Active ingredients: Alfacalcidol
DEDIOL 2 mcg / ml oral drops, solution
DEDIOL 0.25 mcg soft capsules
Why is Dediol used? What is it for?
DEDIOL contains alfacalcidol, a precursor of vitamin D3.
DEDIOL is indicated in adults and children for the treatment of:
- fragility and decreased bone mass and susceptibility to fractures in patients with kidney disease (renal failure osteodystrophy) who are undergoing dialysis (a blood filtration system) or not.
- reduced function of the parathyroid glands, located in the neck (hypoparathyroidism).
- bone diseases caused by poor metabolism of vitamin D, even in patients with kidney disease (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 texture after menopause (postmenopausal osteoporosis) (only in postmenopausal adult women).
Contraindications When Dediol should not be used
Do not take / give your child DEDIOL
- if you are allergic to alfacalcidol or any of the other ingredients of this medicine,
- if you are pregnant,
- if you suffer from high levels of calcium in the blood (hypercalcaemia).
Precautions for use What you need to know before taking Dediol
Talk to your doctor or pharmacist before taking / giving your child DEDIOL.
Throughout the treatment period, your doctor will ask you / your child to have blood tests (calcium and phosphate levels, PTH, alkaline phosphatase and calcium x phosphate product) and regular checks.
An increase in blood calcium levels (hypercalcaemia) may occur during treatment with DEDIOL, symptoms of which may be loss of appetite (anorexia), tiredness, nausea and vomiting, constipation or diarrhea, frequent urination (polyuria), sweating , headache, intense thirst (polydipsia), high blood pressure (hypertension), sleepiness and dizziness (see section 4 Possible side effects).
In particular, tell your doctor if you / your child suffer from:
- hardening of the arteries, the large blood vessels in the body (arteriosclerosis), hardening (sclerosis) of the heart valves, stones (pebbles) in the kidney (nephrolithiasis), as in these cases temporary or permanent damage to the kidneys 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 (kidney bone disease) or severely reduced kidney function. Your doctor may prescribe a medicine called a phosphate-binding agent to avoid high levels of phosphate in the blood (hyperphosphataemia) and a potential calcium deposit in healthy tissues (metastatic calcification);
- an inflammatory disease that can involve the whole body and leads to the formation of nodules (sarcoidosis) or a similar disease; - a disease of the kidneys (chronic kidney failure).
Also tell your doctor if you / your child are taking digitalis glycosides, medicines to treat heart disorders. You may experience increased calcium levels in your blood while taking these medicines and consequently your chance of heart rhythm disturbances increases.
For those who carry out sports activities
The use of medicines containing ethyl alcohol (DEDIOL oral drops) can determine positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.
Interactions Which drugs or foods can modify the effect of Dediol
Tell your doctor or pharmacist if you / your child are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you / your child are taking:
- anticonvulsants (eg barbiturates, phenytoin, carbamazepine or primidone), medicines to treat uncontrolled body movements, as an increase in the doses of DEDIOL may be needed;
- magnesium-based antacids, medicines to treat heartburn;
- thiazide diuretics (medicines to treat high blood pressure) or calcium-containing preparations. Your doctor may ask you / your child to have 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 your child DEDIOL at least 1 hour before, or 4 to 6 hours after the bile acid sequestering agent.
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.
Pregnancy
DEDIOL should not be used during pregnancy unless your doctor considers it strictly necessary.
Feeding time
Alfacalcidol is excreted in human milk. Your doctor will decide whether to discontinue breast-feeding or to discontinue DEDIOL therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for you. Your doctor will closely monitor your breastfed baby during your treatment with DEDIOL.
Driving and using machines
Alfacalcidol has no or negligible influence on the ability to drive and use machines. However, dizziness may occur during treatment and therefore this should be taken into account when driving or using machines.
DEDIOL capsules contain sesame oil
It can rarely cause severe allergic reactions.
DEDIOL drops contains ethanol, sorbitol, methyl-p-hydroxybenzoate, glycerol polyethylene glycol oxystearate
This medicine contains 14 vol% ethanol (alcohol), eg. up to 340 mg per dose (corresponding to 6 mcg of alfacalcidol), equivalent to 9 ml of beer, 4.5 ml of wine per dose.
It can be harmful to alcoholics. To be taken into consideration in pregnant or lactating women, children and high-risk groups such as people with liver disease or epilepsy.
This medicine contains sorbitol: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains methyl-p-hydroxybenzoate: it can cause allergic reactions (even delayed).
This medicine contains glycerol polyethylene glycol oxystearate: it can cause stomach upset and diarrhea.
Dose, Method and Time of Administration How to use Dediol: Posology
Always take / give your child this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Throughout the treatment period, your doctor will ask you / your child to have regular blood tests and check-ups.
Adults (all indications)
The recommended starting dose is 1 mcg per day (equivalent to 26 drops of oral solution).
The recommended maintenance dose is between 0.25 and 1 mcg per day based on the results obtained with the therapy and the laboratory tests that your doctor will ask you to do during the treatment.
If you have osteoporosis, your doctor will advise you on the most suitable dose for you based on your state of health.
In patients with severe bone dysfunction (except those with renal insufficiency) the doctor may increase the dosage to between 1 and 3 mcg per day. In patients with severe hypocalcaemia the doctor may increase the dosage to between 3 and 5 micrograms per day.
In such patients, the doctor may also prescribe other calcium-containing medicines.
Children weighing more than 20 kg
The recommended starting dose is 1 mcg per day (equivalent to 26 drops of oral solution).
The recommended maintenance dose is determined by the doctor based on the results obtained with the therapy and the laboratory tests that the doctor will ask you to have your child do during treatment.
Children weighing less than 20 kg
The dose depends on the weight of the child.
The recommended starting dose is 0.05 mcg / kg per day, equivalent to approximately 1 drop / kg (e.g. for a 10 kg child the dose is 13 drops per day).
To facilitate the calculation of the dosage in these children, an exemplary dose / weight table is provided below:
It is advisable not to administer the product directly but to use a teaspoon to correctly dose the exact number of drops to be administered.
If you forget to take / give your child DEDIOL
Do not take / give your child a double dose to make up for a forgotten dose.
If you stop taking DEDIOL
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Dediol
In case of accidental intake / ingestion of an excessive dose of DEDIOL, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Dediol
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you / your child have any of the following symptoms, stop using DEDIOL immediately and contact your doctor or the nearest hospital where they will undergo appropriate and specific treatment:
High levels of calcium in the blood (hypercalcemia); your doctor will then restart your therapy at half the dose;
- High levels of phosphorus in the blood (hyperphosphorus);
- High levels of calcium in the urine (hypercalciuria over 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 (hyperphosphataemia)
- increased levels of calcium in the urine (hypercalciuria)
- abdominal pain and discomfort
- skin rash (various types of rash such as erythematous, maculo-papular and pustular rash have been reported)
- itch
uncommon (may affect up to 1 in 100 people)
- headache
- diarrhea
- He retched
- constipation
- nausea
- muscle pain (myalgia)
- stones (pebbles) in the kidney (nephrolithiasis / nephrocalcinosis)
- fatigue / weakness / malaise
- formation of calcium deposits in the tissues (calcinosis)
rare (may affect up to 1 in 1,000 people)
- dizziness frequency not known (frequency cannot be estimated from the available data)
- kidney damage (including acute kidney failure)
- confusional state
Additional side effects in children
The observed safety profile is similar between adults and children.
Reporting of side effects
If you / your child 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 via the national reporting system at “www.agenziafarmaco.it/it/responsabili.” By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Oral drops, solution: Store in a refrigerator (2 ° C - 8 ° C).
Capsules: store at a temperature not exceeding 25 ° C.
Store in the original package to protect the medicine 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 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.
Other information
What DEDIOL contains
Oral drops, solution:
- The active ingredient is alfacalcidol 2 mcg / ml
- The other ingredients are glycerol polyethylene glycol oxystearate; citric acid; sodium citrate; sorbitol; d, lα-tocopherol; methyl-p-hydroxybenzoate; ethanol (see section 2. DEDIOL drops contains ethanol, sorbitol, methyl-p-hydroxybenzoate, glycerol polyethylene glycol oxystearate); purified water.
Capsules:
- The active ingredient is alfacalcidol 0.25 mcg.
- The other ingredients are: d, lα-tocopherol, sesame oil (see section 2. DEDIOL capsules contain sesame oil). The capsule consists of: gelatin; glycerine; potassium sorbate; titanium dioxide (E171).
Description of what DEDIOL looks like and contents of the pack
DEDIOL oral solution is presented as a solution contained in a 10 ml facone.
Capsules
DEDIOL comes as capsules.
It is available in packs with 30 capsules of 0.25 mcg of active ingredient.
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
DEDIOL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Capsules
One capsule contains:
- Active principle:
alfacalcidol (1st hydroxyvitamin D3) 0.25 mcg
Excipient with known effects: sesame oil
Oral drops, solution (per ml of solution)
- Active principle:
alfacalcidol (1st hydroxyvitamin D3) 2 mcg
Excipients with known effects: glyceropolyethylene glycol oxystearate, sorbitol, methyl-p-hydroxybenzoate, ethanol
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Capsules.
Oral drops, solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Renal insufficiency osteodystrophy on dialysis or not.
Hypoparathyroidism.
D resistant or D dependent rickets and osteomalacia (pseudo-deficient).
Rickets and osteomalacia due to renal alterations due to the metabolism of vitamin D.
Postmenopausal osteoporosis.
04.2 Posology and method of administration
Dosage
Starting dose for all indications.
Adults: 1 mcg per day.
Children weighing more than 20 kg: 1 mcg per day.
Children weighing less than 20 kg: 0.05 mcg / kg per day.
1 ml of solution contains 2 mcg of active ingredient.
Pediatric population
For children weighing less than 20 kg the dosage is 0.05 mcg / kg / day. To facilitate the calculation of the dosage in these children, an exemplary dose / weight table is provided below:
Method of administration
It is advisable not to administer the product directly but to use a teaspoon to correctly dose the exact number of drops to be administered.
It is important to adjust the dosage in accordance with the biochemical responses in order to avoid the onset of hypercalcemia. The parameters to be evaluated include plasma calcium levels, alkaline phosphatase, parathyroid hormone, urinary calcium excretion as well as histological and radiographic examinations. .
Patients with severe bone dysfunction (except for those with renal insufficiency) can tolerate a higher posology without hypercalcaemia occurring.
In any case, the failure to rapidly increase plasma calcium in patients with osteomalacia does not imply the need to increase the dosage as the calcium resulting from increased intestinal absorption can be incorporated into demineralized bones.
In this case, most patients will respond to a posology of 1-3 mcg / day.
Dosage should be reduced in skeletal system abnormalities when there is biochemical and radiographic evidence of healing and in hypoparathyroid patients when normal plasma calcium levels have been achieved. Maintenance doses are generally between 0.25 and 1 mcg / day.
Renal insufficiency osteodystrophy
Most patients with fibrous osteitis and osteomalacia show rapid symptom improvement and gradual biochemical, radiological and histological improvements. In these subjects, the only undesirable effect is hypercalcaemia which is more likely when there is an evident improvement in the bone picture. Patients with a relatively high plasma calcium level may experience autonomic hyperparathyroidism which often does not respond to therapy with 1a OH D3: in in this case it may be appropriate to resort to other therapies. Before and during treatment with 1a OH D3 it is advisable to consider the possibility of using substances that bind to phosphates in order to prevent hyperphosphataemia which, especially when associated with hypocalcemia, increases the risk of calcification Since prolonged hypercalcaemia can aggravate decreased renal function, it is particularly important to constantly monitor the plasma calcium rate in patients with chronic renal failure. "Early hypercalcaemia is more likely in patients with autonomic hyperparathyroidism, with histologically osteomalacia" pure "due, pres humbly to phosphate depletion or aluminum intoxication and in dialysates subject to heavy calcium losses.
Hypoparathyroidism
Contrary to what occurs in response to vitamin D, low plasma calcium levels are returned to normal relatively quickly. With a higher 1a OH D3 dosage (3-5 mcg) and with calcium administration, even severe forms of hypocalcemia can be corrected (for example after extensive surgery on the thyroid) and the related symptoms can be eliminated more quickly. Normocalcaemia can be maintained with a reduced dosage.
Osteomalacia and vitamin D resistant hypophosphatemic rickets
They are characterized by hypophosphataemia due to defective renal tubular reabsorption or impaired intestinal absorption of phosphorus. In such cases, high doses of vitamin D and an additional supply of phosphates may be insufficient, as they can cause hypocalcemia and hyperparathyroidism. Treatment with 1a OH D3 rapidly improves myopathy, if present, increases calcium and phosphorus retention and promotes the repair of bone lesions. Additional phosphate treatment may be required in some patients. Pseudo-deficient (D-dependent) rickets requires high doses of vitamin D, possibly due to a hereditary defect in 1,25 (OH) 2 D3 production. On the other hand, therapeutic doses of 1a OH D3 are sufficient for the remission of nutritional rickets due to vitamin D deficiency.
Rickets and osteomalacia due to renal alterations due to the metabolism of vitamin D
Rickets and osteomalacia due to renal alterations can be rapidly resolved with "physiological" doses of 1a OH D3. Some experiences have shown that patients with malabsorptive osteomalacia who responded only to high doses of parenteral vitamin D achieve good results with small oral doses of 1a OH D3.
04.3 Contraindications
The product must not be administered during pregnancy (see section 4.6) and in subjects with known individual hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or in case of hypercalcaemia.
04.4 Special warnings and appropriate precautions for use
Periodic determinations of plasma calcium level and other necessary parameters are required throughout the treatment period.
Plasma calcium and phosphate levels should be measured weekly and monthly, depending on the patient's progress. Levels of PTH, alkaline phosphatase and calcium x phosphate product should be monitored as clinically indicated.
Frequent checks are particularly necessary in the first treatment period (especially when the plasma calcium level is already relatively high) and later when bone healing occurs.
As hypercalcaemia may occur in patients treated with Dediol, patients should be informed about the associated clinical symptoms. Signs of hypercalcaemia are anorexia, fatigue, nausea and vomiting, constipation or diarrhea, polyuria, sweating, headache, polydipsia, hypertension, sleepiness and dizziness.
Prolonged hypercalcaemia can aggravate atherosclerosis, heart valve sclerosis or nephrolithiasis and should therefore be avoided in patients with these conditions being treated with Dediol.
A transient or permanent deterioration of renal function has also been observed in these patients. Dediol should also be used with caution in patients with lung tissue calcification as this can lead to heart disease.
In patients with renal bone disease or severely reduced renal function, a phosphate binder may be used concurrently with alfacalcidol to avoid hyperphosphataemia and potential metastatic calcification.
Dediol should be used with caution in patients with granulomatous diseases such as sarcoidosis, where sensitivity to vitamin D is increased due to increased hydroxylation activity.
The concomitant use of digitalis glycosides, in the presence of hypercalcemia caused by the administration of vitamin D, increases the potential for cardiac arrhythmias.
If hypercalcaemia occurs, administration of 1a OH D3 should be interrupted until plasma calcium normalization (approximately one week) and then therapy with half the dosage can be resumed.
In cases of severe hypercalcaemia, patients should be treated with a loop diuretic or IV fluids and corticosteroids.
The risk of hypercalciuria is related to various factors, such as defects of any type of mineralization, renal function, 1a OH D3 dosage used. For these reasons, hypercalcemia occurs more likely in osteomalacia and more easily in renal insufficiency. Hypercalcemia occurs when there is biochemical evidence of healing of bone lesions (for example, a normalization of the plasma level of alkaline phosphatase ) and the dosage of 1st OH D3 is not correctly reduced. Prolonged hypercalcaemia should be avoided especially in cases of chronic renal failure.
DEDIOL capsules contain sesame oil, which can rarely cause severe allergic reactions.
DEDIOL drops contains 14 vol% ethanol (alcohol), eg. up to 340 mg per dose (corresponding to 6 mcg of alfacalcidol), equivalent to 9 ml of beer, 4.5 ml of wine per dose.
It can be harmful to alcoholics. To be taken into consideration in pregnant or lactating women, children and high-risk groups such as people with liver disease or epilepsy.
DEDIOL drops contains sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine.
DEDIOL drops contains methyl-p-hydroxybenzoate: it can cause allergic reactions (even delayed).
DEDIOL drops contains glycerol polyethylene glycol oxystearate: it can cause gastric disturbances and diarrhea.
04.5 Interactions with other medicinal products and other forms of interaction
Patients being treated with anticonvulsants (e.g. barbiturates, phenytoin, carbamazepine or primidone) have enzyme inducing effects resulting in increased metabolism of alfacalcidol. Patients being treated with such medicinal products may require higher doses of 1a OH D3 to achieve the same effects. Alfacalcidol increases the absorption of magnesium so that, during concomitant treatment with magnesium-based antacids, there is a risk of hypermagnesemia.
Concomitant use of thiazide diuretics or calcium-containing preparations may increase the risk of hypercalcaemia. Calcium levels should be monitored.
Concomitant use of other vitamin D-containing preparations may increase the risk of hypercalcaemia. The use of multiple vitamin D analogues should be avoided.
Dediol can increase the serum concentration of aluminum. Patients taking aluminum-containing preparations (eg aluminum hydroxide, sucralfate) should be monitored for signs of aluminum-related toxicity.
Concomitant oral administration of bile acid sequestrants such as cholestyramine may impair the oral absorption of Dediol, which should be administered at least 1 hour before, or 4 to 6 hours after bile acid sequestering to minimize the risk of interaction.
04.6 Pregnancy and breastfeeding
Pregnancy
There are limited data on the use of alfacalcidol in pregnant women.
Animal studies have shown reproductive toxicity.
Dediol should not be used in pregnancy unless strictly necessary, as hypercalcemia during pregnancy can produce congenital diseases in the offspring. Caution should be exercised in the treatment of women of childbearing age.
Feeding time
Alfacalcidol is excreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue / abstain from DEDIOL therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Breastfed infants of mothers being treated with alfacalcidol should be carefully monitored for the possible occurrence of hypercalcaemia.
Fertility
There are no clinical studies on the effects of DEDIOL on fertility.
A preclinical study showed no effect on fertility in rats.
04.7 Effects on ability to drive and use machines
Alfacalcidol has no or negligible influence on the ability to drive and use machines. However, the patient should be informed that dizziness may occur during treatment and take this into account when driving or using machines.
04.8 Undesirable effects
In patients with renal insufficiency, hypercalcemia and hyperphosphorus may occur with the risk of metastatic calcification in the soft tissues.
In patients with hypoparathyroidism and hypophosphataemia, resistant to vitamin D, and without renal insufficiency, hypercalcemia and hypercalciuria may occur.
This risk can be prevented by discontinuing the administration of alfacalcidol when the calcium urination exceeds 6 mg / kg / 24 h.
The estimate of the frequency of undesirable effects is based on data from clinical studies.
The most frequently reported side effects are various skin reactions such as itching and rash, hypercalcemia, gastrointestinal pain / discomfort and hyperphosphataemia.
Undesirable effects are listed according to MedDRA and the organ and system classification (SOC) of the individual undesirable effects begins with the most frequently reported. Within each frequency class, adverse reactions are reported in order of decreasing severity.
Very common (≥1 / 10)
Common (≥1 / 100,
Uncommon (≥1 / 1,000 to
Rare (≥1 / 10,000,
Very rare (
Not known (frequency cannot be estimated from the available data)
In the post-marketing period, cases of renal impairment (including acute renal failure) and confusional state have been reported. For these undesirable effects, based on the available data, the frequency cannot be defined.
Pediatric population
The observed safety profile is similar between adults and children.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address http://www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Excessive consumption of DEDIOL can lead to the development of hypercalcaemia, however, this effect quickly reverses with discontinuation of the drug.
In severe cases of hypercalcaemia, general supportive measures should be undertaken, such as keeping the patient well hydrated by intravenous infusion of saline (forced diuresis), monitoring of electrolytes, calcium, and renal function indices, evaluation of electrocardiographic abnormalities, particularly on the patient receiving digitalis therapy. More specifically, treatment with glucocorticoids, loop diuretics, bisphosphonates, calcitonin and possibly hemodialysis with low calcium content should be considered.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Vitamin D and analogues, ATC code: A11CC03.
Alfacalcidol 1a OH D 3 is the first precursor of the synthesis of the active metabolite of Vitamin D3.
In the organism, Vitamin D3 is normally transformed into 25 (OH) D3, mainly in the liver, then into 1a 25 (OH) 2D3 (active metabolite) of the 1a renal hydroxylase.
Alfacalcidol, which already has the hydroxyl in position 1a, is directly converted into 1,25 (OH) 2D3 even in cases in which the renal 1 a hydroxylase is inactive.
Alfacalcidol normalizes intestinal absorption of calcium and phosphorus, elevating both calcium and phosphorus. Its action is also expressed when the activity of the renal 1 a hydroxylase is disturbed.
Pharmacodynamic activity occurs rapidly and in proportion to the dose.
05.2 Pharmacokinetic properties
After oral administration, alfacalcidol is rapidly and completely absorbed. The metabolic conversion is total in about 12 hours. The apparent plasma half-life of 1a 25 (OH) 2D3, coming from hydroxylation of 1a (OH) D3 is of about 24 hours.
05.3 Preclinical safety data
After a single administration, the oral LD50 value is 510 mcg / kg in mice and 550 mcg / kg in rats, while for the intravenous route it is 310 mcg / kg in mice. In prolonged (180 days) oral treatments, both in rats and dogs, alfacalcidol is well tolerated and toxic phenomena related to the product-induced hypercalcemia. Alfacalcidol does not interfere with normal embryonic and fetal development; only with the administration of high doses it is possible to highlight the appearance of skeletal alterations as regularly occurs with the administration of derivatives from Vitamin D3.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Capsules:
d, la-tocopherol - sesame oil
• Composition of the capsule
gelatin - glycerin - potassium sorbate - titanium dioxide (E 171)
Oral drops, solution:
glyceropolyethylene glycol oxystearate - citric acid - sodium citrate - sorbitol - d, l a tocopherol - methyl-p-hydroxybenzoate - ethanol - purified water
06.2 Incompatibility
There are no known incompatibilities of alfacalcidol
06.3 Period of validity
The capsule preparation of Dediol is valid for 2 years.
The preparation in oral drops, Dediol's solution, is valid for 3 years.
06.4 Special precautions for storage
Dediol capsules: do not store above 25 ° C.
Keep the blister in the outer carton to protect the medicine from light.
Oral drops, Dediol solution: Store in a refrigerator (2 ° C - 8 ° C).
Keep the bottle in the outer carton to protect the medicine from light.
After use, the drop bottle must be kept tightly closed.
Keep out of reach of children.
06.5 Nature of the immediate packaging and contents of the package
Dediol soft capsules
• 30 capsules of 0.25 mcg, in blisters
Dediol 2 mcg / ml oral drops, solution
• 10 ml bottle of drops
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
LEO Pharma A / S - Ballerup - Denmark
Dealer for sale:
LEO Pharma S.p.A., Via Amsterdam, 125 - Rome, 00144 - Italy
08.0 MARKETING AUTHORIZATION NUMBER
Dediol soft capsules AIC n ° 025487024
Dediol 2 mcg / ml oral drops, AIC solution n ° 025487036
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Dediol soft capsules
Date of first authorization: 20.12.1984
Date of most recent renewal: 01.06.2010
Dediol 2 mcg / ml oral drops, solution
Date of first authorization: 20.12.1984
Date of most recent renewal: 01.06.2010
10.0 DATE OF REVISION OF THE TEXT
January 26, 2017
