2. What should I know before I use Ryzodeg® 70/30 Penfill®?
Do not use if you have ever had an allergic reaction to insulin or any of the ingredients
listed at the end of the CMI.
Do not use if you are experiencing low blood sugar ("hypo") when your dose is due.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
4. How do I use Ryzodeg® 70/30 Penfill®?
Carefully follow all instructions given to you by your doctor, nurse educator and
pharmacist regarding how to use your medicine, including preparing and injecting it.
5. What should I know while using Ryzodeg® 70/30 Penfill®?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you have diabetes and are
using insulin.
Monitor your blood sugar levels regularly
Carry some sugary food or fruit juice with you, in case you experience hypoglycaemia
("a hypo").
|
|
Things you should not do
|
Do not stop using this medicine unless directed to by your doctor.
Do not share your insulin or needles with anyone.
|
|
Driving or using machines
|
If your blood sugar is low or high, your concentration and ability to react might
be affected, and, therefore, also your ability to drive or operate machines.
|
|
Drinking alcohol
|
Alcohol may mask the symptoms of hypos. If you drink alcohol, your need for insulin
may change.
|
|
Looking after your medicine
|
Before first use: Store in a refrigerator (2°C to 8°C).
After first opening or if carried as a spare: You can carry it with you and keep it
at room temperature (below 30 °C) for up to 28 days. Discard any remaining after 28
days.
Do not freeze. Keep away from the freezing element.
|
6. Are there any side effects?
The most common side effect when using insulin is low blood sugar levels (a hypo).
Tell your relatives, friends, close workmates, teachers or carers that you have diabetes.
It is important that they can recognise the signs and symptoms of a hypo. For more
information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s):
70% insulin degludec and 30% insulin aspart
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Ryzodeg® 70/30 Penfill®. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Ryzodeg® 70/30 Penfill®
Where to find information in this leaflet:
1. Why am I using Ryzodeg® 70/30 Penfill®?
Ryzodeg® 70/30 Penfill® contains two types of insulin:
a long-acting insulin, called insulin degludec; and
a fast-acting insulin, called insulin aspart.
Ryzodeg® 70/30 Penfill® is used to treat diabetes mellitus in patients aged 6 years
and above.
Ryzodeg® 70/30 is a modified insulin, also called an insulin analogue, which is similar
to the insulin produced by the pancreas.
There are two types of diabetes mellitus:
Type 1 diabetes
Type 2 diabetes
Patients with type 1 diabetes always require insulin to control their blood sugar
levels.
Some patients with type 2 diabetes may also require insulin after initial treatment
with diet, exercise and tablets is not enough.
Ryzodeg® 70/30 may be used in combination with other antidiabetic drugs (for example,
diabetes tablets) or with a meal-related short- or rapid-acting insulin, such as NovoRapid®.
Ryzodeg® 70/30 can either be used once or twice each day with the main meal(s). When
needed, you can change the time of dosing as long as Ryzodeg® 70/30 is dosed with
the main meal(s). The effect may last for more than 24 hours.
As with all insulins, the duration of action will vary according to the type of insulin,
the dose, injection site, blood flow, temperature and level of physical activity.
Insulin is not addictive. Insulin is available only with a doctor’s prescription.
2. What should I know before I use Ryzodeg® 70/30 Penfill®?
Warnings
If you are blind or have poor eyesight and cannot read the dose counter on your insulin
delivery device, do not use it without help. Get help from a person with good eyesight
who is trained to use the device.
Do not use Ryzodeg® 70/30 Penfill®:
if you are allergic to insulin, or any product containing insulin, or any of the ingredients
listed at the end of this leaflet.
if you are experiencing low blood sugar level (a "hypo") when your dose is due.
if the expiry date printed on the pack has passed, or if the packaging is torn or
shows signs of tampering.
in insulin infusion pumps.
Never inject Ryzodeg® 70/30 into a vein or muscle.
Check with your doctor if you:
are experiencing a lot of hypos, and follow their advice
have any other medical conditions, such as: kidney liver, adrenal gland, pituitary
gland or thyroid gland problems, heart disease or stroke
take any medicines for any other condition
have an infection or fever
are planning to travel.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. Pregnancy can make managing your diabetes more difficult, and may require adjustment
of how much insulin you need.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Children
Ryzodeg® 70/30 Penfill® can be used in adolescents and children from the age of 6
years. Ryzodeg® 70/30 Penfill® should be used with special caution in these patients. The
risk for very low blood sugar levels may be higher in children and adolescents.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with insulin and affect how it works.
Medicines that may
increase
the effect of insulin, and therefore reduce insulin requirements include:
other medicines used to treat type 2 diabetes
octreotide - used to treat gastrointestinal endocrine tumours and enlargement of parts
of the body (e.g. hands, feet, head) caused by abnormal growth hormone levels
lanreotide - used to treat enlargement of parts of the body (e.g. hands, feet, head)
caused by abnormal hormone levels
monoamine oxidase inhibitors (MAOIs) - used to treat depression
non-selective beta-blockers - used to treat certain heart conditions and high blood
pressure. (They
may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia)
alpha-blockers - used to treat high blood pressure and to relieve difficulty in passing
urine caused by an enlarged prostate
angiotensin converting enzyme (ACE) inhibitors - used to treat certain heart conditions,
high blood pressure and elevated protein/albumin in the urine
salicylates, e.g. aspirin - used to relieve pain and lower fever
anabolic steroids - used to promote growth
quinine - used to treat malaria and relieve muscle cramps
quinidine - used to treat heart problems
sulphonamides - a type of antibiotic used to treat bacterial infections.
Medicines that may
reduce
the effect of insulin, and increase insulin requirements include:
oral contraceptives ("the pill") - used for birth control
thiazides, frusemide or ethacrynic acid - used to treat high blood pressure or fluid
retention (oedema)
glucocorticoids (except when applied locally) - used to treat inflammatory conditions
thyroid hormones - used to treat malfunction of the thyroid gland
sympathomimetics - used to treat asthma
octreotide - used to treat gastrointestinal endocrine tumours and enlargement of parts
of the body (e.g. hands, feet, head) caused by abnormal growth hormone levels
lanreotide - used to treat enlargement of parts of the body (e.g. hands, feet, head)
caused by abnormal hormone levels
growth hormone - used to treat growth disorders
diazoxide - used to treat high blood pressure
asparaginase - used to treat leukaemia and lymph gland tumours
nicotinic acid - used to treat high cholesterol levels in the blood
oxymetholone - used to treat certain blood disorders
danazol - used to treat endometriosis, menorrhagia, fibrocystic breast disease and
hereditary angioedema.
Beta-blockers may make it harder to recognise the warning signs of too low blood sugar (hypoglycaemia).
Thiazolidinediones – some patients with long-standing type 2 diabetes and heart disease, or previous
stroke, treated with thiazolidinediones in combination with insulin experienced the
development of symptoms of heart failure. Tell your doctor straight away if you have
signs of heart failure such as shortness of breath, tiredness, fluid retention, rapid
weight gain and ankle swelling.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect
Ryzodeg® 70/30 Penfill®
4. How do I use Ryzodeg® 70/30 Penfill®?
Your doctor, diabetes education nurse or pharmacist will have given you advice on
how to use your medicine. Carefully follow all the directions.
They may differ from the information contained in this leaflet.
If you are blind or have poor eyesight and cannot read the dose counter on your insulin
delivery device, get help from a person with good eyesight who is trained to use the
device.
Any change in dose or type of insulin should be made cautiously and only under medical
supervision.
If you change the type of insulin that you use, you may have to use more or less than
before. This may happen with the first dose or over a period of time.
If you do not understand the instructions, ask your doctor, diabetes education nurse
or pharmacist for help.
How much to use
Your doctor or diabetes education nurse will tell you how much of this medicine you
need to use each day.
It is very important that you manage your diabetes carefully. Too much or too little
insulin can cause serious effects.
Based on your blood sugar level your doctor may change your dose.
When using other medications, ask your doctor if your treatment needs to be adjusted.
When to use Ryzodeg® 70/30 Penfill®
Your doctor or diabetes education nurse will tell you when and how often to inject
your insulin.
Ryzodeg® 70/30 can either be used once or twice each day
Use with the main meal(s) - you can change the time of dosing as long as Ryzodeg®
70/30 is dosed with the main meal(s).
If you want to change your usual diet, check with your doctor, pharmacist or diabetes
education nurse first as a change in diet may later your need for insulin.
How to inject Ryzodeg® 70/30 Penfill®
Penfill® cartridges are designed to be used with Novo Nordisk insulin delivery devices
(such as NovoPen®), and NovoFine® needles.
Make sure you are using the correct type and strength of insulin.
Carefully follow the instructions on how to use your Penfill® in the Novo Nordisk
insulin delivery device.
If you use more than one type of insulin in a Penfill®, you must use a separate insulin
delivery device for each type.
Do not use the insulin level indicator on the device to measure your dose of insulin.
Inject insulin under the skin (subcutaneous injection) as shown to you by your doctor
or diabetes education nurse.
Take care not to drop or knock the device that contains Penfill®.
Checking your Penfill® before injection
Check your Penfill® every time you are preparing your injection to make sure you are
using the correct type and strength of insulin.
Do not use your Ryzodeg® 70/30 Penfill® if the insulin is thickened, coloured, or
if it has solid bits in it.
Do not use your Penfill® if you notice any damage, including any damage to the rubber
plunger (stopper) or if there is a gap between the plunger and the white label band.
Preparing your Penfill® for injection
If Penfill® is already inside your insulin delivery device, check the amount of insulin
remaining. If there is insufficient insulin for your dose, follow the relevant instructions
in the device user manual.
Alternatively, or if your insulin delivery device does not already carry a Penfill®
cartridge, load a new Ryzodeg® 70/30 Penfill®.
Disinfect the rubber membrane of Penfill® with an alcohol swab.
Attach a new NovoFine® needle.
Checking for insulin flow (priming):
Always check your Novo Nordisk insulin delivery device for insulin flow (priming)
before each injection, as described in the device user manual.
The priming procedure may highlight a malfunction with your insulin delivery device.
Priming also removes any air bubbles and helps indicate whether or not a needle is
broken.
Only dial up your required dose after you see a drop of insulin at the needle tip.
After priming, if you need to put the insulin delivery device down, make sure the
needle does not touch anything.
Choose a site for injection
Inject the medicine into the abdomen, thighs, upper arms or buttocks.
Change the injection site so that the same position is not used more often than once
a month. This reduces the risk of developing lumps or skin pitting.
Pinch the skin between two fingers, push the needle into the raised skin, and inject
the full dose of insulin under the skin.
Slowly count to 6 before pulling the needle out.
Keep the push button fully depressed until the needle has been withdrawn.
Apply gentle pressure over the injection site for several seconds
Do not rub the area
After injecting:
Using the outer needle cap, remove the used needle and dispose of it safely into a
yellow plastic sharps container. If you do not remove it, temperature changes may cause liquid to leak out of the
needle.
Health care professionals, relatives and other carers should follow general precautionary
measures for removal and disposal of needles, to eliminate the risk of needlestick
injury.
Do not share needles, insulin cartridges or insulin delivery devices.
Leave Penfill® in the insulin delivery device until it needs to be replaced.
How long to use Ryzodeg® 70/30
Do not stop using Ryzodeg® 70/30 unless your doctor tells you to.
If you forget to inject your insulin - hyperglycaemia
Ryzodeg® 70/30 Penfill® must be used strictly as advised by your doctor or nurse educator.
If you forget your insulin dose, test your blood sugar level as soon as possible.
If you are not sure what to do, talk to your doctor, diabetes education nurse or pharmacist.
Do not use a double dose of your insulin.
If you forget a dose, inject the missed dose with your next large meal on that day,
and then go back to using it as you would normally.
If you use too much insulin - hypoglycaemia
If you think that you have used too much insulin, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Ryzodeg® 70/30 Penfill®?
Hypoglycaemia
Your blood sugar level may become too low (you may experience hypoglycaemia (a hypo))
if you:
accidentally use too much of this medicine
have too much or unexpected exercise
delay eating meals or snacks
eat too little food
are ill.
The first symptoms of mild to moderate hypos can come on suddenly. They may include:
cold sweat, cool pale skin
fatigue, drowsiness, unusual tiredness and weakness
nervousness, feeling anxious, tremor, rapid heart beat
confusion, difficulty concentrating
excessive hunger
vision changes
headache, nausea.
Always carry some sugary food or fruit juice with you.
Do not inject any insulin if you feel a hypo coming on.
Tell your relatives, friends, close workmates or carers that you have diabetes. It
is important that they recognise the signs and symptoms of a hypo.
Make sure they know to give you some sugary food or fruit juice for mild to moderate
symptoms of a hypo.
If you lose consciousness, make sure they know:
to turn you on your side and get medical help immediately
not to give you anything to eat or drink as you may choke.
An injection of the hormone glucagon may speed up recovery from unconsciousness. This
can be given by a relative, friend, workmate or carer who knows how to give it.
If glucagon is used, eat some sugary food or have a sugary
drink as soon as you are conscious again.
If you do not feel better after this, contact your doctor, diabetes education nurse,
or the closest hospital.
See your doctor if you keep having hypo reactions, or if you have ever become unconscious
after using insulin.
Your insulin dose may need to be changed.
If a severe hypo is not treated, it can cause convulsions, brain damage and even death.
Hyperglycaemia
Your blood sugar levels may become high (hyperglycaemia) if you:
miss doses of insulin or use less insulin than you need
have uncontrolled diabetes
exercise less than usual
eat more carbohydrates than usual
are ill or stressed.
High blood sugar levels over a long period of time can lead to too much acid in the
blood (diabetic ketoacidosis).
Contact your doctor immediately if your blood sugar level is high or you recognise
any of the following symptoms.
Symptoms of mild to moderate hyperglycaemia include:
drowsy feeling
flushed face
thirst, loss of appetite
fruity odour on the breath
blurred vision
passing larger amounts of urine than usual
getting up at night more often than usual to pass urine
high levels of glucose and acetone in the urine.
Symptoms of severe hyperglycaemia include:
heavy breathing
fast pulse
nausea, vomiting
dehydration
loss of consciousness.
Severe hyperglycaemia can lead to unconsciousness and in extreme cases death if untreated.
Things you should do
Measure your blood sugar levels regularly.
Make sure all friends, relatives, workmates or carers know that you have diabetes.
If your child has diabetes, it is important to tell their teachers and carers.
Keep using your insulin even if you feel well. It helps to control your diabetes, but does not cure it.
Always carry some sugary food or fruit juice with you. If you experience any of the symptoms of a hypo, immediately eat some sugary food
or have a drink, e.g. lollies, biscuits or fruit juice.
Tell your doctor if you are feeling sick, especially if you are experiencing nausea
or vomiting.
Tell your doctor if you have trouble recognising the symptoms of hypos.
Remind any doctor, dentist or pharmacist you visit that you have diabetes and are
using insulin.
Tell your doctor if your diet changes or you are exercising more.
Tell your doctor if you notice any skin changes at the injection site.
The injection site should be rotated to help prevent changes to the fatty tissue under
the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin
may not work very well if you inject into a lumpy, shrunken or thickened area. Change
the injection site with each injection to help prevent these skin changes.
Tell your doctor if you are ill. Illness, especially with nausea and vomiting, may cause your insulin needs to change.
Even if you are not eating, you still require insulin. You and your doctor should
design an insulin plan for those times when you are sick.
Tell your doctor if you are exercising more than usual. Exercise may lower your need for this medicine. Exercise may also speed up the effect
of a dose of it, especially if the exercise involves the area of the injection site
(e.g. the leg should not be used for injection prior to jogging or running).
Tell your doctor if your diet changes. Changes in diet may cause your insulin needs to change.
Tell your doctor if you are having trouble with your eyesight. Visual disturbances in uncontrolled diabetes are reversed during the early stages
of treatment.
Once established on insulin, if your vision changes, see your doctor as soon as possible.
Tell your doctor, diabetes education nurse or pharmacist if you are travelling. Ask them for a letter explaining why you are taking injecting devices with you. Each
country you visit will need to see this letter, so you should take several copies.
You may need to inject your insulin and eat your meals at different times because
of time differences in and between countries.
You may not be able to get the same type of insulin in the country you are visiting.
Your doctor, diabetes education nurse or pharmacist can provide you with some helpful
information.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are using Ryzodeg® 70/30 Penfill®.
Call your doctor straight away if:
your blood sugar got so low that you passed out
you have used glucagon
you have had too low blood sugar a few times recently
This is because the dosing of your insulin injections, food or exercise may need to
be changed.
Things you should not do
Do not stop using your insulin unless your doctor tells you to.
Do not give your insulin to anyone else, even if they have diabetes.
Do not share needles.
Do not refill your Ryzodeg® 70/30 Penfill®.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how the insulin
affects you.
If your blood sugar is low or high your concentration and ability to react might be
affected, and therefore also your ability to drive or operate a machine.
Bear in mind that you could endanger yourself or others. Please ask your doctor whether
you can drive a car, especially if:
• you have frequent hypos
• you find it hard to recognise hypos.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may mask the signs of a hypo. Carefully monitor your blood sugar levels when
drinking.
Looking after your medicine
Penfill® cartridges that are not being used should be stored between 2°C and 8°C in
the refrigerator (away from the cooling element).
Penfill® cartridges that you are using, or that you are carrying as a spare, should
not be kept in a refrigerator.
Protect the insulin in Penfill® from light by keeping the cartridges in the carton
when not in use.
Do not allow cartridges to be frozen, or exposed to excessive heat and light.
Never use Ryzodeg® 70/30 Penfill® if the solution is not clear and colourless.
Keep it where young children cannot reach it.
When to discard your medicine (as relevant)
You can use Ryzodeg® 70/30 Penfill® for up to 4 weeks (28 days) after taking it out
of the refrigerator if kept below 30°C.
Discard Penfill® cartridges after 4 weeks even if there is still some insulin left
in them.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Never use insulin after the expiry date printed on the Penfill® label and carton after
'Expiry'. The expiry date refers to the last day of that month.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Ryzodeg® 70/30 Penfill® contains
|
Active ingredient
(main ingredient)
|
soluble insulin degludec and insulin aspart 100 U/mL, in the ratio of 70:30.
|
|
Other ingredients
(inactive ingredients)
|
glycerol
phenol (as preservative)
metacresol (as preservative)
zinc acetate
sodium chloride
Water for injections
sodium hydroxide (for pH adjustment)
hydrochloric acid (for pH adjustment)
|
Do not take this medicine if you are allergic to any of these ingredients.
What Ryzodeg® 70/30 Penfill® looks like?
Ryzodeg® 70/30 is a clear colourless solution for subcutaneous injection. Ryzodeg®
70/30 Penfill® 3 mL is a pre-filled glass cartridge designed to be used with Novo
Nordisk insulin delivery systems and NovoFine® needles.
(AUST R 280433)
Who distributes Ryzodeg® 70/30 Penfill®
Ryzodeg® 70/30 Penfill® is supplied in Australia by:
Novo Nordisk Pharmaceuticals Pty Ltd
Level 10
118 Mount Street
North Sydney NSW 2060
Australia
Ryzodeg® 70/30 Penfill® is supplied in in in New Zealand by:
Novo Nordisk Pharmaceuticals Ltd.
PO Box 51-268
Pakuranga
Auckland
New Zealand
Further information
For further information call Novo Nordisk Medical Information on 1800 668 626 (Australia)
or 0800 733 737 (New Zealand).
You can also get more information about diabetes from
Diabetes Australia:
freecall helpline 1300 136 588
Diabetes New Zealand:
freecall helpline 0800 342 238
Ryzodeg® Penfill®, NovoRapid®, NovoPen® and NovoFine® are registered trademarks of
Novo Nordisk A/S.
© 2025
Novo Nordisk A/S
This leaflet was prepared in November 2025