Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: AS Grindeks, Krustpils Iela 53, Riga, 1057, Latvia
Antepartum:
Postpartum:
Oxytocin should not be started for 6 hours following administration of vaginal prostaglandins. Ofost should be administered as an intravenous (i.v.) drip infusion or, preferably, by means of a variable-speed infusion pump. For drip infusion it is recommended that 5 IU of Ofost be added to 500 ml of a physiological electrolyte solution (such as sodium chloride 0.9%). For patients in whom infusion of sodium chloride must be avoided, 5% dextrose solution may be used as the diluent (see section 4.4 Special warnings and precautions for use). To ensure even mixing, the bottle or bag must be turned upside down several times before use.
The initial infusion rate should be set at 1 to 4 milliunits/minute (2 to 8 drops/minute). It may be gradually increased at intervals not shorter than 20 minutes and increments of not more than 1-2 milliunits/minute, until a contraction pattern similar to that of normal labour is established. In pregnancy near term this can often be achieved with an infusion of less than 10 milliunits/minute (20 drops/minute), and the recommended maximum rate is 20 milliunits/minute (40 drops/minute).
When using a motor-driven infusion pump which delivers smaller volumes than those given by drip infusion, the concentration suitable for infusion within the recommended dosage range must be calculated according to the specifications of the pump.
The frequency, strength, and duration of contractions as well as the foetal heart rate must be carefully monitored throughout the infusion. Once an adequate level of uterine activity is attained, aiming for 3 to 4 contractions every 10 minutes, the infusion rate can often be reduced. In the event of uterine hyperactivity and/or foetal distress, the infusion must be discontinued immediately.
If, in women who are at term or near term, regular contractions are not established after the infusion of a total amount of 5 IU, it is recommended that the attempt to induce labour be ceased; it may be repeated on the following day, starting again from a rate of 1 to 4 milliunits/minute (see section 4.3 Contraindications).
Ofost is well tolerated by the tissues therefore inadvertent extravascular infusion is not harmful.
1 ml Ofost 5 IU/ml as i.v. infusion (1.0 ml diluted in physiological sodium chloride solution and administered via i.v. drip infusion or preferably by means of a variable-speed infusion pump over 5 minutes) after delivery.
The usual dose is 5 IU by i.v infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) or 5-10 IU i.m. after delivery of the placenta. In women given Ofost for induction or enhancement of labour, the infusion should be continued at an increased rate during the third stage of labour and for the next few hours thereafter.
5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) or 5-10 IU i.m., followed in severe cases by i.v. infusion of a solution containing 5 to 20 IU of oxytocin in 500 ml of an electrolyte-containing diluent, run at the rate necessary to control uterine atony.
5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), if necessary followed by i.v infusion at a rate of 20 to 40 milliunits/minute. If painful uterus contractions occur, the drop rate should be decreased or the infusion temporarily stopped.
Route of administration: Intravenous (i.v), intramuscular (i.m.) injection and intravenous infusion.
There are no indications for use of Ofost in elderly patients.
No studies have been performed in renally impaired patients.
No studies have been performed in hepatically impaired patients.
There are no indications for use of Ofost in children or adolescents.
Overdosage may cause the following complications: foetal distress (foetal bradycardia, meconium-stained amniotic fluid, asphyxia), hypertonicity, tetanic contractions, rupture of the uterus, water intoxication.
No symptoms were seen when 2‑3 and 10 IU respectively was given i.m. to newborns and 8 IU was given by nasal administration to children of ½‑1½ years of age. Serious intoxication was seen in adults after infusion of 80 IU in a solution of isotonic glucose during 35 hours, infusion of 488 IU during 40 hours and infusion of 800 IU during 60 hours. (1 IU corresponds to 1.67 microgram).
Antidiurethic effect – risk for water intoxication (hyponatraemia, hypo-osmolality, cerebral oedema).Vascular spasm, hypertension.
In the case of fluid retention observation is necessary. In the event of water intoxication, diuretics (mannitol or furosemide), infusion of sodium and cerebral oedema therapy should be administered. Other symptomatic treatment may be used.
3 years.
Do not store above 25°C.
1 ml transparent type I borosilicate glass ampoules with break ring or open point cut.
Pack sizes: 5, 10 or 100 ampoules.
Not all pack sizes may be marketed.
Ofost is compatible with the following infusion fluids, but due attention should be paid to the advisability of using electrolyte fluids in individual patients: sodium chloride 0.9%, dextrose 5%, Ringer’s solution, acetated Ringer’s solution.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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