Apidra 100 units/ml, SoloStar solution for injection in pre-filled pen
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Apidra SoloStar 100 Units/ml solution for injection in pre-filled pen
Insulin glulisine
Read this entire leaflet and the Apidra SoloStar Pre-filled Pen Instructions for Use carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms, as it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist, or nurse, including any side effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Apidra is and what it is used for
- What you need to know before using Apidra
- How to use Apidra
- Possible side effects
- How to store Apidra
- Contents of the pack and other information
1. What Apidra is and what it is used for
Apidra is an antidiabetic agent used to reduce high blood sugar levels in patients with diabetes mellitus. It can be administered to adults, adolescents, and children aged 6 years and older. Diabetes mellitus is a condition in which your body does not produce enough insulin to control blood sugar levels.
It is produced by biotechnology. It has a rapid onset of action within 10–20 minutes and a short duration of action of approximately 4 hours.
2. What you need to know before using Apidra
Do not use Apidra
- If you are allergic to insulin glulisine or to any of the other ingredients of this medicine (listed in section 6).
- If your blood sugar level is too low (hypoglycemia), follow the guidance on hypoglycemia (see the box at the end of this leaflet).
Warnings and precautions
Apidra in a pre-filled pen is intended only for subcutaneous injection (see also section 3). Consult your doctor if you need to administer insulin by another method.
Talk to your doctor, pharmacist, or nurse before starting to use Apidra.
Carefully follow the dosing, monitoring (blood tests), diet, and physical activity (work and exercise) instructions provided by your doctor.
Special patient groups
If you have liver or kidney problems, consult your doctor, as you may require a lower dose.
There is insufficient clinical information on the use of Apidra in children under 6 years of age.
Skin changes at the injection site
Rotate your injection sites to avoid skin changes such as lumps under the skin. Insulin may not work as effectively if injected into a lumpy area (see How to use Apidra). Contact your doctor if you are currently injecting into a lumpy area, before switching to a different site. Your doctor may advise you to monitor your blood sugar levels more closely and may adjust your insulin dose or the dose of your other antidiabetic medications.
Travel
Before traveling, consult your doctor. You may need advice on:
- the availability of your insulin in the country you are visiting,
- supplies of insulin, needles, etc.,
- proper storage of insulin during travel,
- meal times and insulin administration schedules during travel,
- possible effects of traveling across time zones,
- potential new health risks in the countries you are visiting,
- what to do in emergency situations when you are unwell or become ill.
Illness and injury
Managing your diabetes may require special care in the following situations:
- If you are ill or suffer a major injury, your blood sugar level may rise (hyperglycemia).
- If you do not eat enough, your blood sugar level may drop too low (hypoglycemia).
In most cases, you will need medical attention. Make sure you consult a doctor immediately.
If you have type 1 diabetes (insulin-dependent diabetes mellitus), do not stop taking your insulin or consuming sufficient carbohydrates. Always inform anyone caring for or treating you that you require insulin.
Some patients with long-standing type 2 diabetes mellitus and pre-existing heart disease or history of stroke who were treated with pioglitazone and insulin experienced development of heart failure. Inform your doctor as soon as possible if you develop symptoms of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).
Use of Apidra with other medicines
Some medicines can cause changes in blood sugar levels (increase, decrease, or both, depending on the situation). In each case, your insulin dose may need to be adjusted to prevent blood sugar levels from becoming too low or too high. Exercise caution when starting or stopping any other medication.
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Ask your doctor before taking any medicine whether it could affect your blood sugar level and what steps you should take, if any.
Medicines that may cause a decrease in your blood sugar level (hypoglycemia) include:
- all other medicines used to treat diabetes,
- angiotensin-converting enzyme (ACE) inhibitors (used to treat certain heart conditions or hypertension),
- disopyramide (used to treat certain heart conditions),
- fluoxetine (used to treat depression),
- fibrates (used to reduce high lipid levels in the blood),
- monoamine oxidase inhibitors (MAOIs) (used to treat depression),
- pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and moderate fever),
- antibiotics of the sulfonamide group.
Medicines that may cause an increase in your blood sugar level (hyperglycemia) include:
- corticosteroids (such as "cortisone," used to treat inflammation),
- danazol (a medicine that affects ovulation),
- diazoxide (used to treat hypertension),
- diuretics (used to treat hypertension and fluid retention),
- glucagon (a pancreatic hormone used to treat severe hypoglycemia),
- isoniazid (used to treat tuberculosis),
- estrogens and progestogens (such as oral contraceptives used for birth control),
- phenothiazine derivatives (used to treat psychiatric disorders),
- somatropin (growth hormone),
- sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline, used to treat asthma),
- thyroid hormones (used to treat thyroid gland disorders),
- protease inhibitors (used to treat HIV),
- atypical antipsychotic medicines (such as clozapine and olanzapine).
Your blood sugar level may increase or decrease if you take:
- beta-blockers (used to treat hypertension),
- clonidine (used to treat hypertension),
- lithium salts (used to treat psychiatric disorders).
Pentamidine (used to treat certain parasitic infections) may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
Beta-blockers, as well as other sympatholytic medicines (such as clonidine, guanethidine, and reserpine), may weaken or completely suppress the early warning symptoms that help you recognize hypoglycemia.
If you are unsure whether you are taking any of these medicines, ask your doctor or pharmacist.
Use of Apidra with alcohol
Your blood sugar levels may rise or fall if you drink alcohol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Inform your doctor if you are planning to become pregnant or if you are already pregnant. Your insulin dose may need to be adjusted during pregnancy and after childbirth. Careful control of your diabetes and prevention of hypoglycemia are important for your baby's health.
There are no data or the data are limited regarding the use of Apidra in pregnant women.
If you are breastfeeding, consult your doctor, as you may require adjustments to your insulin doses and diet.
Driving and using machines
Your ability to concentrate or react may be reduced if:
- you have hypoglycemia (low blood sugar levels),
- you have hyperglycemia (high blood sugar levels).
Be aware of this potential problem, considering all situations that could pose a risk to you or others (such as driving or operating machinery).
You should ask your doctor for advice on your ability to drive if:
- you experience frequent episodes of hypoglycemia,
- your early warning symptoms of hypoglycemia are reduced or absent.
Important information about some of the ingredients of Apidra
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".
Apidra contains metacresol
Apidra contains metacresol, which may cause allergic reactions.
3. How to use Apidra
Dosage
Follow exactly the instructions given by your doctor for using this medicine. If in doubt, consult your doctor or pharmacist again.
Your doctor will also determine the dose of Apidra you need based on your lifestyle, blood glucose monitoring results, and your previous insulin treatment.
Apidra is a short-acting insulin. Your doctor may instruct you to use it in combination with an intermediate-acting or long-acting insulin, a basal insulin, or with tablets used to treat high blood sugar levels.
If you switch from another insulin to insulin glulisine, your doctor may need to adjust your dose.
Many factors can affect your blood sugar levels. You should be aware of these factors so that you can respond appropriately to changes in your blood glucose levels and to help prevent them from becoming too high or too low. See the information box at the end of this leaflet for more details.
Method of administration
Apidra is injected under the skin (subcutaneously).
Your doctor will show you where on the skin to inject Apidra. Apidra may be injected into the abdominal wall, the thigh, or the upper arm, or administered by continuous infusion into the abdominal wall. The effect will be slightly faster if insulin is injected into the abdomen. As with other insulins, injection and infusion sites within an injection area (abdomen, thigh, or upper arm) should be rotated from one injection to the next.
Frequency of administration
Apidra should be administered shortly (0–15 minutes) before or shortly after meals.
Instructions for proper use
How to use SoloStar
SoloStar is a disposable pre-filled pen containing insulin glulisine. The Apidra pre-filled pen is intended only for subcutaneous injection. Consult your doctor if you need to administer insulin by another method.
Carefully read the “SoloStar Instructions for Use” included in this leaflet. You must use the pen exactly as described in these Instructions for Use.
To prevent possible transmission of disease, each pen must be used by only one patient.
Before use, always attach a new needle and perform a safety test. Use only needles compatible with SoloStar (see “SoloStar Instructions for Use”).
Inspect the sealed cartridge in the disposable injector pen before use. Only use if the solution is clear, colorless, and free of visible particles. Do not shake or mix before use.
Always use a new pen if you notice that your blood sugar control inexplicably worsens. If you suspect a problem with SoloStar, please consult your healthcare professional.
If you use more Apidra than you should
- If you have injected too much Apidra, your blood sugar level may become very low (hypoglycemia).
Check your blood sugar level frequently. In general, to prevent hypoglycemia, eat more and monitor your blood glucose levels. For more information on the treatment of hypoglycemia, see the information box at the end of this leaflet.
If you forget to use Apidra
- If you forget a dose of Apidra or do not inject enough insulin, your blood sugar level may become very high (hyperglycemia). Check your blood sugar level frequently. For more information on the treatment of hyperglycemia, see the information box at the end of this leaflet.
- Do not use a double dose to make up for a missed dose.
If you stop using Apidra
This could lead to severe hyperglycemia (very high blood sugar levels) and ketoacidosis (increased acid levels in the blood due to the body breaking down fats instead of sugar). Do not stop treatment with Apidra without consulting your doctor; he or she will advise you what to do.
If you have any further questions about how to use this medicine, ask your doctor, pharmacist, or nurse.
Insulin mix-ups
Always check the insulin label before each injection to avoid confusion between Apidra and other insulins.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone gets them.
Serious adverse effects
Hypoglycaemia (low blood sugar levels) can be very serious. Hypoglycaemia is a very common adverse effect (may affect more than 1 in 10 patients).
Hypoglycaemia (low blood sugar levels) means that you do not have enough sugar in your blood. If your blood sugar level drops too low, you may lose consciousness. Severe hypoglycaemia can cause brain damage and may be life-threatening. If you experience symptoms of low blood sugar, act immediately to raise your blood sugar level. See the box at the end of this leaflet for more important information about hypoglycaemia and its treatment.
If you experience the following symptoms, contact your doctor immediately:
Systemic allergic reactions are uncommon adverse effects (may affect up to 1 in 100 patients).
Generalised allergy to insulin: related symptoms may include widespread skin reactions (rash and itching all over the body), severe swelling of the skin or mucous membranes (angioedema), difficulty breathing, drop in blood pressure with rapid heartbeat and sweating. These may be symptoms of severe cases of generalised allergy to insulins, including anaphylactic reaction which may be life-threatening.
Hyperglycaemia (high blood sugar levels) means that there is too much sugar in the blood.
The frequency of hyperglycaemia cannot be estimated. If your blood sugar level is too high, this indicates that you may need more insulin than the amount you have injected. This can be serious if your blood sugar level becomes very high.
For more information about the signs and symptoms of hyperglycaemia, see the box at the end of this leaflet.
Other adverse effects
- Skin changes at the injection site.
If you inject insulin too frequently in the same place, the fatty tissue may shrink (lipoatrophy) or become thicker (lipohypertrophy) (may affect up to 1 in 1,000 people). Lumps under the skin may also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; frequency of occurrence is unknown). Insulin may not work as well if injected into a lumpy area. Change your injection site regularly to help prevent these skin changes.
Frequent adverse effects (may affect up to 1 in 10 patients)
- Allergic and skin reactions at the injection site
Reactions may occur at the injection site (such as redness, unusually severe pain during injection, itching, urticaria, swelling or inflammation). These reactions may also spread around the injection site. Most minor reactions to insulin usually resolve within a few days or weeks.
Adverse effects for which frequency cannot be estimated from available data
- Eye reactions
A significant change (improvement or worsening) in your blood sugar control may cause a temporary worsening of your vision. If you have proliferative retinopathy (a diabetes-related eye disease), severe hypoglycaemic attacks may cause temporary vision loss.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Apidra
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the pen after CAD/EXP. The expiry date refers to the last day of the month indicated.
Unused pens
Store in a refrigerator (between 2°C and 8°C).
Do not freeze.
Do not place SoloStar near the freezer compartment or next to a cold pack.
Keep the pre-filled pen in its outer packaging to protect it from light.
Pens in use
Pre-filled pens in use (or carried as a spare) may be kept for up to 4 weeks below 25°C, protected from direct heat or direct light. Pens in use must not be stored in the refrigerator.
Do not use after this period of time has elapsed.
Do not use this medicine if it is not clear and colourless.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Apidra
- The active substance is insulin glulisine. Each ml of solution contains 100 Units of insulin glulisine (equivalent to 3.49 mg).
- The other components are: metacresol (see section 2 “Apidra contains metacresol”), sodium chloride (see section 2 “Important information about some of the components of Apidra”), tromethamine, polysorbate 20, concentrated hydrochloric acid, sodium hydroxide, water for injections.
Nature and contents of the container
Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen. It is a clear, colourless aqueous solution free from visible particles.
Each pen contains 3 ml of solution, equivalent to 300 Units. Packs containing 1, 3, 4, 5, 6, 8, 9 and 10 pre-filled pens are available. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main
Germany
Manufacturer:
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst, D-65926 Frankfurt
Germany
For further information about this medicine, you may contact the local representative of the Marketing Authorisation Holder.
Belgium/Belgium/Belgium Sanofi Belgium Tel/Tel: +32 (0)2 710 54 00 | Luxembourg/Luxembourg Sanofi Belgium Tel/Tel: +32 (0)2 710 54 00 (Belgium/Belgium) |
| Hungary SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0050 |
Czech Republic Sanofi s.r.o. Tel: +420 233 086 111 | Malta Sanofi S.r.l. Tel: +39 02 39394275 |
Denmark Sanofi A/S Tlf: +45 45 16 70 00 | Netherlands Sanofi B.V. Tel: +31 20 245 4000 |
Germany Sanofi-Aventis Deutschland GmbH Tel.: 0800 52 52 010 Tel. from abroad: +49 69 305 21 131 | Norway sanofi-aventis Norge AS Tlf: +47 67 10 71 00 |
Estonia Swixx Biopharma OÜ Tel: +372 640 10 30 | Austria sanofi-aventis GmbH Tel: +43 1 80 185 – 0 |
Greece Sanofi-Aventis Μονοπρóσωπη AEBE Tel: +30 210 900 16 00 | Poland Sanofi Sp. z o.o. Tel.: +48 22 280 00 00 |
Spain sanofi-aventis, S.A. Tel: +34 93 485 94 00 | Portugal Sanofi - Produtos Farmacêuticos, Lda. Tel: +351 21 35 89 400 |
France Sanofi Winthrop Industrie Tél: 0 800 222 555 Call from abroad: +33 1 57 63 23 23 Croatia Swixx Biopharma d.o.o. Tel: +385 1 2078 500 | Romania Sanofi Romania SRL Tel: +40 (0) 21 317 31 36 |
Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00 | Slovenia Swixx Biopharma d.o.o. Tel: +386 1 235 51 00 |
Iceland Vistor hf. Sími: +354 535 7000 | Slovakia Swixx Biopharma s.r.o. Tel: +421 2 208 33 600 |
Italy Sanofi S.r.l. Tel: 800 13 12 12 (technical inquiries) 800 536389 (other inquiries) | Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300 |
Cyprus C.A. Papaellinas Ltd. Tel: +357 22 741741 | Sweden Sanofi AB Tel: +46 (0)8 634 50 00 |
Latvia Swixx Biopharma SIA Tel: +371 6 616 47 50 | United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525 |
Lithuania Swixx Biopharma UAB Tel: +370 5 236 91 40 |
Date of the most recent review of this leaflet:
Another source of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
HYPERGLYCEMIA AND HYPOGLYCEMIA Always carry some sugar with you (at least 20 grams). Always carry identification indicating that you are a person with diabetes. HYPERGLYCEMIA (high blood sugar levels) If your blood sugar level is very high (hyperglycemia), it may be because you have not injected enough insulin. Why does hyperglycemia occur? Examples include:
Warning signs of hyperglycemia Thirst, increased need to urinate, fatigue, dry skin, facial flushing, loss of appetite, low blood pressure, rapid heartbeat, and presence of glucose and ketone bodies in urine. Stomach pain, deep and rapid breathing, drowsiness, or even loss of consciousness may be signs of a serious condition (ketoacidosis) due to lack of insulin. What to do in case of hyperglycemia? You should test your blood sugar level and your urine ketone level as soon as any of the symptoms described above occur. Severe hyperglycemia or ketoacidosis must always be treated by a doctor, usually in a hospital. HYPOGLYCEMIA (low blood sugar levels) If your blood sugar level drops too low, you may lose consciousness. Severe hypoglycemia can cause a heart attack or brain damage and can be life-threatening. Normally, you should be able to recognize when your blood sugar level is dropping too low so you can take appropriate action. Why does hypoglycemia occur? Examples include:
(sugars and sugar-like substances are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),
Hypoglycemia is also more likely if:
Warning signs of hypoglycemia
Examples of symptoms indicating that your blood sugar level is dropping too low or too quickly: sweating, moist and clammy skin, anxiety, rapid heartbeat, high blood pressure, palpitations, and irregular heartbeat. These symptoms often occur before symptoms related to low brain sugar appear.
Examples of symptoms indicating low sugar levels in the brain: headache, intense hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggressive behavior, difficulty concentrating, altered reactions, depression, confusion, speech disturbances (sometimes complete loss of speech), visual disturbances, trembling, paralysis, tingling sensations (paresthesia), numbness and tingling around the mouth, dizziness, loss of self-control, inability to care for yourself, seizures, and loss of consciousness. The early warning symptoms of hypoglycemia (“warning symptoms”) may change, diminish, or be completely absent if:
In such cases, you may develop severe hypoglycemia (or even faint) before realizing there is a problem. Always be aware of your personal warning symptoms. If necessary, more frequent blood sugar testing may help detect mild hypoglycemic episodes that might otherwise go unnoticed. If you are unsure whether you can recognize your warning symptoms, avoid situations (such as driving) that could endanger you or others due to hypoglycemia. What should you do if you experience hypoglycemia?
Inform your family, friends, and close contacts: If you are unable to swallow or lose consciousness, you will require an injection of glucose or glucagon (a medication that increases blood sugar levels). Such injections are justified even if there is uncertainty about whether hypoglycemia is present. It is advisable to test your blood sugar level immediately after glucose ingestion to confirm that hypoglycemia is actually present. |
Apidra SoloStar injectable solution in a prefilled pen. INSTRUCTIONS FOR USE
SoloStar is a prefilled insulin injection pen. Your doctor has determined that SoloStar is suitable for you based on your ability to handle SoloStar. Before using SoloStar, speak with your doctor, pharmacist, or nurse about the proper injection technique.
Read these instructions carefully before using your SoloStar. If you are not trained to use SoloStar or to follow the instructions completely on your own, you must only use SoloStar if assisted by someone who can fully follow the instructions. Hold the pen as shown in this leaflet. To ensure correct dose reading, hold the pen horizontally, with the needle on the left and the dose selector on the right, as shown in the illustration below.
You can set doses from 1 to 80 units in 1-unit increments. Each pen contains multiple doses.
Keep this leaflet for future reference.
If you have any questions about SoloStar or about diabetes, consult your doctor, pharmacist, or nurse, or call the local sanofi-aventis telephone number listed on the front of this leaflet.
Important information for using SoloStar:
- Always attach a new needle before each use. Use only needles compatible with SoloStar.
- Do not select a dose or press the button if no needle is attached.
- Always perform the safety test before each injection (see Step 3).
- This pen is for your personal use only. Do not share it with anyone.
- If another person administers your injection, special care must be taken to avoid accidental needle injuries and transmission of infections.
- Never use SoloStar if it is damaged or if you are unsure whether it is working properly.
- Always keep a spare SoloStar in case your pen is lost or damaged.
Step 1. Check the insulin
-
Check the label on your SoloStar to make sure it contains the correct insulin. Apidra SoloStar is blue. It has a dark blue injection button with a protruding ring at the end.
-
Remove the pen cap.
-
Check the appearance of your insulin. Apidra is a clear insulin. Do not use SoloStar if the insulin is cloudy, discolored, or contains particles.
Step 2. Attaching the needle
Always use a new, sterile needle for each injection. This helps prevent contamination and possible needle blockages.
-
Remove the protective seal from the new needle.
-
Align the needle with the pen and keep it straight while inserting (screw on or push on depending on needle type).
- If the needle is not kept straight during insertion, the rubber seal may be damaged, leading to leakage or needle breakage.
Step 3. Safety test
Always perform the safety test before each injection. This ensures that you receive the exact dose because it:
- confirms that the pen and needle are working properly
- removes air bubbles
- Select a dose of 2 units by turning the dose selector.
- Remove the outer needle cap and keep it to remove the used needle after each injection. Remove the inner needle cap and discard it.
-
Hold the pen with the needle pointing upward.
-
Gently tap the insulin reservoir to allow air bubbles to rise toward the needle.
-
Press the injection button fully. Check that insulin appears at the tip of the needle.
You may repeat the safety test several times until insulin appears.
- If no insulin appears, check for air bubbles and repeat the safety test up to two more times to remove them.
- If insulin still does not appear, the needle may be blocked. Change the needle and try again.
- If no insulin appears after changing the needle, your SoloStar may be damaged. Do not use this SoloStar.
Step 4. Selecting the dose
You can select the dose in 1-unit increments, from a minimum of 1 unit to a maximum of 80 units. If you require a dose greater than 80 units, you must administer two or more injections.
-
Check that the dose window shows “0” after the safety test.
-
Select your dose (in the following example, the selected dose is 30 units). If you turn the dose selector too far, you can turn it back.
-
Do not press the injection button while turning, as insulin may be released.
-
You will not be able to turn the dose selector if the number of units exceeds the amount remaining in the pen. Do not force the dose selector. In this case, you may inject the remaining amount in the pen and complete your dose with a new SoloStar, or use a new SoloStar for the full dose.
Step 5. Injecting the dose
-
Use the injection method taught by your doctor, pharmacist, or nurse.
-
Insert the needle into the skin.
- Deliver the dose by pressing the injection button completely. The number in the dose window will return to “0” when the injection is complete.
- Keep the injection button fully pressed. Slowly count to 10 before removing the needle from the skin. This ensures the full dose is delivered.
The plunger in the pen moves with each dose. The plunger will reach the end of the cartridge when all 300 units of insulin have been used.
Step 6. Removing and disposing of the needle
After each injection, remove and dispose of the needle, and store SoloStar without the needle attached.
This helps prevent:
- Contamination and/or infection,
- Air entering the insulin reservoir and insulin leakage, which may lead to an inaccurate dose.
- Place the outer needle cap onto the needle, and use it to unscrew the needle from the pen. To reduce the risk of needlestick injuries, never re-cap the inner needle cap.
- If another person administers your injection, or if you are administering an injection to someone else, take special care when removing and disposing of the needle. Follow recommended safety measures for needle removal and disposal (contact your doctor, pharmacist, or nurse) to reduce the risk of needlestick injuries and transmission of infectious diseases.
-
Dispose of the needle safely, as instructed by your doctor, pharmacist, or nurse.
-
Always replace the pen cap after each injection and store the pen until your next injection.
Storage instructions
Refer to the back of this leaflet for instructions on how to store SoloStar.
If SoloStar has been stored in a cool place, remove it 1 to 2 hours before injection to allow it to reach room temperature. Injecting cold insulin is more painful.
SoloStar must be disposed of according to local regulations.
Maintenance
Protect SoloStar from dust and dirt.
You may clean the exterior of your SoloStar with a damp cloth.
Do not soak, wash, or lubricate the pen, as this may damage it.
SoloStar is designed to operate with precision and safety. Handle it with care. Avoid situations in which SoloStar could be damaged. If you are concerned that your SoloStar may be damaged, use a new one.