100 units/ml solution for injection in the vial ( insulin lispro)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet:
1. What Humalog Mix25 is and what it is used for
2. What you need to know before you use Humalog Mix25
3. How to use Humalog Mix25
4. Possible side effects
5. How to store Humalog Mix25
6. Contents of the packaging and other information

1. What Humalog Mix25 is and what it is used for

Humalog Mix25 is used for treating diabetes. Humalog Mix25 is a ready-mixed suspension. The active substance is insulin lispro. 25% of insulin lispro in Humalog Mix25 is dissolved in water, it acts faster than normal human insulin because the insulin molecule has changed slightly. 75% of insulin lispro in Humalog Mix25 is contained in a suspension containing protamine sulphate, which prolongs the effect.

You get diabetes if your pancreas does not produce enough insulin. Humalog Mix25 replaces your own insulin and is used to control blood glucose levels for a long time. Humalog Mix25 works very quickly and for longer than soluble insulin. You should normally take Humalog Mix25 within 15 minutes before or after a meal.

Your doctor will tell you if you should take Humalog Mix25 with longer-acting human insulin. Each type of insulin has its own user information. Do not change your insulin unless your doctor tells you to. Be very careful if you change your insulin.

2. What you need to know before using Humalog Mix25

DO NOT use Humalog Mix25

– if you think that a so-called insulin sensation (low blood sugar) begins. Later in this user information, there are instructions on how to deal with a mild insulin sensation (see section 3: If you use more Humalog Mix25 than you should).

– if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

  • Always check the packaging and the label of the vial so that the name and type of insulin match when you get it from the pharmacy. Make sure you get the Humalog Mix25 prescribed by your doctor.
  • If your blood sugar is under good control of your current insulin , you may not be able to detect the warning signs when your blood sugar gets too low. Warning signals are listed later in this user information. You should carefully keep track of when you should eat, how often you should exercise and how much you should work. You should also carefully check your blood sugar level by testing your blood sugar frequently.
  • Some people who have had insulin sensations after switching from animal insulin to human insulin have reported that the early warning symptoms were less clear or different. If you often have insulin sensations or have difficulty recognizing them, talk to your doctor.
  • If you answer YES to any of the following questions, talk to your doctor, pharmacist or diabetes nurse.
    – Have you recently become ill?
    – Do you have problems with your liver or kidneys?
    – Do you train more than usual?
  • The amount of insulin you need may change with alcohol intake.
  • You should also talk to your doctor, pharmacist or diabetes nurse if you plan to travel abroad. The time difference between countries may mean that you have to take your injections and eat at other times than when you are at home.
  • Some patients who have had type 2 diabetes mellitus and heart disease for many years or earlier stroke , developed heart failure during treatment with pioglitazone and insulin . Tell your doctor as soon as possible if you get signs of heart failure such as unexpected shortness of breath, rapid weight gain or local swelling ( edema ).

Skin changes at the injection site

To prevent skin changes, e.g. nodules under the skin, you should constantly change the injection site. It may be that insulin et not work as well if you inject in an area of nodules (see “How to use Humalog Mix25). Contact your doctor before changing the injection site if you are currently injecting in an area with lumps. Your doctor may advise you to check your blood sugar more often and to adjust your insulin dose or the dose of other diabetes medicines.

Other medicines and Humalog Mix25

Your insulin needs may change if you take

  • birth control pills ,
  • cortisone ,
  • agents for thyroid disease,
  • tablets for the treatment of diabetes ,
  • acetylsalicylic acid ,
  • sulfate antibiotics,
  • octreotide,
  • beta 2 stimulators (eg ritodrin, salbutamol or terbutaline ),
  • beta blockers ,
  • certain antidepressants ( monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),
  • danazol,
  • certain angiotensin converting (ACE) enzyme inhibitors (eg captopril , enalapril ) and
  • angiotensin II receptor blockers.

Tell your doctor if you are taking, have recently taken, or will take any other medicines, including medicines obtained without a prescription (see “Warnings and Precautions”).

Pregnancy and breastfeeding

Are you pregnant or planning to become pregnant or breastfeeding?

Insulin requirements usually decrease during the first 3 months of pregnancy and then increase during the remaining six months.

If you are breastfeeding, adjusting your insulin dose or diet may be necessary. Consult your doctor.

Driving and using machines

Your ability to concentrate and react may be impaired in hypoglycaemia. Keep this in mind in all situations where you may expose yourself or others to risks (eg while driving or using machines).

Contact your doctor about the suitability of driving again

  • you often suffer from hypoglycemia
  • your warning signs of hypoglycaemia are weakened or completely absent

Humalog Mix25 contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free. is almost “sodium-free”.

3. How to use Humalog Mix25

Always use Humalog Mix25 exactly as your doctor has told you. Consult a doctor if you are unsure.

Dosage

  • You should normally inject Humalog Mix25 within 15 minutes before a meal. If you need to, you can inject shortly after the meal. Dose one is determined by your doctor who adjusts it individually for you. These instructions are personal and just for you. Follow them closely and visit your diabetes clinic regularly.
  • If you change the type of insulin (eg from animal insulin or other human insulin to a Humalog product) you may need to take more or less than before. This may appear at the first injection one or it may be a gradual change over several weeks or months.
  • Inject Humalog Mix25 under the skin. It must not be injected in any other way. Under no circumstances should Humalog Mix25 be injected intravenously .

Preparation of Humalog Mix25

  • Bottles containing Humalog Mix25 should be rolled between the palms of the hands before use so that the insulin suspension mixes well and becomes evenly cloudy or milky. Do not shake vigorously, as foam may form which may affect the dosing accuracy. The bottles should be checked frequently and should not be used if they contain lumps or if solid, white particles stick to the bottom or walls of the bottle and give a frosty appearance. Check before each injection .

Injection of Humalog Mix25

  • Wash your hands.
  • Clean the skin as instructed before injecting. Clean the rubber membrane on the bottle, but do not remove the membrane .
  • Use a clean, sterile syringe and needle and insert the rubber membrane and suck up the amount of Humalog Mix25 you need. Your doctor or diabetes nurse will show you how to do this. Do not share needles or syringes with anyone else.
  • Inject under the skin as instructed. Do not inject directly into a blood vessel. Wait 5 seconds after finishing the injection before pulling out the needle, then you are sure that you have received the full dose one. Do not massage the injection site. Make sure that you have a margin of at least 1 cm to the previous injection site and that you change the injection site as instructed.

If you use more Humalog Mix25 than you should

You may get low blood sugar if you have used too much Humalog Mix25 or are unsure about how much you have injected. Check your blood sugar.

If your blood sugar is low ( weak insulin sensitivity ), take glucose tablets, sugar, or a sweet drink. Then take fruit, biscuits, or a sandwich according to your doctor’s instructions and rest for a while. Often, a weak insulin sensation or a slight overdose of insulin disappears with this treatment. If you get worse, have shortness of breath, and turn pale, contact your doctor immediately.

Quite severe hypoglycaemia can be treated with a glucagon injection. Eat glucose or sugar after the glucagon injection. If you are not improved by glucagon, you should be treated in a hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog Mix25

You may get high blood sugar if you have used too little Humalog or are unsure about how much you have injected. Check your blood sugar.

Failure to treat hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) can have serious consequences and can lead to headaches, nausea, vomiting, dehydration, unconsciousness, coma, and even death (see A and B in section 4 “Possible side effects”). ).

Three simple tips to avoid hypoglycemia or hyperglycemia:

  • Always have a spare syringe and spare bottle of Humalog Mix25 with you
  • Always carry something with you that shows that you are diabetic.
  • Always have sugar with you.

If you stop using Humalog Mix25

You may get high blood sugar if you use too little Humalog Mix25. Do not change your insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• itching all over the body • palpitations
• difficulty breathing • drop in blood pressure
• wheezing • sweating

If you think you may have this type of insulin allergy, talk to your doctor straight away.

Local allergy is common (≥1 / 100 to <1/10). Some people get redness, swelling, or itching at the injection site. This usually stops after a few days or a few weeks. If you get any of these symptoms, talk to your doctor.

Lipodystrophy is less common (≥1 / 1000 to <1/100). If you inject insulin too often in the same place, the adipose tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy). Nodules under the skin can also be caused by the accumulation of a protein called amyloid ( cutaneous amyloidosis). It may be that insulin et not work as well if you inject in an area with nodules. Change the injection site for each injection to prevent these skin changes.

Edema (swollen arms, ankles; fluid retention ) has been reported, especially when starting insulin therapy or when changing treatment to improve the control of your blood sugar.

Common problems with diabetes

A. Hypoglycemia

Hypoglycaemia (low blood sugar) means that there is not enough sugar in the blood. This can be caused by:

  • that you are taking too much Humalog Mix25 or other insulin
  • that you skip or postpone meals or change your diet
  • that you exercise or work too hard just before or after a meal
  • that you have an infection or are ill (especially with diarrhea or vomiting)
  • that your insulin needs have changed, or
  • that you have problems with your kidneys or liver that have gotten worse

Alcohol and certain medications can affect blood sugar levels.

The first symptoms of low blood sugar usually appear quickly and involve

• fatigue • palpitations
• nervousness and tremors • nausea
• headache • cold sweats

If you are not sure of recognizing the warning symptoms, avoid situations, such as driving a car, where you may expose yourself or others to risks due to hypoglycaemia.

B. Hyperglycaemia and diabetic ketoacidosis

Hyperglycemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia may recur

  • you have not taken your Humalog Mix25 or other insulin
  • you have taken less insulin than your doctor told you to
  • you have eaten more than your diet allows, or
  • you have a fever, infection or are emotionally stressed

Hyperglycaemia can lead to diabetic ketoacidosis . The first symptoms creep in for several hours or days. They are

• drowsiness • no appetite
• flushing • fruit smell from the breath
• thirst • nausea or vomiting

Serious symptoms are heavy breathing and rapid heartbeat. Seek medical attention immediately.

C. In case of illness

If you are sick, especially if you feel nauseous or vomit, your insulin needs may change. Even if you do not eat normally, you still need insulin. Test urine or blood, follow the instructions regarding your illness, talk to your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Humalog Mix25

Before using Humalog Mix25, store it in a refrigerator (2 ° C – 8 ° C). Do not freeze. The bottle currently in use should be stored in a refrigerator (2 ° C – 8 ° C) or at room temperature (below 30 ° C) and discarded after 28 days. Do not expose it to strong heat or sunlight.

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton. The expiration date is the last day of the specified month.

Do not use this medicine if you notice lumps or solid, white particles sticking to the bottom or walls of the bottle and giving it a frosty appearance. Check this before each injection.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Contents of Humalog Mix25 100 Units / ml suspension for injection in a vial

– The active substance is insulin lispro. Insulin lispro is manufactured in a laboratory using recombinant DNA technology. It is an altered form of human insulin and therefore differs from other human and animal insulins. Insulin lispro is closely related to human insulin, a natural hormone produced in the pancreas.

The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, disodium phosphate 7 H2O, zinc oxide, and water for injections. Sodium hydroxide or hydrochloric acid may have been added to adjust the acidity.

What the medicine looks like and contents of the pack

Humalog Mix25 100 units/ml injection, the suspension is a white, sterile, suspension containing 100 units of insulin lispro in each milliliter injection (100 units/ml). 25% of insulin lispro in Humalog Mix25 is dissolved in water. 75% of insulin lispro in Humalog Mix25 is contained in a suspension containing protamine sulphate. Each vial contains 1000 units (10 milliliters).

Humalog Mix25 100 units/ml injection, suspension in the vial is in a pack of 1 vial.

Marketing Authorization Holder and Manufacturer

Humalog Mix25 100 units/ml injection, suspension in the vial is manufactured by

  • Lilly SA, Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

The marketing authorization is held by Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Further information on this medicine can be obtained from the representative of the marketing authorization holder:

Muhammad Nadeem

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