Инструкция по применению JENIAD
Содержание инструкции
GENIAD 2 micrograms/ml oral drops, solution
alfacalcidol
Read this leaflet carefully before you take/give this medicine to the child as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed only for you/the child. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If any side effects occur, including those not listed in this leaflet, ask your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What GENIAD is and what it is used for
- 2. What you need to know before you take/give GENIAD to the child
- 3. How to take/give GENIAD to the child
- 4. Possible side effects
- 5. How to store GENIAD
- 6. Contents of the pack and other information
1. What is GENIAD and what is it used for
GENIAD contains alpha calcidol, a precursor of vitamin D3.
GENIAD is indicated in adults and children for the treatment of:
- fragility and decrease in bone mass and predisposition to fractures in patients with a kidney disease (Renal osteodystrophy) who are undergoing dialysis (a blood filtration system) or not.
- reduced functionality of the parathyroid glands, located in the neck (hypoparathyroidism).
- bone diseases caused by poor vitamin D metabolism, including in patients with a kidney disease (Vitamin D-resistant or D-dependent rickets and osteomalacia (pseudo-deficient), rickets and osteomalacia from other renal actions due to vitamin D metabolism).
- loss of bone consistency after menopause (Postmenopausal osteoporosis) (only in adult women in post menopause).
2. What you need to know before taking/giving GENIAD to the child
Do not take/give GENIAD to the child
- if you are allergic to alfacalcidol or any of the other ingredients of this medicine (listed in section 6),
- if you are pregnant,
- if you suffer from high levels of calcium in the blood (hypercalcemia).
Warnings and precautions
Talk to your doctor or pharmacist before taking/giving GENIAD to the child.
Throughout the treatment period, the doctor will ask you/the child to undergo blood tests (calcium and phosphate levels, PTH, alkaline phosphatase and the calcium x phosphate product) and regular checks.
An increase in blood calcium levels (hypercalcemia) may occur during treatment with GENIAD, the symptoms of which may include loss of appetite (anorexia), fatigue, nausea and vomiting, constipation or diarrhea, frequent need to urinate (polyuria), sweating, headache, intense thirst (polydipsia), high blood pressure (hypertension), drowsiness and dizziness (see section 4 Possible undesirable effects).
In particular, inform your doctor if you/the child suffers from:
- hardening of the arteries, the large blood vessels of the body (arteriosclerosis), hardening (sclerosis) of the heart valves, stones (pebbles) in the kidney (nephrolithiasis), as in these cases a transient or permanent kidney damage may develop;
- accumulation of calcium in the lung (calcification of lung tissue). This can cause heart disease;
- a bone disease caused by a kidney problem (renal bone disease) or severely reduced kidney function. The doctor may prescribe a medicine called a phosphate binder to avoid high levels of phosphate in the blood (hyperphosphatemia) and potential calcium deposition in healthy tissues (metastatic calcification);
- an inflammatory disease that can affect the whole body and leads to the formation of nodules (sarcoidosis) or a similar disease;
- a kidney disease (chronic renal failure).
Also inform your doctor if you/the child are taking digitalis glycosides, medicines to treat heart disorders. You may experience increased calcium levels in the blood during taking these medicines and consequently increases the possibility of heart rhythm disturbances
Other medicines and GENIAD
Tell your doctor or pharmacist if you/the child are taking, have recently taken or might take any other medicines.
In particular, inform your doctor if you/the child are taking:
- anticonvulsants (e.g. barbiturates, phenytoin, carbamazepine or primidone), medicines to treat uncontrolled body movements, as an increase in the doses of GENIAD may be necessary;
- magnesium-based antacids, medicines to treat heartburn;
- thiazide diuretics (medicines to treat high blood pressure) or preparations containing calcium. The doctor may ask you/the child to undergo blood tests;
- other preparations containing vitamin D;
- preparations containing aluminum (e.g. aluminum hydroxide, sucralfate);
- bile acid sequestrants, such as cholestyramine, medicines to treat high levels of fat in the blood. Take/give GENIAD at least 1 hour before, or 4 to 6 hours after the bile acid sequestrant.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
GENIAD should not be used during pregnancy unless your doctor considers it strictly necessary.
Breastfeeding
Alfacalcidol is excreted in human milk. The doctor will decide whether to stop breastfeeding or stop therapy with GENIAD taking into account the benefit of breastfeeding for the child and the benefit of therapy for you.
The doctor will carefully monitor the breastfed baby during your treatment with GENIAD
Driving and using machines
Alfacalcidol does not alter or negligibly alters the ability to drive vehicles and use machines.
However, dizziness may occur during treatment and therefore take this into account while driving or using machinery.
GENIAD contains peanut oil
If you are allergic to peanuts or soy, do not use this medicine.
3. How to take/give GENIAD to the child
Take/give this medicine to the child always following exactly the instructions of the doctor or pharmacist. If you have doubts, consult the doctor or pharmacist.
During the entire treatment period, the doctor will ask that you/the child undergo blood tests and regular check-ups.
Adults (all indications)
The recommended initial dose is 1 microgram per day (equivalent to 26 drops of oral solution).
The recommended maintenance dose is between 0.25 and 1 microgram per day based on the results obtained with therapy and laboratory tests that the doctor will ask you to undergo during treatment.
In case of osteoporosis, the doctor will indicate the most suitable dose for you based on your state of health.
In patients with severe bone dysfunction (with the exception of those with renal insufficiency), the doctor may increase the dosage between 1 and 3 micrograms per day.
In patients with severe hypocalcemia, the doctor may increase the dosage between 3 and 5 micrograms per day. In such patients, the doctor may also prescribe other medicines containing calcium.
Children weighing more than 20 kg
The recommended initial dose is 1 microgram per day (equivalent to 26 drops of oral solution).
The recommended maintenance dose is determined by the doctor based on the results obtained with therapy and the laboratory tests that the doctor will ask you to have the child undergo during treatment.
Children weighing less than 20 kg
The dose depends on the child's weight.
The recommended initial dose is 0.05 micrograms / kg per day, equivalent to approximately 1 drop/kg (e.g., for a child of 10 kg the dose is 13 drops per day).
To facilitate the calculation of the dosage in these children, an exemplary dose/weight table is reported below:
| Child's weight | Dose | Number of drops |
| 1 kg | a 0.050 micrograms | 1 gtt |
| 1.5 kg | i
| 2 gtt |
| 2 kg | z
| 2 gtt |
| 2.5 kg | n
| 3 gtt |
| 3 kg | e
| 4 gtt |
| g 3.5 kg |
| 4 gtt |
| A 4 kg |
| 5 gtt |
| 5 kg |
| 6 gtt |
| 5.5 kg |
| 7 gtt |
It is recommended not to administer the product directly but to use a teaspoon to correctly measure the exact number of drops to be administered.
If you take/give the child more GENIAD than you should
In case of accidental ingestion of an excessive dose of GENIAD, immediately inform the doctor or go to the nearest hospital.
If you forget to take/give GENIAD to the child
Do not take/give the child a double dose to compensate for the missed dose.
If you stop the treatment with GENIAD
If you have any doubts about the use of this medicine, consult the doctor or pharmacist.
| 6 kg |
| 8 gtt |
| 6.5 kg |
| 8 gtt |
| 7 kg | 0.350 micrograms | 9 gtt |
| 7.5 kg |
| 10 gtt |
| 8 kg |
| 10 gtt |
|
| 11 gtt |
| 9 kg |
| 11 gtt |
|
| 12 gtt |
| 10 kg |
| 13 gtt |
| 11 kg |
| 14 gtt |
| 12 kg |
| 15 gtt |
| 13 kg |
| 17 gtt |
| 14 kg |
| 18 gtt |
| 15 kg |
| 19 gtt |
| 16 kg |
| a 21 gtt |
| 17 kg |
| i 22 gtt l |
| 18 kg |
| a 23 gtt |
| 19 kg |
| t 25 gtt |
| 20 kg |
| I 26 gtt |
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you/the child experience any of the following symptoms, stop usingGENIAD immediately and
consult a doctor or the nearest hospital where you will be given appropriate and specific treatment:
- High levels of calcium in the blood ( hypercalcemia); your doctor will then have you resume therapy with a halved dose;
- High levels of phosphorus in the blood (hyperphosphoremia);
- High levels of calcium in the urine (hypercalciuria exceeding 6 mg/kg/24 h).
The possible side effects are listed below according to the following frequency:
common (may affect up to 1 in 10 people)
- high levels of calcium in the blood (hypercalcemia)
- high levels of phosphate in the blood (hyperphosphatemia)
- increased levels of calcium in the urine (hypercalciuria)
- abdominal pain and discomfort
- skin rash (various types of rash have been reported such as erythematous, maculo-papular and pustular)
- itching uncommon (may affect up to 1 in 100 people)
- headache
- diarrhoea
- vomiting
- constipation
- nausea
- muscle pain (myalgia)
- stones (calculi) in the kidney (nephrolithiasis/nephrocalcinosis)
- fatigue/weakness/malaise
- formation of calcium deposits in tissues (calcinosis) rare (may affect up to 1 in 1,000 people)
- dizziness frequency not known (the frequency cannot be estimated from available data)
- kidney damage (including acute renal failure)
- confusion
Additional side effects in children
The safety profile observed is similar between adults and children
Reporting of side effects
If you/the child experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at “https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store GENIAD
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 pack after SCAD.
The expiry date refers to the last day of that month.
Keep the medicine, in its original packaging, at a temperature not exceeding 25°C and protected from
light.
After opening, the drop bottle, carefully closed, can be stored at a temperature not exceeding
25°C for a maximum of 10 days.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What GENIAD contains
The active ingredient is Alfacalcidol 2 micrograms/ml
The other ingredients are d,l alpha-tocopherol, peanut oil
Description of the appearance of GENIAD and contents of the pack
Oral drops, solution 2 micrograms/1 ml in a pack containing 1 bottle of 10 ml with a dosing dropper.
Marketing Authorisation Holder
HOLDER
Dymalife Pharmaceutical S.r.l. – Via Bagnulo, 95 – 80063 Piano di Sorrento (NA) Italy
Manufacturer
Special Product’s Line S.p.A -Strada Paduni, 240 03012, Anagni (FR)
Lachifarma S.r.l.- S.S. 16 Adriatica – Zona Industriale - I-73010 ZOLLINO LE
ITALY
- Страна регистрации
- Форма выпускаOral drops, solution, 2 MICROGRAMMI/1 ML
- Код АТХA11CC03
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги JENIADФорма выпуска: Soft capsule, 1 MICROGRAMДействующее вещество: Альфа-кальцидолПроизводитель: DOC GENERICI SRLОтпускается по рецептуФорма выпуска: Soft capsule, 0.25 microgramsДействующее вещество: Альфа-кальцидолПроизводитель: ZENTIVA ITALIA S.R.L.Отпускается по рецептуФорма выпуска: Soft capsule, 0.25 MCGДействующее вещество: Альфа-кальцидолПроизводитель: THERAMEX IRELAND LIMITEDОтпускается по рецепту
Аналоги JENIAD в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог JENIAD в Польша
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Часто задаваемые вопросы
JENIAD требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество JENIAD — Альфа-кальцидол. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
JENIAD производится компанией DYMALIFE PHARMACEUTICAL S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения JENIAD с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
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Вы можете купить JENIAD в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Альфа-кальцидол) включают ALFAKALKIDOLO DOK, ALFAKALKIDOLO TSENTIVA, ALPA D3. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















