METRONIDAZOLE

Страна: Израиль

Язык: английский

Источник: Ministry of Health

Активный ингредиент:

METRONIDAZOLE

Доступна с:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

код АТС:

J01XD01

Фармацевтическая форма:

SOLUTION FOR INFUSION

состав:

METRONIDAZOLE 500 MG / 100 ML

Администрация маршрут:

I.V

Тип рецепта:

Required

Производитель:

B.BRAUN MELSUNGEN AG, GERMANY

Терапевтическая группа:

METRONIDAZOLE

Терапевтические области:

METRONIDAZOLE

Терапевтические показания :

Treatment and prophylaxis of infection which are or may be due to anerobic bacteria,especially Bacteriodes species,including Bacteriodes fragilis, Fusobacterium,Eurobacterium and Clostridium species.

Дата Авторизация:

2020-10-31

тонкая брошюра

24.11.2020
,ה/דבכנ ת/חקור ה/אפור
אפורל ןולעב ןוכדע לע ךעידוהל וננוצרב
METRONIDAZOLE B. BRAUN, SOLUTION FOR INJECTION
: ליעפ רמוח
METRONIDAZOLE B. BRAUN 500 MG / 100 ML
טסקט ,הרמחה ותועמשמ בוהצ ןמוסמ טסקט,
ןוכדע ותועמשמ קורי ןמוסמ טסקט( אפורל
ןולעב םינוכדע ןלהל
:)הקיחמ ותועמשמ
4.3
CONTRAINDICATIONS
In patients with prior history of hypersensitivity to Metronidazole or
other nitroimidazole
derivatives.
During the first trimester of pregnancy in patients with
trichomoniasis.
Hypersensitivity to metronidazole or other nitroimidazole derivatives
or to any of the
excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_Warnings _
Convulsive Seizures and Peripheral Neuropathy:
Convulsive seizures and peripheral neuropathy, the latter
characterized mainly by
numbness or paresthesia of an extremity, have been reported in
patients treated with
metronidazole. The appearance of abnormal neurologic signs demands the
prompt
evaluation of the benefit / risk ratio of the continuation of therapy.
_Precautions _
In case of organic diseases of the C.N.S. and blood dyscrasia such as
granulocytopenia,
metronidazole should be used with necessary caution.
Metronidazole interferes with the spectrophotometric determination of
SGOT, SGPT,
LDH resulting in decreased values.
In patients with severe hepatic disease, who metabolize metronidazole
slowly, doses
below those usually recommended should be administered cautiously
_Side effects _
A serious adverse reaction: convulsive seizures.
2
Very seldom may occur:
G.I. upset (nausea, vomiting, epigastric distress, diarrhea). Burning
sensation in the
tongue, metallic taste, overgrowth of Candida, rash, urticaria.
Central disorders (headache, dizziness, somnolence, in coordination,
depressions).
Drug fever.
Thrombophlebitis.
Darkened urine.
Mild leucopenia may occur. Thus regular blood count is required.
Peripheral neuropathy has been

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Metronidazole B.Braun 500 MG / 100 ML
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains 5 mg of metronidazole
100 ml of solution contain 500 mg of metronidazole
_EXCIPIENT WITH KNOWN EFFECT : _
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
This medicinal product contains 14 mmol (or 322 mg) sodium per 100 ml.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless up to faintly, straw- coloured solution, practically
free from
particles
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of infection which are or may be due to
anerobic
bacteria,especially Bacteriodes species,including Bacteriodes
fragilis,
Fusobacterium,Eurobacterium and Clostridium species
.
The treatment is effective in cases of:
•
Infections of the C.N.S (e.g. brain abscess, meningitis),
•
Infections of the lung and pleura (e.g. necrotizing pneumonia,
aspiration
pneumonia, lung abscess),
•
Endocarditis,
•
After operations (e.g. recto-colonic surgery) and infections of the
G.I. tract,
•
Suppurating diseases in the abdominal and pelvic area (peritonitis,
liver
abscess, endometritis),
•
Gynaecologic infections (e.g. hysterectomy, caesarian section,
childbed
fever, septic abortus),
•
Osteomyelitis,
•
Septicaemia in thrombophlebitis,
•
Severe form of intestinal and hepatic amoebiasis.
A prophylactic use is always indicated in operations with a high risk
of anaerobic
infections (gynaecologic and intra-abdominal operations).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Unless otherwise directed the following dosage guidelines are
recommended:
ADULTS AND CHILDREN OVER 12 YEARS:
Maintenance dose:
Approximately 7.5 mg Metronidazole/kg body weight over one hour every
8 hours,
corresponding to 100 ml
(500 mg) Metronidazole injection for a 70 Kg adult.
L