Flucloxacillin Kabi

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Flucloxacillin sodium monohydrate 544.1mg equivalent to 500 mg flucloxacillin

Prieinama:

Fresenius Kabi New Zealand Limited

Dozė:

500 mg

Vaisto forma:

Powder for injection

Sudėtis:

Active: Flucloxacillin sodium monohydrate 544.1mg equivalent to 500 mg flucloxacillin

Recepto tipas:

Prescription

Terapinės indikacijos:

Flucloxacillin Kabi 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.

Produkto santrauka:

Package - Contents - Shelf Life: Vial, glass, Type II with Type I halobutyl rubber stopper - 5 vials - 24 months from date of manufacture stored at or below 25°C - Vial, glass, Type II with Type I halobutyl rubber stopper - 10 vials - 24 months from date of manufacture stored at or below 25°C

Leidimo data:

2023-01-09

Pakuotės lapelis

FLUCLOXACILLIN KABI
1
FLUCLOXACILLIN KABI
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING GIVEN FLUCLOXACILLIN KABI?
Flucloxacillin Kabi contains the active ingredient flucloxacillin
sodium monohydrate. Flucloxacillin Kabi, belongs to a group of
medicines called penicillins. These antibiotics work by killing the
bacteria causing your infection.
For more information, see Section 1. Why am I using Flucloxacillin? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN FLUCLOXACILLIN KABI?
Do not use if you have ever had an allergic reaction to flucloxacillin
or other penicillin’s or any of the ingredients listed at the
end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given Flucloxacillin Kabi? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Flucloxacillin Kabi and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW AM I GIVEN FLUCLOXACILLIN KABI?
Flucloxacillin Kabi will be given to you by a doctor or nurse. Your
doctor will decide what dose and how long you will receive
Flucloxacillin Kabi for. This depends on your infection and other
factors, such as your weight. For most infections, Flucloxacillin
Kabi is usually given in divided doses throughout the day.
More instructions can be found in Section 4. How am I given
Flucloxacillin Kabi? in the full CMI.
5.
WHAT SHOULD I KNOW AFTER RECEIVING FLUCLOXACILLIN KABI?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Flucloxacillin Kabi.
•
If symptoms of your infection do not improve within a few days, or if
they become worse tell your
doctor.
•
If you develop itching with swellin

Prekės savybės

NEW ZEALAND DATA SHEET
Flucloxacillin Kabi Data Sheet v3
Page 1 of 10
1 PRODUCT NAME
FLUCLOXACILLIN KABI 500 mg powder for injection.
FLUCLOXACILLIN KABI 1000 mg powder for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
FLUCLOXACILLIN KABI powder for injection is the sodium salt of
flucloxacillin.
FLUCLOXACILLIN KABI 500 mg contains 500 mg flucloxacillin (as sodium
monohydrate).
FLUCLOXACILLIN KABI 1000 mg contains 1000 mg flucloxacillin (as sodium
monohydrate).
It should be recognised that each 1 gram of flucloxacillin sodium
monohydrate contains 2.2 mmol (51
mg) of sodium.
This product contains no excipients.
3 PHARMACEUTICAL FORM
Powder for injection.
Flucloxacillin sodium is a white or almost white, crystalline powder,
hygroscopic, freely soluble in
water and in methanol, soluble in alcohol.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FLUCLOXACILLIN KABI 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.
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. Flucloxacillin Kabi may also be administered by
intra-articular or intrapleural
injection.
NEW ZEALAND DATA SHEET
Flucloxacillin Kabi Data Sheet v3
Page 2 of 10
DOSE
_ADULTS _
BY INTRAMUSCULAR INJECTION: Usual dosage 250 mg every 6 hours.
BY INTRAVENOUS INJECTION OR I