Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - kauliv

Document Subject

Generated Narrative: MedicinalProductDefinition mpb811ffa8d83d17ddd48f696870f998c3

identifier: http://ema.europa.eu/identifier/EU/1/22/1710/001 [1 cartridge]

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Kauliv 20 micrograms/80 microliters solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-b811ffa8d83d17ddd48f696870f998c3

identifier: http://ema.europa.eu/identifier/EU/1/22/1710/001 [1 cartridge]

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - kauliv

Attesters

What is in this leaflet

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

Kauliv contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation.

Kauliv is used to treat osteoporosis in adults. Osteoporosis is a disease that causes your bones to become thin and fragile. This disease is especially common in women after the menopause, but it can also occur in men. Osteoporosis is also common in patients receiving medicines called corticosteroids.

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 hypercalcaemia).

• if you suffer from serious kidney problems.

if you have ever had bone cancer or if other cancers have spread (metastasised) to your bones.

if you have certain bone diseases. If you have a bone disease, tell your doctor.

if you have unexplained high levels of alkaline phosphatase in your blood, which means you might have Paget s disease of bone (disease with abnormal bone changes). If you are not sure, ask your doctor.

if you have had radiation therapy involving your bones.

if you are pregnant or breast-feeding.

Warnings and precautions Kauliv may cause an increase in the amount of calcium in your blood or urine.

Talk to your doctor before or while using Kauliv:

if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.

if you suffer from kidney stones or have had kidney stones.

if you suffer from kidney problems (moderate renal impairment).

Some patients get dizzy or get a fast heartbeat after the first few doses of Kauliv. For the first doses, inject Kauliv in a place where you can sit or lie down right away if you get dizzy.

The recommended treatment time of 24 months should not be exceeded.

Before inserting a cartridge in Kauliv pen write down the batch (Lot) number of the cartridge and its first injection date on a calendar and provide this information when reporting any side effects. The date of first injection should also be recorded on the outer carton of Kauliv cartridge (see the provided space on the box: First use ) (see section 3.).

Kauliv should not be used in growing adults.

Children and adolescents
Kauliv should not be used in children and adolescents (aged less than 18 years).

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

Pregnancy and breast-feeding
Do not use Kauliv if you are pregnant or breast-feeding. If you are a woman of child-bearing potential, you should use effective methods of contraception during use of Kauliv. If you become pregnant while using Kauliv, Kauliv should be discontinued. Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Some patients may feel dizzy after injecting Kauliv. If you feel dizzy you should not drive or use machines until you feel better.

Kauliv contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

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

The recommended dose is 20 micrograms (corresponding to 80 microliters) given once a day by injection under the skin (subcutaneous injection) in the thigh or abdomen.
To help you remember to use your medicine, inject it at about the same time each day. Kauliv can be injected at meal time. Inject Kauliv each day for as long as your doctor prescribes it for you. The total duration of treatment with Kauliv should not exceed 24 months. You should not receive more than one treatment course of 24 months over your lifetime.
Your doctor may advise you to use Kauliv with calcium and vitamin D. Your doctor will tell you how much you should take each day.

Kauliv can be given with or without food.
Kauliv cartridges are designed to be used only with the Kauliv multidose pen and compatible pen needles. The pen and injection needles are not included with Kauliv cartridge.
Before the first use, insert the cartridge into the pen. For the correct use of this medicine it is very important to closely follow the detailed Instructions for Use (IFU) of your pen which are provided with the pen.
Use a new injection needle for each injection to prevent contamination and safely dispose of the needle after use.
Never store your pen with the needle attached.
Never share your pen with others.
Do not use your Kauliv pen to inject any other medicine (e.g. insulin).
The pen is customised for use with Kauliv only.
Do not refill the cartridge.
Do not transfer the medicine into a syringe.
You should inject Kauliv shortly after you take the pen with inserted cartridge out of the refrigerator. Put the pen with inserted cartridge back into the refrigerator immediately after you have used it. Do not remove the cartridge from the pen after each use. The cartridge within the pen can additionally be placed in the pouch supplied with the pen in order to protect from light during the whole 28-day treatment period.
Preparing the pen for use

To ensure the correct administration of Kauliv always read the IFU of Kauliv pen, which is included in the carton of the pen.

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 that there are at least 28 days remaining before its expiry date. Insert the cartridge into the pen before the first use as detailed in the pen instructions. Write down the batch (Lot) number of each cartridge and its first injection date on a calendar. The date of first injection should also be recorded on the outer carton of Kauliv cartridge (see the provided 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 which are provided with the pen IFU. Please ensure to prime before each dose as per the instructions given in pen IFU. Injecting Kauliv

Before you inject Kauliv, clean your skin where you intend to inject (thigh or abdomen) as instructed by your doctor.

Gently hold a fold of cleansed skin and insert the needle straight into the skin. Press the push button and hold it pressed in until the dose indication has returned to the start position.

After your injection, leave the needle in the skin for ten seconds to make sure that you receive the whole dose.

As soon as you have finished the injection, attach the outer needle protective cap on the pen needle and screw the cap anti-clockwise to remove the pen needle.

Replace the cap on your pen. Leave the cartridge in the pen. If you use more Kauliv than you should
If, by mistake, you have used more Kauliv than you should, contact your doctor or pharmacist. The expected effects of overdose include nausea, vomiting, dizziness, and headache.
If you forget to use Kauliv If you forget an injection or cannot use your medicine at your usual time, inject it as soon as possible on that day. Do not use a double dose to make up for a forgotten dose. Do not take more than one injection in the same day.

If you stop using Kauliv If you are considering stopping Kauliv treatment, please discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with Kauliv.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Kauliv is not recommended for use by the blind or visually impaired persons without the assistance from a person trained in the proper use of the pen.

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

The most common side effects are pain in limb (which may affect more than 1 in 10 people). Other common side effects (affecting up to 1 in 10 people) include feeling sick, headache and dizziness. If you become dizzy (light-headed) after your injection, you should sit or lie down until you feel better. If you do not feel better, you should call a doctor before you continue treatment. Cases of fainting have occurred after teriparatide use.

If you have discomfort around the area of the injection such as redness of the skin, pain, swelling, itching, bruising or minor bleeding (which can occur commonly), this should clear up in a few days or weeks. Otherwise tell your doctor.

Rarely (may affect up to 1 in 1 000 people), patients may suffer allergic reactions consisting of breathlessness, swelling of the face, rash and chest pain. These reactions usually occur soon after injection. In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis can occur.

Other side effects include:
Common (may affect up to 1 in 10 people)

increase in blood cholesterol levels

depression

nerve pain in the leg

feeling faint

spinning sensation

irregular heartbeats

breathlessness

increased sweating

muscle cramps

loss of energy

tiredness

chest pain

low blood pressure

heartburn (painful or burning sensation just below the breast bone)

being sick (vomiting)

a hernia of the tube that carries food to your stomach (hiatus hernia)

low haemoglobin or red blood cell count (anaemia).

Uncommon (may affect up to 1 in 100 people)

increased heart rate

abnormal heart sound

shortness of breath

piles (haemorrhoids)

leakage of urine

increased need to pass water

• weight increase

kidney stones

pain in the muscles and pain in the joints. Some patients have had severe back cramps or pain which led to admission into hospital.

increase in blood calcium level

increase in blood uric acid level

increase in an enzyme called alkaline phosphatase.

Rare (may affect up to 1 in 1 000 people)

reduced kidney function, including renal failure

swelling, mainly in the hands, feet and legs.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 carton and the cartridge after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C). Do not freeze.
Keep the cartridge in the outer carton in order to protect from light.

You can use Kauliv for up to 28 days after the first injection, as long as the cartridge/pen with the cartridge inserted is stored in a refrigerator (2 C to 8 C). The cartridge/pen can additionally be placed in the pouch supplied with the pen in order to protect from light.

Avoid placing the cartridge close to the ice compartment of the refrigerator to prevent freezing. Do not use Kauliv if it is, or has been, frozen.

Each cartridge should be properly disposed of after 28 days of first use, even if it is not completely empty.

Kauliv contains a clear and colourless solution. Do not use Kauliv if solid particles appear or if the solution is cloudy or coloured.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Kauliv contains

The active substance is teriparatide. Each dose of 80 microliters contains 20 micrograms of teriparatide. Each cartridge of 3 mL contains 750 micrograms of teriparatide (corresponding to 250 micrograms per mL).

The other ingredients are: anhydrous sodium acetate, glacial acetic acid, mannitol, metacresol, diluted hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections. See section 2. Kauliv contains sodium .

What Kauliv looks like and contents of the pack
Kauliv is a colourless and clear solution for injection. It is supplied in a cartridge. Each cartridge contains 3 mL of solution, adequate for 28 doses.
Pack sizes: 1 cartridge or 3 cartridges packed in a plastic tray sealed with lid foil and packed in a carton. Kauliv cartridge and pen pack:
1 inner carton of Kauliv cartridge (containing 1 cartridge) and 1 inner carton of Kauliv Pen (containing 1 pen). Not all pack sizes may be marketed. 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 This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://