2. What should I know before being given MINIRIN Injection?
Do not use MINIRIN Injection if you have ever had an allergic reaction to desmopressin
acetate or to any of the ingredients listed at the end of the CMI. (see Section
7. Product details in the full CMI.)
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. For more information, see Section
2. What should I know before being given MINIRIN Injection? in the full CMI.
3. What if I am taking other medicines?
4. How will I be given MINIRIN Injection?
MINIRIN may be given by injection into a muscle (intramuscularly) or into a vein (intravenously),
depending on its use. MINIRIN Injection is not intended for self-administration.
Cranial diabetes insipidus - the average daily dose for adults is 1 to 4 micrograms by injection. The dose for
children will be up to 0.4 micrograms daily. It is usually given in two doses each
day.
Test the ability of the kidneys to concentrate urine - adults will receive a single dose of up to 4 micrograms at any one time.
Prior to dental or other surgery of patients with mild and moderate haemophilia A
and von Willebrand's disease (but not type IIB) - it is usually given 30 minutes before the procedure or surgery. For cardiac (heart)
surgery, it will be given towards the end of the operation
5. What should I know while being given MINIRIN Injection?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are being given MINIRIN
Injection.
If you are going to have surgery, tell the surgeon or anaesthetist that you are being
given this medicine.
|
|
Things you should not do
|
MINIRIN Injection should not be given to you to treat any other complaints unless
your doctor tells you to do so.
|
|
Looking after your medicine
|
Keep MINIRIN Injection in a refrigerator at a temperature between 2°C and 8 °C. Do
not freeze. Keep it in its original packaging and protect it from light.
Store it in a cool dry place away from moisture, heat or sunlight.
|
6. Are there any side effects?
All medicines can have side effects. Most of them are minor and temporary but some
may need medical attention.
Tell your doctor if you experience any side effects, including headache, stomach pain,
nausea or vomiting, rapid weight gain, confusion or drowsiness. These are signs and
symptoms of hyponatraemia (low sodium levels in the blood), a rare, but serious possible
side effect of MINIRIN Injection. 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.
Active ingredient(s):
desmopressin acetate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about being given MINIRIN Injection. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about being given MINIRIN Injection.
Where to find information in this leaflet:
1. Why am I being given MINIRIN Injection?
MINIRIN Injection contains the active ingredient desmopressin acetate. MINIRIN Injection
is a synthetic version of a naturally occurring substance produced in the brain called
vasopressin.
MINIRIN Injection has several different actions on the body including on the kidneys
to reduce the amount of urine produced. It is used for several different conditions
including:
cranial diabetes insipidus (CDI), large amounts of urine being produced day and night
and constant thirst where intranasal administration is inconvenient
as a diagnostic test to establish the kidneys ability to concentrate urine in adults
to increase the blood clotting factor VIII levels in patients with mild and moderate
haemophilia A and von Willebrand's disease (but not type IIB) prior to dental or other
surgery
to treat excessive bleeding in patients with certain defects of the blood clotting
cells (platelets).
2. What should I know before being given MINIRIN Injection?
Warnings
MINIRIN Injection should not be used if:
you are allergic to desmopressin, or to any of the ingredients listed at the end of
this leaflet
you suffer from polydipsia (have excessive thirst and requiring increased fluid intake)
or psychogenic polydipsia (psychologically-caused increased thirst and increased fluid
intake
you have cardiac insufficiency (heart failure in which the heart is not able to pump
enough blood throughout the body resulting in shortness of breath, swelling of feet
or legs due to fluid build-up)
you have low levels of sodium in your bloodstream
you have SIADH (hormone secretion disorder where there is an overproduction of a hormone
causing fluid retention, resulting in weakness, tiredness or confusion)
you have a history of a condition marked by severe pain in the chest, often also spreading
to the shoulders, arms and neck, owing to an inadequate supply to the heart (angina
pectoris)
you have Von Willebrand disease type IIB (a bleeding disorder)
the expiry date printed on the pack has passed
the packaging is torn or shows signs of tampering.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any other medical conditions especially the following:
a known allergy to anti-diuretic hormone (ADH)
too little or too much fluid in the body
heart or blood vessel disease or any other disease for which you take diuretics (fluid
tablets)
low blood pressure
cystic fibrosis or any other disease which causes fluid or salt imbalance
any disease of the blood clotting cells (platelets)
serious problems with bladder function or with passing urine
raised pressure within your head (increased intracranial pressure)
moderate to severe renal insufficiency
take any medicines for any other condition.
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.
MINIRIN Injection should only be given to a pregnant woman if it is needed. Your doctor
can discuss with you the risks and benefits involved.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
MINIRIN Injection is not recommended while you are breast-feeding.
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 MINIRIN Injection and affect how it works.
Medicines that may
increase
the effect of MINIRIN Injection include:
medications which are known to release antidiuretic hormone, which can increase the
risk of fluid buildup in the body such as:
tricyclic antidepressants
selective serotonin reuptake inhibitors (SSRIs) (anti-depressants)
chlorpromazine (anti-psychotic)
carbamazepine (bipolar disorder and epilepsy medication)
opioids (pain relief medications)
medications which are known to treat high blood
sugar (diabetes) (e.g. medicines in the sulfonylurea group)
non-steroidal anti-inflammatory drugs (NSAIDs), which are medicinal products used
for the treatment of pain and inflammation (e.g. aspirin and ibuprofen). NSAIDs may
induce water retention/low sodium levels in the blood (hyponatraemia).
These medicines may affect how well MINIRIN Injection works. You may need different
amounts of your medicines, or you may need to take different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect MINIRIN Injection.
4. How will I be given MINIRIN Injection?
MINIRIN may be given by injection into a muscle (intramuscularly) or into a vein (intravenously),
depending on its use.
MINIRIN Injection is not intended for self-administration.
How much MINIRIN Injection is given
The dose of MINIRIN Injection prescribed by your doctor will vary depending on the
condition being treated and your response to the treatment.
Cranial diabetes insipidus
the average daily dose for adults is 1 to 4 micrograms by injection. The dose for
children will be up to 0.4 micrograms daily
the dose you receive will be adjusted to suit personal requirement
it is usually given in two doses each day. Sometimes a single daily dose is sufficient
to control your condition.
Test the ability of the kidneys to concentrate urine
Adults will receive a single dose of up to 4 micrograms at any one time.
The dose of MINIRIN Injection you will be given will be calculated based on your body
weight.
When MINIRIN Injection is given
Cranial diabetes insipidus
You will be given MINIRIN Injection at times specified by your doctor.
Test the ability of the kidneys to concentrate urine
Your doctor will advise you.
Patients with mild and moderate haemophilia A and von Willebrand's disease (but not
type IIB) prior to dental or other surgery
if it is used for dental or minor surgery, MINIRIN Injection is usually given 30 minutes
before the procedure or surgery
if you are undergoing cardiac (heart) surgery, MINIRIN Injection will be given towards
the end of the operation
if you have responded to treatment with MINIRIN Injection and require more doses,
further doses may be given every 12 hours for as long as it is needed.
How long MINIRIN Injection is given
This will depend on your condition and on your response to treatment with MINIRIN
Injection.
Cranial diabetes insipidus
MINIRIN Injection can prevent or control the thirst and frequent urination associated
with CDI. You will be less thirsty and urinate a smaller volume less often.
It is likely that you will need to be given MINIRIN Injection or other forms of MINIRIN
for the rest of your life.
This medicine helps to control your condition but does not cure it. It is important
to keep taking your medicine even if you feel well.
Test the ability of the kidneys to concentrate urine
Your doctor will explain the details of the test.
To prevent or control bleeding
It will be given for as long as necessary to stop excessive bleeding.
You doctor will decide when treatment with MINIRIN Injection should be stopped.
What to expect
Individuals will vary greatly in their response to MINIRIN Injection and you may not
feel any effect. You will receive regular monitoring to check on your body's response
to MINIRIN Injection.
If you have a defect in your blood clotting cells, your skin bleeding time will be
monitored before surgery to determine whether you are at high risk of blood loss.
If you are given too much MINIRIN Injection
It is unlikely that you will be given too much MINIRIN Injection.
If you think that you or anyone else may have been given too much MINIRIN Injection,
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.
You may need urgent medical attention.
Symptoms of an overdose may include confusion, drowsiness, continuing headache, nausea
or vomiting, rapid weight gain due to a build-up of water in the body, or, in severe
cases, convulsions.
The signs of overdosage can be treated by restoring your body's fluid balance, lowering
the dose or giving MINIRIN Injection less often or it may be stopped completely.
5. What should I know while being given MINIRIN Injection?
Things you should do
If you are about to be started on any new medicine, remind any doctor, dentist, or
pharmacist you visit that you are being given MINIRIN Injection.
If you are going to have surgery, tell the surgeon or anaesthetist that you are being
given this medicine.
It may affect other medicines used during surgery.
If you become pregnant while being given MINIRIN Injection, tell your doctor immediately.
Your doctor can discuss with you the risks of being given it while you are pregnant.
If you are about to have any blood tests, tell your doctor that you are being given
this medicine.
It may interfere with the results of some tests.
Keep all your doctor’s appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects.
Things you should not do
MINIRIN Injection should not be given to you to treat any other complaints unless
your doctor tells you to do so.
Things to be careful of
Cranial diabetes insipidus
Carefully follow your doctor’s instruction about fluid intake.
It is very important to keep your body water in balance, so that you do not let yourself
get too thirsty or drink too much fluid.
Test the ability of the kidneys to concentrate urine
You must avoid drinking fluids from one hour before being given MINIRIN Injection
until at least eight hours after administration of the injection.
Over this period, drink no more than a few sips of water or other fluids. This is
because a high fluid intake during this period can increase the chance that you will
feel unwell (e.g. headache, nausea, dizziness).
Driving or using machines
This medicine is not expected to affect your ability to drive a car or operate machinery.
Looking after your medicine
MINIRIN Injection is usually stored in the hospital pharmacy or in the ward.
Keep MINIRIN Injection in a refrigerator at a temperature between 2°C and 8 °C. Do
not freeze. Keep it in its original packaging and protect it from light.
If you store the medicine out of its original packaging it may not keep well.
Store it away from moisture, heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
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.
Do not use this medicine after the expiry date. 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.
The elderly may be at an increased risk of some side effects.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Do not be alarmed by the following lists of side effects. You may not experience any
of them.
Side effects
|
Side effects
|
What to do
|
|
Hyponatraemia or low sodium levels in the blood may have the following signs or symptoms:
headache
stomach pain
nausea.
Hyponatraemia can potentially become a serious side effect, see below.
Common side effects (affects between 1 to 10 in 100 users):
fatigue (tiredness)
Rare side effects (affect less than 1 in 1000 users):
dizziness (feeling lightheaded)
Side effects (unknown frequency):
generalised or local swelling (limbs, face)
chills
|
These side effects are not usually serious but can become serious.
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
high or low blood pressure
fast heart rate
emotional or behavioural disturbances
Hypersensitivity or allergic reactions (unknown frequency):
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
*Hyponatraemia or low sodium levels in the blood may have the following serious signs
or symptoms:
confusion or drowsiness
continuing headache
nausea or vomiting
rapid weight gain, which may be due to a build-up of water in the body
convulsions, fitting and blackouts (including coma)
*These side effects are rare
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are being given MINIRIN Injection.
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 MINIRIN Injection contains
|
Active ingredient
(main ingredient)
|
desmopressin acetate
|
|
Other ingredients
(inactive ingredients)
|
sodium chloride
hydrochloric acid (to adjust the pH)
water for injections
|
Do not take this medicine if you are allergic to any of these ingredients.
What MINIRIN Injection looks like
MINIRIN Injection are supplied in 1 mL ampoules and are available in boxes of 10.
MINIRIN desmopressin acetate 4 micrograms/1 mL injection ampoule is a clear colourless
solution for injection packed in 1 mL ampoules (AUST R 40689).
Who distributes MINIRIN Injection
Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1
20 Bridge Street
Pymble, NSW 2073
Toll free: 1800 337 746
This leaflet was prepared in July 2023.
AU-MN-2300011_v.2.0
MINIRIN and FERRING are registered trademarks of Ferring B.V.