METRONIDAZOLE JUNO metronidazole 500mg/100mL solution for injection bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metronidazole, Quantity: 500 mg

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

Metronidazole

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous

Units in package:

10 bags, 20 bags

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

METRONIDAZOLE JUNO is indicated for:Treatment of severe anaerobic infection when oral medication is not possible or is contraindicated, when immediate anti-anaerobic therapy is required. Metronidazole may be used prophylactically to prevent infection of the surgical site which may have been contaminated or potentially contaminated with anaerobic organisms. Procedures in which this may be assumed to have happened 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.

Product summary:

Visual Identification: Almost colourless to pale yellow solution, free from visible particles.; Container Type: Bag; Container Material: PE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2007-05-10

Patient Information leaflet

Metronidazole Juno CMI
1
METRONIDAZOLE JUNO
_Metronidazole _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Metronidazole Juno. 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 receiving metronidazole against
the benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT METRONIDAZOLE
JUNO IS USED FOR
Metronidazole is used to treat
•
serious infections caused by
bacteria and other organisms when
metronidazole cannot be given
orally
•
prevent certain infections that may
occur during surgery.
Metronidazole is an antibiotic.
Metronidazole works by killing or
stopping the growth of bacteria and
other organisms causing these
infections.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
metronidazole for another reason.
This medicine is not addictive.
This medicine is available only with a
doctor's prescription.
BEFORE YOU ARE GIVEN
METRONIDAZOLE JUNO
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN
METRONIDAZOLE JUNO IF:
YOU HAVE AN ALLERGY TO:
•
metronidazole or any other
medicines used to treat infections
•
any of the ingredients listed at the
end of this leaflet
Symptoms of an allergic reaction may
include shortness of breath, wheezing
or difficulty breathing; swelling of the
face, lips, tongue or other parts of the
body; rash, itching or hives on the skin.
YOU MUST NOT BE GIVEN THIS MEDICINE
IF:
•
you have or have had a blood
disorder
•
you have a disease or disorder of
the brain, spinal cord or nerves
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE GIVEN METRONIDAZOLE JUNO,
CONTACT YOUR DOCTOR.
_BEFORE YOU ARE GIVEN IT _
TELL YOUR DOCTOR IF YOU HAVE ANY
ALLERGIES TO ANY

Summary of Product characteristics

Version 10.0
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION -
METRONIDAZOLE JUNO (METRONIDAZOLE)
1.
NAME OF THE MEDICINE
Metronidazole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Metronidazole Juno contains Metronidazole EP 5mg/mL, Citric Acid 0.36
mg/mL, Dibasic
Sodium Phosphate 0.6 mg/mL equivalent to dibasic sodium phosphate
dodecahydrate 1.5
mg/mL, and Sodium Chloride 7.4mg/mL in Water for Injections. Each mL
contains 0.135
mmol sodium.
Metronidazole is a white or yellowish, crystalline powder, slightly
soluble in water, in
acetone, in alcohol and in methylene chloride.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
_ _
Metronidazole Juno is an almost colourless to pale yellow, sterile,
isotonic, preservative-free,
ready to use solution.
4.
CLINICAL PARTICULARS
_ _
4.1
THERAPEUTIC INDICATIONS
Metronidazole Juno is indicated for:
-
treatment
of
severe
anaerobic
infection
when
oral
medication
is
not
possible
or
is
contraindicated, when immediate anti-anaerobic therapy is required
- metronidazole may be used prophylactically to prevent infection of
the surgical site which
may
have
been
contaminated
or
potentially
contaminated
with
anaerobic
organisms.
Procedures in which this may be assumed to have happened 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
4.2
DOSE AND METHOD OF ADMINISTRATION
_ _
Metronidazole Juno contains no microbial agent. It should be used in
one patient on one
occasion only and any residue discarded.
A maximum of 4 g should not be exceeded during a 24 hour period.
DOSAGE
_Adult: _
The adult dose is 500 mg metronidazole (
_i.e._
100 mL) by infusion eight hourly.
_Children over 12 years: _
Same dosage as adults.
_Children under 12 years: _
Eight hourly as for adults but the single intravenous dose is based
on 7.5 mg (1.5 mL) metronidazole/kg bodyweight.
Version 10.0
Page 2 of 15
_Geriatric: _
Use adult