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AstraZeneca

Preotact
parathyroid hormone (rDNA)

Package leaflet: Information for the user


Preotact 100 micrograms powder and solvent for solution for injection in a pre-filled pen

Parathyroid hormone


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

effects not listed in this leaflet


What is in this leaflet:

  1. What Preotact is and what it is used for

  2. What you need to know before you use Preotact

  3. How to use Preotact

  4. Possible side effects

5 How to store Preotact

6. Contents of the pack and other information


  1. What Preotact is and what it is used for


    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.

  2. What you need to know before you use Preotact Do not use Preotact

    • 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;


      Warnings and precautions

      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).

      Measuring of the calcium levels in the blood and/or urine


      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.


      Children and adolescents


      Preotact should not be used in children or adolescents under 18 years old.


      Other medicines and Preotact


      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).


      Pregnancy and breast-feeding

      Ask your doctor or pharmacist for advice before taking any medicine Do not use Preotact if you are pregnant or breast-feeding.


      Driving and using machines


      If you feel dizzy, do not drive or operate any machines until you feel better.


      Medicinal product no longer authorised

      Preotact contains less than 1 mmol sodium (23 mg) per dose. This means that it is essentially “sodium-free”.


  3. How to use Preotact


    Always use Preotact exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.


    Dosage


    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.


    Method of administration


    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.


    Important information when using Preotact

    • 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.

    • Do not shake the pre-filled pen (neither before nor after injection) as it may destroy the effect of the medicine.

    • 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.


      For instructions on how to use the pre-filled pen, please read the ”Instructions for use”.. Duration of treatment

      Keep using Preotact for as long as your doctor prescribes it for you – normally no longer than

      24 months.


      If you use more Preotact than you should


      If, by accident, you inject more than one dose of Preotact in a day, contact immediately your doctor or pharmacist.


      If you forget to use Preotact


      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

      If you stop taking Preotact


      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.


  4. POSSIBLE SIDE EFFECTS


    Like all medicines, Preotact can cause side effects, although not everybody gets them.


    Very common (may affect more than 1 in 10 people):

    • increased level of calcium in the blood,

    • increased level of calcium in the urine,

    • nausea.


      Common (may affect up to 1 in 10 people):

    • 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.

      Uncommon (may affect up to 1 in 100 people):

    • 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..


  5. How to store Preotact


    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.


    Before mixing

    • Do not store above 25°C.

    • Do not freeze.

      Medicinal product no longer authorised

    • Keep Preotact protected from light


      After mixing

    • 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.


  6. Contents of the pack and other information. What Preotact contains

    -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:

    The powder contains:

    • sodium chloride,

    • mannitol,

    • citric acid monohydrate,

    • hydrochloric acid,

    • sodium hydroxide.


      The solvent contains

    • metacresol ,

    • water for injections


What Preotact looks like and contents of the pack


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.


Marketing Authorisation Holder NPS Pharma Holdings Limited Grand Canal House

1 Grand Canal Street Upper Dublin 4

Medicinal product no longer authorised

Ireland


Manufacturer Nycomed Danmark ApS Langebjerg 1

DK-4000 Roskilde Denmark


This leaflet was last approved in MM/YYYY


.eu


INSTRUCTIONS FOR USE


PREOTACT


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:


image

release button dose counter


Medicinal product no longer authorised

injection button


pen body


front part cap


The pre-filled pen after mixing:


image

image


Please read the information in these boxes carefully - they contain important information for you.


The steps you have to go through with a new pre-filled pen:

You will hear and feel a click at the end.


image

image


Do not shake the pre-filled pen



Use each needle only once.


image

Put the cap back on the pre-filled pen and place it in the refrigerator.


Practical Information