400 IU \/ ml Infusion solution
of human insulin<\/p>\n\n\n\n
Insuman Implantable contains the active substance human insulin, which is manufactured using biotechnology and is identical to the body’s own insulin.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Do not use Medtronic’s implantable MiniMed Pump:<\/strong><\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Do not use Insuman Implantable with any syringes or pumps (external or implantable) other than the implantable insulin pump provided by Medtronic MiniMed.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n If you are expected to undergo medical imaging (eg MRI or ultrasound), talk to your doctor.<\/p>\n\n\n\n If you are allergic to this medicine or to insulin of animal origin, talk to your doctor.<\/p>\n\n\n\n Hypoglycemia<\/strong> Hyperglycaemia<\/strong> 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.<\/p>\n\n\n\n The place where the pump is implanted <\/strong>Infection Liver reaction<\/strong><\/p>\n\n\n\n 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).<\/p>\n\n\n\n The antibody is against insulin<\/strong><\/p>\n\n\n\n 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).<\/p>\n\n\n\n Special patient groups<\/strong><\/p>\n\n\n\n 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.<\/p>\n\n\n\n Travel<\/strong><\/p>\n\n\n\n Talk to your doctor to find out what to do if you are planning:<\/p>\n\n\n\n Consult your doctor before setting out on a journey. You may need to raise questions about:<\/p>\n\n\n\n Diseases and injuries<\/strong><\/p>\n\n\n\n In the following situations, the management of your diabetes may require extra care (eg urine and blood tests):<\/p>\n\n\n\n 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. 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Drugs that can lower blood sugar (hypoglycemia) include:<\/strong><\/p>\n\n\n\n Drugs that can increase blood sugar levels ( hyperglycemia ) include:<\/strong><\/p>\n\n\n\n Blood sugar levels can sometimes increase and sometimes decrease if you use:<\/strong><\/p>\n\n\n\n Pentamidine (used to treat certain parasitic infectious diseases) can cause hypoglycemia which can sometimes be followed by hyperglycemia.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n If you are not sure if you should take any of these medicines, ask your doctor or pharmacist.<\/p>\n\n\n\n Your blood sugar levels can either increase or decrease if you drink alcohol.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n There is no clinical information available on the use of Insuman Implantable in an implantable pump in pregnant women.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n If you are breastfeeding, your insulin dose and diet may need to be adjusted, so consult your doctor.<\/p>\n\n\n\n Your ability to concentrate and react may deteriorate if:<\/p>\n\n\n\n Always remember the risk of this in all situations where you may expose yourself and others to danger (such as driving or using machines).<\/p>\n\n\n\n Contact your doctor for advice on driving if:<\/p>\n\n\n\n This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free. it is largely “sodium-free”.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Insuman Implantable is prescribed by a doctor who has been trained in the use of Medtronic’s implantable MiniMed Pump.<\/p>\n\n\n\n Dose<\/strong><\/p>\n\n\n\n Depending on your lifestyle and the results of your blood glucose ( glucose ) test, your doctor will<\/p>\n\n\n\n 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.<\/p>\n\n\n\n See the box at the end of the package leaflet for further information.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Method of administration<\/strong><\/p>\n\n\n\n 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).<\/p>\n\n\n\n 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. Filling the pump<\/strong><\/p>\n\n\n\n Handling of vials<\/em><\/p>\n\n\n\n Your doctor will handle the insulin vials and provide the accessories (such as syringes and needles) and equipment needed to fill your implantable pump.<\/p>\n\n\n\n Blockage of the pump<\/strong> Your doctor will program maximum dose limits in your PPC. This can lead to severe hyperglycemia (very high blood sugar) and ketoacidosis<\/p>\n\n\n\n (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.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them.<\/p>\n\n\n\n Side effects are as reported with insulin<\/strong><\/p>\n\n\n\n The most serious side effects are<\/em><\/p>\n\n\n\n Side effects are reported as common<\/strong>(may affect up to 1 in 10 people)<\/p>\n\n\n\n Side effects are reported as uncommon<\/strong>(may affect up to 1 in 100 people)<\/p>\n\n\n\n Adverse reactions have been reported with unknown frequency<\/strong>(cannot be calculated from the available data)<\/p>\n\n\n\n Other side effects are<\/em><\/p>\n\n\n\n Side effects are reported as usual<\/strong><\/p>\n\n\n\n Adverse reactions that have been reported with an unknown frequency<\/strong><\/p>\n\n\n\n Adverse reactions that have been reported with the implantable pump<\/strong> (including adverse reactions related to pump implantation or pump maintenance)<\/p>\n\n\n\n Side effects are reported as usual<\/strong><\/p>\n\n\n\n Reporting of side effects<\/em><\/p>\n\n\n\n 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.<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the carton and vial label after \u201cEXP\u201d.<\/p>\n\n\n\n The expiration date is the last day of the specified month.<\/p>\n\n\n\n Unopened vials<\/strong><\/p>\n\n\n\n Store in a refrigerator (2 \u00b0 C – 8 \u00b0 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.<\/p>\n\n\n\n In the pump The<\/strong>Warnings and cautions<\/h2>\n\n\n\n
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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
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 \u200b\u200byour pump, consult your doctor.<\/p>\n\n\n\n
You also need to make sure you are getting enough carbs. Always tell those who see you or treat you that you need insulin.<\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
Other medicines and Insuman Implantable<\/h2>\n\n\n\n
Insuman Implantable with alcohol<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Important information about some of the ingredients of Insuman Implantable<\/h2>\n\n\n\n
3. How to use Insuman Implantable<\/h2>\n\n\n\n
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).<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\nIf you take more Insuman Implantable than you should<\/h2>\n\n\n\n
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<\/strong> ” and then ” ACT<\/strong> “. 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.<\/p>\n\n\n\nIf you forget to use Insuman Implantable<\/h2>\n\n\n\n
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.<\/li><\/ul>\n\n\n\nIf you stop using Insuman Implantable<\/h2>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
5. How to store Insuman Implantable<\/h2>\n\n\n\n
the drug is stable in the pump for 45 days at 37 \u00b0 C.<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration Insuman Implantable<\/h2>\n\n\n\n