400 IU / ml Infusion solution
of human insulin

1. What Insuman Implantable is and what it is used for

Insuman Implantable contains the active substance human insulin, which is manufactured using biotechnology and is identical to the body’s own insulin.

Insuman Implantable is an insulin solution with rapid onset of action and a short duration of action. When used with an implantable insulin pump, Insuman Implantable will be delivered continuously into the body and can thus replace long-acting insulin.

Insuman Implantable (400 IU / ml) contains four times as much insulin in 1 ml as standard insulin (100 IU / ml). This means that Insuman Implantable is more concentrated than regular insulin.

Insuman Implantable is used to reduce high blood sugar in adult patients with some form of diabetes ( type 1 diabetes mellitus ). These patients have not been adequately controlled despite intensive treatment with insulin under the skin (multiple daily injections or insulin pumps). Diabetes mellitus is a disease in which the body does not produce enough insulin to control blood sugar levels.

Insuman Implantable can only be used in Medtronic MiniMed pump which is implanted (inserted) under the skin of the stomach and continuously supplies the body with insulin.

2. What you need to know before you use Insuman Implantable

Do not use Insuman Implantable

  • If you are allergic to insulin or any of the other ingredients of this medicine (listed in section 6).
  • via other routes of administration (eg injection).

Do not use Medtronic’s implantable MiniMed Pump:

  • if you are allergic to titanium alloy, polysulfone or silicone material contained in the components of the pump.
  • with insulin other than Insuman Implantable.
  • in adolescents who have not reached adulthood.
  • if you live permanently at altitudes above 2439 meters (8000 feet).

Warnings and cautions

If you are ill or have mental health problems that make it difficult for you to make changes to your pump based on your blood sugar level or to take appropriate action if you experience problems with your pump, talk to your doctor.

Before you can use Medtronic implantable MiniMed Pump, you will receive training. This training is about the implantable insulin pump, how to use it and how to act in different situations, such as hypoglycemia (too low blood sugar level) or hyperglycemia (too high blood sugar level). You should also read and follow the instructions in the patient manual that comes with the Medtronic MiniMed implantable pump.

Do not use Insuman Implantable with any syringes or pumps (external or implantable) other than the implantable insulin pump provided by Medtronic MiniMed.

Carefully follow the instructions for dosing, control (of blood and/or urine), diet, and physical activities (physical work and exercise) as discussed with your doctor.

If you are expected to undergo medical imaging (eg MRI or ultrasound), talk to your doctor.

If you are allergic to this medicine or to insulin of animal origin, talk to your doctor.

Hypoglycemia
Too low blood sugar ( hypoglycemia ) can occur if you add too much insulin.
If you get very low blood sugar levels, it could be due to problems with the pump. If this happens, contact your doctor immediately, who has the expertise to perform investigations on the pump.
You need to closely monitor your blood sugar on refill days. During an insulin refill procedure, a very small amount of Insuman Implantable may end up subcutaneously (under the skin), and it may result in too low blood sugar levels.

Hyperglycaemia
It is possible that insulin may cause a blockage of the implantable pump. You need to check your blood sugar at least four times a day to detect and prevent high blood sugar levels due to the pump not working properly. If you get severe hyperglycemia (very high blood sugar) or ketoacidosis (accumulation of acid in the blood because the body breaks down fat instead of sugar) or coma, it may indicate a problem with the pump. If you notice a rapid rise in blood sugar that does not respond to a bolus dose of insulin, contact your doctor immediately, who has the competence to investigate the pump. If the pump does not work properly, you must always have access to injection aids ( syringe or pen) and insulin suitable for subcutaneous injection. To prevent such pump problems, your doctor will book appointments at least every 6 months to flush your pump.

If your pump is damaged or your PPC (Personal Pump Communicator) is damaged or lost, talk to your doctor about what to do if the pump does not work properly.

The place where the pump is implanted Infection
can occur around the pump, abrasion of the skin where your pump is implanted, and poor healing of the incision in the skin. If you notice pain, redness, swelling in the area of ​​your pump, consult your doctor.

Liver reaction

Insulin delivered via the pump can cause fat to be stored in the liver in isolated, well-defined places (focal hepatic steatosis). This happens when the tip of the catheter is fixed or very close to the liver. It usually passes when the catheter is moved or the insulin infusion is stopped and does not affect your health (see section 4).

The antibody is against insulin

Insulin delivery intraperitoneally (through the abdominal cavity) can cause the formation of antibodies to insulin (substances that react with insulin ). This may require a change in your insulin dose (see section 4).

Special patient groups

If you have problems with your liver or kidneys or if you are older, talk to your doctor as you may need a lower insulin dose.

Travel

Talk to your doctor to find out what to do if you are planning:

  • Settling at an altitude of over 2439 meters (8000 feet)
  • To travel to an altitude of over 2439 meters (8000 feet) in means of transport other than commercial aircraft
  • To dive deeper than 7.6 meters (25 feet).

Consult your doctor before setting out on a journey. You may need to raise questions about:

  • the availability of your insulin and a healthcare facility that can replace Insuman Implantable in the country you are visiting;
  • who to contact if technical problems with the pump arise,
  • times for meals and insulin use during the trip,
  • possible consequences of travel to other time zones,
  • any new health risks in the countries you visit,
  • What to do in an emergency if you feel unwell or become ill.

Diseases and injuries

In the following situations, the management of your diabetes may require extra care (eg urine and blood tests):

  • If you are ill or have a serious accident, your blood sugar level may increase ( hyperglycaemia ).
  • If you do not eat enough, your blood sugar level may become too low ( hypoglycaemia ).In most cases, you will need medical attention. Contact a doctor at an early stage.

If you have type 1 diabetes (insulin-dependent diabetes mellitus ), do not stop taking insulin. If you stop taking your insulin, this can lead to a very high blood sugar level.
You also need to make sure you are getting enough carbs. Always tell those who see you or treat you that you need insulin.

Children and young people

There is no experience with the use of Insuman Implantable in children and adolescents under 18 years of age. Due to the size of the pump, the pump must not be implanted in adolescents who have not reached adulthood.

Other medicines and Insuman Implantable

Some medicines affect your blood sugar level (decrease, increase, or both depending on the circumstances). You may need to adjust your insulin dose to avoid blood sugar levels that are either too low or too high. Think about it when you start or stop taking another medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Before taking any medicine, consult your doctor if it may affect your blood sugar level and if so, what to do next.

Drugs that can lower blood sugar (hypoglycemia) include:

  • all other medicines used to treat diabetes,
  • ACE inhibitors (to treat certain heart conditions or high blood pressure ),
  • disopyramide (to treat certain heart diseases),
  • fluoxetine (to treat depression),
  • fibrates (to lower high levels of blood fats),
  • MAO inhibitors (to treat depression),
  • pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid , used as painkillers and antipyretics),
  • sulfonamide antibiotics.

Drugs that can increase blood sugar levels ( hyperglycemia ) include:

  • corticosteroids (as “cortisone” to treat inflammation ),
  • danazol (medicines that affect ovulation),
  • diazoxide (to treat high blood pressure ),
  • diuretics (to treat high blood pressure or if you have accumulated too much fluid),
  • glucagon (pancreatic hormone used to treat severe hypoglycaemia ),
  • isoniazid (used to treat tuberculosis ),
  • estrogens and progestogens (as in birth control pills ),
  • phentiazine derivatives (for the treatment of mental illness),
  • somatropin ( growth hormone ),
  • sympathomimetics (such as epinephrine [adrenaline], salbutamol , terbutaline used to treat asthma ),
  • thyroid hormones (to treat hypothyroidism),
  • protease inhibitors (to treat HIV ),
  • atypical antipsychotic drugs (eg olanzapine and clozapine). These drugs are used for mental problems that affect how you think, feel or act.

Blood sugar levels can sometimes increase and sometimes decrease if you use:

  • beta-blockers (to treat high blood pressure ),
  • clonidine (to treat high blood pressure ),
  • lithium salts (to treat mental illness).

Pentamidine (used to treat certain parasitic infectious diseases) can cause hypoglycemia which can sometimes be followed by hyperglycemia.

In addition, beta-blockers, as well as other sympatholytic drugs (such as clonidine, guanethidine, and reserpine), may weaken or stop the first warning signs that help you recognize hypoglycemia.

If you are not sure if you should take any of these medicines, ask your doctor or pharmacist.

Insuman Implantable with alcohol

Your blood sugar levels can either increase or decrease if you drink alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is no clinical information available on the use of Insuman Implantable in an implantable pump in pregnant women.

Tell your doctor if you are planning to become pregnant or if you are already pregnant. Your insulin may need to be adjusted during pregnancy and after delivery. For the sake of the child, it is especially important that your diabetes is kept under control and that hypoglycemia is prevented.

If you are breastfeeding, your insulin dose and diet may need to be adjusted, so consult your doctor.

Driving and using machines

Your ability to concentrate and react may deteriorate if:

  • you get hypoglycaemia (low blood sugar levels),
  • you get hyperglycaemia (high blood sugar levels),
  • you have vision problems.

Always remember the risk of this in all situations where you may expose yourself and others to danger (such as driving or using machines).

Contact your doctor for advice on driving if:

  • you often have episodes of hypoglycaemia ,
  • the first warning signs that make you recognize hypoglycaemia are weakened or absent.

Important information about some of the ingredients of Insuman Implantable

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

3. How to use Insuman Implantable

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor, nurse, or pharmacist.

Insuman Implantable is prescribed by a doctor who has been trained in the use of Medtronic’s implantable MiniMed Pump.

Dose

Depending on your lifestyle and the results of your blood glucose ( glucose ) test, your doctor will

  • determine how much Insuman Implantable per day you will need,
  • tell you when to check your blood sugar level and if you need to take a urine sample.

There are many things that can affect blood sugar levels. You need to know these so that you can act correctly when your blood sugar level changes and to prevent the level from getting too high or too low.

See the box at the end of the package leaflet for further information.

The insulin in the pump should be replaced with new insulin every 40-45 days. This time period should not be exceeded. Contact your doctor immediately if you are unable to go to the hospital or healthcare facility to change the insulin in the pump. You may need to replace your insulin earlier depending on your needs.

The pump is not connected to a glucose meter. You need to manage your diabetes carefully and test your blood sugar at least four times daily to check your blood sugar and determine insulin doses.

A portion of the daily insulin dose is delivered continuously by the Medtronic implantable MiniMed Pump, the remaining portion of the daily dose is delivered by you, using the same pump as a pre-meal bolus dose. The amount of insulin is constantly monitored via the PPC that communicates with the pump via radio waves.

Method of administration

Insuman Implantable may only be used in Medtronic MiniMed implantable pumps. Insuman Implantable must not be used with any other type of injection aid (eg syringes).

Medtronic implantable MiniMed Pump, which is implanted under the skin of the abdomen, continuously supplies the body with insulin ( continuous intraperitoneal infusion ). You get Medtronic implantable MiniMed Pump implanted in your stomach in a hospital. The pump system will also be programmed and tested before leaving the hospital.

All pump procedures (such as filling, rinsing the pump, examining the pump to see if it works properly) are performed with sterile technology to avoid the risk of infection. Infection around the pump’s implantation site may require the pump to be removed (explantation of the pump).

Filling the pump

Handling of vials

Your doctor will handle the insulin vials and provide the accessories (such as syringes and needles) and equipment needed to fill your implantable pump.


Filling the pump is a sterile procedure that must be performed in a hospital or clinic. The unused insulin in the pump is removed and the pump is refilled with new insulin.
The insulin in the pump should be changed every 40-45 days with new insulin or earlier, depending on your insulin needs. Your PPC will warn you when the level starts to drop and when the reservoir is empty. Do not exceed this time period (45 days) and contact your doctor immediately if you are unable to go to the hospital or healthcare facility to change the insulin in the pump.
You need to closely monitor your blood sugar on refill days. During this procedure, a very small amount of Insuman Implantable may end subcutaneously, which may result in too low blood sugar levels.

Blockage of the pump
Insulin deposits can cause blockage of the pump. If you need to increase your insulin to maintain your blood sugar level, if you experience difficult-to-treat (refractory) hyperglycemia, this may indicate a problem with the pump. You must immediately contact your doctor who is competent to perform examinations of the pump needed to ensure that your pump is working properly. To prevent such pump problems, your doctor will book appointments at least every 6 months to flush the pump.

If you take more Insuman Implantable than you should

Your doctor will program maximum dose limits in your PPC.
If you try to give more than 2.5 times the maximum dose of over one hour, the alarm “max per hour over undercut ( hourly maximum exceeded)”  appears on your PPC screen. If you need to add an extra bolus dose, press ” SEL ” and then ” ACT “. You can exceed this limit by programming only one bolus dose for 10 minutes. If you try to give a second bolus dose, you will get “max per hour exceeds” the alarm on your PPC screen again.

If you forget to use Insuman Implantable

  • If you miss a dose before a meal:You may feel symptoms of high blood sugar after eating. If this happens, contact your doctor immediately. Your doctor will tell you how to manage your blood sugar levels.
  • If you forget to top up your pump:The insulin in the pump should be changed every 40-45 days with new insulin . Do not extend this period of time (45 days) and contact your doctor immediately if you are unable to go to the hospital or clinic to replace the insulin in the pump.
    You may need to replace your insulin earlier depending on your needs. PPC prompts via on-screen messages. If your pump runs out of insulin or gives you less insulin than you need, you may have symptoms of high blood sugar. If this happens, contact your doctor immediately. Your doctor will tell you how to manage your blood sugar levels.

If you stop using Insuman Implantable

This can lead to severe hyperglycemia (very high blood sugar) and ketoacidosis

(development of acid in the blood because the body breaks down fat instead of sugar). Do not stop taking Insuman Implantable without consulting a doctor who will tell you what needs to be done.

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

4. Possible side effects

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

Side effects are as reported with insulin

The most serious side effects are

Side effects are reported as common(may affect up to 1 in 10 people)

  • The most common side effect is hypoglycaemia (low blood sugar). Severe hypoglycaemia can cause heart attack or brain damage and can be life threatening. For more information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.
  • Hyperglycemia :  If your blood sugar is too high, you may experience hyperglycemia . Hyperglycaemia can become severe and lead to a serious condition ( ketoacidosis ). For more information on the side effects of high blood sugar, see the box at the end of this leaflet.

Side effects are reported as uncommon(may affect up to 1 in 100 people)

  • Severe allergic reaction with low blood pressure ( shock )

Adverse reactions have been reported with unknown frequency(cannot be calculated from the available data)

  • Severe allergic reactions to insulin may occur and these may be life threatening. Such reactions to insulin or to excipients can cause extensive skin reactions (rash and itching all over the body), severe swelling of the skin or mucous membranes ( angioedema ), shortness of breath, drop in blood pressure with high heart rate and sweating.

Other side effects are

Side effects are reported as usual

  • EdemaInsulin treatment can also cause temporary storage of water in the body, with swelling in the calves and ankles.

Adverse reactions that have been reported with an unknown frequency

  • Sodium retentionInsulin can also cause sodium retention, especially if previously poor diabetes control is improved by intensive insulin therapy.
  • Eye reactionsA marked change (improvement or deterioration) in blood sugar control may temporarily interfere with vision. If you have proliferative retinopathy (an eye disease associated with diabetes ), severe hypoglycaemic attacks can cause temporary loss of vision.
  • Antibody is against insulinInsulin delivery intraperitoneally (through the abdominal cavity) can cause the formation of antibodies to insulin (substances that react with insulin ). Elevated levels of antibodies to insulin are not usually related to a need to change the insulin dose or the presence of serious side effects .
  • Liver reactionInsulin delivered via the pump can cause fat to be stored in the liver at isolated, well-defined sites (focal hepatic steatosis ). This happens when the tip of the catheter is fixed or is very close to the liver.

Adverse reactions that have been reported with the implantable pump (including adverse reactions related to pump implantation or pump maintenance)

Side effects are reported as usual

  • Replacement of the pump due to a technical fault
  • Blockage of the pump
  • Occlusion of the catheter
  • Infection in the space where the pump has been implanted (pump pocket)
  • Skin erosion: the movements of the pump can wear away skin
  • External bulge in the umbilical area (umbilical hernia)
  • Magont
  • Pain due to catheter placement

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 Insuman Implantable

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial label after “EXP”.

The expiration date is the last day of the specified month.

Unopened vials

Store in a refrigerator (2 ° C – 8 ° C). Do not freeze. Do not place Insuman Implantable near the freezer compartment or cooling lamp. Keep the vial in the outer carton. Sensitive to light.

In the pump The
the drug is stable in the pump for 45 days at 37 ° C.

6. Contents of the packaging and other information

Content declaration Insuman Implantable

  • The active substance is human insulin. One ml of Insuman Implantable contains 400 IU (International Units) of the active substance insulin human.
  • The other ingredients are: phenol, zinc chloride, trometamol, poloxamer 171, glycerol , hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see section 2 “Important information about some of the ingredients of Insuman Implantable”), water for injections .

Insuman Implantable appearance and pack sizes

Insuman Implantable is a clear, colorless, or almost colorless infusion solution, practically free from visible particles and with a water-like consistency.

Insuman Implantable is supplied in vials containing 10 ml solution (4000 IU). Packs of 1 and 5 10 ml vials are available.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

Germany

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Muhammad Nadeem

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