Download Print this page

Sanofi Lantus SoloStar Package Leaflet/Information For The User page 2

100 units/ml solution for injection in a pre-filled pen insulin glargine

Advertisement

HYPERGLYCAEMIA AND HYPOGLYCAEMIA
Always carry some sugar (at least 20 grams) with you.
Carry some information with you to show you are diabetic.
HYPERGLYCAEMIA
Warning symptoms of hypoglycaemia
(high blood sugar levels)
– In your body
Examples of symptoms that tell you that your blood sugar level
If your blood sugar is too high (hyperglycaemia), you may not
is falling too much or too fast: sweating, clammy skin, anxiety,
have injected enough insulin.
fast heart beat, high blood pressure, palpitations and irregular
heartbeat. These symptoms often develop before the symptoms
Why does hyperglycaemia occur?
of a low sugar level in the brain.
Examples include:
– In your brain
– you have not injected your insulin or not injected enough, or
Examples of symptoms that indicate a low sugar level in
if it has become less effective, for example through incorrect
the brain: headaches, intense hunger, nausea, vomiting,
storage,
tiredness, sleepiness, sleep disturbances, restlessness, aggressive
– your insulin pen does not work properly,
behaviour, lapses in concentration, impaired reactions,
– you are doing less exercise than usual, you are under stress
depression, confusion, speech disturbances (sometimes total
(emotional distress, excitement), or you have an injury,
loss of speech), visual disorders, trembling, paralysis, tingling
operation, infection or fever,
sensations (paraesthesia), numbness and tingling sensations in
– you are taking or have taken certain other medicines (see
the area of the mouth, dizziness, loss of self-control, inability to
section 2, "Other medicines and Lantus").
look after yourself, convulsions, loss of consciousness.
Warning symptoms of hyperglycaemia
The first symptoms which alert you to hypoglycaemia ("warning
Thirst, increased need to urinate, tiredness, dry skin, reddening of
symptoms") may change, be weaker or may be missing
the face, loss of appetite, low blood pressure, fast heart beat, and
altogether if
glucose and ketone bodies in urine. Stomach pain, fast and deep
– you are elderly, if you have had diabetes for a long time or
breathing, sleepiness or even loss of consciousness may be signs of
if you suffer from a certain type of nervous disease (diabetic
a serious condition (ketoacidosis) resulting from lack of insulin.
autonomic neuropathy),
– you have recently suffered hypoglycaemia (for example the day
What should you do if you experience
before) or if it develops slowly,
hyperglycaemia?
– you have almost normal or, at least, greatly improved blood
sugar levels,
Test your blood sugar level and your urine for ketones as soon
– you have recently changed from an animal insulin to a human
as any of the above symptoms occur. Severe hyperglycaemia
insulin such as Lantus,
or ketoacidosis must always be treated by a doctor, normally in a
– you are taking or have taken certain other medicines (see
hospital.
section 2, "Other medicines and Lantus").
HYPOGLYCAEMIA
In such a case, you may develop severe hypoglycaemia (and
(low blood sugar levels)
even faint) before you are aware of the problem. Be familiar
If your blood sugar level falls too much you may become
with your warning symptoms. If necessary, more frequent blood
unconscious. Serious hypoglycaemia may cause a heart attack or
sugar testing can help to identify mild hypoglycaemic episodes
brain damage and may be life-threatening. You normally should
that may otherwise be overlooked. If you are not confident about
be able to recognise when your blood sugar is falling too much so
recognising your warning symptoms, avoid situations (such as
that you can take the right actions.
driving a car) in which you or others would be put at risk by
hypoglycaemia.
Why does hypoglycaemia occur?
Examples include:
What should you do if you experience hypoglycaemia?
– you inject too much insulin,
1. Do not inject insulin. Immediately take about 10 to 20 g
– you miss meals or delay them,
sugar, such as glucose, sugar cubes or a sugar-sweetened
– you do not eat enough, or eat food containing less carbohydrate
beverage. Caution: Artificial sweeteners and foods with artificial
than normal (sugar and substances similar to sugar are
sweeteners (such as diet drinks) are of no help in treating
called carbohydrates; however, artificial sweeteners are NOT
hypoglycaemia.
carbohydrates),
2. Then eat something that has a long-acting effect in raising
– you lose carbohydrates due to vomiting or diarrhoea,
your blood sugar (such as bread or pasta). Your doctor or nurse
– you drink alcohol, particularly if you are not eating much,
should have discussed this with you previously. The recovery
– you are doing more exercise than usual or a different type of
of hypoglycaemia may be delayed because Lantus has a long
physical activity,
action.
– you are recovering from an injury or operation or other stress,
3. If the hypoglycaemia comes back again take another 10 to 20 g
– you are recovering from an illness or from fever,
sugar.
– you are taking or have stopped taking certain other medicines
4. Speak to a doctor immediately if you are not able to control the
(see section 2, "Other medicines and Lantus").
hypoglycaemia or if it recurs.
Hypoglycaemia is also more likely to occur if
Tell your relatives, friends and close colleagues the following:
– you have just begun insulin treatment or changed to another
If you are not able to swallow or if you are unconscious, you will
insulin preparation (when changing from your previous basal
require an injection of glucose or glucagon (a medicine which
insulin to Lantus hypoglycaemia, if it occurs, may be more likely
increases blood sugar). These injections are justified even if it is
to occur in the morning than at night),
not certain that you have hypoglycaemia.
– your blood sugar levels are almost normal or are unstable,
It is advisable to test your blood sugar immediately after taking
– you change the area of skin where you inject insulin (for
glucose to check that you really have hypoglycaemia.
example from the thigh to the upper arm),
– you suffer from severe kidney or liver disease, or some other
disease such as hypothyroidism.
Lantus® SoloStar® solution for injection in a pre-filled pen
SoloStar is a pre-filled pen for the injection of insulin. Your doctor
You can set doses from 1 to 80 units in steps of 1 unit. Each pen
has decided that SoloStar is appropriate for you based on your
contains multiple doses.
ability to handle SoloStar. Talk with your doctor, pharmacist or
nurse about proper injection technique before using SoloStar.
Keep this leaflet for future reference.
Read these instructions carefully before using your SoloStar. If
If you have any questions about SoloStar or about diabetes, ask
you are not able to use SoloStar or follow all the instructions
your doctor, pharmacist or nurse or call the local Sanofi number
completely on your own, you must use SoloStar only if you
on the front of this leaflet.
have help from a person who is able to follow the instructions
completely. Hold the pen as shown in this leaflet. To ensure that
you read the dose correctly, hold the pen horizontally, with the
needle on the left and the dosage selector to the right as shown in
the illustrations below.
Important information for use of SoloStar:
Step 3. Perform a Safety test
• Always attach a new needle before each use. Only use needles that are
Always perform the safety test before each injection. This ensures that you get an
compatible for use with SoloStar.
accurate dose by:
• Do not select a dose and/or press the injection button without a needle
• ensuring that pen and needle work properly
attached.
• removing air bubbles
• Always perform the safety test before each injection (see Step 3).
• This pen is only for your use. Do not share it with anyone else.
A. Select a dose of 2 units by turning the dosage selector.
• If your injection is given by another person, special caution must be taken by
this person to avoid accidental needle injury and transmission of infection.
• Never use SoloStar if it is damaged or if you are not sure that it is working
properly.
• Always have a spare SoloStar in case your SoloStar is lost or damaged.
Step 1. Check the insulin
B. Take off the outer needle cap and keep it to remove the used needle after
injection. Take off the inner needle cap and discard it.
A. Check the label on your SoloStar to make sure you have the correct insulin. The
Lantus Solostar is grey with a purple injection button.
B. Take off the pen cap.
C. Check the appearance of your insulin. Lantus is a clear insulin. Do not use this
SoloStar if the insulin is cloudy, coloured or has particles.
C. Hold the pen with the needle pointing upwards.
D. Tap the insulin reservoir so that any air bubbles rise up towards the needle.
Step 2. Attach the needle
E. Press the injection button all the way in. Check if insulin comes out of the needle
tip.
Always use a new sterile needle for each injection. This helps prevent
contamination, and potential needle blocks.
A. Remove the protective seal from a new needle.
B. Line up the needle with the pen, and keep it straight as you attach it (screw or
push on, depending on the needle type).
• If the needle is not kept straight while you attach it, it can damage the rubber
seal and cause leakage, or break the needle.
You may have to perform the safety test several times before insulin is seen.
• If no insulin comes out, check for air bubbles and repeat the safety test two
more times to remove them.
• If still no insulin comes out, the needle may be blocked. Change the needle and
try again.
• If no insulin comes out after changing the needle, your SoloStar may be
damaged. Do not use this SoloStar.
Pen cap
Outer
Schematic diagram of the pen
needle
cap
Step 4. Select the dose
You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of
80 units. If you need a dose greater than 80 units, you should give it as two or more
injections.
A. Check that the dose window shows "0" following the safety test.
B. Select your required dose (in the example below, the selected dose is 30 units).
If you turn past your dose, you can turn back down.
• Do not push the injection button while turning, as insulin will come out.
• You cannot turn the dosage selector past the number of units left in the pen. Do
not force the dosage selector to turn. In this case, either you can inject what is
remaining in the pen and complete your dose with a new SoloStar or use a new
SoloStar for your full dose.
Keep
Discard
Step 5. Inject the dose
A. Use the injection method as instructed by your doctor, pharmacist or nurse.
B. Insert the needle into the skin.
C. Deliver the dose by pressing the injection button in all the way. The number in
the dose window will return to "0" as you inject.
10 secs
D. Keep the injection button pressed all the way in. Slowly count to 10 before
you withdraw the needle from the skin. This ensures that the full dose will be
delivered.
The pen plunger moves with each dose. The plunger will reach the end of the
cartridge when the total of 300 units of insulin has been used.
INSTRUCTION FOR USE
Pen needle (not included)
Pen body
Protective seal
Insulin reservoir
Inner
needle
Rubber seal
cap
Needle
Step 6. Remove and discard the needle
Always remove the needle after each injection and store SoloStar without a needle
attached.
This helps prevent:
• Contamination and/or infection,
• Entry of air into the insulin reservoir and leakage of insulin, which can cause
inaccurate dosing.
A. Put the outer needle cap back on the needle, and use it to unscrew the needle
from the pen. To reduce the risk of accidental needle injury, never replace the
inner needle cap.
• If your injection is given by another person, or if you are giving an injection to
another person, special caution must
be taken by this person when removing
and disposing of the needle.
• Follow recommended safety measures
for removal and disposal of needles
(contact your doctor, pharmacist
or nurse) in order to reduce the
risk of accidental needle injury and
transmission of infectious diseases.
B. Dispose of the needle safely, as instructed by your doctor, pharmacist or nurse.
C. Always put the pen cap back on the pen, then store the pen until your next
injection.
Storage instructions
See the reverse (insulin) side of this leaflet for instructions on how to store SoloStar.
If your SoloStar is in cool storage, take it out 1 to 2 hours before you inject to allow
it to warm up. Cold insulin is more painful to inject.
Discard your used SoloStar as required by your local authorities.
Maintenance
Protect your SoloStar from dust and dirt.
You can clean the outside of your SoloStar by wiping it with a damp cloth.
Do not soak, wash or lubricate the pen as this may damage it.
It should be handled with care. Avoid situations where SoloStar might be damaged.
If you are concerned that your SoloStar may be damaged, use a new one.
Dose
window
Dosage
Injection
selector
button

Advertisement

loading