Posology : מינונים

4.2 Posology and method of administration                                                           is essential, so that the dosage may be adjusted to individual response.
Oxytocin should be used only in a clinical setting and only under medical supervision. For       • Particular caution is required in the presence of borderline cephalopelvic disproportion, the individual dosage, careful monitoring of the birth is required (CTG, blood pressure and         secondary uterine inertia, mild or moderate degrees of pregnancy-induced hypertension pulse of the mother).                                                                               or cardiac disease, and in patients above 35 years of age or with a history of lower- Induction or enhancement of labour:                                                                 uterine-segment Caesarean section.
For labour induction or to increase contractions, Oxytocin PANPHARMA may only be                 • Disseminated intravascular coagulation: In rare circumstances, the pharmacological administered as an intravenous continuous infusion and never as subcutaneous,                       induction of labour using uterotonic agents, including oxytocin, increases the risk of intramuscular or intravenous bolus injection.                                                       postpartum disseminated intravascular coagulation (DIC). The pharmacological induction itself and not a particular agent is linked to such risk. This risk is increased
Oxytocin PANPHARMA should be administered as an intravenous drip infusion or,                       in particular if the woman has additional risk factors for DIC such as being 35 years preferably, using a variable-speed infusion pump. For drip infusion, it is recommended              of age or over, complications during pregnancy and gestational age more than 40 that 10 lU of Oxytocin PANPHARMA should be added to 1000 mL of an isotonic sodium                   weeks. In these women, oxytocin or any other alternative drug should be used with chloride solution.                                                                                  care, and the practitioner should be alerted by signs of DIC.
For patients in whom infusion of sodium chloride must be avoided, 5% dextrose sodium
may be used as the diluent (see section 4.4 Special warnings and precautions for use). To        Intrauterine death
ensure even mixing, the bottle or bag must be turned upside down several times before            In the case of foetal death in utero, and/or in the presence of meconium-stained amniotic use.                                                                                             fluid, tumultuous labour must be avoided, as it may cause amniotic fluid embolism. The initial infusion rate should be set at 1-4 mU/min (2-8 drops/min). It may be gradually       Water intoxication
increased at intervals not shorter than 20 min, until a contraction pattern similar to that of   Because oxytocin possesses slight antidiuretic activity, its prolonged I.V. administration at normal labour is established. In pregnancy near term, this can often be achieved with an         high doses in conjunction with large volumes of fluid, as may be the case in the treatment infusion of less than 10 mU/min (20 drops/min), and the recommended maximum rate is              of inevitable or missed abortion or in the management of postpartum haemorrhage, may 20 mU/min (40 drops/min). In the unusual event that higher rates are required, as may            cause water intoxication associated with hyponatraemia. The combined antidiuretic effect occur in the management of foetal death in utero or for induction of labour at an earlier        of oxytocin and the I.V. fluid administration may cause fluid overload leading to a stage of pregnancy, when the uterus is less sensitive to oxytocin, it is advisable to use a      haemodynamic form of acute pulmonary oedema without hyponatraemia. To avoid these more concentrated Oxytocin PANPHARMA solution, e.g., 10 IU in 500 ml.                            rare complications, the following precautions must be observed whenever high doses of When using a motor-driven infusion pump, which delivers smaller volumes than those               oxytocin are administered over a long time: an electrolyte-containing diluent must be used given by drip infusion, the concentration suitable for infusion within the recommended           (not dextrose); the volume of infused fluid should be kept low (by infusing oxytocin at a dosage range, must be calculated according to the specifications of the pump.                    higher concentration than recommended for the induction or enhancement of labour at If regular contractions are still absent after the infusion of 500 mL (5 IU), the attempt at     term); fluid intake by mouth must be restricted; a fluid balance chart should be kept, and labour induction should be ceased. A fresh attempt can generally be made on the following        serum electrolytes should be measured when electrolyte imbalance is suspected. day.                                                                                             Renal impairment
Throughout the entire duration of infusion, the frequency, intensity and duration of             Caution should be exercised in patients with severe renal impairment because of possible contractions, as well as the foetal heart rate, must be carefully monitored. As soon as          water retention and possible accumulation of oxytocin (see section 5.2 Pharmacokinetic appropriate uterine activity has been achieved, the infusion rate can often be reduced.          properties).
The infusion must be discontinued immediately in the event of excessive uterine activity
and/or signs of placental malnutrition (foetal distress).                                        4.5 Interactions with other medicinal products and other forms of
interaction
Caesarean section:
Interaction resulting from concomitant use is not recommended.
Immediately after extraction of the infant, 5 IU can be injected slowly I.V.
Prostaglandins and their analogues
Prevention of postpartum uterine haemorrhage:
The usual dose is 5 IU slowly I.V. after delivery of the placenta. In women given Oxytocin       Prostaglandins and their analogues facilitate contraction of the myometrium, hence oxytocin can potentiate the uterine action of prostaglandins and analogues and vice
PANPHARMA for induction or enhancement of labour, the infusion should be continued at an         versa (see section 4.3 Contraindications).
increased rate during the third stage of labour and for the next few hours thereafter.
Drugs prolonging the QT interval
Treatment of postpartum uterine haemorrhage:
Oxytocin should be considered as potentially arrhythmogenic, particularly in patients with
5-10 IU I.M. or 5 IU slowly I.V., followed in severe cases by intravenous infusion of a          other risk factors for torsades de pointes, such as drugs, w hi c h prolong the QT solution containing 5-20 IU of oxytocin in 500 ml of a non-hydrating diluent, run at the
rate necessary to control uterine atony.                                                         interval or in patients with history of long QT syndrome (see section 4.4 Special warnings and precautions for use).
Due to the antidiuretic effect of Oxytocin PANPHARMA which suppresses urine excretion
(see section 4.8 Undesirable effects), the following measures should be observed when            Interactions to be considered
administering Oxytocin PANPHARMA at high doses:                                                  Inhalation anaesthetics
An isotonic sodium chloride solution (not glucose) should be used and the infused volume         Inhalation anaesthetics (e.g., cyclopropane, halothane, sevoflurane, desflurane) have a of fluid must be kept low. At the same time, oral fluid intake should be restricted and the      relaxing effect on the uterus and produce a notable inhibition of uterine tone, and thereby fluid balance monitored. If an electrolyte imbalance is suspected, serum electrolytes must       may diminish the uterotonic effect of oxytocin. Their concurrent use with oxytocin has be monitored.                                                                                    also been reported to cause cardiac rhythm disturbances.
Incomplete, inevitable, or missed abortion:                                                      Vasoconstrictors/Sympathomimetics
5 IU I.M. or slowly I.V., if necessary followed by intravenous infusion at a rate of 20-40       Oxytocin may enhance the vasopressor effects of vasoconstrictors and sympathomimetics, mU/min or higher.                                                                                even those contained in local anaesthetics.