Active ingredients: Cholecalciferol
BASE 10,000 I.U./ml oral drops, solution
BASE 25.000 I.U./2.5 ml oral solution
BASE 50.000 I.U./2.5 ml oral solution
BASE 100,000 I.U./ml solution for injection
DIBASE 300.000 I.U./ml solution for injection
Indications Why is Dibase used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Vitamin D and analogues, cholecalciferol.
THERAPEUTIC INDICATIONS
Prevention and treatment of vitamin D deficiency
Contraindications When Dibase should not be used
Hypersensitivity to cholecalciferol or to any of the excipients.
Hypercalcemia, hypercalciuria.
Kidney stones (nephrolithiasis, nephrocalcinosis).
Renal insufficiency (see "Precautions for use")
Precautions for use What you need to know before taking Dibase
In elderly patients already being treated with cardiac glycosides or diuretics it is important to monitor calcium and calciumuria. In case of hypercalcaemia or renal insufficiency, reduce the dose or discontinue treatment.
The product should be prescribed with caution to patients suffering from sarcoidosis, due to the possible increase in the metabolism of vitamin D in its active form. In these patients, the level of calcium in serum and urine should be monitored.
Patients with renal insufficiency have an impaired metabolism of vitamin D; therefore, if they are to be treated with cholecalciferol, the effects on calcium and phosphate homeostasis should be monitored.
Interactions Which drugs or foods can modify the effect of Dibase
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
The concomitant use of anticonvulsants or barbiturates may reduce the effect of vitamin D3 by metabolic inactivation. In the case of treatment with thiazide diuretics, which reduce the urinary elimination of calcium, monitoring of serum calcium concentrations is recommended.
Concomitant use of glucocorticosteroids may reduce the effect of vitamin D3.
When treated with digitalis-containing drugs, oral administration of calcium combined with vitamin D increases the risk of digitalis toxicity (arrhythmia). Close medical supervision and, if necessary, monitoring of electrocardiography and serum calcium concentrations are therefore required.
A concomitant use of aluminum-containing antacids can interfere with the efficacy of the drug, decreasing the absorption of vitamin D, while preparations containing magnesium may expose you to the risk of hypermagnesaemia.
Animal studies have suggested a possible potentiation of the action of warfarin when administered with calciferol. Although there is no similar evidence with the use of cholecalciferol, caution should be exercised when the two drugs are used concurrently.
Cholestyramine, colestipol and orlistat reduce the absorption of vitamin D, while chronic alcoholism decreases the vitamin D stores in the liver.
Warnings It is important to know that:
Consider the total dose of vitamin D when taking other products that already contain vitamin D, foods supplemented with vitamin D, or when using milk fortified with vitamin D.
Prolonged intake of high doses of vitamin D should be done under strict medical supervision.
Ask your doctor for advice in the following cases, where it may be necessary to increase the dosages compared to those indicated in "Dose, method and time of administration":
- subjects being treated with anticonvulsants or barbiturates (see "Interactions");
- subjects being treated with corticosteroid therapies (see "Interactions");
- subjects being treated with lipid-lowering drugs such as colestipol, cholestyramine and orlistat (see "Interactions");
- subjects being treated with aluminum-containing antacids (see "Interactions");
- obese subjects;
- digestive disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis);
- liver failure.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
In the first 6 months of pregnancy, vitamin D should be taken with caution due to the risk of teratogenic effects (see "Overdose").
When needed, vitamin D can be prescribed during breastfeeding. This supplementation does not replace the administration of vitamin D in the newborn.
Effects on ability to drive and use machines
No data are available on the effects of the product on the ability to drive. However, an effect on this ability is unlikely.
Dosage and method of use How to use Dibase: Dosage
DIBASE can be administered on a daily, weekly, monthly or yearly basis. In case of oral therapy, it is recommended to take DIBASE with meals. Intramuscular therapy is indicated only in cases of malabsorption syndromes.
Prevention of Vitamin D Deficiency:
the preventive administration of DIBASE is recommended in all conditions characterized by greater risk of deficiency or increased need. It is generally recognized that the prevention of vitamin D deficiency must be carried out:
- systematically in the newborn (in particular in the premature baby), in the infant, in the pregnant woman (last trimester) and in the nursing woman at the end of winter and in spring, in the elderly subject, possibly in the child and adolescent if the "sun exposure is insufficient;
under the following conditions:
- poor sun exposure or intense skin pigmentation, unbalanced diet (low in calcium, vegetarian, etc.), extensive skin diseases or granulomatous diseases (tuberculosis, leprosy, etc.);
- subjects being treated with anticonvulsants (barbiturates, phenytoin, primidone);
- subjects being treated with long-term corticosteroid therapies;
- digestive disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis);
- liver failure.
Treatment of vitamin D deficiency:
Vitamin D deficiency must be ascertained clinically and / or with laboratory investigations. Treatment is aimed at restoring vitamin D deposits and will be followed by maintenance therapy if the risk of deficiency persists, at a dose of vitamin D suitable for prevention (see above "Prevention of vitamin D deficiency"). In most cases it is advisable not to exceed a cumulative dose of 600,000 I.U. per year, unless otherwise advised by the doctor.
As an indication, the following dosage schedule is provided, to be adapted according to the physician's judgment on the basis of the nature and severity of the deficiency status (see also "Precautions for use" and "Special warnings").
BASE 10,000 I.U./ml oral drops, solution
The daily doses indicated below can also be taken once a week by multiplying the indicated daily dose by seven.
Infants, Children and Adolescents (<18 years)
Prevention: 2-4 drops per day (equal to 500-1000 I.U. of vitamin D3).
Treatment: 8-16 drops per day (equal to 2,000-4,000 I.U. of vitamin D3) for 4-5 months.
Pregnant women
3-4 drops per day (equal to 750-1,000 I.U. of vitamin D3) in the last quarter.
Adults and Seniors
Prevention: 3-4 drops per day (equal to 750-1,000 I.U. of vitamin D3). In subjects at high risk of deficiency it may be necessary to increase the dosage up to 8 drops per day (equal to 2,000 I.U. of vitamin D3).
Treatment: 20-40 drops per day (equal to 5,000-10,000 I.U. of vitamin D3) for 1-2 months.
Instructions for Use
The package contains a bottle and a dropper. The bottle comes with a child resistant capsule. The dropper comes with a case. For use, follow the instructions below:
- open the bottle by removing the cap as follows: press and unscrew at the same time
- unscrew the plastic case that wraps the dropper tip
- insert the dropper into the bottle to withdraw the contents. Dose in a teaspoon the number of drops prescribed by the doctor and take;
- close the bottle Screw the case back onto the dropper tip;
- put the bottle and the dropper back in the package.
BASE 25.000 I.U./2.5 ml oral solution
Infants, Children and Adolescents (<18 years)
Prevention: 1 single-dose container (equal to 25,000 I.U. of vitamin D3) every 1-2 months.
Treatment: 1 single-dose container (equal to 25,000 I.U. of vitamin D3) once a week for 16-24 weeks.
Pregnant women
1 single-dose container (equal to 25,000 I.U. of vitamin D3) once a month in the last quarter.
Adults and Seniors
Prevention: 1 single-dose container (equal to 25,000 I.U. of vitamin D3) once a month. In subjects at high risk of deficiency it may be necessary to increase the dosage to 2 single-dose containers (equal to 50,000 I.U. of vitamin D3) once a month.
Treatment: 2 single-dose containers (equal to 50,000 I.U. of vitamin D3) once a week for 8-12 weeks.
BASE 50.000 I.U./2.5 ml oral solution
Infants, Children and Adolescents (<18 years)
Prevention: 1 single-dose container (equal to 50,000 I.U. of vitamin D3) every 2-4 months
Treatment: 1 single-dose container (equal to 50,000 I.U. of vitamin D3) once a week for 8-12 weeks.
Pregnant women
2 single-dose containers (equal to 100,000 I.U. of vitamin D3) at the beginning of the last quarter.
Adults and Seniors
Prevention: 1 single-dose container (equal to 50,000 I.U. of vitamin D3) every 2 months. In subjects at high risk of deficiency it may be necessary to increase the dosage to 1 single-dose container (equal to 50,000 I.U. of vitamin D3) once a month.
Treatment: 1 single-dose container (equal to 50,000 I.U. of vitamin D3) once a week for 8-12 weeks
BASE 100,000 I.U./ml solution for injection
Newborns up to 24 months
Prevention: It is recommended to administer the doses with DIBASE 10,000 I.U. / ml oral drops, solution or with DIBASE 25.000 I.U./2.5 ml oral solution or with DIBASE 50.000 I.U. / 2.5 ml oral solution.
Treatment: 1 ampoule (equal to 100,000 I.U. of vitamin D3) once a month for 4-6 months.
Children and Teenagers (2-18 years)
Prevention: 1 ampoule (equal to 100,000 I.U. of vitamin D3) every 4-8 months.
Treatment: 1 vial (equal to 100,000 I.U. of vitamin D3) once a month for 4-6 months.
Pregnant women
1 ampoule (equal to 100,000 I.U. of vitamin D3) at the beginning of the last quarter.
Adults and Seniors
Prevention: 1 ampoule (equal to 100,000 I.U. of vitamin D3) every 4 months. In subjects at high risk of deficiency it may be necessary to increase the dosage to 1 ampoule (equal to 100,000 I.U. of vitamin D3) every 2 months.
Treatment: 2 ampoules (equal to 200,000 I.U. of vitamin D3) once a month for 3 months.
Instructions for Use
Doses can be administered orally or intramuscularly. The vials are equipped with a pre-breaking ring and must be opened as follows: hold the lower part of the vial with one hand; place your other hand on top by placing your thumb over the white ring and exert pressure.
DIBASE 300.000 I.U./ml solution for injection
Newborns up to 24 months
It is recommended to administer the doses with DIBASE 10,000 I.U. / ml oral drops, solution or with DIBASE 25.000 I.U./2.5 ml oral solution or with DIBASE 50.000 I.U. / 2.5 ml oral solution.
Children and Teenagers (2-18 years)
Prevention: 1 ampoule (equal to 300,000 I.U. of vitamin D3) once a year.
Treatment: 1 vial (equal to 300,000 I.U. of vitamin D3) to be repeated after 3 months.
Adults and Elderly
Prevention: 1 ampoule (equal to 300,000 I.U. of vitamin D3) once a year. In subjects at high risk of deficiency it may be necessary to increase the dosage to 1 ampoule (equal to 300,000 I.U. of vitamin D3) every 6 months.
Treatment: 1 vial (equal to 300,000 I.U. of vitamin D3) to be repeated after 6 weeks.
Instructions for Use
Doses can be administered orally or intramuscularly.
The vials are equipped with a pre-breaking ring and must be opened as follows: hold the lower part of the vial with one hand; place the other hand on top by placing your thumb over the white ring and exert pressure.
Overdose What to do if you have taken too much Dibase
Stop taking DIBASE when calcium exceeds 10.6 mg / dl (2.65 mmol / l) or if calcium exceeds 300 mg / 24 h in adults or 4-6 mg / kg / day in children. overdose manifests itself as hypercalciuria and hypercalcemia, the symptoms of which are as follows: nausea, vomiting, thirst, polydipsia, polyuria, constipation and dehydration.
Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcemia
Overdose during the first 6 months of pregnancy can have toxic effects in the fetus: there is a correlation between excess intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed physical and mental development of the child, supravalvular aortic stenosis and retinopathy. Maternal hypercalcemia can also lead to suppression of parathyroid function in infants resulting in hypocalcemia, tetany and convulsions.
Treatment in case of overdose
Discontinue administration of DIBASE and proceed with rehydration.
In case of accidental ingestion / intake of an excessive dose of DIBASE, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of DIBASE, ask your doctor or pharmacist.
Side Effects What are the side effects of Dibase
Like all medicines, DIBASE can cause side effects, although not everybody gets them. If the dosage is in accordance with the actual individual needs, DIBASE is well tolerated, thanks also to the body's ability to accumulate cholecalciferol in the adipose and muscle tissues.
The side effects reported with the use of vitamin D are the following:
Immune system disorders:
hypersensitivity reactions.
Metabolism and nutrition disorders:
weakness, anorexia, thirst
Psychiatric disorders:
drowsiness, confusion.
Nervous system disorders:
headache.
Gastrointestinal disorders:
constipation, flatulence, abdominal pain, nausea, vomiting, diarrhea, metallic taste, dry mouth.
Skin and subcutaneous tissue disorders:
rash, itching.
Renal and urinary disorders:
nephrocalcinosis, polyuria, polydipsia, renal failure.
Diagnostic tests:
hypercalciuria, hypercalcemia.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
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. Undesirable effects can also be reported 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.
Expiry and Retention
See the expiry date printed on the package.
The validity period is intended for the product in intact packaging, correctly stored.
The expiry date refers to the last day of the month.
ATTENTION: Do not use DIBASE after the expiry date indicated on the package
storage
Store at a temperature not exceeding 30 ° C. Do not freeze.
Store in the original package to keep the medicine protected from light.
BASE 10,000 I.U./ml oral drops, solution
The validity of the medicine after first opening the bottle is 5 months (write the date of first opening in the space provided on the box).
After this period, the residual medicinal product must be discarded.
Keep this medicine out of the reach and sight of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
COMPOSITION
BASE 10,000 I.U./ml oral drops, 10 ml solution contain: Active ingredient: cholecalciferol (vitamin D3) 2.5 mg equal to 100,000 I.U. 1 drop contains: 250 I.U. of vitamin D3. Excipients: refined olive oil.
BASE 25.000 I.U./2.5 ml oral solution A single-dose container contains: Active ingredient: cholecalciferol (vitamin D3) 0.625 mg equal to 25.000 I.U. Excipients: refined olive oil.
BASE 50.000 I.U./2.5 ml oral solution A single-dose container contains: Active ingredient: cholecalciferol (vitamin D3) 1.25 mg equal to 50.000 I.U. Excipients: refined olive oil.
DIBASE 100.000 I.U./ml solution for injection Each vial contains: Active ingredient: cholecalciferol (vitamin D3) 2.5 mg equal to 100.000 I.U. Excipients: refined olive oil for injectable use.
DIBASE 300.000 I.U./ml solution for injection Each vial contains: Active ingredient: cholecalciferol (vitamin D3) 7.5 mg equal to 300.000 I.U. Excipients: refined olive oil for injectable use.
PHARMACEUTICAL FORM AND CONTENT
Oral drops, solution: amber glass bottle, closed with a child resistant polypropylene cap. The package contains 1 bottle of 10 ml and 1 dropper.
Oral solution: amber glass container, closed with a polypropylene capsule. Packs of 1, 2 or 4 single-dose containers of 2.5 ml.
Solution for injection: amber glass vials. Packs of 6 vials of 100,000 U.I./ml and 2 vials of 300,000 U.I./ml
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
BASIC
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
BASE 10,000 U.I. / ml oral drops, solution
10 ml contain: cholecalciferol (vitamin D3) 2.5 mg equal to 100,000 I.U.
1 drop contains: 250 I.U. of vitamin D3.
BASE 25.000 I.U./2.5 ml oral solution
A single-dose container contains: cholecalciferol (vitamin D3) 0.625 mg equal to 25,000 I.U.
BASE 50.000 I.U./2.5 ml oral solution
A single-dose container contains: cholecalciferol (vitamin D3) 1.25 mg equal to 50,000 I.U.
BASE 100,000 I.U./ml solution for injection
one vial contains: cholecalciferol (vitamin D3) 2.5 mg equal to 100,000 I.U.
DIBASE 300.000 I.U./ml solution for injection
one vial contains: cholecalciferol (vitamin D3) 7.5 mg equal to 300,000 I.U.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
• Injectable solution;
• oral solution;
• oral drops, solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Prevention and treatment of vitamin D deficiency
04.2 Posology and method of administration
DIBASE can be administered on a daily, weekly, monthly or yearly basis (see section 5.2).
In case of oral therapy, it is recommended to administer DIBASE with meals (see section 5.2). Intramuscular therapy is indicated only in cases of malabsorption syndromes.
Prevention of vitamin D deficiency: the preventive administration of DIBASE is recommended in all conditions characterized by greater risk of deficiency or increased need. It is generally recognized that the prevention of vitamin D deficiency must be carried out:
• systematically in the newborn (in particular in the premature baby), in the infant, in the pregnant woman (last trimester) and in the breastfeeding woman at the end of winter and in spring, in the elderly subject, possibly in the child and adolescent if the sun exposure is insufficient;
• in the following conditions:
§ poor sun exposure or intense skin pigmentation, unbalanced diet (low in calcium, vegetarian, etc.), extensive dermatological pathologies or granulomatous diseases (tuberculosis, leprosy, etc.);
§ subjects being treated with anticonvulsants (barbiturates, phenytoin, primidone);
§ subjects being treated with long-term corticosteroid therapies;
§ digestive pathologies (intestinal malabsorption, mucoviscidosis or cystic fibrosis);
§ liver failure.
Treatment of vitamin D deficiency: Vitamin D deficiency must be ascertained clinically and / or with laboratory investigations. Treatment is aimed at restoring vitamin D deposits and will be followed by maintenance therapy if the risk of deficiency persists, at a dose of vitamin D suitable for prevention (see above "Prevention of vitamin D deficiency").In most cases it is advisable not to exceed a cumulative dose of 600,000 I.U. per year, unless otherwise advised by the doctor.
As an indication, the following dosage schedule is provided, to be adapted in the judgment of the physician on the basis of the nature and severity of the deficiency status (see also section 4.4).
BASE 10,000 I.U./ml oral drops, solution
The daily doses indicated below can also be taken once a week by multiplying the indicated daily dose by seven.
Babies, Children and Adolescents (
Prevention: 2-4 drops per day (equal to 500-1,000 I.U. of vitamin D3).
Treatment: 8-16 drops per day (equal to 2,000-4,000 I.U. of vitamin D3) for 4-5 months.
Pregnant women
3-4 drops per day (equal to 750-1,000 I.U. of vitamin D3) in the last quarter.
Adults and Elderly
Prevention: 3-4 drops per day (equal to 750-1,000 I.U. of vitamin D3). In subjects at high risk of deficiency it may be necessary to increase the dosage up to 8 drops per day (equal to 2,000 I.U. of vitamin D3).
Treatment: 20-40 drops per day (equal to 5,000-10,000 I.U. of vitamin D3) for 1-2 months.
Instructions for Use
The pack contains 1 bottle and a dropper. The bottle comes with a child resistant capsule. The dropper comes with a case. For use, follow the instructions below:
to. open the bottle by removing the cap as follows: press and unscrew at the same time;
b. unscrew the plastic case that wraps the dropper tip;
c. insert the dropper into the bottle to withdraw the contents. Dose the drops in a spoon and administer (see "Posology and method of administration");
d. close the bottle. Screw the case back onto the dropper tip;
And. put the bottle and the dropper back in the package.
BASE 25.000 I.U./2.5 ml oral solution
Babies, Children and Adolescents (
Prevention: 1 single-dose container (equal to 25,000 I.U. of vitamin D3) every 1-2 months.
Treatment: 1 single-dose container (equal to 25,000 I.U. of vitamin D3) once a week for 16-24 weeks.
Pregnant women
1 single-dose container (equal to 25,000 I.U. of vitamin D3) once a month in the last quarter.
Adults and Elderly
Prevention: 1 single-dose container (equal to 25,000 I.U. of vitamin D3) once a month. In subjects at high risk of deficiency it may be necessary to increase the dosage to 2 single-dose containers (equal to 50,000 I.U. of vitamin D3) once a month.
Treatment: 2 single-dose containers (equal to 50,000 I.U. of vitamin D3) once a week for 8-12 weeks.
BASE 50.000 I.U./2.5 ml oral solution
Babies, Children and Adolescents (
Prevention: 1 single-dose container (equal to 50,000 I.U. of vitamin D3) every 2-4 months.
Treatment: 1 single-dose container (equal to 50,000 I.U. of vitamin D3) once a week for 8-12 weeks.
Pregnant women
2 single-dose containers (equal to 100,000 I.U. of vitamin D3) at the beginning of the last quarter.
Adults and Elderly
Prevention: 1 single-dose container (equal to 50,000 I.U. of vitamin D3) every 2 months. In subjects at high risk of deficiency it may be necessary to increase the dosage to 1 single-dose container (equal to 50,000 I.U. of vitamin D3) once a month.
Treatment: 1 single-dose container (equal to 50,000 I.U. of vitamin D3) once a week for 8-12 weeks.
BASE 100,000 I.U./ml solution for injection
Newborns up to 24 months
Prevention: It is recommended to administer the doses with DIBASE 10,000 I.U. / ml oral drops, solution or with DIBASE 25.000 I.U./2.5 ml oral solution or with DIBASE 50.000 I.U. / 2.5 ml oral solution.
Treatment: 1 vial (equal to 100,000 I.U. of vitamin D3) once a month for 4-6 months.
Children and Teenagers (2-18 years)
Prevention: 1 ampoule (equal to 100,000 I.U. of vitamin D3) every 4-8 months.
Treatment: 1 vial (equal to 100,000 I.U. of vitamin D3) once a month for 4-6 months.
Pregnant women
1 ampoule (equal to 100,000 I.U. of vitamin D3) at the beginning of the last quarter.
Adults and Elderly
Prevention: 1 ampoule (equal to 100,000 I.U. of vitamin D3) every 4 months. In subjects at high risk of deficiency it may be necessary to increase the dosage to 1 ampoule (equal to 100,000 I.U. of vitamin D3) every 2 months.
Treatment: 2 ampoules (equal to 200,000 I.U. of vitamin D3) once a month for 3 months.
Instructions for Use
Doses can be administered orally or intramuscularly.
The vials are equipped with a pre-breaking ring and must be opened as follows: hold the lower part of the vial with one hand; place the other hand on top by placing your thumb over the white ring and exert pressure.
DIBASE 300.000 I.U./ml solution for injection
Newborns up to 24 months
It is recommended to administer the doses with DIBASE 10,000 I.U. / ml oral drops, solution or with DIBASE 25.000 I.U./2.5 ml oral solution or with DIBASE 50.000 I.U. / 2.5 ml oral solution.
Children and Teenagers (2-18 years)
Prevention: 1 ampoule (equal to 300,000 I.U. of vitamin D3) once a year.
Treatment: 1 vial (equal to 300,000 I.U. of vitamin D3) to be repeated after 3 months.
Adults and Elderly
Prevention: 1 ampoule (equal to 300,000 I.U. of vitamin D3) once a year. In subjects at high risk of deficiency it may be necessary to increase the dosage to 1 ampoule (equal to 300,000 I.U. of vitamin D3) every 6 months.
Treatment: 1 vial (equal to 300,000 I.U. of vitamin D3) to be repeated after 6 weeks.
Instructions for Use
Doses can be administered orally or intramuscularly.
The vials are equipped with a pre-breaking ring and must be opened as follows: hold the lower part of the vial with one hand; place the other hand on top by placing your thumb over the white ring and exert pressure.
04.3 Contraindications
• Hypersensitivity to cholecalciferol or to any of the excipients.
• Hypercalcemia, hypercalciuria.
• Kidney stones (nephrolithiasis, nephrocalcinosis).
• Renal failure (see section 4.4).
04.4 Special warnings and appropriate precautions for use
In case of prolonged administration with high dosages, it is advisable to monitor the serum level of 25-hydroxy-cholecalciferol. Stop taking DIBASE when the serum level of 25-hydroxy-cholecalciferol exceeds 100 ng / ml (equal to 250 nmol / l).
In elderly patients already being treated with cardiac glycosides or diuretics it is important to monitor calcium and calciumuria. In case of hypercalcaemia or renal insufficiency, reduce the dose or discontinue treatment.
To avoid overdose, take into account the total dose of vitamin D when combining with treatments already containing vitamin D, foods supplemented with vitamin D or when using milk enriched with vitamin D.
In the following cases it may be necessary to increase the dosages compared to those indicated:
• subjects being treated with anticonvulsants or barbiturates (see section 4.5);
• subjects being treated with corticosteroid therapies (see section 4.5);
• subjects being treated with lipid-lowering agents such as colestipol, cholestyramine and orlistat (see section 4.5);
• subjects being treated with aluminum-containing antacids (see section 4.5);
• obese subjects (see section 5.2);
• digestive disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis);
• liver failure.
The product should be prescribed with caution to patients suffering from sarcoidosis, due to the possible increase in the metabolism of vitamin D in its active form. In these patients, the level of calcium in serum and urine should be monitored.
Patients with renal insufficiency have an impaired metabolism of vitamin D; therefore, if they are to be treated with cholecalciferol, the effects on calcium and phosphate homeostasis should be monitored.
04.5 Interactions with other medicinal products and other forms of interaction
The concomitant use of anticonvulsants or barbiturates may reduce the effect of vitamin D3 by metabolic inactivation.
In the case of treatment with thiazide diuretics, which reduce the urinary elimination of calcium, monitoring of serum calcium concentrations is recommended.
Concomitant use of glucocorticosteroids may reduce the effect of vitamin D3.
When treated with digitalis-containing drugs, oral administration of calcium combined with vitamin D increases the risk of digitalis toxicity (arrhythmia). Close medical supervision and, if necessary, monitoring of electrocardiography and serum calcium concentrations are therefore required.
A concomitant use of aluminum-containing antacids can interfere with the efficacy of the drug by decreasing the absorption of vitamin D, while preparations containing magnesium may expose you to the risk of hypermagnesaemia.
Animal studies have suggested a possible potentiation of the action of warfarin when administered with calciferol. Although there is no similar evidence with the use of cholecalciferol, caution should be exercised when the two drugs are used concurrently.
Cholestyramine, colestipol and orlistat reduce the absorption of vitamin D, while chronic alcoholism decreases the vitamin D stores in the liver.
04.6 Pregnancy and lactation
Pregnancy
In the first 6 months of pregnancy, vitamin D should be taken with caution due to the risk of teratogenic effects (see section 4.9).
Feeding time
When needed, vitamin D can be prescribed during breastfeeding. This supplementation does not replace the administration of vitamin D in the newborn.
04.7 Effects on ability to drive and use machines
No data are available on the effects of the product on the ability to drive. However, an effect on this ability is unlikely.
04.8 Undesirable effects
If the dosage is in accordance with actual individual needs, DIBASE is well tolerated, thanks also to the body's ability to accumulate cholecalciferol in adipose and muscle tissues (see section 5.2).
The side effects reported with the use of vitamin D are the following:
Disorders of the immune system :
hypersensitivity reactions.
Metabolism and nutrition disorders :
weakness, anorexia, thirst.
Psychiatric disorders :
drowsiness, confusion.
Nervous system disorders:
headache.
Gastrointestinal disorders :
constipation, flatulence, abdominal pain, nausea, vomiting, diarrhea, metallic taste, dry mouth.
Skin and subcutaneous tissue disorders :
rash, itching.
Renal and urinary disorders :
nephrocalcinosis, polyuria, polydipsia, renal failure.
Diagnostic tests :
hypercalciuria, hypercalcemia.
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
Stop taking DIBASE when calcium exceeds 10.6 mg / dl (2.65 mmol / l) or if calcium exceeds 300 mg / 24 h in adults or 4-6 mg / kg / day in children. overdose manifests itself as hypercalciuria and hypercalcemia, the symptoms of which are as follows: nausea, vomiting, thirst, polydipsia, polyuria, constipation and dehydration.
Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcemia.
Overdose during the first 6 months of pregnancy can have toxic effects in the fetus: there is a correlation between excess intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed physical and mental development of the child, supravalvular aortic stenosis and retinopathy. Maternal hypercalcemia can also lead to suppression of parathyroid function in infants resulting in hypocalcemia, tetany and convulsions.
Treatment in case of overdose
Discontinue administration of DIBASE and proceed with rehydration.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Vitamin D and analogues, cholecalciferol.
ATC code: A11CC05.
Vitamin D corrects a deficiency situation and increases the intestinal absorption of calcium.
05.2 Pharmacokinetic properties
As with the other fat-soluble vitamins, the absorption of cholecalciferol from the intestine is favored by the concomitant intake of foods containing fat.
Cholecalciferol is present in the bloodstream in association with specific α-globulins that transport it to the liver, where it is hydroxylated to 25-hydroxy-cholecalciferol. A second hydroxylation occurs in the kidneys, where 25-hydroxy-cholecalciferol is transformed into 1,25-dihydroxy-cholecalciferol, which is the active metabolite of vitamin D responsible for the effects on phosphocalcic metabolism.
Non-metabolized cholecalciferol is accumulated in adipose and muscle tissues to be made available according to the needs of the organism: for this reason DIBASE can also be administered on a weekly, monthly or annual basis. In obese subjects the bioavailability of vitamin D is reduced. cause of excess adipose tissue.
Vitamin D is eliminated in the faeces and urine.
05.3 Preclinical safety data
Preclinical studies conducted in various animal species show that toxic effects occur in animals at doses significantly higher than those expected for therapeutic use in humans.
In repeat dose toxicity studies, the most commonly seen effects were: increased calcium, decreased phosphaturia and proteinuria.
At high doses, hypercalcemia was observed. In a prolonged condition of hypercalcemia, the most frequent histological changes (calcification) were affecting the kidneys, heart, aorta, testes, thymus and intestinal mucosa.
Reproductive toxicity studies have shown that cholecalciferol has no harmful effects on fertility and reproduction.
At doses that are equivalent to therapeutic ones, cholecalciferol has no teratogenic activity.
Cholecalciferol has no potential for mutagenic and carcinogenic activity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
BASE 10,000 U.I. / ml oral drops, solution: refined olive oil.
BASIS 25.000 I.U. / 2.5 ml oral solution: refined olive oil.
BASIS 50,000 I.U. / 2.5 ml oral solution: refined olive oil.
BASIS 100.000 I.U. / ml solution for injection: refined olive oil for injectable use.
BASIS 300.000 I.U. / ml solution for injection: refined olive oil for injectable use.
06.2 Incompatibility
There are no known incompatibilities with other drugs.
06.3 Period of validity
BASE 10,000 U.I. / ml oral drops, solution: 3 years in intact packaging. After first opening the bottle: 5 months.
BASIS 25.000 I.U. / 2.5 ml oral solution: 2 years.
BASIS 50,000 I.U. / 2.5 ml oral solution: 2 years
BASIS 100.000 I.U. / ml solution for injection: 3 years.
BASIS 300.000 I.U. / ml solution for injection: 3 years.
06.4 Special precautions for storage
Store at a temperature not exceeding 30 ° C, in the original package to keep the medicine protected from light.
Do not freeze.
06.5 Nature of the immediate packaging and contents of the package
BASE 10,000 I.U./ml oral drops, solution
Amber glass bottle containing 10 ml, closed with a child resistant polypropylene cap. The pack contains 1 bottle and 1 dropper.
BASE 25.000 I.U./2.5 ml oral solution
Amber glass container containing 2.5 ml, closed with a polypropylene cap. Packs of 1, 2 or 4 single-dose containers.
BASE 50.000 I.U./2.5 ml oral solution
Amber glass container containing 2.5 ml, closed with a polypropylene cap. Packs of 1, 2 or 4 single-dose containers.
BASE 100,000 I.U./ml solution for injection
Amber glass vial. The pack contains 6 ampoules.
DIBASE 300.000 I.U./ml solution for injection
Amber glass vial. The pack contains 2 ampoules.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
ABIOGEN PHARMA S.p.A. - via Meucci 36 - Ospedaletto - PISA.
08.0 MARKETING AUTHORIZATION NUMBER
BASE 10,000 U.I. / ml oral drops, solution - 10 ml bottle 036635011
BASIS 25.000 I.U. / 2.5 ml oral solution - 1 single-dose container 2.5 ml 036635047
BASIS 25.000 I.U. / 2.5 ml oral solution - 2 single-dose containers 2.5 ml 036635098
BASIS 25.000 I.U. / 2.5 ml oral solution - 4 single-dose containers 2.5 ml 036635050
BASIS 50,000 I.U. / 2.5 ml oral solution - 1 single-dose container 2.5 ml 036635062
BASIS 50,000 I.U. / 2.5 ml oral solution - 2 single-dose containers 2.5 ml 036635086
BASIS 50,000 I.U. / 2.5 ml oral solution - 4 single-dose containers 2.5 ml 036635074
BASIS 100.000 I.U. / ml solution for injection - 6 ampoules 1 ml 036635023
BASIS 300.000 I.U. / ml solution for injection - 2 ampoules 1 ml 036635035
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
October 2010
10.0 DATE OF REVISION OF THE TEXT
AIFA Determination of March 2014
