CEFUROXIME 3 Grams Pdr for Soln for Infusion
Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Характеристики продукта
(SPC)
23-04-2024
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Активный ингредиент:
CEFUROXIME SODIUM
Доступна с:
HOSPIRA UK Ltd
ИНН (Международная Имя):
CEFUROXIME SODIUM
дозировка:
3 Grams
Фармацевтическая форма:
Pdr for Soln for Infusion
Тип рецепта:
Product subject to prescription which may not be renewed (A)
Статус Авторизация:
Withdrawn
Дата Авторизация:
2010-06-22
Характеристики продукта
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefuroxime 3g Powder for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3g cefuroxime (as sodium salt).
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion
Vials containing a white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of systemic infections due to micro-organisms susceptible to this anti-infective, including gram
positive and gram negative organisms and such conditions as respiratory and urinary tract infections, gonorrhoea,
septicaemia, meningitis.
Prophylaxis against infection in abdominal, orthopaedic and other surgical procedures, where there is increased risk
from infection.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cefuroxime 1.5 g Powder for Injection is for intravenous use only. Dosage instructions for intramuscular use are
provided below; other product presentations are available for intramuscular administration.
Cefuroxime 3g Powder for Infusion must be used for Intravenous Infusion only.
For short intravenous infusion (e.g. up to 30 minutes), solutions containing 3 g cefuroxime in 100 ml Water for
Injections may be used. These solutions may be given directly into the vein or introduced into the tubing of the giving
set if the patient is receiving parenteral fluids.
Parenteral cefuroxime dosage recommendations (where intramuscular use is recommended, presentations of
Cefuroxime Powder for Injection licensed for such use should be administered):
_Adults_: The usual dose is 750 mg t.d.s. (three times a day) by intravenous injection.
The total daily dosage is in the range of 1500 mg to 6000 mg in divided doses.
_Infants and Children: _Doses of 30 to 100 mg/kg/day given as three or four divided doses. A dose
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