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8-0191-01-086-3_v1-6:Layout 1 2008-01-11 6:56 AM Page 1 thiazides; glucocorticoids; thyroid hormone Inject the insulin
2. Before you use Mixtard®
plastic cap. If it isn’t in perfect condition ► Inject the insulin under the skin. Use the
hormone; danazol; octreotide or lanreotide.
when you get the vial, return the vial to Do not use Mixtard
injection technique advised by your doctor ► If you are allergic (hypersensitive) to this
PACKAGE LEAFLET:
Pregnancy and breast-feeding
If it hasn’t been stored correctly or been
Keep the needle under your skin for at
insulin product, metacresol or any of the INFORMATION FOR THE USER
If you are pregnant, planning a pregnancy
frozen (see 6 How to store Mixtard) least 6 seconds to make sure that the full or breast-feeding: please contact your doctor
If it’s not uniformly white and cloudy
information). Look out for the signs of Mixtard® 30
allergy in 5 Possible side effectsIf you feel a hypo coming on (a hypo is
Driving and using machines
How to use this insulin
100 IU/ml suspension for injection in a vial
short for a hypoglycaemic reaction and is a 4. What to do in an
If you drive or use tools or machines: watch
Colour: PMS 280C
(subcutaneously). Never inject your insulin emergency
See 4 What to do in an emergency for more Read all of this leaflet carefully before you
concentrate or to react will be less during a directly into a vein or muscle. Always vary the If you get a hypo
start using your insulin.
hypo. Never drive or use machinery if you feel a sites you inject, to avoid lumps (see 5 Possible Keep this leaflet. You may need to read it side effects). The best places to give yourself an A hypo means your blood sugar level is too low.
Take special care with Mixtard
whether you can drive or use machines at all, if The warning signs of a hypo may come on
If you have trouble with your kidneys or
If you have any further questions, ask your you have a lot of hypos or if you find it hard to (abdomen); your buttocks; the front of your suddenly and can include: cold sweat; cool pale liver, or with your adrenal, pituitary or doctor, diabetes nurse or your pharmacist.
thighs or upper arms. Your insulin will work skin; headache; rapid heart beat; feeling sick; This medicine has been prescribed for you.
more quickly if you inject it around the waist.
feeling very hungry; temporary changes in vision; ► If you are drinking alcohol: watch for
Mixtard vials are for use with insulin syringes drowsiness; unusual tiredness and weakness; signs of a hypo and never drink alcohol on them, even if their symptoms are the same 3. How to use Mixtard®
nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
If you are exercising more than usual or if
Talk about your insulin needs with your doctor Just before injecting this insulin
If any of the side effects gets serious, or if If you get any of these signs, eat glucose
1. Roll the vial between your hands until the you notice any side effects not listed in this tablets or a high sugar snack (sweets, biscuits, ► If you are ill: carry on taking your insulin
carefully. This leaflet is a general guide.
liquid is uniformly white and cloudy.
leaflet, please tell your doctor, diabetes ► If you are going abroad: travelling over
If your doctor has switched you from one type Resuspending is easier if the insulin has Don’t take any insulin if you feel a hypo
or brand of insulin to another, your dose may 2. Draw air into the syringe, in the same Carry glucose tablets, sweets, biscuits or fruit Eat a meal or snack containing carbohydrates 1. What Mixtard® is and
Using other medicines
3. Inject the air into the vial: push the needle Tell your relatives, friends and close
what it is used for
Many medicines affect the way glucose works It is recommended that you measure your blood colleagues that if you pass out (become
unconscious), they must: turn you on your side Mixtard® is human insulin to treat
and seek medical advice straight away. They diabetes. Mixtard is a mixture of fast-acting
Before using Mixtard
5. Draw the right dose of insulin into the must not give you any food or drink as it insulin and long-acting insulin. This means that insulin treatment. Talk to your doctor or ► Check the label to make sure it is the
it will start to lower your blood sugar about half pharmacist if you take or have recently taken ► If severe hypoglycaemia is not treated,
an hour after you take it, and the effect will last any other medicines, even those not prescribed.
Disinfect the rubber membrane with a
7. Make sure there is no air left in the syringe: Your need for insulin may change if you also
point the needle upwards and push the air take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; Do not use Mixtard
ACE-inhibitors; acetylsalicylic acid; anabolic ► In insulin infusion pumps
steroids; sulphonamides; oral contraceptives; ► If the protective cap is loose or missing.
Length: Max. 29 mm (100%)Code: 100% Direction 8-0191-01-086-3_v1-6:Layout 1 2008-01-11 6:56 AM Page 2 ► If you have a hypo that makes you pass
Causes of hyperglycaemia
sweating; start being sick (vomiting); have The vials that are not being used are to be
What Mixtard looks like and
out, or a lot of hypos, talk to your doctor.
difficulty in breathing; have a rapid heart stored in a refrigerator (2°C - 8°C).
contents of the pack
Repeatedly taking less insulin than you need beat; feel dizzy; feel like fainting.
Do not store them in or too near the freezer The suspension for injection comes as a cloudy, You may have a very rare serious allergic
reaction to Mixtard or one of its ingredients
Do not freeze. Keep the vials in the original Using glucagon
It is supplied in packs of 1 or 5 vials of 10 ml or (called a systemic allergic reaction). See also in a multipack of 5 × (1 × 10 ml) vials.
warning in 2 Before you use Mixtard. The vials that are being used or about to be
used are not to be kept in a refrigerator. After Diabetic retinopathy (eye background
5. Possible side effects
removing the vial from the refrigerator it is Marketing Authorisation Holder and
changes). If you have diabetic retinopathy and how to use it. If you are given glucagon you recommended to let it reach room temperature Manufacturer
your blood glucose levels improve very fast, the will need glucose or a sugary snack as soon as Like all medicines, Mixtard can cause side before resuspending the insulin as instructed retinopathy may get worse. Ask your doctor you are conscious. If you do not respond to effects, although not everybody gets them.
for the first time use. See 3 How to use glucagon treatment, you will have to be treated Mixtard may cause hypoglycaemia (low blood Mixtard. You can carry them with you and keep in a hospital. Seek medical advice after an sugar). See the advice in 4 What to do in an This leaflet was last approved in
Swollen joints. When you start taking insulin,
them at room temperature (not above 25°C) for injection of glucagon; you need to find the water retention may cause swelling around reason for your hypo to avoid getting more.
Always keep the vial in the outer carton when Side effects reported
you’re not using it in order to protect it from Causes of a hypo
uncommonly
Painful neuropathy (nerve related pain). If
You get a hypo if your blood sugar gets too Mixtard must be protected from excessive heat your blood glucose levels improve very fast it may cause a burning, tingling or electric pain.
Changes at the injection site
This is called acute painful neuropathy and it (Lipodystrophy). If you inject yourself too
usually disappears. If it does not disappear, see often at the same site, fatty tissue under the pharmacist how to dispose of medicines no skin at this site may shrink (lipoatrophy) or longer required. These measures will help to If your blood sugar gets too
thicken (lipohypertrophy). Changing the site Side effects reported very rarely
with each injection may help to prevent such skin changes. If you notice your skin pitting or Your blood sugar may get too high (this is thickening at the injection site, tell your doctor Vision problems. When you first start your
7. Further information
or diabetes nurse because these reactions can treatment, it may disturb your vision, but the The warning signs appear gradually. They
become more severe, or they may change the What Mixtard 30 contains
include: increased urination; feeling thirsty; absorption of your insulin if you inject in such a If any of the side effects gets serious, or if you The active substance is insulin human
losing your appetite; feeling sick (nausea or notice any side effects not listed in this leaflet, made by recombinant biotechnology (30% as vomiting); feeling drowsy or tired; flushed, dry please tell your doctor, diabetes nurse or soluble insulin and 70% as isophane insulin).
skin; dry mouth and a fruity (acetone) smell of Signs of allergy. Reactions (redness, swelling,
1 ml contains 100 IU of insulin human. 1 vial itching) at the injection site may occur (local If you get any of these signs, test your blood
allergic reactions). These usually disappear after The other ingredients are zinc chloride,
sugar level and test your urine for ketones if a few weeks of taking your insulin. If they do 6. How to store Mixtard®
you can. Then seek medical advice straight Seek medical advice immediately:
Keep out of the reach and sight of children.
These may be signs of a very serious condition if signs of allergy spread to other parts of Do not use Mixtard after the expiry date which called diabetic ketoacidosis. If you don’t treat it, is stated on the label and the carton. The expiry this could lead to diabetic coma and death.
if you suddenly feel unwell and you start date refers to the last day of that month.
Length: Max. 29 mm (100%)Code: 100% Direction

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Doi:10.1016/s0003-9993(03)00357-5

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