KAULIV 20 mcg/80 mcl Roztwór do wstrzykiwań

Treść ulotki

1. Kauliv 20 micrograms/80 microliters injectable solution
   1. What is Kauliv and what is it used for
   2. What you need to know before using Kauliv
   3. How to use Kauliv
   4. Possible side effects
   5. How to store Kauliv
   6. Contents of the pack and other information

Kauliv 20 micrograms/80 microliters injectable solution

teriparatide

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful. If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1.
• 2.
• 3.
• 4.
• 5.
• 6. What is Kauliv and what it is used for What you need to know before you use Kauliv How to use Kauliv Possible side effects How to store Kauliv Contents of the pack and other information

1. What is Kauliv and what is it used for

Kauliv contains the active substance teriparatide which is used to make bones stronger and reduce the
risk of fractures by stimulating bone rebuilding.
Kauliv is used to treat osteoporosis in adults. Osteoporosis is a disease that causes the
bones to become thin and fragile. This disease is particularly common in women after
menopause, but can also occur in men. Osteoporosis is also common in patients in
treatment with drugs called corticosteroids.

2. What you need to know before using Kauliv

Do not use Kauliv

• If you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6). If you have high levels of calcium in your blood (pre-existing hypercalcemia). If you suffer from severe kidney problems. If you have had cancer of the bones or if other cancers have spread (have metastasized) to the bones. If you have other bone diseases. If you have a bone disease, tell your doctor. If you have high levels of alkaline phosphatase of unknown origin in your blood, this may mean you have Paget's disease of the bone (a condition with abnormal bone changes). If you are not sure, ask your doctor.
• If you have undergone radiation therapy involving the bones. If you are pregnant or breastfeeding. Warnings and precautionsKauliv can cause an increase in the amount of calcium in the blood or urine.

Consult your doctor before or during the use of Kauliv:

• If you have persistent nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs that there is too much calcium in your blood. If you suffer from or have suffered from kidney stones. If you suffer from kidney problems (moderate renal impairment).

Some patients experience dizziness or an acceleration of the heartbeat after taking the
first doses of Kauliv. During the administration of the first doses, if you experience dizziness, inject Kauliv in
a place where you can sit or lie down.
The recommended treatment period of 24 months should not be exceeded.
Before inserting a cartridge into the Kauliv pen, note the batch number and the date of the first
injection on a calendar and provide this information in case of reporting adverse effects.
The date of the first injection must also be written on the outer box of the Kauliv cartridge
(see the space provided on the box: “First use”) (see section 3).
Kauliv should not be used in adults who are still growing.

Children and adolescents
Kauliv should not be used in children and adolescents (under 18 years of age).

Other medicines and Kauliv
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
This is important because some medicines (e.g. digoxin/digitalis, a medicine used to treat heart
disease) can interact with teriparatide.

Pregnancy and breastfeeding
Do not take Kauliv if you are pregnant or if you are breastfeeding. If you are a woman of childbearing
age, you should use effective methods of contraception during the use of Kauliv. In case of
pregnancy while using Kauliv, the latter should be discontinued. Ask your doctor or
pharmacist for advice before taking any medicine.

Driving and operating machinery
Some patients may experience dizziness after injecting Kauliv. If you feel dizzy, do not
drive and do not use machinery until you feel better.

Kauliv contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to use Kauliv

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is 20 micrograms (corresponding to 80 microlitres) administered once a
day by injection under the skin (subcutaneous injection) in the thigh or abdomen.
To help you remember to take the medicine, inject it at the same time each day. Kauliv can
be injected at mealtimes. Inject Kauliv every day for the entire period of time prescribed by your
doctor. The total duration of treatment with Kauliv should not exceed 24 months. You should not
receive more than one treatment lasting 24 months for the rest of your life.
Your doctor may advise you to take Kauliv with calcium and vitamin D. Your doctor will tell you how much calcium
and vitamin D you need to take each day.
Kauliv can be administered with or without food.
Kauliv cartridges are designed for exclusive use with the Kauliv multi-dose pen and compatible
needles. The pen and injection needles are not supplied with the Kauliv cartridge.
Before first use, insert the cartridge into the pen (which is supplied separately). For correct
use of this medicine, it is very important to carefully follow the detailed Instructions for Use (IFU)
for the pen provided with the pen itself.
Always use a new needle for each injection to prevent contamination and safely dispose of the needle
after use.
Never store the pen with the needle inserted. Never share your pen with others.
Do not use the Kauliv pen to inject other medicines (e.g. insulin). The pen is
customized for exclusive use with Kauliv.
Do not reload the cartridge.
Do not transfer the medicine into a syringe.
You must inject Kauliv shortly after taking the pen with the inserted cartridge from the
refrigerator. After use, immediately return the pen with the inserted cartridge to the refrigerator. Do not
remove the cartridge from the pen after use. The cartridge in the pen can be further inserted
into the case provided with the pen, to protect the medicine from light throughout the treatment period of
twenty-eight days.

Preparing to use the pen

• To ensure correct administration of Kauliv, always read the IFU for the Kauliv pen, included in the pen's packaging. Wash your hands before handling the cartridge or pen. Check the expiry date on the cartridge label before inserting the cartridge into the pen. Make sure there are at least 28 days remaining before the expiry date. Insert the cartridge into the pen before first use as indicated in the pen instructions. Note the lot number of each cartridge and the date of the first injection on a calendar. You should also note the date of the first injection on the outer case of the Kauliv cartridge (see the designated space on the box: “First use”). After inserting a new cartridge and before the first injection from this cartridge, prime the pen according to the instructions provided in the IFU for the pen. Make sure to prime before each dose, as instructed in the IFU for the pen.

Injecting Kauliv

• Before injecting Kauliv, clean the skin where you intend to inject (thigh or abdomen) as instructed by your doctor. Gently pinch a portion of clean skin and insert the needle perpendicularly into the skin. Press the button and hold it down until the dose indicator returns to the starting position.
• After the injection, leave the needle in the skin for ten seconds to ensure you deliver the entire dose. As soon as the injection is finished, insert the protective cap onto the pen needle and screw it counterclockwise to remove the pen needle. Reposition the cap on the pen. Leave the cartridge in the pen.

If you use more Kauliv than you should
If you accidentally take more Kauliv than you should, contact your doctor or pharmacist. Expected effects
of an overdose include nausea, vomiting, dizziness and headache.

If you forget to use Kauliv
If you forget an injection or cannot do it at the time you usually do, inject it during the
day as soon as possible. Do not use a double dose to make up for a missed dose. Do not
have more than one injection in the same day.

If you stop using Kauliv
If you are thinking of stopping treatment with Kauliv, we invite you to discuss this with your doctor. Your
doctor will advise you and decide how long you should be treated with Kauliv.
If you have any doubts about using this medicine, ask your doctor or pharmacist.
The use of Kauliv is not recommended by a blind or visually impaired person without the assistance
of a person trained in the correct use of the pen.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are pain in the limbs (which may affect more than 1 in 10 people).
Other common side effects (may affect up to 1 in 10 people) include feeling of
nausea, headache and dizziness. If you feel dizzy after the injection, you should sit or
lie down until you feel better. If you do not feel better, you should call a doctor before
continuing treatment. Cases of fainting have occurred after the use of teriparatide.
If you experience discomfort around the injection site, as well as redness of the skin, pain,
swelling, itching, bruising or minor bleeding (which may occur
commonly), this should resolve within a few days or weeks. Otherwise, inform your doctor.
Rarely (may affect up to 1 in 1,000), patients have suffered allergic
reactions including shortness of breath, facial swelling, rash and chest pain. These reactions
usually occur shortly after the injection. In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis may occur.
Other side effects include:
Common (may affect up to 1 in 10 people)

• increased levels of cholesterol in the blood depression neuropathic pain in the legs feeling of fainting feeling of dizziness irregular heartbeats shortness of breath increased sweating muscle cramps loss of energy fatigue chest pain decreased blood pressure heartburn (a painful or burning sensation felt just below the breastbone) vomiting the presence of a hernia of the channel leading food into the stomach (hiatal hernia) decreased hemoglobin or number of red blood cells in the blood (anemia)

Uncommon (may affect up to 1 in 100)

• increased heart rate abnormalities in heart sounds labored breathing hemorrhoids
• urine leakage increased need to eliminate fluids weight gain kidney stones muscle pain and joint pain. Some patients have been affected by severe cramps or back pain that led to hospitalization. increased levels of calcium in the blood increased levels of uric acid in the blood increase in an enzyme called alkaline phosphatase
• Rare (may affect up to 1 in 1,000)
• reduced kidney function, including kidney failure appearance of swelling, especially in the hands, feet and legs

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Kauliv

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and cartridge after
SCAD/EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (from 2°C to 8°C). Do not freeze.
Keep the cartridge in the outer packaging to protect it from light.
You can use Kauliv for up to 28 days after the first injection, during this period the cartridge/pen with
the cartridge inserted is stored in a refrigerator (2°C–8°C). The cartridge /pen can be
further inserted into the case provided with the pen to protect the medicine from light.
Avoid placing the pens near the ice compartment in the refrigerator to prevent freezing. Do not use Kauliv if it is or has been frozen.
After 28 days from first use, each cartridge must be disposed of appropriately, even
if it is not completely empty.
Kauliv contains a colourless and clear solution. Do not use Kauliv if you notice the presence of solid
particles or if the solution appears cloudy or coloured.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Kauliv contains

• The active substance is teriparatide. Each dose of 80 microlitres contains 20 micrograms of teriparatide. Each 3 mL cartridge contains 750 micrograms of teriparatide (corresponding to 250 micrograms per mL). The other components are: anhydrous sodium acetate, glacial acetic acid, mannitol, metacresol, diluted hydrochloric acid (for pH adjustment), sodium hydroxide (for the

pH adjustment), water for injections (See section 2 “Kauliv contains
sodium”).

Description of Kauliv and contents of the pack
Kauliv is a colourless and clear injection solution. Kauliv is supplied in a cartridge. Each
cartridge contains 3 mL of solution, sufficient for 28 doses.
Contents of the pack:
1 cartridge or 3 cartridges packaged in a sealed plastic blister with a covering foil
and contained in a carton.
Kauliv pack with cartridge and pen:
1 inner carton with Kauliv cartridge (containing 1 cartridge) and 1 inner carton with Kauliv pen
(containing 1 pen).

Marketing Authorisation Holder
Strides Pharma (Cyprus) Limited
Themistokli Dervi, 3
Julia House, 1st Floor,
1066, Nicosia, Cyprus

Manufacturer
Fairmed Healthcare GmbH
Maria-Goeppert-Strasse 3
23562 Luebeck
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Lietuva
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

България
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Luxembourg/Luxemburg
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Česká republika
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Magyarország
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]

Malta
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Deutschland
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]

Eesti
Strides Pharma (Cyprus) Limited

Norge
Zentiva Denmark ApS
Tlf: +357-2255000
[email protected]
Tlf: +45 787 68 400
[email protected]

Ελλάδα
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Österreich
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

España
Zentiva Spain S.L.U.
Tel: +34 91 111 58 93
[email protected]

Polska
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

France
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Portugal
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]

România
ZENTIVA S.A.
Tel: +4 021.304.7597
[email protected]

Ireland
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Slovenija
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Ísland
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Slovenská republika
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Italia
Zentiva Italia S.r.l.
Tel: +39 800081631
[email protected]

Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]

Κύπρος
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]

Latvija
Strides Pharma (Cyprus) Limited
Tlf: +357-2255000
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu/ .

Instructions for Use
Kauliv Pen
Follow these step-by-step instructions carefully before using the Kauliv pen.
The Kauliv pen must not be used for purposes other than those recommended by the healthcare
professional.
Parts of the Kauliv pen

USE INSTRUCTIONS
The Kauliv pen is a reusable injection pen for the self-administration of subcutaneous injections
of teriparatide. For further information, see "What is Kauliv and what it is used for" and
32 G 4 mm pen needles.
Each cartridge contains 28 doses of teriparatide. Inject a single dose (D) of 20 micrograms
(corresponding to 80 microlitres) every day.
At the beginning of each new 28-day period, a new cartridge must be loaded.
Patients and caregivers administering Kauliv must receive appropriate training and
instructions on how to use the Kauliv pen from a qualified healthcare professional and must read the
leaflet for the Kauliv cartridge before first use. It is important to read, understand and
follow the instructions for use provided in the Instructions for Use of the Kauliv pen

PREPARING THE PEN: FIRST USE AND CARTRIDGE CHANGE
Write the date of the first injection of each new cartridge in the space provided on the cardboard
box. This will help you know when the 28 daily doses contained in each
cartridge have been used (see section 2 "Warnings and precautions" and section 3 "How to use Kauliv" in
Kauliv in the Kauliv pen.

INSERTING THE CARTRIDGE

Remove the pen cap.
Unscrew it by turning the pen body from the cartridge holder (fig. 1).

Check that the internal plunger is fully retracted (fig. 2). If the internal plunger is extended,
see fig. 12 to see how to retract it.

Check the teriparatide cartridge. If the solution is cloudy, use a new cartridge. Load the
Kauliv cartridge into the cartridge holder, first placing the metal cap (fig. 3).

Screw the cartridge holder and the pen body firmly together (fig. 4).

INSERTING A NEW NEEDLE

Remove the protective tab from a new pen needle (Gauge: 32G 4mm).
Screw the pen needle vertically into the cartridge holder (fig. 5a). The pen needle must be changed with each injection.

Remove the
outer cap of the needle and keep it.
Remove the inner needle protection and discard it (fig. 5b).

PRIMING THE PEN

It is important to prime the Kauliv pen before each daily use to remove any air that
may be in the needle and cartridge. (fig. 6a)
Set the dose selector to P to prime the Kauliv pen (fig 6b). If you overshoot the position,
proceed to fig. 7.

Hold the Kauliv pen with the needle pointing upwards. Press and hold the release button in
the direction of the needle until the arrow on the dose selector indicates 0. Continue to turn until Pand
release until a drop of teriparatide appears at the tip of the needle (fig. 7). The Kauliv
pen is now ready for use. (If the arrow does not return to 0after pressing the release button,
see the priming instructions above.)

INJECTING THE DOSE

Make sure the arrow indicates 0on the dose selector (fig. 8a). Then turn to D(fig. 8b).

Using the technique recommended by the healthcare professional, gently insert the Kauliv pen needle
into the injection site. Press the release button towards the pen needle and hold it in
position until the arrow on the dose selector indicates 0and continue to press the release button for 10 seconds, then remove the needle from the skin (fig. 9).

REMOVING THE NEEDLE

Replace the outer cap of the pen needle and unscrew the pen needle (fig. 10). Always check that the pen needle has been removed. Carefully dispose of used pen needles in an
approved sharps container in accordance with the instructions provided by the healthcare professional or
local regulations. Replace the pen cap on the Kauliv pen and refrigerate it for storage.

CHANGING THE CARTRIDGE (EVERY 28 DAYS)
Each cartridge contains enough teriparatide for 28 doses. After 28 days, discard the used cartridge
and insert a new cartridge (fig. 1-4). Dispose of the used cartridge in accordance with the instructions
provided by the healthcare professional or local regulations.

To change the cartridge, make sure the pen needle is removed. Unscrew the
cartridge holder from the pen body and remove the cartridge (fig. 11).

Screw the internal plunger back in by holding the green collar of the pen body between your thumb and index finger (fig 12). Turn the pen body until the internal plunger is
fully retracted (fig. 2). Then return to step 3 to insert the next cartridge.

PRIMING TIP
If, during the process described in fig. 7, the arrow does not indicate 0 (after pressing the release button) and teriparatide does not appear, this may indicate one of the following two possibilities:

• A.The pen needle you are using may be blocked. In this case, remove the pen needle from the pen and replace it with a new one. Then return to fig. 5, fig. 6 and fig. 7.
• B.It may be necessary to remove the protective coating from the cartridge. In this case, follow these steps:
• a.Replace the outer cap of the pen needle.
• b.Unscrew the cartridge holder.
• c.Press and hold the release button towards the internal plunger until the arrow indicates 0 on the dose selector.
• d.Turn to D without re-screwing the pen. Press and hold the release button towards the internal plunger until the arrow indicates 0.
• e.Without rewinding the internal plunger, screw the cartridge holder and the body firmly together. This will remove the protective coating from the cartridge and cause some teriparatide to leak, however the pen will notbe primed.
• f.Repeat fig. 6 and fig. 7 to fully prime the pen.

SAFETY PRECAUTIONS
Wash your hands thoroughly before use.
When the Kauliv cartridge is loaded, the Kauliv pen must be stored in a refrigerator
(2°C - 8°C) between injections up to 28 days of use from the date of first use. The
cartridge/pen can be further inserted into the case provided with the pen to protect
the medicine from light.
The Kauliv pen must be stored with the arrow on the pen body indicating 0 to avoid
damaging the pen.
Check the Kauliv cartridge. If the solution is cloudy, use a new cartridge.
Always make sure that the Kauliv pen has been loaded before each use, according to the

detailed instructions in steps 6 and 7. Failure to perform the exact loading procedures may lead to the delivery of an inaccurate dose.
Never try to turn the dose selector backwards as this may damage the Kauliv pen. Expel the incorrect dose into the air.
Do not inject more than one dose (D) per day.
If you notice any leakage of teriparatide when removing the pen needle, it is possible that
the full dose of teriparatide has not been injected. Do not try to compensate for the reduced dose of
teriparatide by giving a second injection.
The needle must be removed and disposed of immediately after each injection. If the needle is
left on the pen, it may become blocked and compromise the next dose.
Choking hazard - small parts. Keep out of reach of children under 3 years of age.

• STORAGE AND CLEANINGTo clean the Kauliv pen, wipe with a damp cloth. Do not immerse in water. Do not use other solutions to clean the pen, e.g. chemicals, alcohol wipes. The Kauliv pen must always be stored or transported with the pen needle removed and the cap inserted. Dispose of the cartridge 28 days after the date of first use. Before discarding the pen injector, make sure to remove the pen needle. Carefully dispose of used pen needles in a sharps container in accordance with the instructions provided by the healthcare professional/local regulations. Do not dispose of needles directly into household waste. Do not recycle the full sharps container.