| Customization: | Available |
|---|---|
| Application: | Gynaecology |
| Usage Mode: | For external use |
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COMPOSITION:
Each vaginal suppository contains:
Clotrimazole B.P 100mg/200mg/500mg
Suppository base qs
INDICATIONS:
Vaginal discharge caused by fungi (usually candida species) , mixed infections where fungi and /or Trichomonas are present or suspected.
PHARMACOLOGICAL PROPERTIES:
Clotrimazole is primarilyl in action.
Antimycotic effect of clotrimazole stems from inhibitions of ergosterol biosynthesis.
Since ergosterol is an essential component of the cell membrane of fungi , the influence of clotrimazole is such that , after a delay due to consumption of the cycloplasmic ergosterol of the fungi cell , major changes occur in composition and the properties of the membrane. The attendant impairment of membrane permeability finally lead to cell lysis.
INSTRUCTION FOR USE:
Please read carefully.
Do not swallow-for insertion into vagina only.
Dosage & Administration:
If not otherwise prescribed by the Physician , insert one vaginal suppository daily as deep as possible for six consecutive days of 100mg or three consecutive days with 200mg or once with the 500mg, preferably at night.
DIRECTION OF USE:
Not to be taken by mouth.
Moisten with water.
Do not swallow.
For Vaginal insertion.
Treatment should not be performed during menstruation or before it starts.
To avoid possible re-infection , the partner should be examined by the doctor at the same time. Generally, a course of treatment lasting 6 days of 100mg/3days of 200mg/1 day of 500mg is adequate. The treatment can be repeated where necessary.
If you have forgotten and insertion of vaginal suppository continue the treatment as recommended.
Certifacate of Analysis REC-ZL- 0025-00
Repot No:2016-C-21-02-020
| Item Name | Clotrimazole Suppositories | Specification | 100mg | ||
| Batch No | Samples | Code | C-21 | ||
| Quantity | 40 pieces | Testing Department | Warehousing Department | ||
| Testing Date | Nov 12th, 2016 | Report Date | Nov 19th, 2016 | ||
| Inspection Standards | Chinese Pharmacopoeia 2015 II | ||||
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Test Items |
Standards |
Result |
Conclusion |
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Characteristics
Identification
Physical and chemical identification
UV identification
Testing
Weight variation
Melting time
Microbial limit
Assay
|
Should meet the requirement
Should meet the requirement
Should meet the requirement
Should meet the requirement
Should meet the requirement
Should meet the requirement
NLT.90.0% and NMT.110.0% of the labeled amout of clotrimazole suppository(C22H17ClN2) |
Confirm
Confirm
Confirm
Confirm
Confirm
Confirm
97.58%
|
Confirm
Confirm
Confirm
Confirm
Confirm
Confirm
Confirm
|
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| Conclusion: The product complies with requirement of CP2015 II. | |||||
Analyst: Checker: Auditor:
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