Composition, form of production and packaging
The solution for intravenous and intravenous administration is clear, colorless.
carbetocin 100 Ојg
(oxytocin activity of about 50 IU oxytocin / ml)
Excipients: sodium chloride 9 mg, acetic acid ice to pH 3.8, water d / and up to 1 ml.
1 ml - ampoules of colorless glass (5) - packings of cellular (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
Carbetocin (1-deamino-1-monocarba- [2-0-methylthyrosine] -oxytocin) is a long-acting oxytocin agonist.
Like oxytocin, carbetocin selectively binds to oxytocin receptors in the smooth muscles of the uterus, stimulates rhythmic contractions of the uterus, increases the frequency of existing contractions and increases the tone of the uterine musculature.
In the postpartum uterus, carbetocin increases the speed and strength of spontaneous uterine contractions. After the introduction of carbetocin, the contractions of the uterus become more frequent, and after two minutes a sharp contraction occurs.
A single dose of carbetocin 100 mcg is sufficient to maintain adequate uterine contractions that prevent uterine atony and heavy bleeding, which can be compared with the administration of oxytocin, which lasts for several hours.
C max in plasma is achieved within 15 min after administration and is 1035 В± 218 pg / ml within 60 min. Carbetocin penetrates into breast milk, while its C max isapproximately 56 times lower than in blood plasma after 120 minutes.
By analogy with oxytocin, carbetocin is hydrolyzed by proteinases.
Carbetocin excretion has a two-phase character with linear pharmacokinetics in the dose range of 400-800 Ојg. T 1/2 is about 40 minutes. The renal clearance of the unmodified form is low, less than 1% of the administered dose is excreted by the kidneys unchanged.
- Prevention of atony of the uterus after the extraction of the child during operative delivery by cesarean section;
- Prevention of atony of the uterus in parturient women with an increased risk of postpartum hemorrhage after delivery through the natural birth canal.
Pabal is administered 1 time in / in or / m only after the birth of the child. Do not use the drug again. Do not mix Pabal with other drugs in one syringe. Do not use the drug if insoluble particles are observed in the solution or the solution changes color.
Unused medication is subject to destruction.
During a caesarean section, a single dose of Pabal (100 Ојg / ml) is given immediately after the removal of the baby, preferably before the placenta is removed.
When Delivery through the natural birth canal 1 dose of Pabal (100 mcg / ml) is injected into the upper thigh immediately after the release of the afterbirth.
The nature and frequency of side effects with carbetocin are comparable with the side effects of oxytocin:
The type of body system Very often> 1/10 Often> 1/100 and <1/10
From the hematopoietic and lymphatic system Anemia
From the side of the nervous system Headache, tremor Vertigo
From the side of the cardiovascular system Increased blood pressure, hyperemia of the face
On the part of the respiratory system Pain in the chest, dyspnea
On the part of the digestive system Nausea, abdominal pain Metallic taste in the mouth, vomiting
From the musculoskeletal system Back pain
Common reactions: chills, pain at the injection site.
- the period of pregnancy and childbirth until the birth of a child;
- impaired liver or kidney function;
- Serious disorders of the cardiovascular system (rhythm and conduction disorders);
- for induction of labor;
- hypersensitivity to carbetocin, oxytocin, or to one of the components of the drug.
With care, carbetocin has a certain anti-diuretic effect. Therefore it follows that
Consider the possibility of developing hyponatremia with the use of Pabal especially in patients receiving large amounts of IV infusions.
It is necessary to pay attention to the first signs of hyponatremia (drowsiness, apathy, headache) to prevent seizures and coma.
Pabal should be used with caution in migraine, bronchial asthma and cardiovascular diseases, as well as in any conditions in which a rapid increase in volume, extracellular fluid can trigger complications associated with hyperhydration. Decision on the use of the drug Pabal the doctor should take into account the ratio of risk-benefit in each case. Continuous monitoring of blood pressure is necessary in patients with gestosis of the second half of severe pregnancy, eclampsia and preeclampsia.
PREGNANCY AND LACTATION
The use of the drug Pabal is contraindicated in pregnancy and childbirth until the birth of the child.
A small amount of carbetocin can enter the mother's breast milk and then be destroyed by the enzymes of the newborn.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in the violation of kidney function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in the violation of liver function.
Pabal is given in / m or / in only in specialized obstetricheskie.sedeleniya, respectively, equipped and having a staff of qualified and experienced medical staff.
The use of the drug Pabal at any stage of childbirth until the birth of a child is prohibited, since the stimulating effect of carbetocin on the uterus after a single injection of 100 mcg / ml lasts several hours in contrast to the rapid decrease in the effect of oxytocin.
In the case of unceasing uterine bleeding, after the use of Pabal, such reasons as undivided fragments of the placenta and bleeding disorders should be excluded.
Pabal is introduced only once. In the case of hypotension or atony of the uterus accompanied by heavy bleeding, the possibility of using oxytocin and / or ergometrine should be considered.
Since Pabal has a certain anti-diuretic effect, it is necessary to identify the first signs of hyponatremia (drowsiness, apathy and headache) to prevent seizures and coma.
Impact on the ability to drive vehicles and manage mechanisms
Not applicable, given indications for use.
Symptoms: cases of overdose with a single injection of the recommended dose of 100 mcg / ml are very rare. The introduction of Pabal 800 mg / ml can cause tachycardia. Violation of the recommended dosing regimen can trigger hypertension of the myometrium, regardless of the presence or absence of hypersensitivity to carbetocin or postpartum hemorrhage. In severe cases, an overdose of Pabal may lead to hyponatremia and hyperhydration, especially when combined with a simultaneous high volume of IV infusion solutions administered during delivery.
Treatment: is symptomatic and maintenance therapy. If there are signs, or symptoms of an overdose, the woman in labor should provide adequate oxygenation. When water intoxication, it is necessary to limit the flow of fluid, stimulate diuresis, correct electrolyte disturbances, and pay attention to the clinical signs of hyponatremia (drowsiness, apathy, headache) to prevent seizures and coma.
There were no cases of drug interaction with analgesics, antispasmodics and drugs used for epidural or spinal anesthesia. However, do not mix Pabal in one syringe with other drugs.
Since carbetocin is an analog of oxytocin, there may be cases of interaction, characteristic of oxytocin. A sharp rise in blood pressure is possible with the introduction of Pabal 3-4 hours after the prophylactic use of vasoconstrictor, in combination with caudal-conductive anesthesia. It is also possible to increase blood pressure and increase the effect of carbetocin in the joint use of the drug Pabal with ergot preparations (methylergometrine).
It is not recommended to use Pabal simultaneously with prostaglandins in connection with the possible increase in the action of carbetocin. If nevertheless their simultaneous application is necessary, then the patient should be constantly monitored.
Means for inhalation anesthesia (halothane, cyclopropane) can enhance the hypotensive effect and reduce the effect of the drug Pabal on the uterus.
With the simultaneous use of the drug Pabal with oxytocin, the development of arrhythmia is possible.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
Keep out of the reach of children at a temperature of 2-8 В° C. Do not freeze. Shelf life - 2 years.