DALACIN VAGINAL OVULES

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CLINDAMYCIN AS PHOSPHATE

متاح من:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC رمز:

G01AA10

الشكل الصيدلاني:

OVULES

تركيب:

CLINDAMYCIN AS PHOSPHATE 100 MG

طريقة التعاطي:

VAGINAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PHARMACIA & UPJOHN COMPANY , USA

المجموعة العلاجية:

CLINDAMYCIN

المجال العلاجي:

CLINDAMYCIN

الخصائص العلاجية:

Dalacin vaginal ovules are indicated for 3-day treatment of bacterial vaginosis .

تاريخ الترخيص:

2021-04-30

نشرة المعلومات

Dalacin Vaginal Ovules CC PIL 130820
1
2015-0009917, 2017-0031399
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
DALACIN
®
VAGINAL OVULES
Each ovule contains:
Clindamycin (as phosphate) 100 mg
For a list of inactive ingredients and allergens, see section 6
"Further information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
An antibiotic medicine for 3-day treatment of bacterial vaginosis in
women, caused by bacteria
sensitive to clindamycin.
THERAPEUTIC GROUP: Antibiotic of the lincosamides class.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive to the active ingredient clindamycin, to other
antibiotic containing
the ingredient lincomycin or to any of the other ingredients in this
medicine (see
section 6).
•
you have previously had inflammation of the colon (colitis) due to
taking antibiotics
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH DALACIN
®
VAGINAL OVULES, TELL YOUR DOCTOR IF:
•
you have diarrhoea or usually get diarrhoea when you take antibiotics
•
you have a history of inflammatory bowel disease such as Crohn’s
Disease or
Ulcerative Colitis
If you develop severe, prolonged or bloody diarrhea during or after
using Dalacin
®
Vaginal
Ovules, consult your doctor immediately since it may be necessary to
stop the treatment. This
may be a sign of bowel inflammation (pseudomembranous colitis) which
can occur following
treatment with antibiotics.
Consult your doctor if you can use this medicine if:
•
you suffer from problems with the kidneys, liver or immune system.
•
you are under 18 years of age

خصائص المنتج

Dalacin Vaginal Ovules CC LPD 130820
1
2015-0009917, 2017-0031399, 2017-0028547, 2018-0036681
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dalacin Vaginal Ovules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clindamycin (as phosphate) 100 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal ovule.
Off-white, smooth solid ovule.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dalacin vaginal ovules are indicated for 3-day treatment of bacterial
vaginosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one clindamycin vaginal ovule intravaginally,
preferably at bedtime, for
three consecutive days.
_Elderly population _
The use of Dalacin Vaginal Ovule has not been studied in patients over
65 years of age.
_ _
_Patients with renal impairment _
The use of Dalacin Vaginal Ovule has not been studied in patients with
impaired renal function.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance, to lincomycin, or to any of
the excipients listed in section 6.1.
Dalacin Vaginal Ovules is also contraindicated in individuals with a
history of antibiotic-associated
colitis.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Before or after initiation of therapy with Dalacin, other infections
including
_Trichomonas vaginalis, _
_Candida albicans, Chlamydia trachomatis_
and gonococcal infections may need to be investigated by
adequate laboratory tests.
The use of Dalacin may result in the overgrowth of nonsusceptible
organisms, particularly yeasts.
Onset of symptoms suggestive of pseudomembranous colitis may occur
during or after antimicrobial
treatment (see section 4.8). Pseudomembranous colitis has been
reported with nearly all antibacterial
agents, including clindamycin, and may range in severity from mild to
life-threatening. It is therefore,
important that this is considered in patients who present with
diarrhoea subsequent to the
administration of antibacterial agents. Moderate cases may improve
following withdrawal of the drug.
Dalac