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דאלאצין % 2 קרם וגינלי DALACIN 2 % VAGINAL CREAM (CLINDAMYCIN PHOSPHATE)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

וגינלי : VAGINAL

צורת מינון:

קרם : CREAM

Special Warning : אזהרת שימוש

4.4     Special warnings and precautions for use
Before or after initiation of therapy with clindamycin, other infections including Trichomonas vaginalis, Candida albicans, Chlamydia trachomatis and gonococcal infections may need to be investigated by adequate laboratory tests.

The use of clindamycin may result in the overgrowth of non-susceptible 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. Therefore, it is 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.

Clindamycin treatment must be stopped if pseudomembranous diarrhoea occurs. An adequate antibacterial therapy should be prescribed. Drugs inhibiting peristalsis are contraindicated in this situation.

Caution is advised in patients when prescribing clindamycin to individuals with inflammatory bowel disease such as Crohn’s disease or ulcerative colitis.

As with all vaginal infections, sexual intercourse during treatment with clindamycin vaginal cream is not recommended. Latex condoms and diaphragms may be weakened if exposed to the suppository base used in clindamycin vaginal cream. The use of such products within 72 hours following treatment with clindamycin vaginal cream is not recommended as such use could be associated with diminished contraceptive efficacy or protection against sexually transmitted disease.

The use of other vaginal products (such as tampons and douches) during the treatment with clindamycin vaginal cream is not recommended.


Paediatric population
Safety and efficacy in paediatric patients have not been established (see section 4.2).
Excipient information
Dalacin Cream contains propylene glycol, cetostearyl alcohol and benzyl alcohol (see section 2).
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Benzyl alcohol may cause allergic reactions and mild local irritation.

Effects on Driving

4.7     Effects on ability to drive and use machines

The effect of clindamycin on the ability to drive or operate machinery has not been systematically evaluated.

שימוש לפי פנקס קופ''ח כללית 1994 לא צוין
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רישום

064 17 27818 00

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דאלאצין % 2 קרם וגינלי

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