Mixtard 30 HM

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Mixtard 30 HM

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Mixtard 30 HM

Quick Facts
Active Ingredient Insulin Human (30% Soluble / 70% Isophane)
Form Suspension for Injection
Pharmacological Class Antidiabetic / Hypoglycemic Agent
Common Use Managing elevated blood glucose levels
Origin Biosynthetic (Recombinant DNA technology)

What Type of Medicine is Mixtard 30 HM?

Mixtard 30 HM is a brand name for a Biphasic Human Insulin preparation, formally classified as an Antidiabetic agent or Hypoglycemic agent. It is clinically recognized for providing sustained metabolic control in patients requiring insulin to regulate elevated blood glucose levels associated with Diabetes Mellitus. Insulins are essential for moving glucose from the bloodstream into the body’s cells, which helps lower overall blood sugar levels. This medicine is supplied as a suspension for injection, designed for subcutaneous delivery via cartridges or vials, positioning it as a convenient, ready-to-use option compared to formulations requiring on-demand mixing.

Understanding the Mixtard 30 HM Composition and Ratio

The precise identity of Mixtard 30 HM is based on its fixed premixed formulation ratio of the active ingredient, Insulin Human. The preparation consists of 30% Soluble Insulin (the fast-acting component) and 70% Isophane Insulin (the intermediate-acting component). This 30/70 ratio defines the product’s specific pharmacokinetic profile, a formulation validated through decades of clinical use. The Insulin Human contained within is of biosynthetic origin, manufactured through Recombinant DNA technology, ensuring it is molecularly identical to the body’s natural insulin.

How the Dual-Action Profile Provides General Control

The functional advantage of Mixtard 30 HM is its dual-action profile, which delivers both a rapid initial effect and a prolonged, sustained effect from a single injection. The combination ensures the blood sugar is managed immediately after administration and is stabilized continuously throughout the day. This design helps maintain stable blood sugar levels across the daily cycle, addressing a core requirement for comprehensive diabetes management. The predictable nature of this fixed ratio is a defining characteristic, providing a known basis for managing typical daily fluctuations.

Regulatory References

  1. Human Insulin Injection: MedlinePlus Drug Information

What side effects are possible with Mixtard 30 HM?

Possible Side Effects and Safety Information

The safety profile of Mixtard 30 HM is governed by adverse reactions classified in official regulatory documents based on frequency and affected body system. The most frequent and defining risk is hypoglycaemia (low blood glucose), which is classified as a very common adverse reaction, meaning it may affect more than 1 in 10 patients.


Adverse Reactions by Frequency and System-Organ Class

The following are officially documented adverse reactions:

Frequency System-Organ Class Adverse Reaction
Very Common Metabolism and Nutrition Disorders Hypoglycaemia
Common Skin and Subcutaneous Tissue Disorders Lipohypertrophy (fatty lumps at injection site)
Uncommon Skin and Subcutaneous Tissue Disorders Lipoatrophy (shrinking of fatty tissue)
Uncommon Immune System / General Disorders Local allergic reactions (at injection site)

Serious Adverse Reactions

The official labeling documents severe forms of certain reactions. Severe hypoglycaemia is considered a serious adverse reaction due to its potential for seizures, unconsciousness, and death. Systemic hypersensitivity reactions, including anaphylaxis, are also serious but rare events. Hypokalemia (low blood potassium) is noted as a serious potential consequence associated with insulin therapy. Caution is also specified for patients using Mixtard 30 HM alongside pioglitazone, where monitoring for signs of heart failure is required.


Safety Considerations and Constraints

Certain adverse events, such as local reactions, oedema, and temporary changes in vision, are often transitory and may appear at the beginning of treatment. The medicine is formally contraindicated during episodes of existing hypoglycaemia or in cases of known allergy to human insulin. Furthermore, patients with renal or hepatic impairment and older adults may require intensified glucose monitoring and careful dose adjustment, as their insulin needs might be reduced.

Overdose and Emergency Response

Overdose and when to seek help

The official overdose profile for Mixtard 30 HM, as documented by regulatory agencies, is defined entirely by hypoglycemia (abnormally low blood glucose), which can occur if the quantity administered exceeds the body's requirement. Overdose presentations are classified by severity:

Severity Classification Documented Manifestations Emergency Action Required
Mild to Moderate Sweating, tremor, headache, nervousness, confusion, and difficulty concentrating [EMA]. Oral intake of glucose or sugary products [EMA].
Severe Seizures, loss of consciousness (coma), or long-term impairment of brain function [FDA]. Seek immediate medical attention. Administration of glucagon or intravenous glucose by a healthcare professional [EMA].

When to Seek Urgent Help

The explicit regulatory instruction is to seek immediate medical attention for any episode of severe hypoglycemia, particularly if the individual is unconscious or unable to swallow. The intermediate-acting component of the Mixtard 30 HM formulation necessitates an extended observation period in a clinical setting to monitor for the risk of recurrent hypoglycemia. Furthermore, official labeling notes that patients with pre-existing renal or hepatic impairment may be at an increased risk during an overdose event [FDA].

Therapeutic Uses of Mixtard 30 HM

What Mixtard 30 HM Treats: Main Uses and Key Therapeutic Benefits

Mixtard 30 HM is used in areas where short-term symptom management is appropriate. It is applied across domains where additional symptomatic support is needed, often when symptoms become more noticeable. This formulation is considered relevant for easing symptoms and providing metabolic support.

It offers symptomatic relief that may help patients cope more steadily with symptom fluctuations. This formulation is commonly used across conditions presenting with acute episodes and conditions involving episodic or fluctuating manifestations. It assists with managing symptoms associated with acute or episodic changes, which can lead to heightened systemic burden.

Addressing Fluctuating Symptom Patterns

This formulation is generally used for managing symptoms that interfere with daily comfort and activities. It is relevant when supportive symptom management is appropriate and contributes to easing the overall symptom load during symptomatic periods, supporting patients during episodes of heightened discomfort.


Supporting Daily Stability and Comfort

Mixtard 30 HM is often used when symptoms intensify and supportive relief is needed. It is applied across domains where additional symptomatic support is needed, assisting with maintaining functional stability when symptoms are more noticeable.

Quick Fact: Helps manage symptoms that interfere with daily functioning


Summary of therapeutic use: Commonly used across conditions characterized by periods of heightened symptoms and conditions where functional stability becomes affected.

Regulatory References

  1. Mixtard | European Medicines Agency (EMA)

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Mixtard 30 HM

This section outlines the formal eligibility and non-eligibility information for Mixtard 30 HM, strictly based on regulatory documentation.

Eligibility Classification Populations and Restrictions
Contraindicated (Must not use) Patients with hypersensitivity or allergy to human insulin or any of the product's excipients.
Patients experiencing or with suspected hypoglycemia (low blood sugar).
Use Restricted/Prohibited Route Must not be administered intravenously or used in insulin infusion pumps or other non-approved systems.
Special Populations (Permitted with caution) Elderly patients (over 65 years), paediatric population (children and adolescents).
Patients with renal (kidney) impairment or hepatic (liver) impairment.
Pregnancy and Lactation Status Can be used during pregnancy and breast-feeding.
Dosage adjustments are typically required during these periods.

For all special populations, including the elderly and those with renal or hepatic impairment, use is permitted, but it necessitates intensified glucose monitoring and individualized dose adjustment under medical supervision. The regulatory documents emphasize that the medicine is strictly prohibited when hypoglycemia is suspected and in cases of documented allergy to its components.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Mixtard 30 HM (Human Insulin) is a medicine whose effects are highly sensitive to other substances that influence glucose metabolism. The documented interactions are primarily pharmacodynamic, meaning they alter the body's response to insulin, thereby affecting the required insulin dose.


Substances Affecting Insulin Requirement

Many medications can either increase or decrease the blood glucose lowering effect of Mixtard 30 HM. Patients may require close monitoring and potential dose changes when combining insulin with these drug classes:

Interaction Type Examples of Interacting Substances
Increased Hypoglycemic Effect (Requires less insulin) Oral antidiabetics, MAOIs, ACE inhibitors, beta-blockers, salicylates, anabolic steroids, and sulfonamides.
Decreased Hypoglycemic Effect (Requires more insulin) Oral contraceptives, thiazides, glucocorticoids (corticosteroids), thyroid hormones, sympathomimetics, growth hormone, and danazol.

Specific Combination Risks and Notes

  • Beta-blockers may mask the symptoms of hypoglycemia, making low blood sugar more difficult to recognize.
  • Alcohol consumption may either intensify or reduce the blood glucose lowering effect of insulin.
  • Co-administration with Pioglitazone (a thiazolidinedione) requires specific monitoring for signs and symptoms of cardiac failure, such as unusual weight gain or swelling, as this combination has been associated with increased risk, particularly in patients with pre-existing risk factors.

Mechanism of Action

Mixtard 30 HM is a biphasic suspension containing a mixture of soluble insulin and isophane insulin (Neutral Protamine Hagedorn or NPH).

The soluble insulin component exhibits a rapid onset of action. It binds to the insulin receptor (IR), a cell-surface tyrosine kinase receptor present on target cells, including hepatocytes, myocytes, and adipocytes. Ligand binding induces a conformational change in the IR's beta subunits, activating their intrinsic tyrosine kinase activity. This initiates the autophosphorylation of the IR and subsequent phosphorylation of Insulin Receptor Substrates (IRS) proteins. The activated IRS-1/2 recruits and activates Phosphatidylinositol 3-Kinase (PI3K), which catalyzes the formation of phosphatidylinositol (3,4,5)-trisphosphate ( PIP3). PIP3 recruits Pleckstrin Homology (PH) domain containing kinases, such as PDK1, which activates Akt (Protein Kinase B). Akt, a serine/threonine kinase, regulates the fusion of vesicles containing Glucose Transporter type 4 (GLUT4) to the plasma membrane of muscle and adipose cells, promoting glucose uptake. Concurrently, Akt inhibits Glycogen Synthase Kinase 3 (GSK3), leading to the dephosphorylation and activation of Glycogen Synthase, thereby promoting glycogenesis in the liver and muscle. The isophane insulin component, complexed with protamine and zinc, provides an intermediate-acting profile by delaying the systemic absorption of insulin from the subcutaneous injection site. This mechanism modulates circulating glucose concentration by promoting its storage and cellular utilization.

Dosage and Administration Information

How to Use Mixtard 30 HM — Official Administration Guidelines

Mixtard 30 HM is a biphasic insulin formulation administered by subcutaneous injection only; it must never be given intravenously. Intramuscular administration should be avoided. The dosage is highly individual and must be determined by a physician based on the patient's specific metabolic needs, typically ranging from 0.3 to 1.0 International Unit (IU) per kg of body weight daily.

Preparation and Timing

Mixtard 30 HM is a suspension, meaning it must be resuspended immediately before use. This is done by gently rolling the vial or cartridge between the hands until the liquid appears uniformly white and cloudy. The administration is typically performed once or twice daily. Crucially, the injection must be followed within 30 minutes by a meal or snack containing carbohydrates to align with the insulin's onset of action.

Injection Procedure and Sites

The injection is placed under the skin into the thigh, abdominal wall, gluteal region, or deltoid region. Injection into a lifted skin fold is recommended to reduce the risk of unintended injection into the muscle. The abdominal wall offers the fastest absorption rate. It is mandatory to rotate the injection site within the same anatomical region for each dose to minimise the risk of skin reactions such as lipodystrophy. The needle should be held under the skin for at least six seconds after injection to ensure the full dose is delivered.

Special and Missed Doses

Mixtard 30 HM may be used in children, adolescents, and the elderly. Patients with reduced kidney or liver function may require a dose adjustment determined by a healthcare provider. If a dose is missed, it should be taken as soon as possible, unless the next scheduled dose is near, in which case the missed dose should be skipped; a double dose must never be taken.

Recent Clinical Evidence

Research evidence / Overview of Studies for Mixtard 30 HM

This overview describes the types of clinical studies that have examined the biphasic human insulin formulation, detailing what the research explored, what findings were observed, and where data remain insufficient. This is an overview of the evidence landscape and does not provide medical advice or treatment recommendations.


Evidence for Use in Type 2 Diabetes Mellitus

Research exploring the use of this premixed insulin formulation in Type 2 Diabetes involved various designs. These include randomized controlled trials (RCTs) and observational studies, evaluated in adults, particularly those whose blood glucose levels were above target on their previous treatment regimens.

The primary goals of this research were to monitor outcomes related to systemic or functional imbalance. Studies examined long-term measurements, such as shifts in Glycosylated Haemoglobin ( HbA1c) levels, and short-term readings like Fasting Blood Glucose. Comparative trials reported data show patterns related to measured shifts in these glucose biomarkers when compared with other regimens. Observed outcomes were sometimes associated with factors like improved blood glucose monitoring and patient education, in addition to the medication itself.


Evidence for Use in Type 1 Diabetes Mellitus

The evidence base for Type 1 Diabetes involved multicenter randomized controlled trials designed to assess the biphasic human insulin across different age groups. The research examined both adults and specific studies involving children and adolescents. These studies primarily focused on patients who were transitioning from prior insulin treatment plans.

The trials monitored outcomes related to systemic or functional imbalance by measuring changes in HbA1c and blood glucose levels. Research describes how HbA1c levels evolved in the observed populations across the research duration. In some paediatric research, studies reported that measured changes were achieved when the medication was used alongside intensive monitoring and educational support.


Research on Special Populations

Research was studied for use in specific patient groups, including the paediatric population (children and adolescents). Furthermore, studies examined patients whose blood glucose levels were previously difficult to achieve. The findings describe group patterns in these specific cohorts, but research does not provide individual predictions.


Long-Term Data and Follow-up Duration

A significant portion of the comparative efficacy trials for this formulation was conducted over defined time intervals that are relatively short, typically spanning around 12 to 16 weeks. There is limited information for long-term outcomes from extended prospective studies. The evolution of blood glucose levels beyond the initial follow-up periods long-term effects are not fully established. While some studies included follow-up measurements extending to one year, evidence quality varies across studies regarding the durability of the observed patterns.


What is Still Uncertain About the Research Base

There are areas where data remain insufficient or where more research is needed. A key research limitation is that follow-up durations were limited in many interventional studies, meaning long-term effects are not fully established. Another uncertainty is that as a fixed 30/70 ratio, research provides limited insight into how the two components might be separately adjusted.

Frequently Asked Questions (FAQ)

Common questions about Mixtard 30 HM (FAQ)

Q: What exactly is the '30 HM' part of the name Mixtard 30 HM?

According to the official product information, the '30' refers to the composition of the mixture. Mixtard 30 HM contains 30% soluble (fast-acting) human insulin and 70% isophane (intermediate-acting) human insulin. The two components work together to provide blood sugar control over different timeframes.

Q: How is Mixtard 30 HM similar to the insulin produced naturally by the body?

Mixtard 30 HM is a human insulin formulation. This means its active substance is highly similar to the insulin naturally produced by the human pancreas. Official regulatory documents indicate that the medicine is manufactured using recombinant DNA technology.

Q: What is the difference between Mixtard 30, Mixtard 40, and Mixtard 50?

The number in the Mixtard name indicates the percentage of the fast-acting insulin in the mix. Mixtard 30 contains 30% fast-acting insulin, while Mixtard 40 and Mixtard 50 contain 40% and 50% fast-acting insulin, respectively. The specific ratio is a factor that is determined by a healthcare provider based on individual metabolic needs.

Q: What is the total duration of action for Mixtard 30 HM?

The official product information indicates that the total action of Mixtard 30 HM can last for up to 24 hours. This sustained effect is primarily provided by the intermediate-acting (isophane) component of the insulin mixture.

Q: What are the most common reported side effects of Mixtard 30 HM?

The official documentation states that the most common side effect is hypoglycemia, which is low blood glucose. Other common effects reported with insulin therapy include injection site reactions and the potential for weight gain.

Q: Why is low blood sugar (hypoglycemia) the most frequent risk with this medicine?

Hypoglycemia is a consequence of all insulin therapy. The medicine’s function is to lower blood glucose, and official warnings indicate that its effect can sometimes be greater than required by the body's immediate needs, leading to low blood sugar.

Q: What are the typical signs of low blood sugar (hypoglycemia) that may be caused by Mixtard 30 HM?

Symptoms of hypoglycemia, as listed in official warnings, may include cold sweats, cool pale skin, tremor, and anxiety. Other reported signs include difficulty concentrating, nausea, headache, and drowsiness.

Q: Is it common to have redness, swelling, or itching at the injection site when using Mixtard 30 HM?

Regulatory documents indicate that local hypersensitivity reactions, such as redness, swelling, or itching at the injection site, are common and are usually temporary, often resolving during continued use of the medicine.

Q: Can Mixtard 30 HM cause a temporary change in vision when first starting treatment?

Official information indicates that temporary vision changes, known as refraction anomalies, may occur when a patient first begins insulin therapy. These visual changes are usually transitory and tend to resolve over time.

Q: What serious allergic reaction signs should a person watch for when taking Mixtard 30 HM?

Symptoms of severe generalised allergic reaction include a widespread skin rash, itching, sweating, gastrointestinal upset, and difficulties in breathing. This type of reaction is very rare but is recognized as needing immediate medical review.

Q: Does using Mixtard 30 HM lead to long-term weight changes?

The official product information lists weight gain as a commonly reported side effect associated with the use of insulin therapy generally.

Q: What should a patient look for if they suspect high blood sugar (hyperglycemia) while on Mixtard 30 HM?

Symptoms of high blood sugar (hyperglycemia) listed in official warnings include increased thirst, frequent urination, nausea, vomiting, and dry mouth. If these symptoms are experienced, official guidance recommends that blood glucose levels be checked.

Q: Does Mixtard 30 HM affect the ability to drive or operate machinery?

Official warnings state that a person's ability to concentrate and react may be impaired if their blood glucose is too low (hypoglycemia) or too high (hyperglycemia). Regulatory documents indicate that precautions are advised, especially for individuals who have reduced awareness of low blood sugar.

Q: Is dizziness or drowsiness a commonly reported side effect?

Official documents list drowsiness as a symptom associated with both low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Dizziness is also noted as a possible symptom of low blood sugar.

Q: How can changes in diet or exercise affect the required amount of Mixtard 30 HM?

Regulatory warnings state that an adjustment of the required dose may be necessary if a patient undertakes increased physical activity or makes a significant change to their usual diet. The final dose determination remains a responsibility of a healthcare provider.

Q: Is it necessary to monitor blood sugar more closely when traveling across time zones with Mixtard 30 HM?

Official patient information notes that traveling across time zones can affect a patient's need for insulin and the appropriate timing of injections. Official patient information indicates that a healthcare provider should be consulted regarding any necessary adjustments before travel.

Q: Can being ill or having a fever affect a person's need for Mixtard 30 HM?

Official warnings indicate that concomitant illness, particularly infections and feverish conditions, usually increase a patient's insulin requirement. Dose adjustments in these situations require the guidance of a healthcare provider.

Q: Is it known if herbal supplements can affect how Mixtard 30 HM works?

Official regulatory information indicates that a healthcare provider should be informed if a patient is taking non-prescription medications or dietary supplements. Certain non-prescription products may influence blood sugar levels and alter the required insulin dose.

Q: How should unopened Mixtard 30 HM vials or pens be stored?

Unopened products must be stored in a refrigerator (typically 2 C to 8 C) as stated in official documentation. Official storage guidance emphasizes keeping the product away from the freezing compartment.

Q: How long can an open Mixtard 30 HM pen or vial be kept and used?

Once a pen or vial is in use (open), official storage guidelines recommend keeping it at room temperature (not exceeding 30 C). The product must be discarded after a specific period, generally between 28 and 42 days, depending on the specific product presentation.

Q: What happens if Mixtard 30 HM is accidentally frozen?

Official patient information states that Mixtard 30 HM should not be used if it has been frozen. Freezing can damage the insulin, altering its intended effect.

Q: What medical conditions, other than diabetes, would prevent a person from using Mixtard 30 HM?

Official contraindications state that the medicine should not be used if the patient is allergic (hypersensitive) to human insulin or any of its inactive ingredients. It is also contraindicated if a patient is experiencing or suspects the onset of hypoglycemia (low blood sugar).

Q: Is Mixtard 30 HM generally considered safe to use during pregnancy?

Official regulatory documents indicate that there are no restrictions on the use of insulin to treat diabetes during pregnancy, as the insulin does not pass the placental barrier. However, official information notes that the dosage may require adjustment.

Q: Are there any known risks to a breastfed infant if the mother is using Mixtard 30 HM?

Official information confirms that treatment with insulin while breastfeeding is considered to pose no risk to the baby. As with pregnancy, official information notes that the mother’s insulin dose may require adjustment.

Q: Was Mixtard 30 HM compared to insulin analogues in clinical studies?

Clinical trial summaries indicate that studies were conducted comparing Mixtard 30 to a similar premixed insulin formulation that was made up using an insulin analogue (such as insulin aspart).

Q: What kind of monitoring is recommended for patients switching from animal-source insulin to Mixtard 30 HM?

Regulatory warnings indicate that patients transferred between different types of insulin, including older animal-source insulins, may experience a change in the early warning symptoms of hypoglycemia. Regulatory warnings indicate that close blood sugar monitoring is often performed during this type of transition.

Q: Does Mixtard 30 HM have any known habit-forming tendencies?

Official patient safety information explicitly states that Mixtard 30 HM is not habit-forming.

Q: What is lipodystrophy and how is it related to Mixtard 30 HM injections?

Official documents describe lipodystrophy as a risk associated with injections, causing skin thickening, skin shrinking, or the formation of lumps under the skin. The risk of this reaction is officially noted as being reduced through the continuous rotation of the injection site.

Q: What is the recommended way to rotate injection sites for Mixtard 30 HM?

Official guidelines mandate that patients perform continuous rotation of the injection site within a given area, such as the abdomen or thigh. This rotation is officially mandated as a practice to help minimize the risk of skin reactions like lipodystrophy.

Q: Is Mixtard 30 HM Penfill the same as using a vial and syringe?

Mixtard is available in different presentations, including vials, cartridges (often branded as Penfill), or pre-filled pens. Official information indicates that all these forms contain the same active substance, which is human insulin.

How should Mixtard 30 HM be stored and disposed of?

Storage and Handling Requirements for Mixtard 30 HM

Official regulatory labeling dictates specific storage and disposal rules, and the medicine must always be kept out of the sight and reach of children.


Unopened Storage

Unopened Mixtard 30 HM must be stored in a refrigerator between 2°C and 8°C.

  • Protection: It must be kept in the original package to shield it from light. The product must not be frozen and should be discarded if it has been.

In-Use Storage and Disposal

Once in use, the product should not be refrigerated and must be stored at a temperature below 25°C (or 30°C, depending on the label) for a maximum of four weeks.

  • Handling: Do not store the pen with the needle attached. Do not use the medicine if it has passed its expiry date.
  • Disposal: Unused or expired medicine must be disposed of according to local requirements, often by returning it to a pharmacist for safe handling.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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