Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - parsabiv

Document Subject

Generated Narrative: MedicinalProductDefinition mp25b49674d9d703c70f7cbc179ed1a337

identifier: http://ema.europa.eu/identifier/EU/1/16/1142/001 - 1 vial

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Parsabiv 2.5 mg 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-25b49674d9d703c70f7cbc179ed1a337

identifier: http://ema.europa.eu/identifier/EU/1/16/1142/001 - 1 vial

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - parsabiv

Attesters

What is in this leaflet

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

Parsabiv contains the active substance etelcalcetide, which reduces parathyroid hormone known as PTH.

Parsabiv is used to treat secondary hyperparathyroidism in patients with serious kidney disease who need haemodialysis to clear their blood of waste products.

In secondary hyperparathyroidism too much PTH is produced by the parathyroid glands (four small glands in the neck). Secondary means that the hyperparathyroidism is caused by another condition, e.g. kidney disease. Secondary hyperparathyroidism can cause the loss of calcium from the bones, which can lead to bone pain and fractures and problems with blood and heart vessels. By controlling the levels of PTH, Parsabiv helps to control calcium and phosphate in your body.

Do not use Parsabiv

• if you are allergic to etelcalcetide or any of the other ingredients of this medicine (listed in section 6).
• if you have very low levels of calcium in your blood. Your doctor will monitor your blood calcium levels.

Warnings and precautions Before you are given Parsabiv, tell your doctor if you have or have ever had:

heart problems, such as heart failure or arrhythmias (abnormal heart rhythm);

seizures (fits or convulsions).

Parsabiv reduces calcium levels. Please tell your doctor if you have spasms, twitches, or cramps in your muscles, or numbness or tingling in your fingers, toes or around your mouth or seizures, confusion or loss of consciousness while being treated with Parsabiv. For additional information see section 4. Low calcium levels can cause abnormal heart rhythm. Tell your doctor if you experience an unusually fast or pounding heartbeat, if you have heart rhythm problems or heart failure or if you take medicines that can cause heart rhythm problems, while receiving Parsabiv. For additional information see section 4. Very low levels of PTH over long periods can result in a type of abnormal bone structure known as adynamic bone which can only be diagnosed by biopsy. Your PTH levels will be monitored during treatment with Parsabiv and your dose of Parsabiv may be reduced if your PTH levels become very low.

Children and adolescents It is not known whether Parsabiv is safe and effective in children less than 18 years of age as it has not been studied in these patients.

Other medicines and Parsabiv Tell your doctor if you are taking, have recently taken or might take any other medicines, including those medicines obtained without a prescription, or any other medicines that lower serum calcium (e.g. cinacalcet and denosumab).

You should not receive Parsabiv together with cinacalcet. Tell your doctor if you are taking cinacalcet or have recently taken cinacalcet.

Pregnancy
Parsabiv has not been tested in pregnant women. It is not known whether Parsabiv can harm your unborn baby. Tell your doctor if you are pregnant, think you may be pregnant, or plan to get pregnant when taking Parsabiv. As a precautionary measure, it is preferable to avoid the use of Parsabiv during pregnancy.

Breast-feeding It is not known whether Parsabiv can pass into breast milk. Tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Parsabiv, considering the benefit of breast-feeding to the baby and the benefit of Parsabiv to the mother.

Driving and using machines Parsabiv has no or negligible influence on the ability to drive and use machines. However certain symptoms of low calcium levels (such as fits or convulsions) can affect your ability to drive or operate machinery.

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

The recommended starting dose for Parsabiv is 5 mg. It will be given by a doctor or nurse at the end of your haemodialysis treatment through the tube (bloodline) that connects you to the haemodialysis machine. Parsabiv will be given 3 times per week. The dose may be increased up to 15 mg or lowered down to 2.5 mg depending on your response.

You may need to take calcium and vitamin D supplements while being treated with Parsabiv. Your doctor will discuss this with you.

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

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

Low calcium levels in blood (hypocalcaemia) have been reported commonly (may affect up to 1 in people). If you feel numbness or tingling around your mouth or in your extremities, muscle aches or cramps and seizures (fits), you should tell your doctor immediately. These may be signs that your calcium levels are too low.

Very common: may affect more than 1 in 10 people

Nausea

Vomiting

Diarrhoea

Muscle spasms

Low calcium levels in blood with no symptoms

Common: may affect up to 1 in 10 people

High potassium levels in blood

Low phosphate levels in blood

Headache

Numbness or tingling sensation

Worsening heart failure

Disturbances in the heart s electrical activity seen as QT prolongation on electrocardiogram

Low blood pressure

Muscle pain

Uncommon: may affect up to 1 in 100 people

Seizures (fits or convulsions); for additional information see section 2

Not known: frequency cannot be estimated from the available data

Allergic reactions (including anaphylactic reactions)

Reporting of side effects If you get any side effects, talk to your doctor or nurse. 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 after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C). Keep the vial in the outer carton in order to protect from light.

Once removed from the refrigerator:

Parsabiv is stable for a maximum of 7 cumulative days if stored in the original carton. No special temperature storage requirements are needed.

If removed from the original carton Parsabiv is stable for a maximum of 4 hours if protected from direct sunlight.

Do not use this medicine if you notice it has particles or it has changed colour.

For single use only.

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 Parsabiv contains

• The active substance is etelcalcetide. Parsabiv 2.5 mg solution for injection: Each vial contains 2.5 mg of etelcalcetide in 0.5 mL solution (5 mg/mL). Parsabiv 5 mg solution for injection: Each vial contains 5 mg of etelcalcetide in 1 mL solution (5 mg/mL). Parsabiv 10 mg solution for injection: Each vial contains 10 mg of etelcalcetide in 2 mL solution (5 mg/mL).
• The other ingredients are sodium chloride, succinic acid, water for injections, hydrochloric acid, and sodium hydroxide (refer to section 2: Parsabiv contains sodium).

What Parsabiv looks like and contents of the pack Parsabiv is a clear and colourless liquid.

Parsabiv is a solution for injection in a vial.

Pack sizes of 1, 6, 12 and 42 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Amgen Europe B.V. Minervum 74817 ZK Breda The Netherlands

Marketing Authorisation Holder Amgen Europe B.V. Minervum 74817 ZK Breda The Netherlands

Manufacturer Amgen NV Telecomlaan 5-7 1831 Diegem Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien s.a. Amgen n.v. Tel/T l: +32 (0)2 7752Lietuva Amgen Switzerland AG Vilniaus filialas Tel: +370 5 219 7

.: +359 (0)2 424 7Luxembourg/Luxemburg s.a. Amgen Belgique/Belgien Tel/T l: +32 (0)2 7752 esk republika Amgen s.r.o. Tel: +420 221 773 Magyarorsz g Amgen Kft. Tel.: +36 1 35 44 Danmark Amgen, filial af Amgen AB, Sverige Tlf: +45 39617Malta Amgen B.V. The Netherlands Tel: +31 (0)76 5732Deutschland AMGEN GmbH Tel.: +49 89 1490Nederland Amgen B.V. Tel: +31 (0)76 5732Eesti Amgen Switzerland AG Vilniaus filialas Tel: +372 586 09Norge Amgen AB Tel: +47 23308
Amgen . . . .: +30 210 3447 sterreich Amgen GmbH Tel: +43 (0)1 50 Espa a Amgen S.A. Tel: +34 93 600 18 Polska Amgen Biotechnologia Sp. z o.o. Tel.: +48 22 581 3France Amgen S.A.S. T l: +33 (0)9 69 363 Portugal Amgen Biofarmac utica, Lda. Tel: +351 21 4220Hrvatska Amgen d.o.o. Tel: +385 (0)1 562 57 Rom nia Amgen Rom nia SRL Tel: +4021 527 3Ireland Amgen Ireland Limited Tel: +353 1 8527Slovenija AMGEN zdravila d.o.o. Tel: +386 (0)1 585 1 sland Vistor hf. S mi: +354 535 7Slovensk republika Amgen Slovakia s.r.o. Tel: +421 2 321 114 Italia Amgen S.r.l. Tel: +39 02 6241Suomi/Finland Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland Puh/Tel: +358 (0)9 54900K
C.A. Papaellinas Ltd .: +357 22741 Sverige Amgen AB Tel: +46 (0)8 6951Latvija Amgen Switzerland AG R gas fili le Tel: +371 257 25United Kingdom (Northern Ireland) Amgen Limited Tel: +44 (0)1223 420This leaflet was last revised in

Other sources of information

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