100 units/ml solution for injection in a vial of 
insulin glulisine

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, pharmacist, or nurse.
  • 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

What Apidra is and what it is used for

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.

Apidra is manufactured using biotechnology. Apidra has a rapid onset of action within 10‑20 minutes and a short duration of action, approximately 4 hours.

What you need to know before using Apidra

Do not use Apidra

  • If you are allergic to insulin glulisine or any of the other ingredients of this medicine (listed in section 6).
  • If your blood sugar is too low (hypoglycemia), follow the instructions for hypoglycemia (see box at the end of this leaflet).

Warnings and cautions

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.

Special patient groups

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

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

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

  • the availability of your insulin in the country you are visiting,
  • the availability of insulin, syringes, etc.,
  • the storage of insulin during the journey,
  • 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.

Illnesses and injuries 
In the following situations, the management of your diabetes may require extra care:

  • If you are ill or have a serious accident, your blood sugar level may rise (hyperglycemia).
  • If you do not eat enough, your blood sugar level may become too low (hypoglycemia).

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 ), 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 ).

Other medicines and Apidra

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:

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

Drugs that can raise your blood sugar (hyperglycemia) include:

  • corticosteroids (eg cortisone used to treat inflammation ),
  • danazol (medicines that affect ovulation),
  • diazoxide (used to treat high blood pressure ),
  • diuretics (used to treat high blood pressure or if you have accumulated too much fluid),
  • glucagon (a pancreatic hormone used to treat severe hypoglycemia),
  • isoniazid (used to treat tuberculosis ),
  • estrogens and progestogens (eg birth control pills used for birth control),
  • phenazine derivatives (used to treat mental illness),
  • somatropin ( growth hormone ),
  • sympathomimetics (eg epinephrine ( adrenaline ) or salbutamol, terbutaline used in the treatment of asthma ),
  • thyroid hormones (used in the treatment of thyroid disease),
  • protease inhibitors (used in the treatment of HIV ),
  • atypical psychotropic drugs (eg olanzapine and clozapine).

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

  • beta-blockers (used to treat high blood pressure ),
  • clonidine (used to treat high blood pressure ),
  • lithium salts (used in the treatment of mental illness)

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.

Apidra with alcohol

Your blood sugar can either be raised or lowered if you drink alcohol.

Pregnancy and breastfeeding

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

Driving and using machines

Your ability to concentrate or react may be impaired if:

  • you get hypoglycemia (low blood sugar levels),
  • you get hyperglycemia (elevated blood sugar levels).

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:

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

Important information about any of the excipients in Apidra

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

Apidra contains metacresol

Apidra contains metacresol, which may cause allergic reactions.

3. How to use Apidra

Dose

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

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 ​​the 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

Apidra should be taken shortly (0-15 minutes) before or shortly after a meal.

Instructions for proper handling


Handling of vials
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.

If you need to mix two types of insulin
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.

Insulin pump handling
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.

What do I do if the insulin pump stops working or if the pump is used incorrectly?
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.

If you use more Apidra than you should 

If you have injected too much Apidrayour 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.

If you forget to use Apidra

  • If you miss a dose of Apidra or if you have not injected enough insulin your blood sugar level may become too high (hyperglycemia). 
    Check your blood sugar often. For information on treating hyperglycemia, see the box at the end of this leaflet.
  • Do not take a double dose to make up for a forgotten dose.

If you stop using Apidra

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

You must always check the insulin label before each injection to avoid confusing Apidra with other insulins.

4. Possible side effects

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

Serious side effects are

Hypoglycemia (low blood sugar) can be very serious. 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. 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 to raise your blood sugar level. 
See the box at the end of this leaflet for more important information about hypoglycemia and its treatment.

If you experience the following symptoms, contact a doctor immediately:

Systemic allergic reactions are side effects reported as less common (may affect up to 1 in 100 people).

Generalized allergic reaction to insulin: 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.

Hyperglycemia (high blood sugar) means that there is too much sugar in the blood. The incidence of hyperglycemia cannot be calculated. Too high a blood sugar level means that you needed more insulin than you injected.

Hyperglycemia can cause diabetic ketoacidosis (accumulation of acid in the blood because the body breaks down fat instead of sugar).

These side effects are serious.

These conditions can occur if there is a problem with the infusion pump or if the pump system is used incorrectly.

This means that you do not always get enough insulin to treat your diabetes.

If this happens, you must seek immediate medical attention.

Always have an alternative injection aid (for injection under the skin) for insulin available (see section 3 under “Insulin pump management” and “What do I do if the insulin pump stops working or if the pump is used incorrectly?”).

For more information on the signs and symptoms of hyperglycemia, see the box at the end of this leaflet.

Other side effects ar

  • Skin changes at the injection site: 
    If you inject insulin too often at the same site, the adipose tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy) ( may affect up to 1 in 100 people). 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.

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

  • Skin side effects and allergic reactions at the injection site reactions may occur (eg redness, unusually intense pain on injection, itching, hives, swelling, or inflammation ). These reactions can also spread around the injection site. Most less severe insulin reactions usually last from a few days to a few weeks.

Adverse s (frequency can not be estimated from available data)

  • Visual impacts marked change (improvement or deterioration) in blood sugar control may temporarily impair your eyesight. If you have proliferative retinopathy (an eye disease associated with diabetes ), severe hypoglycaemic attacks can cause temporary loss of vision.

Reporting of side effects

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. 

5. How to store Apidra

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 “EXP”. The expiration date is the last day of the specified month.

Unopened vials

Store in a refrigerator (2ºC-8ºC). 
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.

Opened vials

The vial currently used can be stored for a maximum of 4 weeks in the outer carton at a maximum of 25 o C in protection against direct heat and direct light. After this time, the vial should not be used. 
It is recommended to note on the label the date of the first use of the vial.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is insulin glulisine. Each milliliter of the solution contains 100 units of insulin glulisine (equivalent to 3.49 mg). Each vial contains 10 ml of solution for injection, which is equivalent to 1000 units.
  • The other ingredients are metacresol (see section 2 under “Apidra contains metacresol”), sodium chloride (see section 2 under “Important information about some of the excipients in Apidra”), trometamol, polysorbate 20, concentrated hydrochloric acid, sodium hydroxide, water for injections.

What the medicine looks like and the contents of the pack

Apidra 100 Units/ml solution for injection in a vial is a clear, colorless, aqueous solution, with no visible particles. 
Each vial contains 10 ml of solution (1000 units). Packs of 1, 2, 4 and 5 vials are available. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: 
Sanofi-Aventis Deutschland GmbH 
D – 65926 Frankfurt am Main 
Germany

Manufacturer: 
Sanofi-Aventis Deutschland GmbH 
Industriepark Höchst, D 65926 Frankfurt am Main 
Germany

Contact the representative of the marketing authorization holder to find out more about this medicine

Belgium / Belgique / BelgienSanofi BelgiumTel: +32 (0) 2 710 54 00 Luxembourg / LuxemburgSanofi BelgiumPhone: +32 (0) 2 710 54 00 (Belgium / Belgium)
BulgariaSANOFI BULGARIAEOODTel: +359 (0) 2 970 53 00 HungarySANOFI-AVENTIS Zrt.Tel .: +36 1 505 0050
Czech Republicsanofi-aventis, sroTel: +420 233 086 111 MaltaSanofi SpATel: +39 02 39394275
DenmarkSanofi A / STel: +45 45 16 70 00 The Netherlandssanofi-aventis Netherlands BVTel: +31 20 245 4000
GermanySanofi-Aventis Deutschland GmbHTel .: 0800 52 52 010Tel. from abroad: +49 69 305 21 131 Norwaysanofi-aventis Norge ASTel: +47 67 10 71 00
Eestisanofi-aventis Estonia OÜTel: +372 627 34 88 Austriasanofi-aventis GmbHTel: +43 1 80 185 – 0
Greecesanofi-aventis AEBE:Ηλ: +30 210 900 16 00 Polandsanofi-aventis Sp. z ooTel .: +48 22 280 00 00
Spainsanofi-aventis, SATel: +34 93 485 94 00 PortugalSanofi – Pharmaceutical Products, LdaTel: +351 21 35 89 400
Francesanofi-aventis FranceTel: 0 800 222 555Call from abroad: +33 1 57 63 23 23 RomaniaSanofi Romania SRLTel: +40 (0) 21 317 31 36
Croatiasanofi-aventis Croatia dooTel: +385 1 600 34 00
Irelandsanofi-aventis Ireland Ltd. T / A SANOFITel: +353 (0) 1 403 56 00 Sloveniasanofi-aventis dooTel: +386 1 560 48 00
IcelandVistor hf.Phone: +354 535 7000 Slovak Republicsanofi-aventis Pharma Slovakia sroTel: +421 2 33 100 100
ItalySanofi SpATel: 800 13 12 12 (technical type domande)800 536389 (altre domande) Finland / FinlandSanofi OyPuh / Tel: +358 (0) 201 200 300
Κύπροςsanofi-aventis Cyprus Ltd.:Ηλ: +357 22 871600
Latviasanofi-aventis Latvia SIATel: +371 67 33 24 51 United KingdomSanofiTel: +44 (0) 845 372 7101
LithuaniaUAB “SANOFI-AVENTIS LIETUVA”Tel: +370 5 2755224

Muhammad Nadeem

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