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ETALPHA 1 microgram INJECTABLE SOLUTION

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About the medicine

How to use ETALPHA 1 microgram INJECTABLE SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Etalpha 1 microgram solution for injection

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, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

  1. What is Etalpha and what is it used for
  2. What you need to know before you are given Etalpha
  3. How Etalpha is used
  4. Possible side effects
  5. Storage of Etalpha
  6. Contents of the pack and further information

1. What is Etalpha and what is it used for

Etalpha belongs to a group of medicines called vitamin D analogues that regulate calcium and phosphorus 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 in situations where there is an alteration of calcium and phosphorus metabolism due to reduced production of 1,25-dihydroxyvitamin D in patients undergoing long-term haemodialysis.

Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you are given Etalpha

Do not use Etalpha

  • if you are allergic to alfacalcidol or any of the other ingredients of this medicine (listed in section 6).
  • if you have high levels of calcium in your blood (hypercalcaemia).

As during treatment with Etalpha, high levels of calcium in your blood (hypercalcaemia) may appear, you should know the following signs and symptoms of hypercalcaemia:

  • loss of appetite (anorexia)
  • fatigue
  • nausea
  • vomiting
  • constipation or diarrhoea
  • increased urine production
  • sweating
  • headache
  • thirst
  • high blood pressure
  • drowsiness
  • dizziness

Warnings and precautions

Talk to your doctor or pharmacist before you start using Etalpha.

Be particularly careful with Etalpha if:

  • you have arteriosclerosis, cardiac valve sclerosis or kidney stones (nephrolithiasis). These conditions may worsen if you have high levels of calcium in your blood (hypercalcaemia).
  • you suffer from lung tissue calcification.
  • you have renal bone disease or any kidney disorder. To maintain acceptable serum phosphorus levels, phosphorus binders may be used.
  • you suffer from inflammatory diseases such as sarcoidosis. These conditions have the potential to increase sensitivity to Etalpha.
  • if you are being treated with heart medications (cardiac glycosides). If your blood calcium levels rise too high (hypercalcaemia), the use of these medications can cause changes in your heart rhythm.

During treatment, your doctor will perform blood tests to monitor your calcium and phosphorus levels.

Using Etalpha with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

It is particularly important that you tell 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 (hypercalcaemia).
  • you are being treated with anti-epileptic medications (barbiturates, phenytoin, carbamazepine or primidone). You may need a higher dose of Etalpha.
  • you are taking antacids that contain magnesium, as they may increase the risk of high magnesium levels in your blood (hypermagnesaemia).
  • you are being treated with preparations that contain aluminium (such as aluminium hydroxide or sucralfate), as they may increase aluminium absorption.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Etalpha may be used during pregnancy and breastfeeding only when your doctor considers it essential.

Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

Etalpha has no or negligible influence on the ability to drive and use machines.

However, dizziness may occur during treatment, which you should take into account if you drive or use machines.

Etalpha contains ethanol, propylene glycol and sodium

This medicine contains up to 160 mg of ethanol per dose (which corresponds 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 in this medicine does not produce any noticeable effect.

This medicine contains 415 mg of propylene glycol per millilitre, equivalent to 20.75 mg/kg/day (which corresponds to 0.1 micrograms/kg/day of alfacalcidol).

If the baby is less than 4 weeks old, talk to your doctor or pharmacist, especially if the baby has been given other medicines that contain propylene glycol or alcohol.

This medicine contains less than 23 mg (1 mmol) of sodium per millilitre, so it is essentially "sodium-free".

3. How Etalpha is used

Etalpha will be administered to you by a healthcare professional via intravenous injection.

Adults and children over 20 kg in weight:

The initial dose is 1 microgram (0.5 ml) per day.

Children under 20 kg in weight:

The initial dose is 0.05 micrograms (0.025 ml) per kilogram of body weight per day.

The maintenance dose is usually between 0.25 and 2 micrograms (0.125 to 1 ml) per day.

The ampoules should be shaken well before use.

Your doctor may adjust these doses according to your needs. To do this, 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. The maximum recommended dose is 6 micrograms (3 ml) per dialysis and no more than 12 micrograms (6 ml) per week.

If you receive more Etalpha than you should

If you receive more Etalpha than you should, it may cause an increase in calcium levels in your blood, which is controlled by discontinuing treatment.

If your blood calcium levels are very high, you may need to be given a diuretic and intravenous fluids or you may be given corticosteroids.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20, stating the medicine and the amount used.

If you miss your treatment with Etalpha

Talk to your doctor as soon as possible so that they can tell you what to do in these cases.

If you stop treatment with Etalpha

Your doctor will tell you how long you need to use Etalpha. Do not stop treatment before then, as it may be harmful to your health.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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

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

  • high levels of calcium in the blood
  • excessive phosphorus in the blood
  • abdominal pain and discomfort
  • skin rash
  • itching
  • excess calcium in the urine

Uncommon side effects (may affect up to 1 in 100 people):

  • confusion
  • headache
  • diarrhoea
  • vomiting
  • constipation
  • nausea
  • muscle pain
  • worsening of kidney function (including acute kidney failure)
  • kidney stones
  • calcium deposits in the kidneys
  • fatigue
  • tiredness
  • discomfort
  • calcium deposits in non-osseous tissues

Rare side effects (may affect up to 1 in 1,000 people):

  • dizziness

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website: https://www.notificaram.es. By reporting side 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 which is stated on the packaging after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Etalpha

  • The active substance is alfacalcidol.

1 ml of solution for injection contains 2 micrograms of alfacalcidol. Each ampoule contains 1 microgram of alfacalcidol in 0.5 ml of solution for injection.

  • The other ingredients are ethanol, citric acid monohydrate, sodium citrate, propylene glycol and water for injections.

Appearance and packaging of the product

Etalpha 1 microgram is presented as a solution for injection, colourless and transparent, 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)

You can obtain further information on this medicine by contacting 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 last revision of this leaflet: January 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.

Online doctors for ETALPHA 1 microgram INJECTABLE SOLUTION

Discuss questions about ETALPHA 1 microgram INJECTABLE SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
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  • review and interpretation of lab tests, imaging reports, and medical documents;
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Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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Chikeluo Okeke

General medicine 4 years exp.

Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

Dr Okeke focuses on general internal medicine and adult primary care, combining clinical accuracy with careful attention to lifestyle, personal context, and everyday health concerns. His consultations are particularly well suited for people who seek medical advice online, live abroad, or need clear guidance without unnecessary complexity.

He provides online consultations covering symptom assessment, prevention, and long-term management of chronic conditions, helping patients understand what is happening and decide on appropriate next steps.

Common reasons for consultation:

  • General internal medicine concerns and initial health assessment.
  • Acute symptoms such as fever, cough, infections, pain, or weakness.
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Dr Okeke is known for his clear communication, calm approach, and cultural awareness. He listens carefully, explains medical decisions in a structured way, and supports patients in making informed choices about their health.

Online consultations with Dr Chikeluo Okeke offer reliable internal medicine care without geographic limitations, focused on medical relevance, clarity, and patient comfort.

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Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
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Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
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  • Preconception counselling and postpartum support.
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Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Andrei Popov

General medicine 7 years exp.

Dr. Andrei Popov is a family physician with specialized training in the management of chronic pain. He provides video consultations for adults in Spain and across Europe: whether you have been living with pain for months that no one has been able to properly explain, or you need to resolve a health issue without waiting weeks for an appointment.

His approach is clear: to listen, organize your case, and provide you with a practical roadmap based on evidence-based medicine and adapted to your medical history and personal needs.

Pain: how he can help

  • Chronic pain (more than 3 months
  • Migraine and recurrent or high-intensity headaches
  •  Neck, lower back, back and joint pain
  •  Post-traumatic pain after injuries or surgeries
  •  Pain of neurological origin: neuralgia, neuropathic pain, fibromyalgia

General medicine

  • Frequent respiratory infections (cold, flu, persistent cough)
  • Hypertension, diabetes and metabolic disorders
  • Review of laboratory tests and MRI/CT reports (explained in clear language)
  • Preventive medicine and health monitoring
  • Second opinions and treatment adjustments (when clinically appropriate)

What the consultation is like
 Each session lasts up to 30 minutes. We review symptoms, medical history, medications and any tests you provide, and you finish the consultation with a clear treatment plan, defined next steps, and criteria to understand when follow-up may be needed. If warning signs are detected, he will clearly advise whether you need in-person care or urgent medical attention.

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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Doctor

Joao Silva

General medicine 6 years exp.

Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

Subsequently, between January 2021 and December 2021, he completed the General Internship at the Entre Douro e Vouga Hospital Center in Santa Maria da Feira, where he had the opportunity to work in different hospital settings and deepen his competencies in several areas of medicine.

From January 2022 until March 2026, he works as a Resident Physician in General and Family Medicine at USF Salvador Machado in Oliveira de Azeméis, developing clinical activities in primary healthcare, follow-up of chronic patients, and health promotion in the community.

Complementing his medical training, Dr. João Silva also completed a Postgraduate Degree in Continuing and Palliative Care at CESPU, strengthening his preparation in the comprehensive approach to patient care, especially in situations requiring prolonged care and multidisciplinary support.

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Frequently Asked Questions

Is a prescription required for ETALPHA 1 microgram INJECTABLE SOLUTION?
ETALPHA 1 microgram INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ETALPHA 1 microgram INJECTABLE SOLUTION?
The active ingredient in ETALPHA 1 microgram INJECTABLE SOLUTION is alfacalcidol. This information helps identify medicines with the same composition but different brand names.
Who manufactures ETALPHA 1 microgram INJECTABLE SOLUTION?
ETALPHA 1 microgram INJECTABLE SOLUTION is manufactured by Cheplapharm Arzneimittel Gmbh. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ETALPHA 1 microgram INJECTABLE SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ETALPHA 1 microgram INJECTABLE SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ETALPHA 1 microgram INJECTABLE SOLUTION?
Other medicines with the same active substance (alfacalcidol) include ETALPHA 2 micrograms/ml ORAL DROPS IN SOLUTION, ETALPHA 2 micrograms INJECTABLE SOLUTION, ALDEXINA 25,000 IU HARD CAPSULES. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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