InVita D3 25,000units/1ml oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Colecalciferol

Available from:

Consilient Health Ltd

ATC code:

A11CC05

INN (International Name):

Colecalciferol

Dosage:

25000unit/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060400; GTIN: 5391512451981

Patient Information leaflet

Read all of 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 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 invitaD3 is and what it is used for
2. What you need to know before you use invitaD3
3. How to use invitaD3
4. Possible side effects
5. How to store invitaD3
6. Contents of the pack and other information
1. WHAT INVITAD3 IS AND WHAT IT IS USED FOR
invitaD3 is a vitamin product containing colecalciferol (equivalent to
vitamin D
3
). Vitamin D can be
found in some foods and 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.
invitaD3 25,000 IU is used:
•
for the prevention of 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 INVITAD3
Do not use invitaD3
•
if you are allergic to vitamin D or any of the other ingredients of
invitaD3 (listed in section 6)
•
if you have hypercalcaemia (high levels of calcium in the blood)
•
if you have hypercalciuria (high levels of calcium in the urine)
•
if you have pseudohypoparathyroidism (disturbed parathyroid hormone
metabolism)
•
if you have renal calculi (kidney stones)
•
if you have hypervitaminosis D (high levels of vitamin D in the
blood).
Warnings and precautions
Talk to your doctor, pharmacist or nurse bef

Summary of Product characteristics

OBJECT 1
INVITA D3 25,000 IU ORAL SOLUTION
Summary of Product Characteristics Updated 11-May-2017 | Consilient
Health Ltd
1. Name of the medicinal product
InvitaD3 25,000 IU oral solution
2. Qualitative and quantitative composition
1 ml solution (1 single-dose oral solution) contains 0.625 mg
colecalciferol, equivalent to 25,000 IU
vitamin D. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution
Clear, slightly yellow, oily liquid with an orange odour.
4. Clinical particulars
4.1 Therapeutic indications
The prevention and treatment of vitamin D deficiency.
As an adjunct to specific therapy for osteoporosis in patients with
vitamin D deficiency or at risk of
vitamin D insufficiency.
4.2 Posology and method of administration
Posology
Paediatric posology:
- Prevention of deficiency 0-1 years 25,000 IU (1 single-dose oral
solution) every 8 weeks.
- Prevention of deficiency 1-18 years 25,000 IU (1 single-dose oral
solution) every 6 weeks.
- Treatment of deficiency 0-18 years 25,000 IU (1 single-dose oral
solution) once every 2 weeks for 6
weeks (followed by maintenance therapy of 400-1000 IU/day, such as
25,000 IU (single-dose oral
solution) per month).
Pregnancy and breastfeeding:
- The high strength formulation is not recommended.
Adults:
- Prevention of vitamin D deficiency 25,000 IU/month (1 single-dose
oral solution).
Higher doses may be required in certain situations, see below
- As an adjunct to specific therapy for osteoporosis: 25,000 IU/month
(1 single-dose oral solution.
- Treatment of vitamin D deficiency (<25 nmol/l) 50,000 IU/week (2
single-dose oral solutions) for 6-8
weeks, followed by maintenance therapy (1400-2000 IU /day may be
required such as 50,000 IU (2
single-dose oral solutions) per month); follow-up 25(OH)D measurements
should be made approximately
three to four months after initiating maintenance therapy to confirm
that the target level has been
achieved).
Certain populations are at high risk of vitamin D deficiency, and may
require higher doses
and monitoring