InVita D3 2,400 IU/ml oral drops, solution

Țară: Regatul Unit

Limbă: engleză

Sursă: myHealthbox

Ingredient activ:

Cholecalciferol

Disponibil de la:

Consilient Health Limited

Codul ATC:

A11CC05

INN (nume internaţional):

Cholecalciferol

Dozare:

1 drop contains 1.67 microgram equivalent to 67 IU vitamin D3

Forma farmaceutică:

Oily liquid

Calea de administrare:

Oral use

Unități în pachet:

1, 2, 3 or 4 dropper container(s) with 10 ml solution

Tip de prescriptie medicala:

POM - Prescription Only Medicine

Produs de:

SMB Technology S.A

Grupul Terapeutică:

Vitamin D and analogues, cholecalciferol

Indicații terapeutice:

Prevention of vitamin D deficiency in infants and children; prevention of vitamin D deficiency in pregnant and breast-feeding women

Statutul autorizaţiei:

Authorised

Data de autorizare:

2015-01-28

Prospect

Read all of this leaflet carefully before you start using 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 or pharmacist, or
nurse.
•
This medicine has been prescribed for you only. Do not pass it onto
others. It may
 harm them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, or pharmacist, or
nurse. This includes
 any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What InVita D3 is and what it is used for
2.  What you need to know before you use InVita D3
3.  How to use InVita D3
4.  Possible side effects
5.  How to store InVita D3
6.  Contents of the pack and other information
  1. WHAT INVITA D3 IS AND WHAT IT IS USED FOR
InVita D3 oral drops contain cholecalciferol (vitamin D). Vitamin D
can be found in some
foods and is also produced by the body when skin is exposed to
sunlight. Vitamin D
helps the kidneys and intestine absorb calcium and it helps build
bones.
InVita D3 oral drops are used:
•
 to prevent vitamin D deficiency when there is a significant risk of
deficiency or an
increased demand for vitamin D
•
 with other medicines to treat certain bone conditions, such as
thinning of the bone
(osteoporosis)
•
 to treat vitamin D deficiency that has been confirmed by laboratory
tests.
  2. WHAT YOU NEED TO KNOW BEFORE YOU USE INVITA D3 
Do not use InVita D3 
•
if you are allergic to vitamin D or any of the other ingredients of
this medicine (listed
in section 6)
•
if you have high levels of calcium in your blood (hypercalcaemia) or
urine
(hypercalciuria)
•
if you have kidney stones (renal calculi)
•
if you have high levels of vitamin D in your blood (hypervitaminosis
D).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using InVita D3 if
you:
•
are undergoing treatment with certain medicines used to treat heart
disor

Caracteristicilor produsului

Invita D3 2,400 IU/ml oral drops, solution
Summary of Product Characteristics Updated 17­Jun­2015 | Consilient Health Ltd
1. Name of the medicinal product
InVita D3 2,400 IU/ml oral drops, solution
2. Qualitative and quantitative composition
1 ml solution (36 drops) contains 0.06 mg cholecalciferol, equivalent to 2,400 IU vitamin D3.
1 drop contains 1.67 microgram cholecalciferol, equivalent to 67 IU vitamin D3.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Clear, slightly yellow, oily liquid with an orange odour
4. Clinical particulars
4.1 Therapeutic indications
­ Prevention of vitamin D deficiency in infants and children
­ Prevention of vitamin D deficiency in pregnant and breast­feeding women
4.2 Posology and method of administration
Posology
1 drop contains 67 IU vitamin D3.
• Paediatric posology
­ prevention of deficiency 0­1 years 400 IU/day (6 drops)
­ prevention of deficiency 1­18 years 600 IU/day (9 drops)
• Pregnancy and breast­feeding posology
­ prevention of deficiency 400 IU/day (6 drops)
• Special populations
­ patients with renal impairment: no specific adjustment is required
­ Other conditions: in obese patients, patients with malabsorption syndromes, and patients on medications affecting
vitamin D metabolism, higher doses are required for the treatment and prevention of vitamin D deficiency (2 ­ 3 times
higher).
Method of administration
Patients should be advised to take InVita D3 preferably with a meal (see section 5.2 Pharmacokinetic properties ­
“Absorption”).
The product should be shaken before use.
InVita D3 can be taken as is or to facilitate the intake it can also be mixed with a spoonful or a small amount of cold or
lukewarm food immediately prior to use. The patient should be sure to take the en