Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
1. NAME OF THE MEDICINAL PRODUCT                                                                 Oxytocin PANPHARMA must only be administered as an I.V. infusion and never by I.V.
Oxytocin PANPHARMA Injection 10 I.U./ML                                                          bolus injection as it may cause an acute short-lasting hypotension accompanied with flushing and reflex tachycardia.
2.   QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxytocin.                                                                                        Induction of labour 1 ml solution for injection contains 10 IU oxytocin.                                             The induction of labour by means of oxytocin should be attempted only when strictly indicated for medical reasons. Administration should only be under hospital conditions For the full list of excipients, see section 6.1.                                                and qualified medical supervision.
3.   PHARMACEUTICAL FORM                                                                         Cardiovascular disorders
Solution for Injection                                                                           Oxytocin PANPHARMA should be used with caution in patients who have a pre-disposition For I.M., I.V Injection and I.V. Infusion                                                        to myocardial ischaemia due to pre-existing cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease and/or ischaemic heart disease including coronary A clear, colourless sterile solution in 1 ml clear glass ampoules                                artery vasospasm), to avoid significant changes in blood pressure and heart rate in these 4.   CLINICAL PARTICULARS                                                                        patients.
QT syndrome
4.1 Therapeutic indications
Oxytocin PANPHARMA should be given with caution to patients with known ‘long QT Oxytocin PANPHARMA may be used for:                                                              syndrome’ or related symptoms and to patients taking drugs that are known to prolong
• Induction of labour for medical reasons;                                                       the QTc interval (see section 4.5 Interaction with other medicinal products and other
• Stimulation of labour in hypotonic uterine inertia;                                            forms of interaction).
• During Caesarean section following the delivery of the child;                                  When Oxytocin PANPHARMA is given for induction and enhancement of labour:
• Prevention and treatment of postpartum uterine atony and haemorrhage. Oxytocin                 • Foetal distress and foetal death: Administration of oxytocin at excessive doses results in PANPHARMA may also be indicated in early stages of pregnancy as an adjunctive therapy               uterine overstimulation, which may cause foetal distress, asphyxia and death, or may for the management of incomplete, inevitable or missed abortion.                                    lead to hypertonicity, tetanic contractions or rupture of the uterus. Careful monitoring of foetal heart rate and uterine motility (frequency, strength, and duration of contractions) 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).                                        

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