PRANDIN E2 Vaginal Gel Ref.[50238] Active ingredients: Dinoprostone

Source: Marketing Authorisation Holder  Revision Year: 2018  Publisher: Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton, 2196, South Africa

4.1. Therapeutic indications

PRANDIN E2 Vaginal Gel is indicated for induction of labour in at-term or near-term pregnant patients where there are no foetal or maternal contraindications.

4.2. Posology and method of administration

For labour induction at-/or near-term, the initial dose is 1 mg of PGE2 gel into the posterior fornix of the vaginal canal. After 6 hours, a second dose of either 1 or 2 mg of PRANDIN E2 Vaginal Gel may be administered depending upon need; i.e. an absence of response to the initial 1 mg dose indicates the 2 mg dose should be given, while a 1 mg dose would be suggested to augment an already present response to the initial dose. A maximum dose of 3 mg may be used.

4.9. Overdose

The principal expressions of an exaggerated response to PRANDIN E2 Vaginal Gel are either myometrial, hypercontractility or hypertonus. Management of an exaggerated myometrial response should include evacuation of the medication from the vaginal tract, placing the patient in a lateral semi-recumbent position and administration of oxygen. An adrenergic β2-stimulant may be given intravenously to alleviate the hypertonus.

6.4. Special precautions for storage

Store in a refrigerator (2-8°C).

Keep out of reach of children.

6.5. Nature and contents of container

A colourless, semi-translucent, viscous gel.

PRANDIN E2 1 mg or 2 mg Vaginal Gel is supplied as a semi-translucent, thixotropic sterile gel as follows: 1 mg or 2 mg PGE2 per 3 g in syringes for intravaginal application.

6.6. Special precautions for disposal and other handling

Instructions on the method of assembly:

  1. Remove syringe from blister pack.
  2. Remove protective end cap (to serve as plunger extension).
  3. Insert protective end cap into syringe.
  4. Administer syringe contents.

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