Metronidazole-Claris

দেশ: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

Metronidazole 5 mg/mL

থেকে পাওয়া:

Baxter Healthcare Ltd

INN (আন্তর্জাতিক নাম):

Metronidazole 5 mg/mL

ডোজ:

500 mg/100mL

ফার্মাসিউটিকাল ফর্ম:

Solution for infusion

রচনা:

Active: Metronidazole 5 mg/mL Excipient: Citric acid monohydrate Dibasic sodium phosphate Sodium chloride Water for injection

প্যাকেজ ইউনিট:

Bag, plastic, Non-PVC infusion bag 10 x 100mL, 1 L

শ্রেণী:

Prescription

প্রেসক্রিপশন টাইপ:

Prescription

Manufactured by:

Corden Pharma Bergamo SpA

থেরাপিউটিক ইঙ্গিত:

Metronidazole-Claris intravenous infusion is indicated: · For treatment of anaerobic infections in patients for whom oral administration is not possible. · When immediate anti-anaerobic therapy is required. · When prophylactic cover is required at lower abdominal surgical sites presumed contaminated or potentially contaminated by anaerobic micro-organisms. Procedures of this type include appendicectomy, 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.

পণ্য সারাংশ:

Package - Contents - Shelf Life: Bag, plastic, Non-PVC infusion bag 10 x 100mL - 1 L - 12 months unopened stored at or below 25°C protect from light. Do not freeze. - Bag, plastic, PVC infusion bag 100mL - 5 dose units - 36 months unopened stored at or below 25°C protect from light. Do not freeze. - Bag, plastic, PVC infusion bag 100mL - 6 dose units - 36 months unopened stored at or below 25°C protect from light. Do not freeze. - Bag, plastic, PVC infusion bag 100mL - 10 dose units - 36 months unopened stored at or below 25°C protect from light. Do not freeze. - Bag, plastic, Non-PVC infusion bag - 100 mL - 12 months unopened stored at or below 25°C protect from light. Do not freeze. - Bag, plastic, Individual bag - 100 mL - 7 days unopened stored at or below 25°C protect from light. Individual bag with overwrap stored outside of carton 36 months from date of manufacture stored at or below 25°C - Bag, plastic, PVC infusion bag - 100 mL - 36 months unopened stored at or below 25°C protect from light. Do not freeze. - Bag, plastic, Non-PVC infusion bag 5 x 100mL - 500 mL - 12 months unopened stored at or below 25°C protect from light. Do not freeze. - Vial, glass, Type II, grey siliconised rubber closure with flip off seal, 100 mL - 1 dose units - 36 months from date of manufacture stored at or below 25°C - Vial, glass, Type II, grey siliconised rubber closure with flip off seal, 100 mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C - Vial, glass, Type II, grey siliconised rubber closure with flip off seal, 100 mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C

অনুমোদন তারিখ:

2005-04-14

পণ্য বৈশিষ্ট্য

METRONIDAZAOLE BAXTER Data Sheet 14 March 2018
Page 1 of 11
Baxter Healthcare Ltd
DATA SHEET
1.
METRONIDAZOLE‐CLARIS (METRONIDAZOLE INTRAVENOUS
INFUSION 500 MG/100ML)
METRONIDAZOLE‐CLARIS, Metronidazole Intravenous Infusion 500
mg/100ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
METRONIDAZOLE‐CLARIS 5 mg/ml
100 ml of solution for infusion containing 500 mg of Metronidazole
For the full list of excipients,
see section 6.1
3.
PHARMACEUTICAL FORM
METRONIDAZOLE‐CLARIS 5 mg/mL Infusion is a clear, colourless to pale
yellow solution each mL
contains metronidazole 5mg, together with sodium chloride, anhydrous
disodium hydrogen
phosphate, citric acid monohydrate and water for injections. The
solution has a pH of between
4.5 and 6.0 with a calculated osmolarity of 310.8 mOsm/L.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
METRONIDAZOLE‐CLARIS 500mg/100ml Intravenous Infusion is indicated
in adults and children
when
oral medication is not possible for the following indications:
-
The prophylaxis of postoperative infections due to sensitive anaerobic
bacteria
particularly
species of Bacteroides and anaerobic Streptococci, during abdominal,
gynaecological
gastrointestinal or colorectal surgery which carries a high risk of
occurrence of this type of
infection. The solution may also be used in combination
with an antibiotic active against aerobic
bacteria.
-
The treatment of severe intraabdominal and gynaecological infections
in which sensitive
anaerobic bacteria particularly Bacteriodes and anaerobic Streptococci
have been identified or
are suspected to be the cause.
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
4.2
DOSE AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION_
METRONIDAZOLE‐CLARIS 500mg/100ml Intravenous Infusion should be
infused intravenously at
an
approximate rate of 5 ml/minute (or one bag infused over 20 to 60
minutes). Oral medication
should be substituted as soon as feasible.
_PROPHYLAXIS AGAINST POSTOPERATIVE INFECTIONS CAUSED BY