DALACIN 2 % VAGINAL CREAM

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

CLINDAMYCIN PHOSPHATE

Mevcut itibaren:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC kodu:

G01AA10

Farmasötik formu:

CREAM

Kompozisyon:

CLINDAMYCIN PHOSPHATE 2 %W/W

Uygulama yolu:

VAGINAL

Reçete türü:

Required

Tarafından üretildi:

PHARMACIA & UPJOHN COMPANY , USA

Terapötik grubu:

CLINDAMYCIN

Terapötik alanı:

CLINDAMYCIN

Terapötik endikasyonlar:

Treatment of bacterial vaginosis only if bacteria susceptible to clindamycin were found.

Yetkilendirme tarihi:

2014-05-31

Bilgilendirme broşürü

Dalacin 2% Vaginal Cream PIL CC 230323 Technical change
2023-0084860
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor's prescription only
DALACIN
® 2% VAGINAL CREAM
CLINDAMYCIN PHOSPHATE 2%
Inactive ingredients and allergens: see section 2 under ‘Important
information about some of this medicine’s
ingredients’ and 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?
The medicine is intended for treatment of bacterial vaginal
infections, if bacteria susceptible to
clindamycin have been identified.
THERAPEUTIC GROUP:
Lincosamide antibiotics.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:

you are sensitive (allergic) to the active ingredient clindamycin or
to lincomycin or to any of the other
ingredients in this medicine (see section 6).

you suffer or have previously suffered from inflammatory bowel disease
or antibiotic-associated
colitis (inflammation of the colon).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
Tell your doctor before using this medicine if you have diarrhoea or
usually get diarrhoea when you take
antibiotics.
If you develop severe, prolonged or bloody diarrhoea during or after
using Dalacin 2% Vaginal Cream,
contact 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.
As with all vaginal infections, sexual intercourse during treatment
with Dalacin 2% Vaginal Cream is not
recommended. Dalacin 2% Vaginal Cream may decrease the effectiveness
of condoms or diaphragms. Do
not rely

Ürün özellikleri

Dalacin 2% Vaginal Cream LPD CC 301122
Page 1 of 7
DALACIN
® 2% VAGINAL CREAM
1.
NAME OF THE MEDICINAL PRODUCT
Dalacin
®
2% Vaginal Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains clindamycin phosphate equivalent to 20 mg
or 2.0% w/w
clindamycin. Each applicator full of 5 grams of vaginal cream contains
approximately 100 mg
of clindamycin phosphate.
Excipients of known effect
Dalacin Cream contains 160.5 mg cetostearyl alcohol in each 5 g
applicator which is
equivalent to 32.1 mg/g.
Dalacin Cream contains 250 mg propylene glycol in each 5 g applicator
which is equivalent
to 50 mg/g.
Dalacin Cream contains 50 mg benzyl alcohol in each 5 g applicator
which is equivalent to 10
mg/g
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Vaginal Cream
White, semi-solid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of bacterial vaginosis only if bacteria susceptible to
clindamycin were found.
DALACIN
®
2% Vaginal Cream can be used to treat non-pregnant women and pregnant
women during their second and third trimesters.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose is one applicatorful of clindamycin vaginal cream
2% intravaginally,
preferably at bedtime, for three or seven consecutive days.
Paediatric population
Safety and efficacy in paediatric patients have not been established
(see section 4.4).
Elderly
No clinical studies have been conducted in populations older than 60.
_ _
4.3
CONTRAINDICATIONS
Dalacin
®
2% Vaginal Cream is contra-indicated in patients with a history of
hypersensitivity
to clindamycin, lincomycin, or to any of the excipients listed in
section 6.1.
Dalacin
®
2% Vaginal Cream is also contraindicated in individuals with a history
of
inflammatory bowel disease or a history of antibiotic-associated
colitis.
Dalacin 2% Vaginal Cream LPD CC 301122
Page
2
of
7
2014-0004758
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Before or after initiation of therapy with clindamycin, other
infections including
Trichomonas vaginalis,