Flucloxin

Страна: Нова Зеландія

мова: англійська

Джерело: Medsafe (Medicines Safety Authority)

Активний інгредієнт:

Flucloxacillin sodium monohydrate 500mg;  

Доступна з:

Douglas Pharmaceuticals Limited

ІПН (Міжнародна Ім'я):

Flucloxacillin sodium monohydrate 500 mg

Дозування:

500 mg

Фармацевтична форма:

Powder for injection

Склад:

Active: Flucloxacillin sodium monohydrate 500mg  

Одиниць в упаковці:

Vial, glass, 5x500mg, 5 dose units

Клас:

Prescription

Тип рецепту:

Prescription

Виробник:

Aurobindo Pharma Limited

Огляд продуктів:

Package - Contents - Shelf Life: Vial, glass, - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light

Дата Авторизація:

1983-08-17

інформаційний буклет

CONSUMER MEDICINE INFORMATION
FLUCLOXIN®
_flucloxacillin 250 mg, 500 mg and 1 g _
_powder for solution for injection _
•
Please read this leaflet carefully before you
start using Flucloxin® injection.
•
This leaflet answers some common questions
about Flucloxin® injection. It does not contain
all the available information. It does not take
the place of talking to your doctor or
pharmacist.
•
All medicines have risks and benefits. Your
doctor has weighed the risks of you using
Flucloxin® injection against the benefits they
expect it will have for you.
•
If you have any questions, concerns or
experience any side effect, then talk to your
doctor or pharmacist.
•
Keep this leaflet with the medicine. You may
need to read it again.
IN THIS LEAFLET:
1.
What is Flucloxin® and what is it used for
2.
Before you are given Flucloxin® Injection
3.
How Flucloxin® should be given
4.
Possible side effects
5.
How to store Flucloxin®
6.
Further information
1. WHAT IS FLUCLOXIN® AND WHAT IS IT USED FOR?
Flucloxin® is an antibiotic which belongs to a
group of medicines called penicillins. These
medicines work by killing bacteria that cause
infections. Flucloxin® Injection is used for the
treatment of skin and soft tissue infections, for
example: infections in joints or within the lining
of the heart (endocarditis), respiratory tract or
urinary tract or middle ear infections, infected
blood and meningitis. It is also used to prevent
infections that can occur during major surgical
operations such as heart and lung operations
(cardiothoracic surgery) and bone, joint and
muscle operations (orthopaedic surgery).
Your doctor may have prescribed Flucloxin®
injection for another reason.
Ask your doctor if you have any questions about
why Flucloxin® injection has been prescribed for
you.
This medicine is available only with a doctor’s
prescription.
2. BEFORE YOU TAKE FLUCLOXIN®
YOU SHOULD NOT BE GIVEN FLUCLOXIN® INJECTION IF
YOU:
• are allergic to flucloxacillin, cephalosporins,
penicillin, or any other ß-lactam

Характеристики продукта

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Flucloxin® 250 mg powder for injection
Flucloxin® 500 mg powder for injection
Flucloxin® 1 g powder for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The flucloxacillin is present as flucloxacillin sodium monohydrate in
Flucloxin.
Each 1.088 g (1088 mg) of flucloxacillin sodium monohydrate is
equivalent to approximately 1 g
(1000 mg) of anhydrous flucloxacillin.
Flucloxin 250 mg powder for injection/infusion contains 250mg
flucloxacillin.
Flucloxin 500 mg powder for injection/infusion contains 500 mg
flucloxacillin.
Flucloxin 1 g powder for injection/infusion contains 1 g
flucloxacillin.
EXCIPIENT(S) WITH KNOWN EFFECT
Flucloxin contains only flucloxacillin sodium monohydrate, with no
additional ingredients.
Each one gram of flucloxacillin sodium monohydrate contains
approximately 2.2 mmol of
sodium.
3.
PHARMACEUTICAL FORM
Flucloxin powder for injection vials: Glass vials containing a white
powder for reconstitution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Flucloxin is indicated in adults and children for the following:
-
The treatment of skin and soft tissue infections caused by susceptible
organisms and
infections due to penicillinase producing staphylococci and for mixed
streptococcal and
staphylococcal infections where the staphylococci are resistant to
penicillin. For
example, infections of the joints, respiratory tract and urinary
tract, otitis media,
endocarditis, septicaemia, and meningitis.
-
Prophylaxis of staphylococcal infections during major surgical
procedures, particularly in
cardiothoracic or orthopaedic surgery.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
2 | P a g e
4.2.
DOSE AND METHOD OF ADMINISTRATION
The dosage depends on the severity and nature of the infection.
The usual routes of administration are by intramuscular injection,
slow intravenous injection and
intravenous infusion. Flucloxin may also be administered by
intra-articular or intrapleural
injection.
DOSE