Sondelbay 20 microgramos/80 microlitros solucion inyectable en pluma precargada
Introduction
Prospect: information for the user
Sondelbay 20 micrograms/80 microliters injectable solution in pre-filled pen
teriparatida
This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.
Read this prospect carefully before starting to use this medicine, because it contains important information for you.
- Keep this prospect, as you may need to read it again.
- If you have any doubts, consult your doctor or pharmacist.
- This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
- If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.
Content of the prospect
- What Sondelbay is and for what it is used
- What you need to know before starting to use Sondelbay
- How to use Sondelbay
- Possible adverse effects
- Storage of Sondelbay
- Contents of the package and additional information
1. What is Sondelbay and what is it used for
Sondelbay contains the active ingredient teriparatide, which is used to increase bone strength and reduce the risk of fractures by stimulating bone formation.
Sondelbay is used for the treatment of osteoporosis in adults. Osteoporosis is a disease that causes bones to wear away and become fragile. This disease is especially common in women after menopause, but it can also occur in men. Osteoporosis is also common in patients treated with corticosteroids.
2. What you need to know before starting to use Sondelbay
Your healthcare professional will teach you how to use the Sondelbay pen.
Do not use Sondelbay
- if you are allergic to teriparatide or any of the other components of this medication (listed in section 6).
- if you have high levels of calcium (pre-existing hypercalcemia).
- if you have severe kidney problems.
- if you have ever been diagnosed with bone cancer or other types of cancer that have spread (metastasized) to your bones.
- if you have certain bone diseases. If you have a bone disease, consult your doctor. If you have high levels of alkaline phosphatase in your blood without apparent explanation, which could indicate that you have Paget's disease of the bone (a disease with abnormal bone changes). If you are unsure, consult your doctor.
- if you have received radiation therapy that may have affected your bones.
- if you are pregnant or breastfeeding.
Warnings and precautions
Sondelbay may cause an increase in the amount of calcium in your blood or urine.
Consult your doctor or pharmacist before starting to use or while using Sondelbay:
- if you have persistent nausea, vomiting, constipation, low energy, or muscle weakness, tell your doctor. These may be symptoms of too much calcium in your blood.
- if you have kidney stones or a history of kidney stones.
- if you have kidney problems (moderate renal insufficiency), tell your doctor.
Some patients experience dizziness or increased heart rate after the first doses. For the first doses, use Sondelbay in a place where you can sit or lie down immediately if you feel dizzy.
The recommended treatment duration of 24 months should not be exceeded. Sondelbay should not be used in adults in growth.
Children and adolescents
Sondelbay should not be used in children and adolescents (under 18 years).
Other medications and Sondelbay
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, as occasional interactions may occur (e.g. digoxin/digitals, a medication used to treat heart diseases).
Pregnancy and breastfeeding
Do not use Sondelbay if you are pregnant or breastfeeding. If you are a fertile woman, you should use effective contraceptive methods during treatment with Sondelbay. If you become pregnant, treatment with Sondelbay should be discontinued. Consult your doctor or pharmacist before using this medication.
Driving and operating machines
Some patients may feel dizzy after the Sondelbay injection. If you feel dizzy, do not drive or operate machines until you feel better.
Sondelbay contains sodium
This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".
3. How to use Sondelbay
Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
The recommended dose is 20 micrograms (in 80 microliters) administered once a day via subcutaneous injection in the thigh or abdomen. To help you remember to inject your medication, inject it at the same time every day.
Inject Sondelbay every day for as long as your doctor prescribes. The total duration of treatment with Sondelbay should not exceed 24 months. You should not receive more than one 24-month treatment cycle with Sondelbay throughout your life.
See the usage instructions on how to use the Sondelbay pen.
No needles are included with the pen. You can use pen needles (31G or 32G; 4mm, 5mm, or 8mm).
The Sondelbay injection should be performed shortly after removing the pen from the refrigerator, as indicated in the User Manual. Return the pen to the refrigerator immediately after use. You should use a new needle for each injection and discard it after each use. Do not store the pen with the needle attached. Never share your Sondelbay pen with others.
Your doctor may recommend taking calcium and vitamin D with Sondelbay. Your doctor will tell you how much to take each day.
Sondelbay can be used with or without food.
If you use more Sondelbay than you should
If you accidentally administer more Sondelbay than prescribed, consult your doctor or pharmacist.
The expected effects of an overdose may include nausea, vomiting, dizziness, and headache.
If you forget or cannot inject Sondelbay at the usual time, do it as soon as possible that same day. Do not administer a double dose to compensate for missed doses. Do not inject more than once in the same day. Do not attempt to compensate for the missed dose.
If you interrupt treatment with Sondelbay
If you are thinking of interrupting treatment with Sondelbay, please consult with your doctor. Your doctor will advise you and decide how long you should be treated with Sondelbay.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most common side effects are pain in the limbs (very common, may affect more than 1 in 10 patients), discomfort, headache, and dizziness (common). If you feel dizzy after an injection, sit or lie down until you feel better. If you do not improve, consult your doctor before continuing treatment. Cases of fainting associated with the use of teriparatide have been reported.
If you experience discomfort such as skin redness, pain, swelling, itching, bruises, or light bleeding around the injection site (common), these should disappear within a few days or weeks. If not, tell your doctor as soon as possible.
Some patients may have experienced allergic reactions immediately after the injection, consisting of difficulty breathing, facial swelling, skin rash, and chest pain (rare frequency). In rare cases, severe and potentially life-threatening allergic reactions, including anaphylaxis, may occur.
Other side effects are:
Common: may affect up to 1 in 10 patients
- increase in blood cholesterol levels
- depression
- neuropathic pain in the leg
- sensation of fainting
- irregular heart palpitations
- difficulty breathing
- increased sweating
- muscle cramps
- loss of energy
- fatigue
- chest pain
- low blood pressure
- acid reflux (pain or burning sensation just below the sternum)
- vomiting
- hernia of the tube that carries food to the stomach
- low hemoglobin or low red blood cell count (anemia)
Uncommon: may affect up to 1 in 100 patients
- increased heart rate
- abnormal heart sound
- shortness of breath
- hemorrhoids
- accidental loss or leakage of urine
- increased need to urinate
- weight gain
- kidney stones
- muscle and joint pain.Some patients have experienced severe back spasms or pain and had to be hospitalized.
- increase in blood calcium levels
- increase in blood uric acid levels
- increase in levels of an enzyme called alkaline phosphatase.
Rare: may affect up to 1 in 1,000 patients
- kidney function reduction, including renal insufficiency
- swelling, mainly in the hands, feet, and legs.
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Sondelbay Storage
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the packaging and the pen after CAD and EXP respectively. The expiration date is the last day of the month indicated.
Sondelbay must be stored always in a refrigerator (between 2 °C and 8 °C). Once opened, Sondelbay can be stored at temperatures up to 25 °C for a maximum of three days when refrigeration devices are not available. After this period, the medication must be returned to a refrigerator and used within a period of 28 days from the first injection. The Sondelbay pen must be discarded if it has remained outside the refrigerator at temperatures up to 25 °C for more than three days.
Do not freeze Sondelbay. Avoid placing the pens near the freezer of the refrigerator to prevent freezing. Do not use Sondelbay if it is or has been frozen.
Store in the original packaging (the outer cardboard box) to protect it from light.
Each pen must be disposed of properly after 28 days, even if it is not completely empty.
Sondelbay contains a transparent and colorless solution. Do not use Sondelbay if there are solid particles or if the solution is cloudy or has a color.
Never transfer the medication to a syringe.
Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.
6. Contents of the packaging and additional information
- The active ingredient is teriparatide. Each milliliter of injectable solution contains 250 micrograms of teriparatide. Each dose of 80 microliters contains 20 micrograms of teriparatide. A preloaded pen of 2.4 ml contains 600 micrograms of teriparatide.
- The other components are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injectable preparations. Additionally, a solution of hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH (see section 2 “Sondelbay contains sodium”).
Appearance of the product and contents of the package
Sondelbay is a transparent and colorless solution. It is presented in a cartridge included in a disposable preloaded pen. Each preloaded pen contains 2.4 ml of solution sufficient for 28 doses. Sondelbay is available in packages containing one or three preloaded pens. Only some package sizes may be available.
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Centre,
Moll de Barcelona s/n, Edifici Est, 6th Floor,
08039, Barcelona, Spain
Manufacturer
Accord Healthcare BV,
Netherlands Winthontlaan 200,
Utrecht, 3526KV, Netherlands
Accord Healthcare Polska Sp.z o.o.,
ul.Lutomierska 50,
95-200 Pabianice,Poland
Last review date of this leaflet:
The detailed information on this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu/
Pen user manual
Sondelbay20 micrograms/80 microliters injectable solution in preloaded pen teriparatide
Instructions for use
Please read both sides of these Instructions for use in their entirety before using your new pen.. On the back, you will find information on detecting and resolving problems and additional data.
Follow these instructions carefully each time you use the Sondelbay pen. Also, read the patient information leaflet provided in the package, with information for the patient.
Do not share the Sondelbay pen or needles with others, as this may pose a risk of transmission of infections or other conditions.
Your pen contains medication for 28 days.
Dispose of the Sondelbay pen after 28 days from the first injection, even if the cartridge is not completely empty.
Do not inject more than one dose of Sondelbay on the same day.
Parts of the Sondelbay pen | ||
The needles are not included | ||
Checkthe dose counter window to determine the number of doses remaining. The needle indicates the number of doses remaining. A new pen should contain 28 doses. The black dots that appear in the dose counter window indicate the odd-numbered doses remaining in the |
It should be used with needles for pens (31G or 32G; 4mm, 5mm, or 8mm). Ask your pharmacist for the ideal needle size for you. Use a new needle for each injection. | pen. Do not use the pen if the counter indicates ‘00’ as this means there are no doses remaining. The Sondelbay pen does not need priming. |
1 Preparation | Prepare the injection site (thigh or abdomen) according to your doctor's or pharmacist's instructions. |
A new pen should contain 28 doses. | Remove the pen cap. |
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2 Place a new needle | Find a new needle (see previous section). Remove the paper tab. | Place the needle at pressuredirectlyover the medication cartridge. | Twistthe needle until it isfirmlysecured. | Remove the pen cap andstoreit. You will need it to remove the needle after use. |
3 Program the dose | Verifythat a blank circle appears in the dose programming window. | Turnthe dose programming dial to the right; arrows appear in the dose programming window. | Continue turning until you hear a “click” and see ablack circlein the dose programming window. | Release the dose programming dial. In the window, you will see a black circle with a bar aboveit. This confirms that the dose has been programmed. | Removethe needle guard anddiscardit. |
4 Inject the dose | Pinch the skin of the thigh or abdomen gently and insert the needle directly into the skin, making sure tobe able to see the dose programming window. | Maintain the needle in the skin,pressthe injection button until it stops. This initiates the injection. | Maintain the needle in the skin and wait until a blank circleappears in the dose programming window. Thencount slowly to 5,and remove the needle from the skin. |
5 Confirm the dose | Once the injection is completeand the needle is removed from the skin,ensurethat there is a blank circlein the dose programming window. | Ifno blank circle appearsin thedose programming window, even after pressing the injection button to its maximum and waiting, what should you do? You will need to reprogram the pen. See section D of Detecting and resolving problems. |
6 Remove the needle | Place the needle cap over the needle, as indicated, and thenpushit to secure it in place. To avoid needlestick injuries,never attemptto reattach the needle cap, nor touch the needle. | Twist the needle cap to the left at least 5 times to unscrew it from the pen. | Removethe needle and discard it according to your doctor's or pharmacist's instructions. | Place the cap back on the pen and secure it firmly. Immediately after use, store the pen in therefrigerator. |
Unscrew the needle and discard it according to your doctor's or pharmacist's instructions.
This problem can be avoided by always using a new needle for each injection, and also by pressing the injection button to its maximum. Wait until the blank circle appears and then count to 5 before removing the needle from the skin. | ||
E. | How can I know that my Sondelbay pen is working properly? | The Sondelbay pen is designed to deliver a complete dose each time it is used according to the Instructions for use. After the injection, the blank circleappears in thedose programming windowto indicate that the complete dose of medication has been administered. Thedose counter windowindicates the number of doses remaining in the pen. It counts down each time a dose is administered. This also indicates that the pen is working properly. Use a new needle for each injection to ensure the Sondelbay pen is working correctly. |
F. | I cannot remove the needle from the Sondelbay pen. |
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Cleaning and storage |
Cleaning of your Sondelbay pen:
Storage of the Sondelbay pen:
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Disposal of the Sondelbay pen and needles |
Disposal of the Sondelbay pen:
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Unscrew the needle and discard it according to your doctor's or pharmacist's instructions.
This problem can be avoided by always using a new needle for each injection, and also by pressing the injection button to its maximum. Wait until the blank circle appears and then count to 5 before removing the needle from the skin. | ||
Additional information | ||
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Last review date of this manual:
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