GLUCOSE INTRAVENOUS INFUSION BP 70 %w/v Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GLUCOSE ANHYDROUS

Available from:

B. Braun Medical Limited

INN (International Name):

GLUCOSE ANHYDROUS

Dosage:

70 %w/v

Pharmaceutical form:

Solution for Infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Authorization status:

Withdrawn

Authorization date:

2012-08-15

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)
PA0179/001/038
Case No: 2039324
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
B. BRAUN MEDICAL LIMITED
3 NAAS ROAD INDUSTRIAL PARK, DUBLIN 12, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
GLUCOSE INTRAVENOUS INFUSION BP 70% W/V, SOLUTION FOR 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 26/11/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/11/2007_
_CRN 2039324_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucose Intravenous Infusion BP 70% w/v, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 0.7 g anhydrous glucose, as glucose monohydrate.
1000 ml of solution contain
500 ml of solution contain
Anhydrous glucose
700.0 g
350.0 g
(as glucose monohydrate)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless or slightly yellowish aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Parenteral nutrition;
High-caloric carbohydrate therapy, especially when fluid intake is restricted, as for exampl