Pabal solution for injection 100 mcg/ml ampoule 1 ml No. 5

Ferring International Center

Composition of the medicinal product:

Pharmacological properties

Pharmacodynamics. Carbetocin is a long-acting oxytocin agonist. Like oxytocin, the active ingredient of the drug pabu - carbetocin - selectively binds to oxytocin receptors of smooth muscle cells of the myometrium, stimulates rhythmic uterine contractions, increases the frequency of contractions that have already begun, and increases uterine muscle tone.
In the postnatal period, carbetocin is able to increase the frequency and strength of spontaneous uterine contractions. After the introduction of the drug into the uterus, the onset of intense contractile activity with powerful uterine contractions is achieved within 2 minutes.
A single injection of 100 mcg of the drug PABA IV after childbirth is sufficient to maintain adequate uterine contractility, in order to prevent uterine atony and excessive blood loss compared with oxytocin infusion for several hours.
Pharmacokinetics. Carbetocin has a biphasic elimination pattern after IV administration with linear pharmacokinetics in the dose range of 400-800 mcg. T ½ is about 40 min. Renal clearance of the unchanged form is low, less than 1% of the administered dose is excreted unchanged by the kidneys.
In 5 healthy breast-feeding mothers, C max of carbetocin in plasma was determined within 15 min, which was 1,035 ± 218 pg / ml within 60 min. C max in breast milk was approximately 56 times lower than in plasma, after 120 min.

Indication

prevention of uterine atony during cesarean section, which is performed using spinal or epidural anesthesia.

Method of application

The drug PABA is administered only intravenously under appropriate medical supervision in a hospital setting.
The drug is administered in a dose of 1 ml over 1 minute once after cesarean section and childbirth. The drug should be administered immediately after childbirth, preferably before placental abruption. The drug should not be administered later.

Contraindication:

pregnancy and pregnancy-related.
Should not be used to stimulate labor.
Hypersensitivity to carbetocin or oxytocin.
Liver and kidney disease.
Episodes of eclampsia and preeclampsia.
Severe diseases of the cardiovascular system.
Epilepsy.

SIDE EFFECTS:

During clinical trials of carbetocin, the frequency and nature of side effects were similar to those seen with oxytocin for cesarean section under spinal or epidural anesthesia:

During clinical trials, isolated cases of tachycardia and increased sweating were noted.

Carbetocin should only be used in well-equipped obstetric hospitals with trained and qualified personnel.
Pabu is intended for intravenous administration only. For administration, a solution that does not contain any particles should be used.
Unused drug. Read the current regulatory documents.
In the absence of compatibility studies, this medicinal product should not be mixed with other drugs.
The use of carbetocin at any stage of labor is unacceptable because its hysterotonic effect persists for several hours after a single bolus injection. This property is a significant difference compared with the rapid cessation of the effect after interruption of the oxytocin infusion.
If uterine bleeding continues after administration of carbetocin, the cause should be investigated. Possible causes include incomplete placental abruption, inadequate uterine closure, and coagulopathy.
If persistent uterine hypotension or atony develops and, as a consequence, prolonged bleeding, the possibility of additional administration of oxytocin and/or ergometrine should be considered.
To date, there are no data on the repeated administration of carbetocin, as well as on its use after oxytocin in persistent uterine atony.
In experimental studies on animals, it was found that carbetocin has a slight antidiuretic activity, therefore the possibility of developing hyponatremia cannot be excluded, especially in patients undergoing intensive infusion therapy. In order to prevent the development of convulsive syndrome and coma, early manifestations of this condition, such as drowsiness, lethargy and headache, should be observed.
Carbetocin should be used with caution in patients with a history of migraine, asthma, cardiovascular disease, or any condition associated with a sudden increase in extracellular fluid volume that may increase cardiovascular overload. In such cases, the decision to administer carbetocin should be made by the physician after careful consideration of the potential benefits of its administration.
There are currently no studies of the use of the drug during pregnancy in the presence of diabetes mellitus. The effectiveness of carbetocin in the normal course of labor has also not been studied.
Use during pregnancy or breastfeeding. Carbetocin is contraindicated for use in the induction of labor.
During clinical studies, no significant effect on lactation was found. It has been established that a small amount of carbetocin penetrates into breast milk. It is assumed that after a single injection, a small amount of carbetocin penetrates into colostrum or breast milk and is subsequently destroyed by the intestinal enzymatic system.
Ability to influence the reaction rate when driving vehicles or working with other mechanisms. The effect on the ability to drive vehicles and work with complex mechanisms has not been evaluated due to the inconsistency of the clinical situation.

Interaction with other drugs

When using carbetocin in combination with various analgesics, antispasmodics, and drugs for spinal and epidural anesthesia, no signs of any drug interaction were found.
Since carbetocin is chemically similar to oxytocin, the possibility of interactions characteristic of oxytocin cannot be excluded.
Severe hypertension was noted after oxytocin was administered 3-4 hours after prophylactic administration of vasoconstrictors for spinal anesthesia.
Oxytocin and carbetocin, when used concomitantly with ergot alkaloids such as methylergometrine, may increase blood pressure, potentiating the effects of these drugs. The risk of cumulative effects is increased if oxytocin or methylergometrine is administered after carbetocin.
Since prostaglandins have been shown to potentiate the effect of oxytocin, it can be assumed that a similar effect may occur with carbetocin. Therefore, the combined use of prostaglandins and carbetocin is undesirable. If the drugs are administered simultaneously, careful monitoring of the patient's condition is necessary.
Some inhalation anesthetics, such as halothane and cyclopropane, may enhance the hypotensive effect and reduce the effect of carbetocin on the uterus. Cases of arrhythmia have been described with the simultaneous administration of carbetocin with oxytocin.

Conditions and shelf life

Exceeding the dose of carbetocin may cause increased uterine activity both in the presence and absence of hypersensitivity to this drug.
Hyperactivity, accompanied by strong (tonic) or prolonged (clonic) uterine contractions, caused by carbetocin overdose, can lead to uterine rupture and postpartum hemorrhage.
In severe cases, oxytocin overdose may cause hyponatremia and hyperhydration, especially in connection with the simultaneous administration of excessive amounts of fluid. Since carbetocin is an analogue of oxytocin, the possibility of developing similar effects cannot be excluded.
Treatment of overdose is symptomatic and supportive. If symptoms of overdose are present, the woman in labor should begin oxygen therapy. In case of hyperhydration, it is important to limit the amount of fluid and stimulate diuresis, correct electrolyte imbalance, and stop convulsive syndrome if it occurs.

STORAGE CONDITIONS:

in the original carton to protect from light. Store in a refrigerator at 2-8°C. Do not freeze.