ZYMAD VITAMIN D 000IU 200 BULB ORAL 2ML

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ZYMAD VITAMIN D 000IU 200 BULB ORAL 2ML: The essential role of vitamin D in the intestine, which increases the ability to absorb calcium and phosphate, and the skeleton where it promotes mineralization (through its direct actions on bone formation and its indirect actions intestine, parathyroid, and bone mineralization already).

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ZYMAD VITAMIN D 000IU 200 BULB ORAL 2ML

 

Description zymad Vitamin D 000IU 200 oral vial 2ml

 

Treatment and / or prophylaxis of vitamin D.


The essential role of vitamin D in the intestine, which increases the ability to absorb calcium and phosphate, and the skeleton where it promotes mineralization (through its direct action on bone formation and its indirect actions intestine, parathyroid, and bone mineralization already).


Application advice and opinions on zymad 200 000IU vitamin D oral vial 2ml

 

DOSAGE AND ADMINISTRATION

Orally.

The contents of the ampoule can be taken in a teaspoon pure or mixed in a liquid or semi-liquid food.

Vitamin A deficiency in children

Prophylaxis

Its implementation is:

Mandatory for all infants 0-18 months and in winter for children up to 5 years of age (ministerial circular of 21 February 1963 and 6 January 1971)

Recommended for children and adolescents when living conditions include:

Do you even lift           insufficient exposure to sunlight,

Do you even lift           a diet low in vitamin D.

+ Premature: it is preferable to administer daily doses drops

+ 0 to 18 months: without fortified with vitamin D in children or pigmented skin milk: 1 bulb every 6 months.

+ 18 months to the end of adolescence:

Without digestive pathology: 1 bulb at the beginning of winter

With gastrointestinal disease or receiving anticonvulsants: 1 ampoule every 3 months.

Treatment

1 bulb, renewable one time in six months, then resume the usual prophylaxis to prevent relapse. Do not exceed a total dose of 600,000 IU / year.

Vitamin deficiency in adults and the elderly

Prophylaxis

Elderly: 1 bulb every 6 months.

Adult at risk of deficiency (digestive pathology, institution, anti-convulsant treatment ...): 1 bulb every 6 months.

Treatment

1 ampoule renewable 1 or 2 times in 6 months, then resume the usual prophylaxis to prevent relapse. Do not exceed a total dose of 600,000 IU / year.

 

Composition zymad Vitamin D 000IU 200 oral vial 2ml

 

EXPRESSED BY BULB

Active ingredients

IU cholecalciferol 200000.0

Excipients

Sweet orange essential oil
Macrogolglycerides oleic
Refined olive oil for injections
 

Precaution for use with zymad Vitamin D 000IU 200 oral vial 2ml

 

In patients with a history of hypersensitivity to cholecalciferol or any component of the product.

Hypercalcemia, hypercalciuria, calcium nephrolithiasis.

 

To avoid overdose, consider the total doses of vitamin D when combined with a treatment already contains this vitamin or when using milk fortified with vitamin D.

In indications requiring strong and repeated doses, monitor serum calcium and urinary calcium and stop intakes of vitamin D if serum calcium exceeds 106 mg / l (2.65 mmol / l) or urinary calcium exceeds 300 mg/24 h in adult or 4-6 mg/kg/24 h in children

 

ADVERSE REACTIONS

Skin and subcutaneous tissue disorders: pruritus, rash, erythema, edema.

 

PREGNANCY AND BREASTFEEDING

If necessary, vitamin D may be prescribed an appropriate dose during pregnancy and lactation. However, this assay is not suitable for pregnant women. This supplement does not replace the administration of vitamin D in the newborn.

 

Warnings on drugs

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Attention to incompatibilities on products in your.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find record of the drug at the site of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related adverse event (s) (s) (s) the use of a drug

 

VIDAL OF THE FAMILY

ZYMAD 80,000 and 200,000 IU

Vitamin D

vitamin D3

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

ZYMAD 80 000 IU: oral solution (orange flavoring); 2 ml ampoule.
Refunded at 65%. - price: 1,25 euro (s).
List II

ZYMAD 200 000 IU: oral solution (orange flavoring); 2 ml ampoule.
Refunded at 65%. - price: 1,25 euro (s).
List II

Laboratory Meda Pharma

COMPOSITION (summary)
p amp p amp
Colecalciferol (vitamin D3) 80,000 IU 200,000 IU

INDICATIONS (summary)
This medicine contains vitamin D, which allows bone fixation of calcium and whose deficiency causes rickets .
It is used to prevent and treat vitamin D deficiencies.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • excess calcium in the blood or urine,
  • a history of kidney stones containing calcium.
WARNING (Contents)
An overdose of vitamin D exposes to serious adverse effects.
Vitamin D is present in many infant formulas and medicines available without a prescription: take the advice of your doctor or pharmacist to avoid any risk of overdose .
DRUG INTERACTIONS (summary)
Inform your doctor or pharmacist if you are taking a medication containing orlistat.
PREGNANCY AND BREAST-FEEDING (summary)
This medication may be used in pregnant or nursing women, but the dosage prescribed by the doctor should not be exceeded.
Hypercalcemia during pregnancy could be harmful to the unborn child. Be sure not to take several medications containing vitamin D during pregnancy.
DIRECTIONS FOR USE AND DOSAGE (summary)
Solutions can be taken pure or diluted in a liquid (milk from the bottle or juice) or in a semi-liquid food. Do not put them in a hot liquid or heat them.

Usual dosage:

80,000 IU bulb:
In the prevention of deficiency in vitamin D:
  • Breast-fed infant and young child up to 5 years of age: 1 ampoule every 6 months for infants taking milk fortified with vitamin D; 1 ampoule every 2 or 3 months for breastfed infants or without milk fortified with vitamin D.
  • Child and adolescent: 1 ampoule every 2 or 3 months during the winter. In the presence of a gastrointestinal disease or an antiepileptic treatment, the dosage is 1 or 2 ampoules every 3 months.
  • Pregnant woman: 1 ampoule in the 6th or 7th month of pregnancy.
  • Adults at risk of deficiency and elderly: 1 ampoule every 2 or 3 months.
In the treatment of deficiency in vitamin D: the dosage is strictly individual.
Bulb at 200,000 IU:
In the prevention of deficiency in vitamin D:
  • Infant under 18 months (without milk enriched in vitamin D or dark skin): 1 ampoule every 6 months.
  • Child over 18 months and adolescent: 1 ampoule at the beginning of winter. In the presence of a gastrointestinal disease or an antiepileptic treatment, the dosage is 1 ampoule every 3 months.
  • Adults at risk of deficiency and elderly: 1 ampoule every 6 months.
In the treatment of deficiency in vitamin D: 1 bulb renew as recommended by the doctor.
TIPS (summary)
The deficiencies in vitamin D are especially common in young children or little dark skin exposed to the sun; in fact, vitamin D is made by the skin under the influence of ultraviolet rays.
Prevention of rickets by vitamin D should be routine in infants and young children.
This medication should be stored in a dark place.
POSSIBLE ADVERSE EFFECTS (summary)
Itching, rash, swelling.
Other side effects include overdosage and medical advice: headache, tiredness, loss of appetite, weight loss, nausea, vomiting, increased urine volume, intense thirst, dehydration, kidney stones, kidney failure .


GLOSSARY (summary)


antecedent
Affection healed or always in evolution. The antecedent may be personal or family. The background is the history of a person's health.


deficiency
Deficit usually involving nutrients, vitamins, minerals, etc. A diversified diet is the best prevention of deficiencies.


hypercalcemia
Excess of calcium in the blood, due to illness or the use of certain drugs (excess vitamin D).


infants
Child from one to 30 months. A child under one month is a newborn.


dosage
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


rickets
Disease of growth due to deficiency of vitamin D. It results in a deformation of the bones and cartilages, and disorders of the general state. Vitamin D is manufactured in the skin provided that it is sufficiently exposed to the sun; it promotes the absorption and fixation of calcium and phosphorus, the main constituents of bone.


overdose
Excessive intake of a drug may result in an increase in the intensity of adverse effects or even in the development of specific adverse effects.
This overdose may result from accidental or voluntary poisoning for suicide, so consult your local Poison Control Center (listed in the appendix to the book). However, in most cases, overdose is the result of an error in the understanding of the prescription, or the search for an increase in efficacy by exceeding the recommended dosage. Finally, untimely self-medication may lead to excessive absorption of the same substance contained in different drugs. Some drugs are particularly prone to this risk because they are (wrongly) considered to be harmless: vitamins A and D, aspirin, etc. Stopping or decreasing drug intake helps to remove the disorders associated with an overdose.


ultraviolet
Ultraviolet rays are radiation emitted naturally by the sun or artificially by certain lamps. UV A and UVB are distinguishable. Short-wave UV B are stopped in the outermost layers of the skin. They are responsible for burns (sunburn). The UVA, of wider wavelength, penetrate deeply and reach the dermis. They induce pigmentation (tanning). Repeated intense UV exposure causes premature aging of the skin and increases the risk of skin cancer.
Abbreviation: UV.


vitamin
An essential ingredient for the growth and proper functioning of the body. Vitamin requirements are normally covered by a varied diet. In developed countries, only vitamin D deficiency, in the young child or the old man who is exposed to the sun, justifies systematic supplementation. Superior intake, especially with medicines, can lead to overdose and various disorders (mainly vitamins A and D).

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Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Updated on: 20/07/2017

Name of the medicinal product

ZYMAD 200,000 IU oral solution in ampoule

cholecalciferol

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

· Keep this leaflet, you may need to read it again

· If you have any further questions, ask your doctor, pharmacist or nurse.

· This medicine has been prescribed for you. Do not give this to anyone else. It could be harmful to them, even if the signs of their illness are the same as yours.

· If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.

Review summary

In this notice :

1. WHAT IS ZYMAD 200 000 IU, drinkable solution in ampoule AND WHAT CASES IS IT USED FOR?

2. BEFORE YOU TAKE ZYMAD 200,000 IU, drinkable solution in ampoule?

3. HOW TO TAKE ZYMAD 200,000 IU, oral solution in ampoule?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE ZYMAD 200,000 IU, oral solution in ampoule?

6. ADDITIONAL INFORMATION

1. WHAT IS ZYMAD 200 000 IU, drinkable solution in ampoule AND WHAT CASES IS IT USED FOR?

Pharmacotherapeutic group

This medication is a vitamin D.

Therapeutic indications

It is indicated for the treatment and / or prevention of vitamin D deficiency.

2. BEFORE YOU TAKE ZYMAD 200,000 IU, drinkable solution in ampoule?

List of information needed before taking the medication

Not applicable.

Cons-indications

Do not take ZYMAD 200,000 IU oral solution in ampoule

· if you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medication mentioned in section 6;

· if you have hypercalcemia (excess calcium in the blood), hypercalciuria (excess calcium in the urine), calcium lithiasis (kidney stones).

· If you have a disease that can lead to hypercalcemia and / or hypercalciuria.

· If you have hypervitaminosis D

Precautions for use; special warnings

Warnings and Precautions

Talk to your doctor, pharmacist or nurse before taking ZYMAD 200,000 IU, oral solution in ampoule.

To avoid overdosage, take into account the total doses of vitamin D when combined with a treatment already containing this vitamin or when using milk supplemented with vitamin D.

Interaction with other medicines

Other medicines and ZYMAD 200 000 IU oral solution in ampoule

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

Interactions with food and beverages

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

Pregnancy

If needed, vitamin D may be prescribed during pregnancy. ZYMAD 200,000 IU is not a dosage suitable for pregnant women.

Ask your doctor or pharmacist for advice before taking any medicine.

feeding

If necessary, vitamin D may be prescribed during breastfeeding. However, this supplementation does not replace the administration of vitamin D in the newborn.

Ask your doctor or pharmacist for advice before taking any medicine.

Sport

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

Not applicable.

3. HOW TO TAKE ZYMAD 200,000 IU, oral solution in ampoule?

Instructions for proper use

Oral use.

The contents of the ampoule can be taken pure in a small spoon or mixed in a liquid or semi-liquid food.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Adult and elderly

Prophylaxis

1 ampoule every 6 months.

Treatment

1 ampoule renewable 1 to 2 times depending on the intensity of the deficiency until normalcy of calcemia and phosphoræmia, by monitoring the calciuria to avoid an overdose, then prophylactic treatment according to the above plan, without exceeding 600 000 IU per year.

Pediatric population

Prophylaxis

Its implementation is imperative for all infants from 0 to 18 months and then in winter for children up to 5 years (ministerial circulars of 21 February 1963 and 6 January 1971), due to:

· insufficient exposure to the sun,

· of a diet low in vitamin D.

It is generally recommended to ensure vitamin D supplementation in children and adolescents throughout the growth.

o Premature: it is preferable to administer daily doses in drops

o from 0 to 18 months: Milk-free or milk-free enriched with vitamin D or in children with pigmented skin: 1 ampoule every 6 months.

o from 18 months to late adolescence: 1 ampoule at the beginning of winter

In the presence of particular risks (such as strong skin pigmentation, absence of sun exposure, digestive malabsorption, renal insufficiency, antiepileptic treatment, obesity ...), it may be justified to continue supplementation throughout the year or increase doses in certain pathological situations.

Treatment

1 ampoule that is renewable once every 6 months depending on the intensity of the deficiency until calcium and phosphoric acid return to normal, by monitoring calcium in order to avoid overdosage and then prophylactic treatment according to the above scheme.

Administration mode

Oral use

The contents of the ampoule can be taken pure in a small spoon or mixed in a liquid or semi-liquid food.

Symptoms and Instructions for Overdose

If you take more than ZYMAD 200,000 IU, drinkable solution in ampoule that you should not have

Immediately consult your doctor or pharmacist.

Clinical signs of overdose are:

· headaches, tiredness, loss of appetite, slimming, stopping growth;

· nausea, vomiting;

· abundant urine, intense thirst, dehydration;

· kidney stone, calcification of tissues, especially kidney and vessels;

· renal failure (failure of kidney functions).

The biological signs of an overdose are:

· increased calcium in blood and urine and increased phosphorus levels in blood and urine, low parathyroid hormone concentration and elevated 25-hydroxyvitamin D

· In case of overdose, stop treatment, limit calcium intake (milk) and consult your doctor.

Instructions for omission of one or more doses

If you forget to take ZYMAD 200 000 IU, oral solution in ampoule:

Do not take a double dose to make up for a missed dose.

Risk of withdrawal syndrome

If you stop taking ZYMAD 200,000 IU, oral solution in ampoule:

Not applicable

If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, this medicine may cause side effects, although not everybody gets them.

In general, the frequency of adverse reactions is classified as follows:

· Very common (more than 1 in 10 people);

· Common (more than 1 in 100 people and less than 1 in 10 people);

· Uncommon (more than 1 in 1,000 people and less than 1 in 100 people);

· Rare (more than 1 in 10,000 people and less than 1 in 1,000 people);

· Very rare (less than 1 in 10,000 people);

· Frequency not known (can not be estimated from the available data).

Skin and subcutaneous tissue disorders may occur:

· Not known: pruritus, rash, erythema, edema.

Declaration of side effects

If you experience any side effects, talk to your doctor at your pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE ZYMAD 200,000 IU, oral solution in ampoule?

Keep this medicine out of the reach and sight of children.

Expiration date

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.

Storage conditions

Store at a temperature not exceeding 25ºC.

Keep the bulb in the outer carton, away from light.

If necessary, warnings against visible signs of deterioration

Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What is ZYMAD 200 000 IU, oral solution in ampoule?

The active substance is: cholecalciferol (vitamin D3) (200,000 IU per ampoule).

The other components are: sweet orange essential oil, oleic macrogolglycerides, refined olive oil.

Pharmaceutical form and content

Aspect of ZYMAD 200 000 IU, oral solution in ampoule and contents of the pack?

This medication is in the form of a drinkable solution in ampoule. Box of 1 ampoule of 2 ml.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Marketing Authorization Holder and Manufacturer

Holder

ROTTAPHARM

25 BOULEVARD OF AMIRAL BRUIX

75016 PARIS

exploiting

MYLAN MEDICAL SAS

40-44 Washington Street

75008 PARIS

Maker

LABORATORIES M. RICHARD

REYS DE SAULCE

26270 SAULCE SUR RHONE

or

RENAUDIN LABORATORY

ARTISANAL AREA ERROBI

64250 ITXASSOU

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

Date of approval of the notice

The last date on which this notice was revised is {MM / YYYY}

AMM under exceptional circumstances

Not applicable.

Internet Information

Detailed information on this medicine is available on the ANSM website (France).

Information for health professionals only

Not applicable.

Other

Not applicable.

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