Western Medicine GMP Clotrimazole Suppositoires B. P. 100mg/200mg/500mg Antimycotic Vaginitis

• Application: Gynaecology
• Usage Mode: For external use
• Suitable for: Adult
• State: Solid
• Shape: Suppositoires
• Type: Biological Products
• Model NO.: 100mg
• Pharmaceutical Technology: Chemical Synthesis
• Transport Package: CTN
• Specification: 100MG
• Trademark: As per request
• Origin: China
• HS Code: 3004909099
• Production Capacity: 5000000

Product Description

 

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
Test Items	Standards		Result		Conclusion
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
Conclusion: The product complies with requirement of CP2015 II.

 

Analyst: Checker: Auditor: