isophane Insulin Injection IP. Insugen-50/50 100 IU Refill. [Revised in July 2020]. [Accessed on 18th February 2023]. https://www.biocon.com/docs/domestic-market-pi/metabolics/INSUGEN-50%2050%20REFILL%20PI.pdf

4. Biocon Ltd. Biphasic Isophane Insulin Injection IP. Insugen-30/70 (Biphasic)100 IU. [Revised in May 2012]. [Accessed on 18th February 2023]. https://www.biocon.com/docs/prescribing_information/diabetology/insugen3070100iu_pi.pdf

5. Novo Nordisk A/S. Mixtard 30 40 IU/ml (international units/ml) suspension for injection in vial. European Medical Agency. [Revised in September 2007]. [Accessed on 18th February 2023]. https://www.ema.europa.eu/en/documents/product-information/mixtard-epar-product-information_en.pdf

6. Sanofi-Aventis Deutschland GmbH. Biphasic Isophane Insulin Injection I.P. [Revised in March 2017]. [Accessed on 18th February 2023]. https://www.sanofi.in/dam/jcr:23695177-c3f1-4924-9907-de78b1c3acef/Insuman_PI.pdf

USEFUL DIAGNOSTIC TESTS

• Glucose - Fasting Blood
• Glucose - Postprandial Blood
• Glycosylated Hemoglobin