Metronidazole 5 mg/ml solution for infusion

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Metronidazole

Доступна с:

B. Braun Melsungen AG

код АТС:

J01XD; J01XD01

ИНН (Международная Имя):

Metronidazole

дозировка:

5 milligram(s)/millilitre

Фармацевтическая форма:

Solution for infusion

Тип рецепта:

Product subject to prescription which may not be renewed (A)

Терапевтические области:

Imidazole derivatives; metronidazole

Статус Авторизация:

Marketed

Дата Авторизация:

2001-06-06

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METRONIDAZOLE 5MG/ML SOLUTION FOR INFUSION
Metronidazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
● Keep this leaflet. You may need to read it again.
● If you have any further questions, ask your doctor.
● This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if
their signs of illness are the same as yours.
● If you get any side effects, talk to your doctor. This includes
any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Metronidazole 5mg/ml is and what it is used for
2. What you need to know before you use Metronidazole 5mg/ml
3. How to use Metronidazole 5mg/ml
4. Possible side effects
5. How to store Metronidazole 5mg/ml
6. Contents of the pack and other information
1. WHAT METRONIDAZOLE 5MG/ML IS AND WHAT IT IS USED FOR
Metronidazole 5mg/ml belongs to a group of medicines known as
antibiotics and is used to treat severe
infections caused by bacteria that can be killed by the active
substance metronidazole.
In general this medicine is suitable for adults, adolescents, children
and newborns. Your doctor will
decide if the solution is suitable for your individual situation.
You may be given Metronidazole 5mg/ml for the treatment of any of the
following diseases:
● infections of the central nervous system such as abscesses (local
infection with pus) in the brain,
inflammation of the meninges (lining of brain)
● infections of the lungs and lung lining, such as pneumonia
accompanied by tissue destruction,
pneumonia following entry of stomach contents into the lungs,
abscesses in the lungs,
● infections of the gastro-intestinal tract, such as inflammation of
the internal lining of the abdomen
and pelvic walls, abscesses in the liver, large bowel or rectal
surgery, infections with pus in the abdomen
and pelvis,
● infections of the female sex organs, such as inflammation within
the

Характеристики продукта

Health Products Regulatory Authority
09 June 2023
CRN00D9M0
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metronidazole 5 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 5 mg of metronidazole
100 ml of solution contain 500 mg of metronidazole
_Excipients:_
1 ml solution contains
Sodium chloride 7.4 mg
Disodium phosphate dodecahydrate 1.5 mg
_Electrolyte content (per 100 ml):_
Sodium 14 mmol
Chloride 13 mmol
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless or sightly yellowish aqueous solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment and prophylaxis of infections caused by metronidazole
susceptible microorganisms (mainly anaerobic bacteria).
Metronidazole is indicated in adults and children for the following
indications when caused by bacteria susceptible to
metronidazole:

infections of the central nervous system-(e.g. brain abscess,
meningitis)

infections of lung and pleura (e.g. necrotising pneumonia, aspiration
pneumonia, lung abscess)

endocarditis

infections in the gastrointestinal tract and the abdominal area (e.g.
peritonitis, liver abscess, postoperative
infections after colonic and rectal surgery, purulent diseases in the
abdominal and pelvic cavities)

gynaecologic infections (e.g. endometritis, after hysterectomy or
caesarean section, puerperal pyrexia, septic
abortion)

infections in the ear-nose-throat and tooth-mouth-jaw regions (e.g.
necrotising ulcerative gingivostomatitis)

bone and joint infections (e.g. osteomyelitis)

gas gangrene

septicaemia with thrombophlebitis.
In a mixed aerobic and anaerobic infection, antibiotics appropriate
for the treatment of the aerobic infection should be used in
addition to Metronidazole 5mg/ml.
A prophylactic use may be indicated prior to operations with a high
risk of anaerobic infections (gynaecologic and
intra-abdominal operations).
Consideration should be given to offic