Preotact
parathyroid hormone (rDNA)
Parathyroid hormone
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet
What is in this leaflet:
What Preotact is and what it is used for
What you need to know before you use Preotact
How to use Preotact
Possible side effects
5 How to store Preotact
6. Contents of the pack and other information
Medicinal product no longer authorised
Preotact is used to treat osteoporosis in women past menopause with high risk of fractures. Osteoporosis is a disease that causes bones to become thin and fragile. It is especially common in women after the menopause. The disease progresses gradually so you may not feel any symptoms at first. But if you have osteoporosis, it makes you more likely to break bones, especially in your spine, hips and wrists. It may also cause back pain, loss of height, and a curved back.
Preotact reduces the risk of breaking spinal bones because it increases your bone quality and strength. It has not been shown that Preotact reduces the risk of breaking your hip.
if you are allergic to parathyroid hormone or any of the other ingredients of this medicine (listed in section 6);
if you shall have or previously have had radiation therapy to the skeleton;
if you have cancer of the bones;
if you suffer from high calcium levels in your blood or other disturbances in the calcium- phosphor metabolism;
if you have other bone disease (including hyperparathyroidism or Paget’s disease);
if you have high levels of alkaline phosphatase (an enzyme produced by the organism; may signal certain medical conditions, related to bones and liver);
if you suffer from severe kidney problems;
if you suffer from severe liver disease;
Talk to your doctor or pharmacist before using Preotact if you:
have a high level of calcium in your urine;
suffer from kidney stones;
receive heart medicine (e.g. digoxin also known as digitalis).
Your doctor will check your response to the treatment at regular intervals. Your doctor will perform blood and/or urine tests to measure the level of calcium in your blood and/or urine at month 1, 3 and 6 after starting your treatment with Preotact.
Preotact should not be used in children or adolescents under 18 years old.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You should use Preotact with caution if you receive heart medicine (e.g. digoxin also known as digitalis).
Ask your doctor or pharmacist for advice before taking any medicine Do not use Preotact if you are pregnant or breast-feeding.
If you feel dizzy, do not drive or operate any machines until you feel better.
Medicinal product no longer authorised
Always use Preotact exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of Preotact is 100 micrograms per day.
Your doctor may advise you to take supplementary calcium and vitamin D. Your doctor will tell you how much you should take each day.
Before it is used for the first time, the medicine in the Preotact pre-filled pen has to be mixed (please refer to the “Instructions for use”).
After you do this, the Preotact pre-filled pen is ready for use and the medicine is ready to be injected into the abdomen (under the skin).
When you are not using it, put the pre-filled pen back into the refrigerator.
Inject yourself with Preotact shortly after you have taken your pre-filled pen out of the refrigerator.
Put the pre-filled pen back into the refrigerator immediately after you have used it.
Use a new needle for each injection and throw the needle away after each use.
Never store your pre-filled pen with the needle attached.
Always attach a new needle before use
Never share your pre-filled pen with anyone.
Keep using Preotact for as long as your doctor prescribes it for you – normally no longer than
If, by accident, you inject more than one dose of Preotact in a day, contact immediately your doctor or pharmacist.
If you forget to take Preotact (or cannot take Preotact at your usual time), take it as soon as possible on that day.
Never inject more than one dose in the same day.
Do not take a double dose to make up for a forgotten dose.
Medicinal product no longer authorised
Discuss with your doctor if you consider stopping the treatment with Preotact before you finish the prescribed period.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Preotact can cause side effects, although not everybody gets them.
increased level of calcium in the blood,
increased level of calcium in the urine,
nausea.
back pain,
constipation, diarrhoea,
decreased muscle strength, muscle cramps, dizziness,
reddening of the skin (erythema) at injection site,
fast or irregular heart beats,
headache,
pain in arms and legs (extremities),
stomach upset, vomiting,
tiredness.
abdominal pain,
flu,
increased level of uric acid in the blood,
increased level of alkaline phosphatase in the blood ,
irritation of the skin at the injection site,
loss of appetite,
smell disturbance, taste disturbance.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet..
Keep this medicine out of sight and reach of children.
Do not use Preotact after the expiry date which is stated on the pre-filled pen and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not freeze.
Medicinal product no longer authorised
Keep Preotact protected from light
Store in a refrigerator (2-8°C).
Do not freeze.
You should keep the mixed pre-filled pen for maximum 28 days in the refrigerator.
Do not use this medicine for more than 28 days after it has been mixed.
You can store the mixed pre-filled pen for up to 7 days outside the refrigerator (below 25°C) during the 28-day use period.
Do not use this medicine if it has not been stored correctly, even if it is not used up.
Do not use this medicine if you notice that it became cloudy or coloured.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
-The active substance is parathyroid hormone. Each pre-filled pen contains 1.61 mg parathyroid
hormone corresponding to 14 doses. After reconstitution, each dose of 71.4 microlitre contains 100 micrograms parathyroid hormone.
The other ingredients are:
sodium chloride,
mannitol,
citric acid monohydrate,
hydrochloric acid,
sodium hydroxide.
metacresol ,
water for injections
Preotact is a powder and solvent for solution for injection in a pre-filled pen.
Preotact is supplied in a pre-filled pen containing a cartridge. The first chamber contains 1.61 mg parathyroid hormone as powder and the second chamber contains 1.13 ml of solvent.
Preotact is available in a pack with 2 pre-filled pens.
1 Grand Canal Street Upper Dublin 4
Medicinal product no longer authorised
Ireland
DK-4000 Roskilde Denmark
INSTRUCTIONS FOR USE
THE PRE-FILLED PEN
The Preotact pre-filled pen has been designed especially to make it easy for you to take your osteoporosis treatment.
Before taking your first injection with a new pre-filled pen you have to add a needle and mix the medicine by following the instructions in this leaflet. Only mix one pen at the time.
The pre-filled pen contains medicine for 14 days.
Every day you have to check that the medicine is clear, add a new needle, take the injection in your abdomen and then throw away the needle before storing your pre-filled pen in the refrigerator (2-8°C).
The pre-filled pen before mixing:
release button dose counter
Medicinal product no longer authorised
injection button
pen body
front part cap
The pre-filled pen after mixing:
The steps you have to go through with a new pre-filled pen:
Add a needle
Mix the medicine
Release residual air (prime the pen)
Take your daily dose or store the pre-filled pen
The steps you have to go through for each of the 14 injections:
Add a needle
Take the daily injection
Store the pre-filled pen
pre-filled
index
pen is full
number of doses left
pre-filled pen is empty
needle
inner needle cover
outer needle cover
When you receive your pre-filled pen the dose counter is at , to show that it is full.
When the dose counter is at 0, the pre-filled pen is empty and you must take a new pre-filled pen.
Medicinal product no longer authorised
Adding a needle
Wash your hands with soap and water before you handle the pre-filled pen.
Pull the cap straight off from the front end of the pre-filled pen.
Peel off the protective paper from the needle cover.
Hold on to the clear front end of the pre-filled pen and screw the needle all the way onto the clear front end of the pre-filled pen.
Medicinal product no longer authorised
Be careful not to push the yellow release button while you handle the pre-filled pen – if you accidentally do so, the blue injection button will pop out.
Mixing the medicine
“click” • Point the needle end straight up
Screw the pre-filled pen together until the clear front part and the pen body meet.
You will hear and feel a click at the end.
Let it sit for about one minute until the medicine is completely mixed.
Check that the medicine is clear.
Preparing the new pre-filled pen for use – releasing air (priming)
Medicinal product no longer authorised
Press the yellow release button to release the blue injection
button.
Pull both needle covers off.
Save the outer needle cover as you will need it to remove the needle after the
injection.
“click”
Point the needle straight up and press the blue injection button until it is fully depressed.
You will hear a “click” (see picture). This will release most of the air in the
pre-filled pen and is called ‘priming’.
The priming should be done every time you mix a new
pre-filled pen.
Some medic may come out – this is normal.
A small air bubble may remain in the pre-filled pen – this is normal.
The daily injection
Medicinal product no longer authorised
The dose counter now shows 14 and the pre-filled pen is ready to use. You can choose to continue and take your daily injection now or store the pre-filled pen in the refrigerator, as described under ‘Practical information’, at the end of the Instructions for use.
Ensure that you have a needle on the pre-filled pen (see pictures 3 and 4).
If you have just mixed a new pre-filled pen you can use the needle already on.
Press the yellow release button to release the blue injection button.
Pinch a skin fold in the abdomen and take the injection in a 90° degree angle as you have been instructed by your doctor or nurse.
Medicinal product no longer authorised
Press the blue injection button until it is fully depressed –then count slowly to 10 and remove the needle from your skin.
The dose counter has now decreased by one.
Put the outer needle cover on.
Screw the needle off.
Throw away the needle as you have been instructed by your doctor or nurse
Use each needle only once.
Put the cap back on the pre-filled pen and place it in the refrigerator.
Practical Information
The pre-filled pen has an expiration date printed on it; do not use the medicine after this date.
The medicine should not be used for more than 28 days after it has been mixed.
You can store the unmixed pre-filled pen at temperatures between 2-25°C.
Medicinal product no longer authorised
Remove the needle after each daily injection and return the pre-filled pen to the refrigerator at 2-8°C.
You can store the mixed pre-filled pen for up to 7 days at room temperature, between 2-25°C.
Protect the medicine and pre-filled pen against direct sunlight.
Do not use the medicine if it is cloudy or coloured (if it is unclear).
Do not store the pre-filled pen with the needle on.
Do not share your medication with others.
If you drop your pre-filled pen you must replace it.