Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - eladynos

Document Subject

Generated Narrative: MedicinalProductDefinition mp3aa969282c152694c6f4b966217ad337

identifier: http://ema.europa.eu/identifier/EU/1/22/1706/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Eladynos 80 micrograms/dose solution for injection in pre-filled pen.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-3aa969282c152694c6f4b966217ad337

identifier: http://ema.europa.eu/identifier/EU/1/22/1706/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - eladynos

Attesters

What is in this leaflet

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

Eladynos contains the active substance abaloparatide. It is used to treat osteoporosis in women after menopause.

Osteoporosis is especially common in women after menopause. The disease causes bones to become thin and fragile. If you have osteoporosis, you are more likely to break bones, especially in your spine, hips and wrists.

This medicine is used to make bone stronger and less likely to break.

Do not use Eladynos if you

• are allergic to abaloparatide or any of the other ingredients of this medicine (listed in section 6)
• are pregnant or breast-feeding
• are still able to get pregnant
• have high blood calcium levels
• have severely reduced kidney function
• have unexplained high blood levels of the enzyme alkaline phosphatase
• have had radiation therapy involving your bones
• have ever been diagnosed with bone cancer or other cancers that have spread to your bones

Warnings and precautions Talk to your doctor or pharmacist before or while using Eladynos if you:

• get dizzy when standing up, which may be because of a fall in blood pressure. Some patients may get dizzy or have a fast heartbeat within 4 hours after Eladynos has been injected. The first injection/injections should be performed under the guidance of a health care professional who may observe you during the first hour after injection. Always inject Eladynos in a location where you can sit or lie down right away if you get dizzy.
• have heart disease or high blood pressure. Your doctor may want to monitor you more closely.
• have continuing nausea, vomiting, constipation, low energy or muscle weakness. These may be signs of too much calcium in your blood.
• have high level of calcium in the urine, have or have had kidney stones. Eladynos may worsen your condition.

Before you begin treatment with Eladynos your blood pressure and condition of your heart will be examined.

The recommended treatment time of 18 months should not be exceeded.

Children and adolescents Eladynos should not be used in children and adolescents under 18 years.

Other medicines and Eladynos Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Especially tell your doctor or pharmacist if you take:

• digoxin or digitalis: medicines used to treat heart weakness, as the levels of calcium in your blood may increase with use of abaloparatide
• medicines to control high blood pressure, as they may worsen symptoms of low blood pressure, including dizziness

Pregnancy and breast-feeding Do not use Eladynos if you are pregnant, may become pregnant or are breast-feeding.

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

Eladynos contains sodium This medicine contains less than 1 mmol sodium (23 milligrams) 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 one injection (80 micrograms) once daily under the skin in the lower abdomen (belly). See grey shaded area of the first figure in Step 5 in the Instructions for use at the end of the package leaflet.

Preferably, inject Elyadynos at the same time each day to help you remember to use your medicine.

Do not inject Eladynos in the same place on your belly on consecutive days. Change where you inject this medicine each day to reduce the risk of injection site reactions. Only inject into clear skin. Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks.

Please carefully follow the Instructions for use at the end of the package leaflet.

Your doctor may advise you to take supplementary calcium and vitamin D. Your doctor will tell you how much you should take each day.

Duration of use Inject Eladynos each day for as long as prescribed by your doctor. The maximum total duration of treatment with Eladynos should not exceed 18 months.

If you use more Eladynos than you should If you accidentally use more Eladynos than you should, contact your doctor or pharmacist. The effects of overdose that might be expected include nausea, vomiting, dizziness (especially when getting up quickly), faster heartbeat and headache.

If you forget to use Eladynos If you miss a dose, use it as soon as possible within 12 hours of the normally scheduled time. Then inject your next dose the usual time next day.

If it is more than 12 hours since you should have used Eladynos, skip the missed dose. Then inject your next dose as usual on your next scheduled day.

Do not use a double dose to make up for a forgotten dose. Do not use more than one injection in the same day.

If you stop using Eladynos Discuss this with your doctor before stopping treatment. Your doctor will advise you and decide how long you should be treated with Eladynos.

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

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

Stop taking Eladynos and immediately contact your doctor or go to the emergency centre if you experience the following symptoms (severe allergic reaction): swelling of the face or tongue; wheezing and trouble breathing; hives, itching and flushed skin; severe vomiting or diarrhea; lightheadedness or loss of consciousness (frequency not known). These symptoms may be serious and potentially life-threatening. Other side effects can occur with the following frequencies: Very common (may affect more than 1 in 10 people)

• increase in calcium level seen in urine tests
• dizziness see section 2 Warnings and Precautions

Common (may affect up to 1 in 10 people)

• increase in calcium level seen in blood tests
• increase in uric acid level seen in blood tests
• headache
• palpitations, increased heartbeat
• increase in blood pressure
• abdominal pain
• constipation, diarrhoea
• feeling sick (nausea), vomiting
• weakness, tiredness, feeling unwell
• injection site reactions such as bruising, rash and pain
• pain in bones, joints, hands, feet or back
• muscle spasms (back and legs)
• difficulty sleeping
• kidney stones
• itching, rash

Uncommon: may affect up to 1 in 100 people

• allergic reactions
• feeling bloated
• pain
• feeling dizzy or lightheaded on standing or sitting up because of a drop in blood pressure

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 pen after EXP. The expiry date refers to the last day of that month.

Before first use, store in a refrigerator (2 C 8 C). Do not freeze. Avoid placing the pens close to the ice compartment of the refrigerator to prevent freezing. Do not use Eladynos if it is, or has been, frozen.

After first use, store below 25 C and discard after 30 days.

Eladynos may only be stored at room temperature (below 25 C) for 30 days. Note the date of Day 1 in the space provided on the carton. Day 1 is the date of first use or the date the pen was removed from the refrigerator. This is to ensure you do not use the pen for more than 30 consecutive days or store the pen for longer than 30 days. After 30 days, throw away your pen in accordance with local requirements, even if it still contains unused medicine.

• Dispose of your old pen prior to opening a new Eladynos pen, to avoid potential confusion.
• Do not store the pen with the needle attached.
• Do not use this medicine if the solution is cloudy, coloured or contains particles.

Do not throw away any medicines or needles 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 Eladynos contains

• The active substance is abaloparatide. Each dose of 40 microliters contains 80 micrograms of abaloparatide. Each pre-filled pen contains 3 mg of abaloparatide in 1.5 mL of solution (corresponding to 2 milligrams per mL).
• The other ingredients are:

• phenol
• water for injections
• sodium acetate trihydrate (See section 2 Eladynos contains Sodium ) and acetic acid (both for pH adjustment)

What Eladynos looks like and contents of the pack Eladynos is a colourless and clear solution for injection (injection). It is supplied in a carton containing one or three pre-filled multi-dose pens each with 30 doses. Not all pack sizes may be available.

Marketing Authorisation Holder Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1 D01 YEIreland

Manufacturer Cilatus Manufacturing Services Ltd Pembroke House, 28-32 Pembroke Street Dublin, D02 EK84, Ireland

This leaflet was last revised in. Other source of information

Detailed information on this medicine is available on the European Medicines Agency web site: