Carbetocin Prescribing Information. Please refer to the Carbetocin Summary of Product Characteristics for full details. Product name: Carbetocin 100 micrograms solution for injection in pre-filled syringe Composition: Each pre-filled syringe contains 1 mL with 100 micrograms of carbetocin. Therapeutic indications: Carbetocin is indicated for the prevention of postpartum haemorrhage due to uterine atony. Posology and method of administration: Posology: Caesarean section under epidural or spinal anaesthesia: Inject 1 ml of Carbetocin containing 100 micrograms carbetocin and administer only by intravenous injection, under adequate medical supervision in a hospital. Vaginal delivery: Inject 1 ml of Carbetocin containing 100 micrograms carbetocin and administer by intravenous injection or intramuscular injection, under adequate medical supervision in a hospital. Method of administration: For intravenous or intramuscular administration. Carbetocin must only be administered after delivery of the infant, and as soon as possible after delivery, preferably before the delivery of the placenta. For intravenous administration carbetocin must be administered slowly, over 1 minute. Carbetocin is intended for single use only. No further doses of carbetocin should be administered. Paediatric population: There is no relevant use of carbetocin in children below 12 years of age. The safety and efficacy of carbetocin in adolescents has not yet been established. Contraindications: Hypersensitivity to carbetocin, oxytocin or to any of the ingredients listed in section 6.1 of the full SmPC, during pregnancy and labour before delivery of the infant, Carbetocin must not be used for the induction of labour, Hepatic or renal impairment, Severe cardiovascular disorders, Epilepsy. Warnings and precautions (see SmPC for full details): During clinical trials, no drug interactions have

been identified. Specific interaction studies have not been undertaken. Since carbetocin is closely related in structure to oxytocin, the occurrence of interactions known to be associated with oxytocin cannot be excluded. Severe hypertension has been reported when oxytocin was given 3 to 4 hours following prophylactic administration of a vasoconstrictor in conjunction with caudal-block anaesthesia. During combination with ergot-alkaloids, such as methylergometrine, oxytocin and carbetocin may enhance the blood pressure enhancing effect of these agents. If oxytocin or methylergometrine are administered after carbetocin there may be a risk of cumulative exposure. Since it has been found that prostaglandins potentiate the effect of oxytocin, it is expected that this can also occur with carbetocin. Therefore, it is not recommended that prostaglandins and carbetocin are used together. If they are concomitantly administered, the patient should be carefully monitored. Some inhalation-anesthetics, such as halothane and cyclopropane may enhance the hypotensive effect and weaken the effect of carbetocin on the uterus. Arrhythmias have been reported for oxytocin during concomitant use. Fertility, pregnancy, and lactation: Pregnancy: Carbetocin is contraindicated during pregnancy and must not be used for the induction of labour Breastfeeding: No significant effects on milk let-down have been reported during clinical trials. Small amounts of carbetocin have been shown to pass from plasma into breast

milk of nursing women (see section 5.2 of the SmPC). The small amounts transferred into colostrum or breast milk after a single injection of carbetocin, and subsequently ingested by the infant are assumed to be degraded by enzymes in the gut. Breast-feeding does not need to be restricted after the use of carbetocin. Undesirable effects: Common (21/100 and<1/10) Anaemia, Dizziness, Chest pain, Dyspnoea, Metallic taste, vomiting, Back pain, Chills, pain Uncommon (21/1,000 and<1/100) Anaemia, Headache, dizziness, Tachycardia, Hypotension, Chest pain, Nausea, abdominal pain, vomiting (refer to the SmPC for full list) NHS Price: £70 per pack 5 £14 per pre-filled syringe Special precautions for storage: Keep syringes in the outer carton to protect from light. Store in a refrigerator (2°C to 8°C). Shelf life: 4 years Legal Classification: POM MA number: PL 24837/0131 Marketing Authorisation Holder: Consilient Health Limited, Floor 3, Block 3, Miesian Plaza, Dublin 2, Ireland, D02 Y754. Further information is available on request from: Consilient Health (UK) Ltd, 1 Church Road, Richmond upon Thames, Surrey, TW9 2QE or drugsafety@consilienthealth.com. Job Code: UK-HSP-1(1)a Date of preparation: October 2024.