100 units/ml solution for injection in cartridge
Insulin glargine
1. What ABASAGLAR is and what it is used for
ABASAGLAR contains insulin glargine. This is a modified insulin, very similar to human insulin.
ABASAGLAR is used to treat diabetes mellitus in adults, adolescents and children from 2 years of age.
Diabetes mellitus is a disease in which the body does not produce enough insulin to control blood sugar levels. Insulin glargine has a long and even blood sugar lowering effect.
2. What you need to know before using ABASAGLAR
Do not use ABASAGLAR
If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to a doctor, pharmacist or nurse before using ABASAGLAR.
Be sure to follow the dosing instructions and instructions for control (of blood and urine), diet and physical activities (physical work and exercise) as discussed with your doctor.
If your blood sugar is too low ( hypoglycaemia ), follow the instructions for treating hypoglycaemia (see box at the end of the package leaflet).
Skin changes at the injection site:
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.
Travel
Consult your doctor before setting out on a journey. You may need to raise questions about:
– availability of your insulin in the country you are visiting,
– availability of insulin, etc.,
– storage of insulin during the journey,
– times for meals and insulin use during the trip,
– possible effects 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 (for example, adjustment of insulin dose, blood and urine tests):
– If you are ill or have a serious accident, your blood sugar may rise ( hyperglycaemia).
– If you do not eat enough, your blood sugar 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 ), 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.
Insulin treatment can cause the body to make antibodies against insulin (substances that react with insulin ). This will, although very unusual, require a change in your insulin dose.
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 (oedema).
Insulin confusions
You must always check the package and insulin label before each injection, to avoid confusing ABASAGLAR with other insulins.
Children
There is no experience with the use of ABASAGLAR in children under 2 years of age.
Other medicines and ABASAGLAR
Some medicines affect the blood sugar level (lowering the blood sugar, raising the blood sugar or both, depending on the circumstances). In all cases, it may be necessary to adjust your insulin dose to avoid your blood sugar level becoming either 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 ( hypoglycaemia ) include:
– all other medicines used to treat diabetes,
– ACE inhibitors (for the treatment of certain heart conditions or high blood pressure),
– disopyramide (for the treatment of certain heart conditions),
– fluoxetine (for treating depression),
– fibrates (used to lower high levels of blood fats),
– MAO inhibitors (for the treatment of depression),
– pentoxifylline, propoxyphene, salicylates (eg acetylsalicylic acid used as painkillers and
antipyretics),
somatostatin analogues (as octreotide, used in the treatment of a less common disease involving the production of too much growth hormone ),
sulfonamide antibiotics.
Drugs that can raise your blood sugar ( hyperglycaemia ) include:
– corticosteroid s (e.g. corticosteroid used in the treatment of inflammation s),
– danazol (medicines that affect ovulation),
– diazoxide (for the treatment of hypertension ),
– diuretics (for the treatment of high blood pressure or if you have accumulated too much fluid),
– glucagon (a pancreatic hormone used in the treatment of severe hypoglycaemia ),
– isoniazid (for the treatment of tuberculosis ),
– estrogens and progestogens (eg birth control pills used for birth control),
– phenothiazine derivatives (for the treatment of mental illness),
somatropin ( growth hormone ),
– sympathomimetics (eg epinephrine ( adrenaline ) or salbutamol, terbutaline used in the treatment
of asthma ),
– thyroid hormones (for the treatment of thyroid diseases),
– atypical psychotropic drugs (eg clozapine, olanzapine),
– protease inhibitors (for the treatment of HIV ).
Blood sugar levels can sometimes increase and sometimes decrease if you use:
– beta-blockers (for the treatment of hypertension ),
– clonidine (for the treatment of hypertension ),
lithium salts (for the treatment of mental illness).
Pentamidine (used to treat certain infections caused by parasites) can cause hypoglycaemia, which can sometimes be followed by hyperglycaemia.
In addition, beta-blockers, as well as other sympatholytic drugs (eg clonidine, guanethidine and reserpine), may cause the first warning signs that make you recognize hypoglycaemia to be weakened or absent.
If you are not sure if you are taking any of these medicines, ask your doctor or pharmacist for advice.
ABASAGLAR with alcohol
Your blood sugar can either be raised or lowered if you drink alcohol.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any 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 sake of the child, it is especially important that your diabetes is monitored and that hypoglycaemia is prevented.
If you are breast-feeding, your insulin dose and diet may need to be adjusted, consult your doctor.
Driving and using machines
Your ability to concentrate or react may be impaired if:
– you get hypoglycaemia (low blood sugar levels),
– you get hyperglycaemia (elevated blood sugar levels),
– you have vision problems.
Think of the risk of this in all situations where you can expose yourself and others to danger (eg when driving or using machines). Contact your doctor for advice on driving if:
– you often have episodes of hypoglycaemia,
– if the first warning signs that make you recognize hypoglycaemia are weakened or absent.
ABASAGLAR contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.
3. How to use ABASAGLAR
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Although ABASAGLAR contains the same active substance as Toujeo ( insulin glargine 300 units/ml), these medicines are not interchangeable. Switching from one insulin treatment to another requires prescription, medical monitoring and blood glucose monitoring. Consult a physician for further information.
Dose
Depending on your lifestyle and the results of your blood glucose ( glucose ) test and your previous insulin therapy, your doctor will:
– determine how much ABASAGLAR you will need per day and at what time of day,
– tell you when to check your blood sugar level and if you need to take a urine sample,
– tell you when you may need to increase or decrease the dose of ABASAGLAR.
ABASAGLAR is a long-acting insulin. Your doctor may prescribe it in combination with fast-acting insulin or with tablets to treat high blood sugar.
There are many factors that can affect blood sugar levels. 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.
Time of administration
You will need one injection of ABASAGLAR per day, at the same time
Method of administration
ABASAGLAR is injected under the skin. You should NEVER inject ABASAGLAR into a blood vessel, as this would alter the effect and may cause hypoglycaemia.
Your doctor will show you in which area of skin you should inject ABASAGLAR. Change the injection site each time in the area of the skin that you use for injection.
Handling of the cartridge is
To ensure that you get the correct dose, should ABASAGLAR cartridge you used only with Lilly insulin pens. Not all of these pens may be marketed in your country.
The pen should be used according to the instructions provided with the pen.
The instructions for using the pen must be followed carefully for cartridge one should be charged, the needle should be applied and for the administration of insulin injection.
To prevent disease transmission, each pen should only be used by one patient.
Check cartridge one before use. The only a transparent and colourless water-like solution, without visible solid particles, may be used. It should not be shaken or mixed before use.
Always take a new cartridge if you notice that your blood sugar control is unexpectedly deteriorating. You should do this because insulin may have lost some of its effects. If you suspect that you have problems with ABASAGLAR, you should talk to your doctor, pharmacist or nurse.
Precautions for injection
Remove any air bubbles before injecting one (see the instructions for use of the pen).
It is important to make sure that insulin is not contaminated with alcohol, other disinfectants or other substances.
Do not refill or reuse empty cartridges. Other insulin must not be added to the cartridge. Do not mix ABASAGLAR with other insulin or drugs. Do not dilute it. Mixing or diluting may alter the effect of ABASAGLAR.
Problems with the insulin pen?
Please see the instruction manual.
If the insulin pen is damaged or does not work properly (due to mechanical failure) it must be discarded and a new insulin pen must be used.
Insulin confusions
You must always check the insulin label before each injection to avoid confusing ABASAGLAR with other insulins.
Use for children and adolescents
ABASAGLAR can be used by young people and children from 2 years of age. Use this medicine according to your doctor’s instructions.
If you use more ABASAGLAR than you should
- If you have injected too much ABASAGLAR, your blood sugar level may become too low ( hypoglycaemia ). Check your blood sugar often. To avoid hypoglycaemia, you usually need to eat more food and control your blood sugar. For information on treating hypoglycaemia, see the box at the end of this leaflet.
If you forget to use ABASAGLAR
- If you have missed a dose of ABASAGLAR or if you have not injected enough insulin or are unsure how much you have injected, your blood sugar level may become too high ( hyperglycaemia ). Check your blood sugar often. For information on treating hyperglycaemia, see the box at the end of this leaflet.
- Do not take a double dose to make up for a forgotten dose.
After injection
If you are not sure how much you have injected, check your blood sugar before deciding to take another injection.
If you stop using ABASAGLAR
This can lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis(accumulation of acid in the blood because the body breaks down fat instead of sugar). Do not stop ABASAGLAR treatment 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
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice that your blood sugar is too low ( hypoglycaemia ), take immediate action to raise your blood sugar level. Hypoglycaemia (low blood sugar) can be very serious and is very common with insulin therapy (may affect more than 1 in 10 people). Low blood sugar means that there is not enough sugar in your blood. If your blood sugar level gets too low, you may faint (become unconscious). Severe hypoglycaemia can cause brain damage and can be life-threatening. For more information, see the box at the end of this leaflet.
Severe allergic reaction (rare, may affect up to 1 in 1,000 people) – 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, drop in blood pressure with rapid heartbeat and sweating. Severe allergic reaction to insulin can be life-threatening. Contact a doctor immediately if you notice signs of a severe allergic reaction.
– Skin changes at the injection site
If you inject insulin too often in the same place, 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.
Common side effects are (may affect up to 1 in 10)
– Skin side effects and allergic reactions at the injection site
Reactions may include redness, unusually intense pain during injection, itching, hives, swelling and inflammation. These reactions may spread around the injection site. Most less severe insulin reactions usually go away within a few days to a few weeks.
Rare side effects are (may affect up to 1 in 1000)
– Visual impact
A 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.
– General symptoms
In rare cases, insulin treatment may cause temporary accumulation of water in the body, with swelling of the calves and ankles.
Very rare side effects are (may affect up to 1 in 10 000 users)
In very rare cases, dysgeusia (taste change) and myalgia (muscle pain) may occur.
Use in children and adolescents
In general, the side effects in children and adolescents aged 18 or younger are the same as in adults.
Complaints of injection site reactions (injection site pain, injection site reactions) and skin reactions (rash, hives ) are comparatively more frequently reported in children and adolescents 18 years of age or younger than in adults.
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 ABASAGLAR
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 cartridge label after “EXP”. The expiration date is the last day of the specified month.
Unopened cartridges you
Store in a refrigerator (2º C-8º C). Do not freeze.
Do not store in direct contact with the freezer compartment or cooling lamp.
Keep the cartridge one in the outer carton. Sensitive to light.
The cartridge is in use
Cartridges during use (in the insulin pen) or in reserve can be stored for a maximum of 28 days at a maximum of 30º C and in protection against direct heat or direct light. The cartridges used must not be stored in the refrigerator. Do not use the cartridge after this time period.
Do not use ABASAGLAR if you see particles in it. Only use ABASAGLAR if the solution is clear, colourless and water-like.
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 glargine. Each millilitre solution contains 100 units of the active substance insulin glargine (equivalent to 3.64 mg).
The other ingredients are zinc oxide, meta-cresol, glycerol, sodium hydroxide (see section 2 “ABASAGLAR contains sodium”), hydrochloric acid and water for injections.
What the medicine looks like and contents of the pack
ABASAGLAR 100 units/ml solution for injection in a cartridge is a clear and colourless solution.
ABASAGLAR supplied in cartridges you only be used with inulinpenna from Lilly. Each cartridge contains 3 ml of solution for injection (equivalent to 300 units). Packs of 5 and 10 cartridges are available.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Manufacturer
Lilly France SAS, rue du Colonel Lilly, F-67640 Fegersheim, France.