CERNEVIT BIO-SET
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
RETINOL PALMITATE COLECALCIFEROL DL-ALFA-TOCOFEROL ASCORBIC ACID COCARBOXYLASE TETRAHYDRATE RIBOFLAVIN SODIUM PHOSPHATE PYRIDOXINE HYDROCHLORIDE CYANOCOBALAMIN FOLIC ACID DEXPANTHENOL BIOTIN NICOTINAMIDE
Available from:
Baxter Healthcare Limited
Pharmaceutical form:
Pdr for Soln Inj/Inf
Authorization date:
2007-06-22
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0167/097/002
Case No: 2068802
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
BAXTER HEALTHCARE LIMITED
CAXTON WAY, THETFORD, NORFOLK IP24 3SE, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CERNEVIT, BIOSET,POWDER FOR SOLUTION FOR INJECTION OR INFUSION
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 09/04/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/04/2010_
_CRN 2068802_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cernevit, Bioset,Powder for Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains:
Retinol Palmitate (Vit A)
3500
IU
Colecalciferol (Vit D
3
)
220
IU
DL
tocopherol (Vit E)
10.20
mg
- corresponding to -tocopherol
11.200 IU
Ascorbic acid (Vit C)
125
mg
Cocarboxylase tetrahydrate
5.80
mg
- corresponding to Thiamine (Vit B
1
)
3.510
mg
Riboflavin dihydratedsodium phosphate (Vit B
2
)
5.67
mg
- corresponding to Riboflavin
4.14
mg
Pyridoxine hydrochloride (Vit B
6
)
5.50
mg
- corresponding to Pyridoxine
4.53
mg
Cyanocobalamin (Vit B
12
)
6
micrograms
Folic acid
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