METRONIDAZOLE KABI metronidazole 500mg/100mL solution for injection bottle

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

metronidazole, Quantity: 500 mg

Доступна с:

Fresenius Kabi Australia Pty Ltd

Фармацевтическая форма:

Injection, solution

состав:

Excipient Ingredients: citric acid monohydrate; water for injections; sodium chloride; dibasic sodium phosphate dodecahydrate

Администрация маршрут:

Intravenous Infusion

Штук в упаковке:

10, 5, 12

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Metronidazole intravenous infusion is indicated:,(a) for treatment of anaerobic infections in patients for whom oral administration is not possible.,(b) where immediate anti-anaerobic chemotherapy is required.,(c) where prophylactic cover is required at lower abdominal surgical sites presumed contaminated or potentially contaminated by anaerobic micro-organisms. Procedures of this type include appendectomy, colonic surgery, vaginal hysterectomy, abdominal surgery in the presence of anaerobes in the peritoneal cavity and surgery performed in the presence of anaerobic septicaemia.,Note: Metronidazole is inactive against aerobic or facultative anaerobic bacteria.

Обзор продуктов:

Visual Identification: colourless to pale yellow ready to use solution, practically free from visible particles.; Container Type: Bottle; Container Material: PE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Статус Авторизация:

Registered

Дата Авторизация:

2019-12-04

тонкая брошюра

Metronidazole Kabi
Page 1 of 4
METRONIDAZOLE KABI
[METRONIDAZOLE]
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
Metronidazole
Kabi.
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
taking
Metronidazole
Kabi
against
the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT
METRONIDAZOLE
KABI IS USED FOR
The name of your medicine is
Metronidazole Kabi. It contains the
active ingredient metronidazole.
Metronidazole Kabi is an
antimicrobial agent used to treat
infections in different parts of the
body caused by certain
microorganisms.
Metronidazole Kabi is also
used to prevent infections before,
during and after surgery.
Metronidazole Kabi belongs to
a group of antimicrobials called
nitroimidazoles. These
antimicrobials work by killing the
micro-organisms that are causing
your infection.
Your doctor may have prescribed
Metronidazole Kabi for another
reason. Ask your doctor if you have
any questions about why
Metronidazole Kabi has been
prescribed for you.
Metronidazole Kabi is available
only with a doctor's prescription.
Metronidazole Kabi is not
addictive.
BEFORE
YOU
ARE
GIVEN
METRONIDAZOLE KABI
_WHEN YOU MUST NOT TAKE IT _
DO NOT USE METRONIDAZOLE KABI
IF:
1. YOU HAVE AN ALLERGY TO
METRONIDAZOLE, ANY OTHER
NITROIMIDAZOLES OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include
wheezing, shortness of breath,
swelling of the face, lips or
tongue which may cause
difficulty in swallowing or
breathing, skin rash, itching or
hives.
2. YOU HAVE OR HAVE EVER HAD A
BLOOD DISORDER.
3.
YOU
HAVE
A
DISEASE
OF
THE
BRAIN, SPINAL CORD OR NERVES.
DO NOT USE METRONIDAZOLE KABI IF
THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
DO NOT USE ME

Характеристики продукта

AUSTRALIAN PRODUCT INFORMATION-
METRONIDAZOLE KABI (METRONIDAZOLE)
1 NAME OF THE MEDICINE
Metronidazole
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Metronidazole Kabi contains the active substance metronidazole, which
belongs to the
substance group of nitroimidazole derivatives.
Active: metronidazole, concentration: 500 mg/100 mL
Metronidazole is a white or yellowish crystalline powder with melting
point 159-162°C.
Solubility in water at 20°C is 1 g/100 mL; in ethyl alcohol, 0.5
g/100 mL; and soluble in dilute
acids. When reconstituted as Metronidazole Kabi, it has a pH of
between 4.5 and 6.0. Each
mL contains 0.135 mmol sodium.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Metronidazole Kabi is a clear and slightly yellowish, sterile,
isotonic infusion solution for
intravenous use only. Solution is practically free from visible
particles.
Solutions that are
hazy or contain visible particulate matter should be discarded.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metronidazole intravenous infusion is indicated:
(a) for treatment of anaerobic infections in patients for whom oral
administration is not
possible.
(b) where immediate anti-anaerobic chemotherapy is required.
(c) where prophylactic cover is required at lower abdominal surgical
sites presumed
contaminated or potentially contaminated by anaerobic micro-organisms.
Procedures of this
type include appendectomy, colonic surgery, vaginal hysterectomy,
abdominal surgery in the
presence of anaerobes in the peritoneal cavity and surgery performed
in the presence of
anaerobic septicaemia.
Note: Metronidazole is inactive against aerobic or facultative
anaerobic bacteria.
4.2
DOSE AND METHOD OF ADMINISTRATION
A maximum of 4 g should not be exceeded in a 24 hour period. For
prophylactic use, the
appropriate dose should be infused shortly before surgery and repeated
every eight hours
for the next 24 hours. Dosages should be decreased in patients with
severe hepatic disease;
plasma metronidazole levels should be mon