Pabal (Pabal)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCarbetocinCarbetocin
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  • Pabal
    solution w / m in / in 
    Ferring GmbH     Germany
    • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    Composition per one ampoule:

    active substance: carbetocin 100 μg (oxytocin activity about 50 ME oxytocin / ml);

    Excipients: sodium chloride 9 mg, acetic acid ice to pH 3.8, water for injection up to 1 ml.

    Description:

    Transparent colorless liquid.

    Pharmacotherapeutic group:generic activity stimulant - oxytocin preparation
    ATX: & nbsp

    H.01.B.B.03   Carbetocin

    Pharmacodynamics: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 musculature of the uterus, stimulates rhythmic contractions of the uterus, increases frequency of available contractions and increases the tone of the uterine musculature.

    In the postnatal uterus carbetocin increases the speed and strength of spontaneous uterine abbreviations. After the introduction of carbetocin, the contractions of the uterus become more frequent, and after two minute comes a sharp fight.

    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.

    Pharmacokinetics:Distribution: the maximum concentration in the plasma is reached within 15 minutes after administration and is 1035 ± 218 pg / ml within 60 minutes. Carbetocin penetrates into breast milk, while its maximum concentration is approximately 56 times lower than in blood plasma after 120 minutes.
    Metabolism: by analogy with oxytocin, carbetocin is hydrolyzed by proteinases.
    Excretion: Carbetocin excretion has a two-phase character with linear pharmacokinetics in the dose range of 400-800 μg. The half-life is about 40 minutes. Renal clearance of unchanged form is low, less than 1% of the administered dose is excreted by the kidneys unchanged.

    Indications:

    - 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.

    Contraindications:

    - Hypersensitivity to carbetocin, oxytocin or to one of the components of the drug;

    - PPregnancy and delivery before delivery;

    - Mr.the destruction of the liver or kidney;

    - fromSerious disorders of the cardiovascular system (rhythm disturbances and conductivity);

    - epilepsy;

    - Pabal is contraindicated for induction of labor.

    Carefully:Carbetocin has a certain antidiuretic effect. Therefore, the possibility of developing hyponatremia with the use of Pabal preparation should be considered, especially in patients receiving large amounts of intravenous 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 rapid increased volume, extracellular fluid can trigger complications, associated with hyperhydration. Decision to use the drug Pabal doctor must take into account the ratio of "risk-benefit" in each case. Continuous monitoring of blood pressure is necessary in patients with gestosis II half of severe pregnancy, eclampsia and preeclampsia.

    Pregnancy and lactation:

    The use of Pabal is contraindicated during pregnancy and childbirth until the moment of a child's birth. A small amount of carbetocin can penetrate into the The breast milk of the mother and then destroyed by the enzymes of the newborn.

    Dosing and Administration:Pabal is administered once intravenously or intramuscularly only after the birth of a child. Do not use the drug again. Do not mix Pabal with other drugs in one syringe. Do not use the drug if in solution insoluble particles are observed or the solution has changed color. Unused the drug is subject to destruction.

    During cesarean operation one dose of the drug Pabal (100 mcg / ml) is administered immediately after the extraction of the baby, preferably before the placenta is separated.

    When delivering through natural birth canal one dose of Pabal (100 μg / ml) is injected into the upper part of the thigh immediately after the release of the afterbirth.

    Side effects:

    The nature and incidence of side effects with carbetocin are comparable with side effects of oxytocin:

    Type of body system

    Very often> 1/10

    Often> 1/100 and <1/10

    Disturbances from the hematopoietic and lymphatic system


    Anemia

    Disturbances from the nervous system

    Headache, tremor

    Dizziness

    Disorders from the cardiovascular system

    Increased blood pressure, hyperemia of the face


    Disturbances from the respiratory organs


    Chest pain, dyspnea

    Disorders from the gastrointestinal tract

    Nausea, abdominal pain

    Metallic taste in the mouth, vomiting

    Disturbances from the skin

    Itching


    Disturbances from the musculoskeletal system


    Backache

    General reactions

    Feeling of heat

    Chills, pain at the injection site

    Overdose:

    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. Disruption 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 of solutions administered during delivery.

    Treatment: is symptomatic and maintenance therapy. When signs or symptoms of an overdose 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.

    Interaction:

    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.

    Because the 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 administration of Pabal 3-4 hours after the prophylactic use of vasoconstrictors 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 (methylergomethrin).

    It is not recommended to use Pabal simultaneously with prostaglandins in connection with a 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.
    Special instructions:Pabal is injected intramuscularly or intravenously only in specialized obstetric departments, respectively equipped and with qualified and experienced medical personnel in the staff. Use of Pabal at any stage of labor before the birth of a child is prohibited, since the stimulating effect of carbetocin on the uterus after a single injection of 100 μg / ml lasts several hours, in contrast to a 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 development hyponatremia (drowsiness, apathy and headache) to prevent seizures and coma.

    Effect on the ability to drive transp. cf. and fur:Not applicable, given indications for use.
    Form release / dosage:

    The solution for intravenous and intramuscular injection is 100 μg / ml.

    Packaging:1 ml of solution in 1 ml ampoule of colorless glass type I, with possible color coding as a color point and / or one or more rings.
    For 5 ampoules in a cell box in a cardboard box with instructions for medical use.
    Storage conditions:

    At a temperature of 2-8 ° C in the dark place. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001424
    Date of registration:12.01.2012
    The owner of the registration certificate: Ferring GmbH Ferring GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspFERRING PHARMACEUTICALS LLCFERRING PHARMACEUTICALS LLCRussia
    Information update date: & nbsp29.10.2014
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