Active ingredients: Cholecalciferol (vitamin D3), Vitamin A
ADHYSTEROL 50,000 IU / ml + 10,000 IU / ml oral and injectable solution for intramuscular use
ADHYSTEROL 100,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use
ADHYSTEROL 300,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use
ADHYSTEROL 600,000 IU / 2 ml + 40,000 IU / 2 ml oral and injectable solution for intramuscular use
Adisterol package inserts are available for pack sizes: - ADHYSTEROL 50,000 IU / ml + 10,000 IU / ml oral and injectable solution for intramuscular use, ADHYSTEROL 100,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use, ADHYSTEROL 300,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use, ADHYSTEROL 600,000 IU / 2 ml + 40,000 IU / 2 ml oral and injectable solution for intramuscular use
- ADHYSTEROL 10,000 IU / ml +10,000 IU / ml oral drops, solution
Why is Adisterol used? What is it for?
ADHYSTEROL contains vitamin A and cholecalciferol, better known as vitamin D3.
ADHYSTEROL is indicated in adult patients for the prevention and treatment of vitamin A and D deficiency (osteomalacia, spasmophilia, etc.).
Contraindications When Adisterol should not be used
Do not take ADHYSTEROL
- if you are allergic to vitamin A, cholecalciferol (vitamin D3) or any of the other ingredients of this medicine (listed in section 6).
- If you have high levels of calcium in the blood (hypercalcaemia).
Precautions for use What you need to know before taking Adisterol
Talk to your doctor or pharmacist before taking ADISTEROL.
In particular, tell your doctor:
- if you suffer from kidney disease (kidney failure)
- if you suffer from a disease of the blood vessels characterized by their hardening, which appears with advancing age (arteriosclerosis)
- if you suffer from a disease of the vessels that carry blood to the heart (coronary arteries)
- if you are elderly.
If you take ADISTEROL in high doses or for a long time, your doctor will have blood or urine tests to monitor calcium levels and blood tests to monitor alkaline phosphatase levels.
Doses exceeding 25,000 I.U./die of vitamin A can only be used under medical supervision, in order to avoid the appearance of undesirable effects.
Interactions Which drugs or foods can modify the effect of Adisterol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking contraceptives (pills), medicines used to prevent pregnancy.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy, take ADISTEROL under close supervision of your doctor. Daily amounts of vitamin A higher than 10,000 I.U. they should be avoided during pregnancy (especially in the first months), as they can have harmful effects on the fetus
Driving and using machines
ADHYSTEROL has no effect on the ability to drive and use machines.
Dose, Method and Time of Administration How to use Adisterol: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
ADHYSTEROL 50,000 IU / ml + 10,000 IU / ml oral and injectable solution for intramuscular use
One vial for injection into a muscle or by mouth every 5-7 or more days, in the judgment of the doctor.
ADHYSTEROL 100,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use
One vial for injection into a muscle or by mouth every 5-7 or more days, in the judgment of the doctor.
ADHYSTEROL 300,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use
One vial for injection into a muscle or by mouth every 7 or more days, in the judgment of the doctor.
ADHYSTEROL 600,000 IU / 2 ml + 40,000 IU / 2 ml oral and injectable solution for intramuscular use
One vial for injection into a muscle or by mouth every 7 or more days, in the judgment of the doctor.
The doses must be taken by mouth or injected into a muscle.
Warm the vial in your hands before use if the solution appears cloudy as a result of the lowering of the ambient temperature
Do not mix ADHYSTEROL with solutions containing oxidizing substances or with aqueous solutions
Overdose What to do if you have taken too much Adisterol
If you take more ADISTEROL than you should
In case of accidental ingestion / intake of an excessive dose of ADHYSTEROL, notify your doctor immediately or go to the nearest hospital.
If you take an excessive dose of this medicine, you may have general disorders related to hypervitaminosis D syndromes such as: stomach and / or intestinal (gastrointestinal) disorders, weight loss, irritability, tiredness (asthenia), low-grade fever, changes in calcium turnover, dryness of the skin with peeling and yellowing of the skin, pain in the bones or joints.
In children there may be premature closure of the epiphyses, stunted growth of long bones, intracranial hypertension (an increase in pressure within the skull).
Treatment
Stop taking ADISTEROL and contact your doctor.
If you forget to take ADHYSTEROL
Do not take a double dose to make up for a forgotten dose.
If you stop taking ADISTEROL
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Adisterol
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, reported as a result of taking excessive doses of ADISTEROL for incorrect and / or prolonged use, stop the treatment and contact your doctor immediately:
Effects affecting metabolism and nutrition:
- Loss of appetite (anorexia)
Effects affecting the skin:
- Itching
Diagnostic tests:
- Increased levels of calcium in the blood and urine (hypercalcemia, hypercalciuria)
- Increased levels of phosphates in the blood (hyperphostataemia)
- Alteration of kidney function tests
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the "Agenzia Italiana del Farmaco" 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.
Expiry and Retention
Keep in the original package to protect from light.
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.
Do not use this medicine if you notice that the oily solution is opalescent and / or contains visible particles and / or is yellow-brown or brown in color.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What ADHYSTEROL contains
ADHYSTEROL 50,000 IU / ml + 10,000 IU / ml oral and injectable solution for intramuscular use
- The active ingredients are concentrated vitamin A, synthetic, oily form (vit. A acetate) 3.44 mg equal to 10,000 I.U. and cholecalciferol (vitamin D3) 1.25 mg equal to 50,000 I.U.
- The other component is refined olive oil for injectable use.
ADHYSTEROL 100,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use
- The active ingredients are concentrated vitamin A, synthetic, oily form (vit. A acetate) 6.88 mg equal to 20,000 I.U. and cholecalciferol (vitamin D3) 2.5 mg equal to 100,000 I.U.
- The other component is refined olive oil for injectable use.
ADHYSTEROL 300,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use
- The active ingredients are concentrated vitamin A, synthetic, oily form (vit. A acetate) 6.88 mg equal to 20,000 I.U. and cholecalciferol (vitamin D3) 7.5 mg equal to 300,000 I.U.
- The other component is refined olive oil for injectable use.
ADHYSTEROL 600,000 IU / 2 ml + 40,000 IU / 2 ml oral and injectable solution for intramuscular use
- The active ingredients are concentrated, synthetic, oily vitamin A (vitamin A acetate) 13.76 mg equal to 40,000 I.U. and cholecalciferol (vitamin D3) 15 mg equal to 600,000 I.U.
- The other component is refined olive oil for injectable use.
Description of how ADHYSTEROL looks and contents of the pack
Oral and injectable solution for intramuscular use
ADHYSTEROL comes as a clear, colorless to yellow or greenish-yellow oily solution contained in white glass vials.
ADHYSTEROL 50,000 IU / ml + 10,000 IU / ml oral and injectable solution for intramuscular use It is available in packs of 10 ampoules of 1 ml.
ADHYSTEROL 100,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use It is available in packs of 10 ampoules of 1 ml.
ADHYSTEROL 300,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use It is available in packs with 2 ampoules of 1 ml.
ADHYSTEROL 600,000 IU / 2 ml + 40,000 IU / 2 ml oral and injectable solution for intramuscular use It is available in packs with 1 ampoule of 2 ml.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ADHYSTEROL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
ADHYSTEROL 10,000 IU / ml +10,000 IU / ml oral drops, solution
10 ml contain: cholecalciferol (vit. D3) 2.5 mg equal to 100,000 I.U .; concentrated vitamin A, synthetic, oily form (vit. A acetate) 34.4 mg equal to 100,000 I.U ..
ADHYSTEROL 50,000 IU / ml + 10,000 IU / ml oral and injectable solution for intramuscular use
one vial contains: cholecalciferol (vit. D3) 1.25 mg equal to 50,000 I.U .; concentrated vitamin A, synthetic, oily form (vit. A acetate) 3.44 mg equal to 10,000 I.U ..
ADHYSTEROL 100,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use
one vial contains: cholecalciferol (vit. D3) 2.5 mg equal to 100,000 I.U .; concentrated vitamin A, synthetic, oily form (vit. A acetate) 6.88 mg equal to 20,000 I.U ..
ADHYSTEROL 300,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use
one vial contains: cholecalciferol (vit. D3) 7.5 mg equal to 300,000 I.U .; concentrated vitamin A, synthetic, oily form (vit. A acetate) 6.88 mg equal to 20,000 I.U ..
ADHYSTEROL 600,000 IU / 2 ml + 40,000 IU / 2 ml oral and injectable solution for intramuscular use
one vial contains: cholecalciferol (vitamin D3) 15 mg equal to 600,000 I.U .; concentrated vitamin A, synthetic, oily form (vit. A acetate) 13.76 mg equal to 40,000 I.U ..
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Oral drops, solution.
Oral and injectable solution for intramuscular use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Vitamin deficiency prophylaxis and therapy A and D (rickets, osteomalacia, spasmophilia, teething disorders, etc.).
04.2 Posology and method of administration
ADHYSTEROL 10,000 IU / ml +10,000 IU / ml oral drops, solution
Infants: 2-4 drops per day.
Children: 5-10 drops, 1-2 times a day, according to age.
Adults: 10-20 drops, 1-2 times a day.
1 drop contains: 250 I.U. of vitamin D3 and 250 I.U. of vitamin A.
ADHYSTEROL 50,000 IU / ml + 10,000 IU / ml oral and injectable solution for intramuscular use
One vial for intramuscular or oral injection every 5-7 or more days, in the judgment of the physician.
ADHYSTEROL 100,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use
One vial for intramuscular or oral injection every 5-7 or more days, in the judgment of the doctor.
ADHYSTEROL 300,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use
One vial for intramuscular or oral injection every 7 or more days, in the judgment of the physician.
ADHYSTEROL 600,000 IU / 2 ml + 40,000 IU / 2 ml oral and injectable solution for intramuscular use
One vial for intramuscular or oral injection every 7 or more days, in the judgment of the physician.
04.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
States of hypercalcemia.
04.4 Special warnings and appropriate precautions for use
Doses exceeding 25,000 I.U./dies of vitamin A can only be used under medical supervision, in order to avoid the appearance of undesirable effects of overdose.
The use of high doses or for protracted therapies makes it necessary to periodically check calcium, calcium and the serum level of alkaline phosphatase.
To be used with caution and at lower dosages in subjects suffering from arteriosclerosis, severe coronary artery disease or nephropathy and in the elderly.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interactions or incompatibilities with other drugs.
The use of contraceptives can increase the plasma rate of Vit. A.
04.6 Pregnancy and lactation
Very high doses of vitamin A in animals are teratogenic and have been associated in isolated cases with malformations in humans. Daily doses of vitamin A higher than 10,000 IU should be avoided during pregnancy (especially in the first months) and a doctor should be consulted for advice on the total amount of vitamin A that can be taken from the different sources.
04.7 Effects on ability to drive and use machines
The medicine does not affect the ability to drive and use machines.
04.8 Undesirable effects
No undesirable effects were found.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via https: / /www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
There are no known cases of overdose. In the event of overdose due to incorrect and / or prolonged use, general disorders may occur which can be referred to hypervitaminosis D syndromes such as: gastrointestinal disorders, weight loss, irritability, asthenia, low-grade fever, changes in calcium exchange, dry skin with flaking and yellow pigmentation, osteoarticular pains. In children, premature closure of the epiphyses, growth arrest of long bones, intracranial hypertension may occur.
In case of accidental ingestion of very large quantities of medicine it is advisable to practice gastric lavage, fluid therapy and any diuretic therapy.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Vitamins A and D in combination.
ATC code: A11CB.
Adisterol is an oily solution of cholecalciferol (vitamin D3) in high concentration associated with a high dose of vitamin A acetate.
Vit. D3 essential for the organism carries out its therapeutic action by increasing the absorption of calcium in the intestine and rebalancing the phosphocalcic exchange.
Vit.A stimulates the activity of osteoblasts, carries out its eutrophic action at the level of the epithelia and strengthens the immune defense processes, exerting an adjuvant action in chronic toxinfections (especially in those of a tuberculous nature) and in infectious complications of rickets.
05.2 "Pharmacokinetic properties
The oily solution of vit. A and vit. D3 is well absorbed even by oral administration.
05.3 Preclinical safety data
Vitamin A acetate: LD50 / os in mice 14,500,000 IU / kg
Cholecalciferol: LD50 / os in mice 5,416,000 IU / kg
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Adisterol oral drops, solution: refined olive oil.
Adisterol oral and injectable solution for intramuscular use: refined olive oil for injectable use.
06.2 Incompatibility
Solutions containing oxidizing substances, aqueous solutions.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
Adisterol oral and injectable solution for intramuscular use: Store in the original container to protect from light.
Adisterol oral drops, solution: This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
ADHYSTEROL 10,000 IU / ml +10,000 IU / ml oral drops, solution - glass bottle with dropper - 10 ml
ADHYSTEROL 50,000 IU / ml + 10,000 IU / ml oral and injectable solution for intramuscular use - white glass ampoules - 10 ampoules - 1 ml
ADHYSTEROL 100,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use - white glass ampoules - 10 ampoules - 1 ml
ADHYSTEROL 300,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use - white glass ampoules - 2 ampoules - 1 ml
ADHYSTEROL 600,000 IU / 2 ml + 40,000 IU / 2 ml oral and injectable solution for intramuscular use - white glass vials - 1 vial - 2 ml
06.6 Instructions for use and handling
07.0 MARKETING AUTHORIZATION HOLDER
ABIOGEN PHARMA S.p.A.
Via Meucci 36 - Ospedaletto - PISA.
08.0 MARKETING AUTHORIZATION NUMBER
ADHYSTEROL 10,000 IU / ml +10,000 IU / ml oral drops, solution 001738057
ADHYSTEROL 50,000 IU / ml + 10,000 IU / ml oral and injectable solution for intramuscular use 001738044
ADHYSTEROL 100,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use 001738032
ADHYSTEROL 300,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use 001738020
ADHYSTEROL 600,000 IU / 2 ml + 40,000 IU / 2 ml oral and injectable solution for intramuscular use 001738018
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
ADHYSTEROL 10,000 IU / ml +10,000 IU / ml oral drops, solution - March 1949 / May 2010
ADHYSTEROL 50,000 IU / ml + 10,000 IU / ml oral solution and injectable for intramuscular use - May 1979 / May 2010
ADHYSTEROL 100,000 IU / ml + 20,000 IU / ml oral solution and injectable for intramuscular use - May 1979 / May 2010
ADHYSTEROL 300,000 IU / ml + 20,000 IU / ml oral and injectable solution for intramuscular use - March 1949 / May 2010
ADHYSTEROL 600,000 IU / 2 ml + 40,000 IU / 2 ml oral and injectable solution for intramuscular use - March 1949 / May 2010
10.0 DATE OF REVISION OF THE TEXT
October 2015
