OFLOXACIN TEVA 200 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

OFLOXACIN

Tilgængelig fra:

ABIC LTD.

ATC-kode:

J01MA01

Lægemiddelform:

TABLETS

Sammensætning:

OFLOXACIN 200 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY, HUNGARY

Terapeutisk gruppe:

OFLOXACIN

Terapeutisk område:

OFLOXACIN

Terapeutiske indikationer:

Bacterial infections due to ofloxacin-susceptible microorganisms, such as:- acute, chronic, or recurrent lower respiratory tract infections (bronchitis) pneumonia (not for the treatment of first choice in pnemonia caused by pneumococci). - Chronic and recurrent infections of the ear, nose, and throat. Ofloxacin is in general not indicated for the treatment of acute tonsillitis caused by betahaemolytic streptococci. - Infections of soft tissues and skin. - Infections of the bones and joints. - Abdominal infections including infections in the pelvis minor and bacterial enteritis. - Infections of the kidney, urinary tract, and genital organs, gonorrhoea.Prevention of infections due to ofloxacin-susceptible pathogens in patients with a significant reduction in resistance to infections (e.g. in neutropenic state).

Autorisation dato:

2021-02-28

Indlægsseddel

DOR-Ofl-200mg-PIL-0522-10 :ءاودلا لوانت نع تفقوت اذإ
نود نم يئاودلا جلاعلا اذه نع فقوتلا كل
زوجي لا ،ةيحصلا كتلاح ىلع نسحت أرط اذإ
ىتح
.ةيناث ضارعلأا رهظت دقف ،كلذ لعفت مل
اذإ .بيبطلا ةراشتسا يف ة
ّ
يئاودلا ةعرجلا نمو ءاودلا ة
ّ
وبع ىلع قصلملا نم ق
ّ
قحت !ملاظلا يف ةيودلأا لوانت عنم
ُ
ي .اهيلإ ةجاحب تنك اذإ ةي
ّ
بطلا تارا
ّ
ظنلا عض .ءاود اهيف لوانتت ة
ّ
رم
ّ
لك .يلديصلا وأ بيبطلا ر
ِ
شتسا ،ءاودلا لامعتساب ق
ّ
لعتت ةيفاضإ ةلئسأ
َ
كيدل تناك اذإ .
ةيبناجلا ضارعلأا
لا .نيم
ِ
دختسملا ضعب ىدل ةيبناج ا
ً
ضارعأ عڨيت نيساسكولفوأ لامعتسا ب
ّ
بسي دق ،ةيودلأا عيمجك
.اهنم
ٍ
ّ
يأ نم يناعت
ّ
لاأ لمتحملا نمف .ة
ّ
يبناجلا ضارعلأا ةمئاق ةءارق دنع عزفت ىلإ لااح هجوتو عڨيت نيساسكولفوأ
لامعتسا نع فقوت ،ةيلاتلا ةيبناجلا
ضارعلأا ترهظ اذإ :ىفشتسملا وأ بيبطلا
مروت ىلع لمتشي دقو ،ىلولأا ةعرجلا
لوانت دعب انايحأ ثدحي هنأ ىتح ،يسسحت
لعف در
ةريتو ،ىرش وأ يدلج حفط ،سفنتلا يف ةداح
تابوعص ىلإ يدؤيو ،قنعلا وأ هجولا
،نيتفشلا
،ريفص ،لاعس ،ةرجنحلا ج
ّ
يهت ،نينيعلا يف ةقرح ،ى
ّ
م
ُ
ح ،ضفخنم مد طغض ،ةعيرس بلق مظن
.مدلا يف لكاشم وأ ةمدص
لئاوسلا سابتحا ،)
drug eruption ( ثولت وأ يسسحت لعف در وه اهردصم
ةيدلج لكاشم
سمشلا ةعشلأ ضرعتلا ةجيتن يدلج حفط
،)تارثب عم حفط( دلجلا لفسأ وأ لخاد
نيعلل ره

Produktets egenskaber

Page 1 of 20
Ofloxacin-Teva -200mg-tablets-SPC-notif-KK-12-2023_clean
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ofloxacin Teva 200mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of ofloxacin.
Excipients with known effect:
This product contains lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
White, round film-coated tablets, 11 mm diameter, scored on both
sides. One side of
the tablet is debossed “FXN” on one side of the breakline and
“200” on the other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1 Therapeutic Indications
Ofloxacin Teva is indicated for the treatment of bacterial infections
due to ofloxacin-
susceptible microorganisms, such as:

Acute, chronic, or recurrent lower respiratory tract infections
(bronchitis),
pneumonia (not for the treatment of first choice in pnemonia caused by
pneumococci).

Chronic and recurrent infections of the ear, nose, and throat.
Ofloxacin is in
general
not
indicated
for
the
treatment
of
acute
tonsillitis
caused
by
betahaemolytic streptococci.

Infections of soft tissues and skin.

Infections of the bones and joints.

Abdominal infections including infections in the pelvis minor and
bacterial
enteritis.

Infections of the kidney, urinary tract, and genital organs,
gonorrhoea.
Prevention of infections due to ofloxacin-susceptible pathogens in
patients with a
significant reduction in resistance to infections (e.g. in neutropenic
state).
4.2 Posology and method of administration
Duration of treatment
The duration of treatment depends on the response of the pathogen and
the clinical
condition. Basically, it is advisable to continue the treatment for at
least three days
after the resolution of fever and the disappearance of symptoms.
In acute infections, treatment for 7 to 10 days is usually sufficient.
The usual duration
Page 2 of 20
Ofloxacin-Teva -200mg-tablets-SPC-notif-KK-12-2023_clean
of treatment is