100 units\/ml solution for injection in a vial of
insulin glulisine<\/p>\n\n\n\n
Apidra is an antidiabetic medicine used to lower high blood sugar in patients with diabetes mellitus. Apidra can be given to adults, adolescents, and children from 6 years of age. Diabetes mellitus is a disease in which the body does not produce enough insulin to control blood sugar levels.
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Apidra is manufactured using biotechnology. Apidra has a rapid onset of action within 10\u201120 minutes and a short duration of action, approximately 4 hours.
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Talk to your doctor, pharmacist, or nurse before using Apidra.
Be sure to follow the dosing instructions and the instructions for checking (of blood), eating habits, and physical activities (physical work and exercise) as discussed with your doctor.
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Special patient groups<\/strong><\/p>\n\n\n\n Impaired liver or kidney function may require a lower dose, in which case consult your doctor. There are no adequate clinical data from the use of Apidra in children under 6 years of age. Skin changes at the injection site<\/strong><\/p>\n\n\n\n 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 Apidra). 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. Travel<\/strong><\/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 Illnesses and injuries<\/strong> In most cases, you will need medical attention. Contact a doctor at an early stage.<\/strong> If you have type 1 diabetes (insulin-dependent diabetes mellitus ), you should not stop taking insulin and you should continue to add enough carbohydrates. Always tell those who see you or treat you that you need insulin. Some patients with long-term type 2 diabetes mellitus and heart disease or previous stroke, treated with pioglitazone and insulin, developed heart failure. Tell your doctor as soon as possible if you get signs of heart failure such as increased shortness of breath, rapid weight gain, or local swelling ( edema ).<\/p>\n\n\n\n Some medicines affect the blood sugar level (lowering the blood sugar, raising the blood sugar, or both, depending on the circumstances). In any case, it may be necessary to adjust your insulin dose to prevent your blood sugar levels from getting too low or too high. Keep this in mind 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. Drugs that can lower your blood sugar (hypoglycemia) include:<\/strong><\/p>\n\n\n\n Drugs that can raise your blood sugar (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 infections caused by parasites) can cause hypoglycemia, which can sometimes be followed by hyperglycemia. In addition, beta-blockers as well as other sympatholytic drugs (eg clonidine, guanethidine, and reserpine) may cause the initial warning signs that make you recognize hypoglycemia to be weakened or absent. If you are not sure if you are taking any of these medicines, ask your doctor or pharmacist.<\/p>\n\n\n\n Your blood sugar can either be raised or lowered if you drink alcohol.<\/p>\n\n\n\n If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Tell your doctor if you intend to become pregnant or if you are already pregnant. The insulin dose may need to be adjusted during pregnancy and after delivery. For the health of the baby, it is especially important that your diabetes is monitored and that hypoglycemia is prevented. There are no or limited amount of data from the use of Apidra in pregnant women. Your ability to concentrate or react may be impaired if:<\/p>\n\n\n\n Always remember the risk of this in all situations where you may expose yourself and others to danger (eg when driving or using machines). Ask your doctor about driving if:<\/p>\n\n\n\n This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. Apidra contains metacresol<\/strong><\/p>\n\n\n\n Apidra contains metacresol, which may cause allergic reactions. Dose<\/strong><\/p>\n\n\n\n Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse. Depending on your lifestyle and the results of your blood glucose ( glucose ) test and your previous insulin use, your doctor will decide how much Apidra you will need. Apidra is a short-acting insulin. Your doctor will tell you if you should use it with a medium-acting, long-acting insulin or basal insulin or with tablets for the treatment of high blood sugar. If you are switching from another insulin to insulin glulisine, your dose may need to be adjusted by your doctor. There are many factors that can affect your blood sugar level. You need to know these factors to be able to react correctly when your blood sugar level changes and to prevent the level from becoming too high or too low. See the box at the end of the package leaflet for further information. Method of administration<\/strong><\/p>\n\n\n\n Apidra is injected under the skin ( subcutaneously ). It can also be given intravenously by healthcare professionals under the close supervision of a doctor. Your doctor will show you in which area of \u200b\u200bthe skin Apidra should be injected. Apidra can be injected into the abdominal wall, thigh, or upper arm or by continuous infusion into the abdominal wall. The effect is slightly faster if insulin is injected into the abdominal wall. As with all insulins, the injection site and the infusion site must be changed each time within the injection area (abdomen, thigh, or upper arm) used. Time of administration<\/strong><\/p>\n\n\n\n Apidra should be taken shortly (0-15 minutes) before or shortly after a meal. Instructions for proper handling<\/strong><\/p>\n\n\n\n If you have injected too much Apidra<\/strong>, your<\/strong> blood sugar level may become too low (hypoglycemia). Check your blood sugar often. To avoid hypoglycemia, you usually need to eat more food and control your blood sugar. For information on the treatment of hypoglycemia, see the box at the end of the package leaflet.<\/p>\n\n\n\n This can lead to severe hyperglycemia (very high blood sugar) and ketoacidosis(accumulation of acid in the blood because the body breaks down fat instead of sugar). Do not stop taking Apidra without consulting your 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. Insulin confusions<\/strong><\/p>\n\n\n\n You must always check the insulin label before each injection to avoid confusing Apidra with other insulins.<\/p>\n\n\n\n Like all medicines, Apidra can cause side effects, although not everybody gets them. Serious side effects are<\/strong><\/p>\n\n\n\n Hypoglycemia (low blood sugar) can be very serious. <\/strong>Hypoglycemia is a side effect reported as very common (may affect more than 1 in 10 people). Hypoglycemia (low blood sugar) means that there is not enough sugar in the blood. <\/strong>If your blood sugar level drops too much, you may become unconscious. Severe hypoglycemia can cause brain damage and can be life threatening. If you have symptoms of low blood sugar, take action immediately<\/strong> to raise your blood sugar level. If you experience the following symptoms, contact a doctor immediately:<\/strong><\/p>\n\n\n\n Systemic allergic reactions<\/strong> are side effects reported as less common (may affect up to 1 in 100 people).<\/p>\n\n\n\n Generalized allergic reaction to insulin:<\/strong> Associated symptoms may include widespread skin reactions (rash and itching all over the body), severe swelling of the skin or mucous membranes ( angioedema ), shortness of breath, rapid fall in blood pressure, and sweating. These may be symptoms of severe cases of a general allergic reaction (including anaphylaxis ) to insulin and may be life threatening.<\/strong> Hyperglycemia (high blood sugar) means that there is too much sugar in the blood. <\/strong>The incidence of hyperglycemia cannot be calculated. Too high a blood sugar level means that you needed more insulin than you injected.<\/p>\n\n\n\n Hyperglycemia can cause diabetic ketoacidosis (accumulation of acid in the blood because the body breaks down fat instead of sugar).<\/strong><\/p>\n\n\n\n These side effects are serious.<\/strong><\/p>\n\n\n\n These conditions can occur if there is a problem with the infusion pump or if the pump system is used incorrectly.<\/strong><\/p>\n\n\n\n This means that you do not always get enough insulin to treat your diabetes.<\/strong><\/p>\n\n\n\n If this happens, you must seek immediate medical attention.<\/strong><\/p>\n\n\n\n Always have an alternative injection aid (for injection under the skin) <\/strong>for insulin available<\/strong> (see section 3 under \u201cInsulin pump management\u201d and \u201cWhat do I do if the insulin pump stops working or if the pump is used incorrectly?\u201d).<\/p>\n\n\n\n For more information on the signs and symptoms of hyperglycemia, see the box at the end of this leaflet. Other side effects ar<\/strong><\/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 Adverse s<\/strong> (frequency can not be estimated from available data)<\/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 includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. 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. Do not use this medicine after the expiry date which is stated on the carton and on the vial label after \u201cEXP\u201d. The expiration date is the last day of the specified month. Unopened vials<\/strong><\/p>\n\n\n\n Store in a refrigerator (2\u00baC-8\u00baC). Opened vials<\/strong><\/p>\n\n\n\n The vial currently used can be stored for a maximum of 4 weeks in the outer carton at a maximum of 25 o<\/sup> C in protection against direct heat and direct light. After this time, the vial should not be used. Do not use this medicine if the solution is not clear and colorless. Medicines 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.<\/p>\n\n\n\n
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In the following situations, the management of your diabetes may require extra care:<\/p>\n\n\n\n
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Pregnancy and breastfeeding<\/h2>\n\n\n\n
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If you are breast-feeding, your insulin dose and diet may need to be adjusted, so consult your doctor.<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
Important information about any of the excipients in Apidra<\/h2>\n\n\n\n
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<\/p>\n\n\n\n3. How to use Apidra<\/h2>\n\n\n\n
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<\/td><\/tr>Handling of vials<\/em><\/td><\/tr> Apidra vials are for use with syringes designed with a compliant device scale and in insulin pump systems.
Check the vial before using it. It may only be used if the solution is clear, colorless and does not contain any visible solid particles.Do not shake or mix before use.
Always take a new vial if you notice that your blood sugar control is unexpectedly deteriorating. You should do this because insulin may have lost some of its effect. If you suspect you have a problem with Apidra, talk to your doctor or pharmacist.<\/td><\/tr>
<\/td><\/tr>If you need to mix two types of insulin<\/td><\/tr> Apidra must not be mixed with any preparation other than NPH insulin.
If Apidra is mixed with NPH insulin, Apidra should be drawn into the syringe first. The injection should be taken immediately after reconstitution.<\/td><\/tr>
<\/td><\/tr>Insulin pump handling<\/td><\/tr> Before using Apidra in a pump system, you should have received detailed instructions on how to use the pump system. You should also be given information on what to do if you become ill, have too high or too low blood sugar or if the pump system stops working.Use the pump system recommended by your doctor. Read and follow the instructions that come with your infusion pump. Follow your doctor’s instructions on the infusion rate of the basal insulin and how to take the insulin bolus at meal time. Measure your blood sugar levels regularly to make sure you get the most out of your insulin infusion and that your insulin pump works properly.
The infusion set and container should be changed at least every 48 hours with aseptic (bacteria-free) technology. These instructions may differ from the instructions that come with your infusion pump. When using Apidra in the pump system, it is important that you always follow these special instructions. Failure to follow the specific instructions for Apidra can lead to very serious side effects .
Apidra must never be mixed with diluents or other insulin when used in a pump.<\/td><\/tr>
<\/td><\/tr>What do I do if the insulin pump stops working or if the pump is used incorrectly?<\/td><\/tr> Problems with the pump or infusion set, or if the pump is used incorrectly, may result in you not getting enough insulin. This can quickly give you high blood sugar and diabetic ketoacidosis (accumulation of acid in the blood because the body breaks down fat instead of sugar). If your blood sugar level starts to rise, contact your doctor, pharmacist, or nurse as soon as possible. They will tell you what needs to be done. You may need to use Apidra with syringes or pens. You should always have an alternative injection device (for injection under the skin) for insulin available, should your pump stop working.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n If you use more Apidra than you should <\/h2>\n\n\n\n
If you forget to use Apidra<\/h2>\n\n\n\n
Check your blood sugar often. For information on treating hyperglycemia, see the box at the end of this leaflet.<\/li>If you stop using Apidra<\/h2>\n\n\n\n
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<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
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See the box at the end of this leaflet for more important information about hypoglycemia and its treatment.
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If you inject insulin too often at the same site, the adipose tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy) ( may<\/em> affect up to 1 in 100 people). <\/em>Nodules under the skin can also be caused by the accumulation of a protein called amyloid ( cutaneous amyloidosis. How often this occurs is not known). 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.<\/li><\/ul>\n\n\n\n5. How to store Apidra<\/h2>\n\n\n\n
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Do not freeze.
Do not store in direct contact with a freezer compartment or cooling lamp.
Keep the vial in the outer carton. Sensitive to light.
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It is recommended to note on the label the date of the first use of the vial.
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<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n