PROSTIN E2 Vaginal tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Prostin E2 Vaginal Tablets 3mg.
Qualitative and quantitative composition
Each tablet contains 3 mg dinoprostone. For the full list of excipients, see section 6.1.
Pharmaceutical form
Vaginal tablet. White, biconvex, oblong tablet, embossed with Upjohn 715 on one side and plain on the other.
Therapeutic indications
Oxytocic agent. Prostin E2 Vaginal Tablets are indicated for the induction of labour, especially in patients with favourable induction features, when there are no foetal or maternal contra-indications. ...
Posology and method of administration
Posology Adults One tablet to be inserted high into the posterior fornix. A second tablet may be inserted after six to eight hours if labour is not established. Maximum dose 6 mg. Elderly Not applicable. ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Prostin E2 Vaginal Tablets should not be used where the patient is sensitive to prostaglandins or other constituents ...
Special warnings and precautions for use
This product is only available to hospitals and clinics with specialised obstetric units and should only be used where 24-hour resident medical cover is provided. Use caution in handling this product to ...
Interaction with other medicinal products and other forms of interaction
Since it has been found that prostaglandins potentiate the effect of oxytocin, it is not recommended that these drugs are used together. If used in sequence, the patients uterine activity should be carefully ...
Pregnancy and lactation
Pregnancy Prostin E2 Vaginal Tablets are only used during pregnancy, to induce labour. Breast-feeding Prostaglandins are excreted in breast milk. This is not expected to be a hazard given the circumstances ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Cardiac disorders: Cardiac arrest Vascular disorders: Hypertension Gastrointestinal disorders: Diarrhoea, nausea, vomiting General disorders and administration site conditions: Fever Immune system disorders: ...
Overdose
Overdosage may be expressed by uterine hypercontractility and uterine hypertonus. During use, uterine activity, fetal status and the progression of cervical dilation should be carefully monitored to detect ...
Pharmacodynamic properties
Pharmacotherapeutic group: Prostaglandins ATC-code: G02AD02 Dinoprostone is a prostaglandin of the E series with actions on smooth muscle; the endogenous substance is termed prostaglandin E<sub>2</sub> ...
Pharmacokinetic properties
Following insertion of the tablet, PGE<sub>2</sub> absorption (as measured by the presence of PGE2 metabolites) increases to reach a peak at about 40 minutes. PGE<sub>2</sub> is rapidly metabolised to ...
Preclinical safety data
Animal studies lasting several weeks at high doses have shown that prostaglandins of the E and F series can induce proliferation of bone. Such effects have also been noted in newborn infants who received ...
List of excipients
Lactose Microcrystalline cellulose Colloidal silicon dioxide Maize starch Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Store in a refrigerator at 2-8°C. Where the tablets are packed in a bottle, the tablets should be used within one month of opening the bottle.
Nature and contents of container
Amber glass bottle with screw cap and tac seal. Each bottle contains a desiccant capsule and 4 tablets. Aluminium foil strip of 4 tablets, each box containing 4 or 8 tablets. Not all pack sizes may be ...
Special precautions for disposal and other handling
Wash hands thoroughly with soap and water after administration. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
Marketing authorization number(s)
PL 00057/1516
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 March 1982 Date of last renewal: 28 October 2004
Date of revision of the text
01/2018
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