1 syringe (3 g gel) contains 1 mg of dinoproston;
other ingredients:silica colloidal anhydrous, glycerol triacetate.The
basic physico-chemical properties:translucent viscous gel.The
Tools that increase the tone and contractile activity of the myometrium. Prostaglandins. Code G02A ATX D02.The
Dinoproston or prostaglandin Is2(PGE2) belongs to the family of natural unsaturated fatty acids. Prostaglandins have a wide range of pharmacological properties, including the ability to stimulate organs that have in their composition smooth muscle tissue, and change in the desired direction of the response of organs to other hormonal stimuli.
the Main branch of clinical application of dinoproston is based on his ability to accelerate the maturation of the cervix and stimulate uterine contractions. At the heart of the changes occurring in the cervix during its pharmacologically induced softening, smoothing and expansion (jointly defined as maturation of the cervix), is not only the reduction of smooth muscle cells, which are not really so much in the cervix.
natural prostaglandins are synthesized very quickly from the corresponding free polyunsaturated fatty acids. Even in a minimal amount, these substances induce significant changes, after which they quickly turn into inactive metabolites.
after endocervical application of 0.5 mg of dinoproston, its maximum concentration in blood plasma is measured in 30-45 minutes, after which they quickly return to initial values, regardless of uterine activity.
Sheets2, the vaginal gel is indicated for induction of labour in women with term or near term pregnancy who have a Mature cervix and one fruit in the occipital previa.
the use of sheets Is2, vaginal gel is contraindicated:
1. In patients with a hypersensitivity to dinoprostone or to any subsidiary of the drug substance.
2. Patients who have common contraindications to the use of oxytocin analogues, in the following cases:The
Interaction with other medicinal products and other forms of interaction.
oxytocin Response may be increased if exogenous prostaglandins are used: simultaneous use of two agents is not recommended.
one should Therefore make a careful observation of the patient.
the Recommended interval between administration of oxytocin and dinoprostone is at least 6:00.
Since prostaglandins have numerous pharmacological effects, concurrent use of nonsteroidal anti-inflammatory drugs or other substances that affect the metabolism of prostaglandins, requires special care.
This drug should be used only in a hospital.
before using the drug should be carefully evaluated the proportional ratio of the size of the fetus and pelvis. It is necessary to prevent the introduction of gel above the level of internal cervical yawn, as with the extraamniotic administration of the drug there were cases of hyperstimulation of the uterus.
Sheets Have2, vaginal gel should be used with caution in patients who have a history of cardiovascular, hepatic or renal impairment, patients with bronchial asthma or bronchial asthma in history, epilepsy or epilepsy in history, glaucoma (or increased intraocular pressure) or rupture of chorioamniotic membranes.
Before and during the application of the prepatami is recommended to control the characteristics of the cervix (opening, softening and expanding) for the timely detection of adverse reactions, such as hypertonicity, tetany of the uterus or baby is in distress.
continuous electronic monitoring of uterine contractility and fetal heart rate is recommended Before and during use.
in patients with uterine hypertension or its increased contractility, or those who experience pathological changes in the heart rate of the fetus, delivery should be conducted in such a way as to ensure the overall safety of the fetus and mother.
As in the case of the use of any analogues of oxytocin in the presence of excessive activity of the uterus or abnormal pain in the uterus should be considered a risk of uterine rupture.
the response to oxytocin may be enhanced by the use of exogenous prostaglandins.
it Was shown that women aged 35 years old, had complications during pregnancy, and those whose period of pregnancy is above 40 weeks have an increased risk of postpartum disseminated intravascular coagulation. In addition, these factors can further increase the risk associated with inducing labor (see "Adverse reactions"). Therefore, dinoproston should be used with caution in such women. Measures should be taken to detect the development of fibrinolysis in the immediate postpartum period as soon as possible.
the Doctor should bear in mind that intra-cervical administration of dinoproston gel can lead to unintentional rupture and subsequent embolization with antigenic tissue, in rare cases leads to the development of anaphylactoid pregnancy syndrome (amniotic fluid embolism).
the use of prostaglandins and prostaglandin analogues for injection was reported the development of severe cardiovascular complications which may be fatal (myocardial infarction and/or ventricular fibrillation). The risk of developing such complications increases with age, in chronic and recent Smoking.
currently, there are no reports of the development of such complications after vaginal prostaglandin Use2no. However, as a preventive measure, patients are asked not to smoke for several days before the use of dinoprostone.
studies of the drug in animals using high doses for several weeks have shown that prostaglandins groups E and F, can cause the proliferation of bone tissue. This effect was observed in newborns receiving long - term therapy with prostaglandin E1. With short-term therapy with the drug, similar effects on bone tissue were not observed.
Dinoproston is intended for women with full-term or near-term pregnancy.
Prostaglandin E2caused an increase in the frequency of malformation of bone tissue in rats and rabbits.
it has been shown that dinoproston is embryotoxic for rats and rabbits, and any dose causes a prolonged increase in uterine tone, may have a risk for the fetus (see section "application Characteristics").
Prostaglandins penetrate into breast milk in very low concentrations. No measurable difference in their concentration in breast milk was observed in women with preterm and full-term pregnancies.The
the Drug should be used only in a hospital.
for induction of labor in women with full-term or almost full-term pregnancy initial dose of the drug, sheets Have21 mg, vaginal gel, apply by carefully introducing the full content of the syringe in the posterior fornix. If necessary, after 6: 00, you can apply a second dose of the drug, the sheets Are2:The
instructions for using the syringe
1. Remove the protective cap (to use as an extension of the piston).
2. Insert the protective cap into the piston.
3. Enter the contents of the syringe.The
the Drug should not be used in children.
Because clinical studies antagonist of prostaglandins has not yet reached the point where it is possible to define recommendations currently, treatment in case of overdose should be symptomatic.
Symptoms of overdose may be uterine hypertension or pathological force, or the frequency of uterine contractions, which can lead to fetal distress.
due to the temporary nature of prostaglandin-induced there are2hyperstimulations of myometrium, it has been determined that in most cases non-specific conservative treatment is effective; that is, a change in the posture of the mother and oxygenotherapy.
if excessive stimulation of the uterus (and/or fetal distress) does not disappear after the termination of treatment, an intravenous beta-mimetic agent can be used. If tocolytic treatment has been unsuccessful, shows immediate progresista.
when applying the bed sheet there2, vaginal gel observed the following adverse reactionsThe
from the immune system:hypersensitivity reactions, such as anaphylactic reactions, anaphylactic shock, anaphylactoid reactions.
from the respiratory system, chest and mediastinal organs: wheezing, shortness of breath, sensation of lack of air, cough, asthma, bronchospasm.
from the gastrointestinal tract:diarrhea, nausea, vomiting.
on the part of vessels:hypotension and, in rare cases - seizures. There were reports of hypertension (the report related to dosage forms of vaginal tablets, oral tablets and sterile solution).
on the part of the musculoskeletal system and connective tissue:back pain.
pregnancy, postpartum and perinatal Periods:pathological changes in uterine contractile activity (increase in frequency, strength or duration of contractions), uterine rupture, placenta rupture, pulmonary embolism with amniotic fluid, rapid cervical opening.
on the part of the reproductive system and mammary glands:feeling warm or burning in the vagina.
General disorders and changes in the site of administration:fever, back pain.
from the heart:there have been reports of cardiac arrest (the message related to the dosage form of oral tablets and sterile solution).The
Pregnancy, postpartum and perinatal periods:stillbirths, premature births, the deterioration of the health of newborns (below 7 points on the Apgar scale), acidosis of the fetus.
Study:baby is in distress, violation of heart rate of the fetus.
body temperature may Sometimes rise and leukocytosis may occur, but soon after discontinuation of treatment indicators usually return to normal.
As with all intrauterine injections, the risk of developing local infections should be taken into account in extraamniotic procedures. In such cases, the infection should be treated.
at post-registration supervision it was noted:
& nbsp;on the part of the blood and lymphatic system:in patients who had delivery induced by pharmacological agents, dinoproston or oxytocin, an increase in the risk of postpartum syndrome of disseminated intravascular coagulation was described (see section "application Features"). However, the expected frequency of this undesirable phenomenon is low (The
2 years old.
Store in a refrigerator at 2-8 ° C.
keep out of reach of children.The
3 g gel in pre-filled syringe. 1 syringe in a cardboard box.The
According to the recipe.The
Pfizer of Manufacturing Belgium NV.
Rijksweg 12 Puurs, B-2870, Belgium.
the Drug improves tone and reduces the function of the myometrium in the area of organs with smooth muscles. Prostin E2 belongs to the category of prostaglandins, which allow to increase uterine contractions.
Prostin E2 is effective in:
Prostin E2 is only used within the hospital! Contraindications are multiple pregnancy, scar tissue from previous births, as well as incorrect presentation of the fetus.
prohibits the use of oxytocin simultaneously with the gel. Due to the increase in the number of cuts, the interval between the use of the drug should be at least 6 hours.
reactions such as lower back pain, sensation of warmth in the vagina, diarrhea, and nausea are possible when using the gel.
the Therapeutic effect is achieved 30-45 minutes after the introduction of the gel into the posterior vaginal vault.