Etalpha 2 mcg /ml injection Solution Alfacalcidol
1. What Etalpha Is And What It Is Used For
Etalpha is used when the body produces too little vitamin D. D vitamin is necessary for the body to absorb calcium. Etalpha can normalize calcium levels and counteract the deficiency symptoms (fatigue, muscle weakness, itching and depression).
Etalpha injection treats too high parathyroid hormone levels if you suffer from kidney failure and receive dialysis.
Alfacalcidol contained in Etalpha may also be approved for treating other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professionals if you have further questions and always follow their instructions.
2. What You Need To Know Before You Use Etalpha
Do Not Use Etalpha
- If you are allergic to Etalpha Alfacalcido or any of the other ingredients of this medicine (listed in section 6).
- If you have too high a calcium level in your blood (hypercalcemia).
Warnings And Cautions
Talk to your doctor or pharmacist before using Etalpha.
For the following diseases, Etalpha should be used with caution. Therefore you should inform your doctor before treatment if you have the following:
- Kidney stone
- Arteriosclerosis
- Calcification of heart valve or lung tissue
- The disease that increases the sensitivity to vitamin D (e.g. sarcoidosis ).
During treatment with Etalpha, the calcium and phosphate levels in the blood should be checked.
For the following conditions, pay extra attention:
- Suppose you experience
- Decreased appetite
- Fatigue
- Nausea and vomiting
- Constipation or diarrhea
- Large amounts of urine
- Sweating
- Headaches
- Strong thirst
- High blood pressure
- Drowsiness
- Dizziness. In that case, you may have elevated calcium levels in your blood. In case of these symptoms, you need to talk to your doctor.
- If you have high levels of calcium in your blood caused by vitamin D intake, at the same time, use Etalpha and digitalis glycosides (heart medicine increases the risk of affecting the heart rhythm).
- Suppose you suffer from incomplete or deficient bone tissue formation ( renal osteodystrophy ) or severe renal impairment. You may need to take phosphate-binding medicines to prevent elevated phosphate levels in your blood during treatment with Etalpha.
Other Medicines Ad Etalpha
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Concomitant treatment with agents for the treatment of epilepsy ( barbiturate s phenytoin, primidone, or carbamazepine) may cause the dose of Etalpha must be increased.
As Etalpha may increase magnesium uptake, magnesium-containing antacids (preparations that relieve heartburn and acid reflux) should not be used during treatment, as this may lead to elevated magnesium levels in the blood.
Concomitant use of other vitamin D-containing preparations, thiazide diuretics or calcium-containing preparations may increase the risk of increased calcium levels in the blood.
Etalpha can increase the aluminum content in the blood. If you take aluminum-containing preparations simultaneously, your aluminum levels in the blood should be checked.
Etalpha With Food And Drink
Etalpha can be taken independently of food.
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 taking this medicine.
Pregnancy
Limited experience of use during pregnancy. Etalpha should not be used during pregnancy unless necessary. Elevated blood calcium levels during pregnancy can cause birth defects in the baby. Caution should be exercised when treating women of childbearing potential.
Breast-feeding
Etalpha is excreted in human milk. A decision on whether to discontinue breastfeeding or discontinue/discontinue treatment may be made, considering the benefit of breastfeeding for the child and the benefit of treatment for the woman.
Breastfed newborns/infants to mothers treated with Etalpha should be closely monitored for elevated blood calcium levels.
Driving And Using Machines
The active substance in Etalpha does not directly affect the ability to drive and use machines. As dizziness can be a side effect of the treatment, you should consider this when driving or using machines.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Etalpha Contains Ethanol, Sodium And Propylene Glycol
This medicinal product contains up to 160 mg alcohol ( ethanol ) per dose (2 ml equivalent to 4 micrograms alpha-calcidiol), corresponding to 10% by volume. The dose of this medicine corresponds to less than 4 ml of beer or 1.7 ml of wine. The low amount of alcohol in this medicine does not produce any noticeable effects.
This medicine contains less than 1 mmol sodium (23 mg) per ml, essentially ‘sodium-free.’
This medicine contains 415 mg propylene glycol per ml, equivalent to 20.75 mg/kg/day (equivalent to 0.1 micrograms/kg/day alfacalcidol). If your child is younger than 4 weeks, consult a doctor or pharmacist before using the medicine, especially if the child is taking other medicines that contain propylene glycol or alcohol.
3. How To Use Etalpha
- Initially, 1 microgram is given after each dialysis, but a maximum of 3 micrograms/week. Dose one can then be increased at 1-week intervals by 1 microgram up to a maximum dose of 12 micrograms/week or 4 micrograms / dialysis.
- Injection one is given for 30 seconds at the end of dialysis one. Dose one is determined based on the level of calcium in the blood.
- Instructions for use
- The solution should be shaken well before use.
If You Take More Etalpha Than You Should
If you have ingested too much medicine or if, e.g. a child ingested the medicine by mistake, contact a doctor, hospital or the Poison Information Center (tel. 112) for risk assessment and advice.
If You Forget To Take Etalpha
- Do not take a double dose to make up for a forgotten dose.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible Etalpha Alfacalcidol Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
The most common side effects (affects more than 1 user in 100)
- Skin reactions include
- Itching and rash
- Elevated calcium and phosphate levels in the blood and urine
- Stomach pain/discomfort
Uncommon Etalpha Alfacalcidol side effects (affects less than 1 in 100 people)
- Confusion
- Headache
- Diarrhea
- Vomiting
- Constipation
- Nausea
- Fatigue
- Weakness
- Malaise
- Muscle aches
- Effects on kidney function and calcification of tissues.
Rare side effects (affecting less than 1 user in 1,000)
- Dizziness
Symptoms that can be noted in connection with
- Elevated calcium levels in the blood decreased appetite
- Fatigue
- Nausea and vomiting
- Constipation or diarrhea
- Large amounts of urine
- Sweating
- Headache
- Strong thirst
- High blood pressure
- Drowsiness
- Dizziness.
If you experience any of the above symptoms, ask your doctor for a check-up.
Reporting of side effects
Talk to your doctor, pharmacist, or nurse if you get any side effects. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
5. How To Store Etalpha
- Keep this medicine out of sight and reach of children.
- Store in a refrigerator (2 ºC – 8 ºC).
- Store in the outer carton. Sensitive to light.
- Do not use this medicine after the expiry date stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
6. Contents Of The Packaging And Other Information
Content Declaration
- The active substance is Alpha-calcidiol, 2 micrograms per ml.
- The other ingredients are Water for injections, citric acid monohydrate, sodium citrate, ethanol and propylene glycol.
What The Medicine Looks Like And The Contents Of The Pack
- Solution for injection
- Clear, colourless solution.
- Ampoule containing:
- 10×0.5 ml
- 10×1 ml
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder
LEO Pharma AB
Box 404
201 24 Malmö
Tel. 040-35 22 00
Manufacturer
Cenexi SAS, 52, rue Marcel et Jacque Gaucher, 94120 Fontenay-sous-Bois, France