Etalpha 2 micrograms solution for injection
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Etalpha 2 micrograms injectable solution
alfacalcidol
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
- This medicine will be administered to you by a healthcare professional.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Etalpha is and what it is used for
- What you need to know before you are given Etalpha
- How Etalpha is used
- Possible side effects
- How to store Etalpha
- Contents of the pack and other information
1. What Etalpha is and what it is used for
Etalpha belongs to a group of medicines called vitamin D analogues that regulate calcium and phosphate levels in your body.
The active substance of Etalpha is alfacalcidol. Alfacalcidol works by being converted into calcitriol (the active form of vitamin D) in the liver.
This medicine is indicated for conditions in which there is a disturbance in calcium and phosphate metabolism due to reduced production of 1,25-dihydroxyvitamin D in patients undergoing long-term haemodialysis.
2. What you need to know before Etalpha is administered to you
Do not use Etalpha
- if you are allergic to alfacalcidol or to any of the other components of this medicine (listed in section 6).
- if you have high levels of calcium in your blood (hypercalcemia).
As high levels of calcium in the blood (hypercalcemia) may occur during treatment with Etalpha, you should be aware of the following signs and symptoms of hypercalcemia:
- loss of appetite (anorexia)
- fatigue
- nausea
- vomiting
- constipation or diarrhea
- increased urine production
- sweating
- headache
- thirst
- high blood pressure
- drowsiness
- dizziness
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Etalpha.
Take special care with Etalpha if:
- you have atherosclerosis, calcification of heart valves, or kidney stones (nephrolithiasis). These conditions may worsen if you have high levels of calcium in your blood (hypercalcemia).
- you suffer from calcification of lung tissue.
- you have renal bone disease or any kidney disorder. Phosphate binders may be used to maintain an acceptable serum phosphate level.
- you have inflammatory diseases such as sarcoidosis. These conditions may increase your sensitivity to Etalpha.
- you are being treated with heart medications (cardiac glycosides). If your blood calcium level becomes too high (hypercalcemia), using these medications may cause disturbances in your heart rhythm.
During treatment, your doctor will perform blood tests to monitor your calcium and phosphate levels.
Use of Etalpha with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
It is important that you inform your doctor if:
- you are being treated with diuretics, calcium-containing preparations, or other vitamin D-containing preparations, as these may increase the risk of elevated calcium levels in your blood (hypercalcemia).
- you are being treated with antiepileptic drugs (barbiturates, phenytoin, carbamazepine, or primidone). You may require a higher dose of Etalpha.
- you are taking magnesium-containing antacids, as they may increase the risk of high magnesium levels in your blood (hypermagnesemia).
- you are being treated with aluminum-containing preparations (such as aluminum hydroxide or sucralfate), as this may increase aluminum absorption.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Etalpha may be used during pregnancy and breastfeeding only if your doctor considers it essential.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
The influence of Etalpha on the ability to drive and operate machinery is negligible or none.
However, dizziness may occur during treatment, which you should take into account if you drive or operate machinery.
Etalpha contains ethanol, propylene glycol, and sodium
This medicine contains up to 160 mg of ethanol per dose (corresponding to 4 micrograms of alfacalcidol), equivalent to 10% ethanol (alcohol). The amount in each dose of this medicine is equivalent to 4 ml of beer or 1.7 ml of wine.
The small amount of alcohol contained in this medicine does not produce any perceptible effect.
This medicine contains 415 mg of propylene glycol in each milliliter, equivalent to 20.75 mg/kg/day (corresponding to 0.1 micrograms/kg/day of alfacalcidol).
If the infant is less than 4 weeks old, consult your doctor or pharmacist, especially if the infant has been administered other medicines containing propylene glycol or alcohol.
This medicine contains less than 23 mg (1 mmol) of sodium per ml of solution and is therefore considered essentially “sodium-free”.
3. How Etalpha is used
Etalpha will be administered intravenously by a healthcare professional.
Adults and children weighing more than 20 kg:
The initial dose is 1 microgram (0.5 ml) per day.
Children weighing less than 20 kg:
The initial dose is 0.05 micrograms (0.025 ml) per kg of body weight per day.
The maintenance dose generally ranges between 0.25 and 2 micrograms (0.125 to 1 ml) per day.
Vials should be shaken well before use.
Your doctor may adjust these doses according to your needs. For this purpose, your doctor will perform blood tests or may request other diagnostic tests.
When administered to patients undergoing dialysis, the initial dose for adults is 1 microgram (0.5 ml) per dialysis session. The maximum recommended dose is 6 micrograms (3 ml) per dialysis session, and not more than 12 micrograms (6 ml) per week.
If you receive more Etalpha than you should
If you receive more Etalpha than prescribed, it may cause an increase in calcium levels in your blood, which is managed by discontinuing treatment.
If calcium levels in your blood are very high, administration of a diuretic and intravenous fluids may be required, or corticosteroids may be given.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone number: 91 562 04 20, stating the medication and amount used.
If you forget your Etalpha treatment
Contact your doctor as soon as possible to find out what you should do in such cases.
If you stop Etalpha treatment
Your doctor will advise you on the duration of your treatment with Etalpha. Do not stop treatment prematurely, as this could be harmful to your health.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
Frequent adverse effects (may affect up to 1 in 10 patients):
- elevated levels of calcium in blood
- excessive amount of phosphorus in blood
- abdominal pain and discomfort
- skin rash
- itching
- excess calcium in urine
Uncommon adverse effects (may affect up to 1 in 100 patients):
- confusion
- headache
- diarrhea
- vomiting
- constipation
- nausea
- muscle pain
- worsening of kidney function (including acute renal failure)
- kidney stones
- calcium deposits in the kidneys
- fatigue
- tiredness
- malaise
- calcium deposits in non-bone tissues
Rare adverse effects (may affect up to 1 in 1000 patients):
- dizziness
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Etalpha
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (between 2°C and 8°C).
Keep the ampoules in the outer packaging to protect them from light.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Etalpha
- The active substance is alfacalcidol.
One ml of injectable solution contains 2 micrograms of alfacalcidol. Each ampoule contains 2 micrograms of alfacalcidol in 1 ml of injectable solution.
- The other components are ethanol, citric acid monohydrate, sodium citrate, propylene glycol, and water for injections.
Appearance of the product and contents of the pack
Etalpha 2 micrograms is available as an injectable solution, colourless and clear, for intravenous administration, in amber glass ampoules. Each pack contains 10 ampoules.
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer
CENEXI SAS
Rue Marcel et Jacques Gaucher,
94120 Fontenay-sous-Bois (France)
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Laboratorios Rubió, S.A.
Industria, 29 - Pol. Ind. Comte de Sert
08755 Castellbisbal (Barcelona)
Spain
Date of the most recent revision of this leaflet: January 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.