PROSTIN E2 Concentrate for solution for infusion (2018)
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Περιεχόμενα
Name of the medicinal product
Prostin E2 Sterile Solution 1 mg/ml.
Qualitative and quantitative composition
Each ml contains 1 mg dinoprostone (750 micrograms per ampoule). Following dilution in accordance with instructions, each ml of the resultant solution for infusion contains 1.5 micrograms dinoprostone. ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear, colourless, alcoholic solution free from particulate matter, which after appropriate dilution is intended for intravenous ...
Therapeutic indications
Oxytocic agent. Prostin E2 Sterile Solution 1 mg/ml is indicated for the induction of labour by the intravenous route.
Posology and method of administration
Posology Adults Directions for the Preparation of a Dilute Solution: For use by IV drip (a drip set delivering 60 drops/per ml must be used) or constant rate infusion pump. Withdraw 0.75 ml from the ampoule ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Prostin E2 Sterile Solution should not be used where the patient is sensitive to prostaglandins. Prostin E2 ...
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 Sterile Solution 1 mg/ml is 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
The amount of alcohol (ethanol) in this medicinal product may impair the patients ability to drive or use machines.
Undesirable effects
Cardiac disorders: Cardiac arrest Vascular disorders: Hypertension Gastrointestinal disorders: Diarrhoea, nausea, vomiting General disorders and administration site conditions: Fever, local tissue irritation/erythema ...
Overdose
Over dosage 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. It induces contraction of uterine muscle at any stage of pregnancy. ...
Pharmacokinetic properties
Dinoprostone is rapidly metabolised in the body. Intravenous administration results in very rapid distribution and metabolism, with only 3% of unchanged drug remaining in the blood after 15 minutes. At ...
Preclinical safety data
There are no preclinical data of relevance which are additional to that already included in other sections of the Summary of Product Characteristics.
List of excipients
Dehydrated alcohol (ethanol)
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Store in a refrigerator at 2-8°C. Once diluted, the diluted solution should be stored in a refrigerator at 2-8°C and used within 24 hours.
Nature and contents of container
Ph. Eur. Type I glass ampoule, containing 0.75 ml sterile solution, packed in a carton.
Special precautions for disposal and other handling
Use caution in handling this product to prevent contact with skin. Wash hands thoroughly with soap and water after administration. Any unused medicinal product or waste material should be disposed of in ...
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
Marketing authorization number(s)
PL 00057/1028
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 June 1986 Date of latest renewal: 28 October 2004
Date of revision of the text
01/2018
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