DELFEN®II
SCHEDULING STATUS:
Schedule 1
PROPRIETARY NAME
(and dosage form):
DELFEN®II
Contraceptive Jelly
COMPOSITION:
Nonoxynol-9 0,1g/5g with methylparaben 0,2% m/m as the preservative.
PHARMACOLOGICAL CLASSIFICATION:
A 18.7 Contraceptive preparations.
PHARMACOLOGICAL ACTION :
Nonoxynol-9 has spermicidal action. DelfenII is a clear, unscented, unflavoured water dispersible spermicidal jelly which contains 2% nonoxynol-9 buffered to normal vaginal pH.
Nonoxynol-9 has spermicidal properties and has been shown in vitro to inactivate certain bacteria and viruses responsible for some sexually transmitted diseases.
INDICATIONS:
DelfenII is indicated for contraception in conjunction with an occlusive diaphragm or a condom.
CONTRA-INDICATIONS:
Hypersensitivity to the product. Where avoidance of pregnancy is essential, the choice of contraceptive should be made in consultation with a doctor or a family planning clinic.
WARNINGS:
For contraceptive effectiveness, the diaphragm should remain in place for 6hours after intercourse and should be removed as soon as possible thereafter. Continuous wearing of a contraceptive diaphragm for more than 24hours is not recommended. Retention of the diaphragm for prolonged periods may encourage the growth of certain bacteria in the vaginal tract.
DOSAGE AND DIRECTIONS FOR USE:
The use of DelfenII must be in conjunction with an occlusive vaginal diaphragm or condom.
Directions for use with an occlusive diaphragm:
The jelly should be spread over the surface of the diaphragm which will be in contact with the cervix and on the rim.
The diaphragm must be allowed to remain in place for six hours after coitus. A fresh application of DelfenII must be made prior to any subsequent act of coitus within this period of time without removing the diaphragm. A vaginal applicator should be used for inserting more jelly. If a douche is desired, it should be deferred for at least six hours after intercourse.
Directions for use with a condom:
Fill the applicator tube with jelly from the tube and insert into vagina. Squeeze a further approximately 2,5cm jelly from the tube and insert this into the tip of the condom before it is applied. Then lubricate the outside of the condom with the jelly from the applicator. A fresh condom and application of DelfenII should be used for every subsequent sexual intercourse. If a douche is desired, it should be deferred for at least six hours after intercourse.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
One or other partner may experience a degree of irritation, in which case an alternative contraceptive method or preparation is recommended.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
This has not been encountered. Treatment would be symptomatic.
IDENTIFICATION:
A smooth, unscented, translucent jelly.
PRESENTATION :
Aluminium tube, containing 81g of jelly, with a polyethylene screw cap.
STORAGE INSTRUCTIONS:
Store below 25°C.
Keep out of reach of children.
REGISTRATION NUMBER:
T/18.7/106
NAME AND BUSINESS ADDRESS OF APPLICANT:
JANSSEN-CILAG
Janssen Pharmaceutica (Pty) Ltd.,
(Reg. No. 80/11122/07)
15th Road,
HALFWAY HOUSE, 1685
© JPh (Pty) Ltd. SA 1993.
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
14 December 1989.
Code No.: 023039
99GB
® Trademark
Updated on this site: January 2001 |
