FENDIVIYA

Active material: Fentanyl
When ATH: N02AB03
CCF: Actually opioid receptor agonists. Analgesic
ICD-10 codes (testimony): R52.2
When CSF: 03.01.01.02
Manufacturer: NYCOMED DENMARK ApS (Denmark)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Transdermal therapeutic system (TST) with a contact surface 4.2 cm² release rate of fentanyl and 12.5 g / h; a translucent adhesive (width 18 ± 0.5 mm, length of 24 ± 0.5 mm) rectangular with rounded corners on a removable transparent protective film; protective film is bigger, than the plaster and is divided by a sinusoidal cut into two parts; on a patch of color printing is applied by a brown sign “Fentanyl 12.5 μg/hour”.

The composition of the outer protective film: polyethylene terephthalate film.
The composition of the reservoir layer: Silicone adhesive layer, Dimethicone (E900).
Composition microreservoir, soderzhashtih fentanyl: dipropylene, giproloza (E463).
Composition of releasing the membrane: ethylene-vinyl acetate copolymer.
The composition of the skin and the adhesive layer: Silicone adhesive layer, Dimethicone (E900).
Composition removable protective film: polyester film coated with a fluorine-containing polymer.

1 PC. – sealable bags (5) – packs cardboard.

Transdermal therapeutic system (TST) with a contact surface 8.4 cm² release rate of fentanyl and 25 g / h; a translucent adhesive (width 24.6 ± 0.5 mm, length of 37 ± 0.5 mm) rectangular with rounded corners on a removable transparent protective film; protective film is bigger, than the plaster and is divided by a sinusoidal cut into two parts; on a patch of color printing method applied red inscription “Fentanyl 25 μg/hour”.

The composition of the outer protective film: polyethylene terephthalate film.
The composition of the reservoir layer: Silicone adhesive layer, Dimethicone (E900).
Composition microreservoir, soderzhashtih fentanyl: dipropylene, giproloza (E463).
Composition of releasing the membrane: ethylene-vinyl acetate copolymer.
The composition of the skin and the adhesive layer: Silicone adhesive layer, Dimethicone (E900).
Composition removable protective film: polyester film coated with a fluorine-containing polymer.

1 PC. – sealable bags (5) – packs cardboard.

Transdermal therapeutic system (TST) with a contact surface 16.8 cm² release rate of fentanyl and 50 g / h; a translucent adhesive (width 34 ± 0.5 mm, length of 51.3 ± 0.5 mm) rectangular with rounded corners on a removable transparent protective film; protective film is bigger, than the plaster and is divided by a sinusoidal cut into two parts; on a patch of color printing is applied by a green label “Fentanyl 50 μg/hour”.

The composition of the outer protective film: polyethylene terephthalate film.
The composition of the reservoir layer: Silicone adhesive layer, Dimethicone (E900).
Composition microreservoir, soderzhashtih fentanyl: dipropylene, giproloza (E463).
Composition of releasing the membrane: ethylene-vinyl acetate copolymer.
The composition of the skin and the adhesive layer: Silicone adhesive layer, Dimethicone (E900).
Composition removable protective film: polyester film coated with a fluorine-containing polymer.

1 PC. – sealable bags (5) – packs cardboard.

Transdermal therapeutic system (TST) with a contact surface 25.2 cm² release rate of fentanyl and 75 g / h; a translucent adhesive (width 42 ± 0.5 mm, length of 61.7 ± 0.5 mm) rectangular with rounded corners on a removable transparent protective film; protective film is bigger, than the plaster and is divided by a sinusoidal cut into two parts; on a patch of color printing is applied by a light blue label “Fentanyl 75 μg/hour”.

The composition of the outer protective film: polyethylene terephthalate film.
The composition of the reservoir layer: Silicone adhesive layer, Dimethicone (E900).
Composition microreservoir, soderzhashtih fentanyl: dipropylene, giproloza (E463).
Composition of releasing the membrane: ethylene-vinyl acetate copolymer.
The composition of the skin and the adhesive layer: Silicone adhesive layer, Dimethicone (E900).
Composition removable protective film: polyester film coated with a fluorine-containing polymer.

1 PC. – sealable bags (5) – packs cardboard.

Transdermal therapeutic system (TST) with a contact surface 33 cm² release rate of fentanyl and 100 g / h; a translucent adhesive (width 49 ± 0.5 mm, length of 70 ± 0.5 mm) rectangular with rounded corners on a removable transparent protective film; protective film is bigger, than the plaster and is divided by a sinusoidal cut into two parts; on the method of color printing adhesive coated gray inscription “Fentanyl 100 μg/hour”.

The composition of the outer protective film: polyethylene terephthalate film.
The composition of the reservoir layer: Silicone adhesive layer, Dimethicone (E900).
Composition microreservoir, soderzhashtih fentanyl: dipropylene, giproloza (E463).
Composition of releasing the membrane: ethylene-vinyl acetate copolymer.
The composition of the skin and the adhesive layer: Silicone adhesive layer, Dimethicone (E900).
Composition removable protective film: polyester film coated with a fluorine-containing polymer.

1 PC. – sealable bags (5) – packs cardboard.

Pharmacological action

The drug Fendiviya a transdermal patch, providing a constant flow system for fentanyl 72 no.

Fentanyl is an opioid analgesic with an affinity, mainly, μ-opioid receptors of the central nervous system, spinal cord and peripheral tissues. Increases activity antinociceptive system, increases pain threshold. The drug has mainly analgesic and sedative effects.

Fentanyl has a depressing effect on the respiratory center, slow heart rate, ons centers n.vagus and vomiting center, It increases the tone of smooth muscles of biliary tract, sphincter (incl. urethra, bladder and sphincter of Oddi), improves water absorption from the gastrointestinal tract. It lowers blood pressure, motility and renal blood flow. The blood concentration increases of amylase and lipase; reduces the concentration of growth hormone, catecholamine, ACTH, Cortisol, prolactin.

It promotes sleep onset (preferably in connection with the removal of pain). It causes euphoria. The rate of drug dependence and tolerance to the analgesic action is significant individual differences. Unlike other opioid analgesics is significantly less likely to cause histamine reaction.

Pharmacokinetics

Minimum effective analgesic concentration in the blood of patients, not previously used opioids, is 0.3-1.5 ng / ml.

Absorption

After the first application of the patch fentanyl concentration in serum increases gradually, evening usually between 12 and 24 no, and then remains relatively constant for the remainder of the 72 hour period. By the second 72-hour application of the patch achieved constant drug concentration in serum, which is stored in the subsequent application of the patch of the same size. Fentanyl concentration in the blood is proportional to the size of the TTS. The absorption of fentanyl may differ somewhat depending on the application site. Several reduced absorption of fentanyl (approximately 25 %) observed in studies, conducted in healthy volunteers, during application of the patch on the chest in comparison with the upper arm and the back.

Distribution

Fentanyl is bound to plasma proteins 84%, penetrate the BBB, the placenta and breast milk.

Metabolism

Fentanyl has linear kinetics and is metabolized by biotransformation, Firstly, by enzymes in the liver CYP3A4. The main metabolite of fentanyl – norfentanil, which is not active.

Deduction

After removal of the patch, soderzhashtego fentanyl, its serum concentrations decline gradually. T_1/2 after the application of fentanyl TTS - 17 no (13-22 no) a single application, and 17-30.8 hours after 5 applications for the duration of 72 no. The continued absorption of fentanyl transdermal causes slower elimination of the drug from the serum as compared with the I / administration.

Fentanyl is excreted in the urine (75% - As metabolites and 10% - Unchanged) and the bile (9% - As metabolites).

Pharmacokinetics in special clinical situations

Violation of the liver or kidneys can cause increased serum concentrations of fentanyl.

In elderly patients, malnourished or debilitated patients may be reduced clearance of fentanyl, which may result in a longer T_1/2 substances.

Testimony

Chronic pain severe and moderate severity, requiring anesthesia opioids:

- Pain, cause cancer;

- Pain than cancer genesis, requiring multiple analgesia opioid analgesics (eg, neuropathic pain, arthritis and arthrosis, phantom pain after amputation).

Dosage regimen

Transdermal patches, soderzhashtie fentanyl, release the active substance during 72 no. The release rate of fentanyl 12.5; 25; 50; 75 and 100 g / h, and the area corresponding to the active surface is 4.2; 8.4; 16.8; 25.2 and 33.6 cm².

The required fentanyl dosage is adjusted individually and should be assessed regularly after each use.

Selection of initial dosage

The dose of fentanyl is set depending on the level of opioids in the previous period, as well as the possible development of tolerance, concomitant medicinal treatment, overall health of the patient and the severity of the disease.

If the nature of the response to opioids during this painful syndrome is not fully studied, initial dose should not exceed 25 g / h.

Transition from receiving other opioids

In the transition of a patient with oral and parenteral opioids fentanyl initial treatment dosage is calculated as follows::

- Should determine the amount of analgesics, which were needed in the past 24 no;

- The amount received should be converted to the corresponding oral morphine dosage using Table 1;

- Appropriate dose of fentanyl should be determined using a table 2.

Table 1. Doses of drugs, equivalent efficacy analgesia

All / m and oral doses, shown in Table, are equivalent in analgesic effect 10 mg morphine, injected i / m.

* On the basis of research results, obtained after a single administration of drugs, wherein v / m administration of each medicament was compared with morphine, to achieve equivalent efficiency. Oral doses - a dose, recommended to go with the parenteral route of administration for the oral route of administration.

** The ratio of the effectiveness of morphine intramuscular / oral route, equal 3:1, which is based on studies, obtained in patients with chronic pain.

Table 2. The recommended initial dose Fendiviyav depending on daily oral morphine dose

The initial evaluation of the maximum analgesic effect of the drug Fendiviyamozhet be held not earlier than 24 h after application. This limitation is due to the fact, that the increase in the serum concentrations of fentanyl in the first 24 hours after application occurs gradually. Therefore, when switching from one drug to another previous analgesic therapy should be withdrawn gradually after the initial dose application until Fendiviya, until its analgesic effect stabilizes.

Titration and maintenance therapy

The transdermal patch should be replaced every new 72 no. The dose is adjusted individually to achieve the desired level of anesthesia. If after 48-72 hours after the initial dose application there is a significant reduction in analgesic effect, the replacement of the patch may be required by 48 no. Dose 12.5 ug / hr is usually sufficient for the titration in the lower dosage range. If anesthesia was insufficient at the end of the first period of application, the dose can be increased through 3 days until, until a desired effect.

Usually for 1 once the dose is increased by 12.5 g / h, or 25 g / h, however, should take into account the patient's condition and the need for additional analgesia. In order to achieve a dose 100 g / h can use several patches. In the event “erupting” pain patients may require periodic supplemental doses of a short-acting analgesic. If the dose Fendiviyaprevyshaet 300 g / h, should consider the use of complementary or alternative methods of analgesia or alternative methods of administration of opioid analgesics.

In the transition from long-term treatment with morphine to transdermal fentanyl withdrawal may occur, despite adequate analgesic effect. When the withdrawal is recommended the introduction of short-acting morphine in patients at low doses.

Discontinuation of treatment Fendiviya

If you want to interrupt the use of the transdermal patch, then replace any other opioids should be gradual, starting with a low dose and increasing it slowly. This is, content of fentanyl in the blood serum after removal of the patch decreases gradually; to reduce the concentration of fentanyl in serum for 50% required, at least, 17 no. There is a general rule: cancellation of opioid analgesic agents should be carried out gradually, to avoid the appearance of a withdrawal syndrome (nausea, vomiting, diarrhea, anxiety and muscle tremor).

Mode of application

The drug is administered transdermally. The patch should be applied on a flat surface intact and unexposed skin of the body or shoulder. For the application it is recommended to choose a place with minimal scalp (preferably without hair). Before applying the hair on the area of ​​application should be cut off (not to shave!). If before applying the patch application site should wash, this should be done with clean water. Do not use soap, Lotions, oils, alcohol or other means, tk. they may cause skin irritation or modify its properties. Before applique skin is completely dry.

Unnecessarily. transdermal patch is protected by an outer waterproof protective film, it can be worn for short stays in the shower.

The transdermal patch, soderzhashtiy fentanyl, It should be applied immediately after removal from a heat-sealable package. After removing the protective film transdermal patch must be firmly pressed his hand on the spot applications around 30 sec. Make sure, that adheres the patch to the skin, especially at the edges. May require additional fixation plaster. The drug should be worn continuously for 72 no, after which it must be exchanged for a new patch. A new transdermal patch should always apply to another area of ​​the skin, not capturing the place of the previous application. On the same place the patch application can be applied again no earlier than 7 days.

The transdermal patch should not be divided or cut.

Side effect

To describe the incidence of adverse effects, the following terms: Often (>1/10), often (>1/100, <1/10), infrequently (>1/1000, <1/100), rarely (>1/10000, <1/1000), rarely (<1/10000), including isolated reports.

The most dangerous side effect is respiratory depression.

From the central and peripheral nervous system: Often – drowsiness, hypersomnia, headache, dizziness; often – sedation, confusion, depression, anxiety, nervousness, hallucinations, anorexia nervosa, involuntary muscle contractions, gipesteziya; infrequently – euphoria, amnesia, insomnia, ažitaciâ, tremor, paraesthesia, speech disorder; rarely – amblyopia; rarely – delirium, asthenia, sexual dysfunction, ataxia, myoclonic seizures.

Cardio-vascular system: often – palpitations; infrequently – bradycardia, tachycardia, hypotension, arterial hypertension; rarely – arrhythmia, vasodilation.

The respiratory system: often – zevota, rhinitis; infrequently – dyspnoea, gipoventilyatsiya; rarely – respiratory depression (incl. respiratory insufficiency, Apnea and bradypnea), hemoptysis, obstructive lung disease, pharyngitis, laringospazm.

From the digestive system: Often – nausea, vomiting, constipation; often – abdominal pains, xerostomia, dyspepsia; infrequently – diarrhea; rarely – Ikotech; rarely – ileus, boleznennыy flatulence.

Allergic reactions: infrequently – itch; rarely – anaphylactic shock, anaphylactic reactions, anaphylactoid reactions, rash.

Dermatological reactions: Often – Sweating, itch; often – skin reactions at the site of application (change in skin appearance, peeling, exudation, petechial erosion, microcracks, poison); infrequently – rash, эritema. Rash, erythema and itching at the site of application in most cases disappear within one day after removal of the patch.

From the urinary system: infrequently – urinary retention, urinary tract infection; rarely – oligurija, painful bladder, spasm of the ureter.

Other: infrequently – conjunctivitis, fatigue, malaise, flu-like symptoms; rarely – edema, feeling cold.

Chronic administration of fentanyl can develop tolerance, physical and psychic dependence, short-term stiffness (incl. infants). When replacing the previously prescribed opioid analgesics to transdermal patch, soderzhashtiy fentanyl, or in case of abrupt termination of therapy may develop a withdrawal syndrome, including, eg, nausea, vomiting, diarrhea, anxiety and shivering.

Contraindications

- Depression of the respiratory center, incl. acute respiratory depression;

- Irritation, irradiated or damaged skin at the site of application;

- Diarrhea with pseudomembranous colitis, due Cephalosporins, lincosamides, penicillins;

- Toksicheskaya dyspepsia;

- Up to 18 years;

- The drug should not be used for the treatment of acute or postoperative pain due to lack of opportunities titration in a short period of time and the probability of life-threatening respiratory depression;

- Severe CNS;

- Simultaneous use of MAO inhibitors or taking over the 14 days after their cancellation;

- Hypersensitivity to the active substance or excipients of the drug.

FROM caution use in patients with chronic lung diseases, intracranial hypertension, brain tumors, traumatic brain injuries, ʙradiaritmijax, hypotension, kidney and liver failure, with renal or hepatic colic (incl. history), in cholelithiasis, gipotireoze, in elderly, emaciated and debilitated patients, acute surgical diseases of the abdominal cavity before the diagnosis, in acute serious condition, benign prostatic hypertrophy, urethrostenosis, Drug Dependence, alcoholism, suicidal, Hyperthermia, while taking insulin, GCS, antihypertensive drugs.

Pregnancy and lactation

The safety of transdermal patches, soderzhashtih fentanyl, during pregnancy has not been established.

Fentanyl during pregnancy should only be used when absolutely necessary. Long-term treatment during pregnancy may cause withdrawal symptoms in newborns.

Fentanyl should not be taken during labor and delivery (including caesarean section), tk. fentanyl passes through the placenta and may cause respiratory depression of the fetus or newborn.

Fentanyl is excreted in breast milk and may cause sedation and respiratory depression in the breastfed baby. Hence, if necessary, the appointment during lactation should stop breastfeeding (the duration of application and 72 h after the last application).

Cautions

Use of the drug Fendiviya be used as part of an integrated treatment of pain in patients with adequate medical, social and psychological assessment of their condition.

After developing severe side effects the patient should be monitored for 24 hours after the removal of the transdermal patch, soderzhashtego fentanyl, due to the long T_1/2 fentanyl.

As unused, and used transdermal patches, soderzhashtie fentanyl, They must be kept away from children.

Transdermal patches should not be separated or cut into pieces, as there was no established quality, efficacy and safety of a patch, razdelennogo parts.

As with other potent opioid, using a transdermal patch, soderzhashtego fentanyl, some patients may develop respiratory depression, and therefore, patients should be monitored. Respiratory depression may persist after removal of the patch. The incidence of respiratory depression increases as the dose of fentanyl. Neurotropic drugs may enhance the effect of respiratory depression. Patients with asymptomatic respiratory depression, fentanyl should be used with extreme caution and only in small doses.

If patients have to go through the procedure, which completely eliminates the feeling of pain (eg, regionarnaya analgesia), it is advisable to provide for the possibility of respiratory depression. Before carrying out these procedures should be to reduce the dosage of fentanyl or replace it with an opioid drug or a short series of rapid action.

In patients with chronic obstructive or other pulmonary diseases fentanyl may cause more serious side effects. In these patients, opioids may decrease respiratory function and increase airway resistance.

With regular administration of opioids may develop tolerance, physical and psychic dependence, however, they are rare in the treatment of pain, related tumors.

The drug Fendiviya should be used with caution in patients, which may be particularly sensitive to an increase of CO₂. These patients are those, which was an increase of intracranial pressure, impaired consciousness or coma. Fentanyl should be used with caution in patients diagnosed with a brain tumor.

Fentanyl may cause bradycardia. Hence, patients with bradyarrhythmias Fendiviya drug should be administered with caution.

Opioids may cause hypotension especially in patients with hypovolemia. It is therefore necessary to take precautionary measures in the treatment of patients with hypotension and / or hypovolemia.

Fentanyl metaboliziruetsya in baked, thus, in patients with liver disease may slow elimination. Patients with impaired hepatic function should be monitored, and if necessary dose for these patients should be reduced.

Less 10% Fentanyl is excreted by kidneys in unchanged form, and unlike morphine no active metabolites, excreted by the kidneys. Data, obtained when I / fentanyl in patients with renal insufficiency, talk about, that dialysis V_d Fentanyl may vary. This may affect the serum concentration of the drug. If patients with renal impairment receive transdermal fentanyl, they should be monitored closely for signs of fentanyl toxicity, and if necessary dose for these patients should be reduced.

Patients with elevated body temperature requires very close monitoring for the presence of side effects of opioids, and if necessary - correction of the dose of fentanyl. Also, patients should be advised to avoid exposure to the field of application of the transdermal patch Fendiviya direct external heat sources, such, as the warmer, hot water bottles, heated blankets, heating lamps, hot tubs, Jacuzzi, as it is likely temperature-dependent increase of the release of fentanyl from the patch.

Before sauna transdermal patch must always be removed from the skin. Admission sauna only possible when replacing a transdermal patch (at intervals of 72 no). New plaster should be imposed on the cold and completely dry the area of ​​skin.

The results of studies on / in use fentanyl show, that elderly patients reduced clearance, increased half-life, and that they are more sensitive to the drug, than younger patients. Elderly patients should be carefully monitored for signs of fentanyl toxicity, and if necessary, they should reduce the dose of the drug.

Because, that emaciated and debilitated patients decreases clearance and increases T_1/2 fentanyl, Such patients need careful monitoring for symptoms of possible overdose of fentanyl, and if necessary, they should reduce the dose of the drug.

In applying the drug may occur Fendiviya myoclonic seizures. When treating patients with myasthenia gravis should take precautions.

In applying the drug Fendiviya alcohol is not recommended.

Even after use in transdermal patches are large amounts of fentanyl. For safety and environmental purity used transdermal patches, as well as unused patches, They should be removed. Used transdermal patches should be folded into the sticky surface, to release the membrane was completely closed, and return the medical or pharmaceutical staff. The unused transdermal patches should be returned to medical or pharmaceutical staff.

Use in Pediatrics

The use of a transdermal patch for the treatment of children Fendiviya not recommended.

Effects on ability to drive vehicles and management mechanisms

Transdermal patches, soderzhashtie fentanyl, may affect the mental and / or physical functions, necessary for the performance of potentially hazardous work, such as driving or working with machinery. Mainly, it is to be expected at the beginning of treatment, as well as any change of dosage.

In the period of treatment should refrain from activities potentially hazardous activities, require high concentration and speed of psychomotor reactions.

No need to impose restrictions on the patients, constantly receiving individually tailored dose. In this case, the doctor must decide, Whether the patient is allowed to drive a vehicle or equipment.

Overdose

Symptoms: lethargy, coma, depression of the respiratory center with Cheyne-Stokes respiration and / or cyanosis. Other symptoms may be hypothermia, decreased muscle tone, bradycardia, hypotension. Signs of toxicity are – glubokaya sedation, ataxia, mioz, convulsions and respiratory depression (It is the main symptom).

Treatment: removal of the patch, vvedenie spetsificheskogo antagonist - naloxone, verbal or physical impact on the patient; symptomatic and supportive therapy of vital functions (incl. introduction of muscle relaxants, IVL, When bradycardia – atropine, In marked decrease in blood pressure – vospolnenie OCK).

The recommended starting dose for adults is 0.4-2 mg naloxone in / in. If necessary,, can be administered the same dose every 2-3 min or to appoint a long-term administration 2 mg, dissolved in 500 ml 0.9 % sodium chloride solution or 5% dextrose (0.004 mg / ml). The rate of administration should be adjusted to the previous bolus injections and the individual response of the patient. If / introduction impossible, the naloxone can be assigned / m or s / c. After the / m or s / naloxone onset of action will be slower compared with / in the introduction. V / m introduction gives a more prolonged effect, than / introduction. Respiratory depression due to overdose can persist for a longer time, Cem эffekt of antagonist opioidov. Removing the narcotic effect can lead to an increase of acute pain and release of catecholamines. If necessary, treat the patient in intensive care.

Drug Interactions

It should be excluded concomitant use of barbituric acid derivatives, as they may increase the effect of respiratory depression of fentanyl.

Concomitant other means, suppress the central nervous system, including opioids, anxiolytics, trankvilizatorы, for narcosis, general anesthetics, phenothiazines, muscle relaxants, antihistamines to sedating, ethanol, may cause additive sedative effects; hypoventilation may occur, hypotension, glubokaya sedation or coma. Hence, receive any of the above tools require observation of the patient.

Dinitrogen oxide enhances muscle rigidity; It reduces the effect of buprenorphine.

MAO inhibitors increase the effect of opioid analgesics, especially in patients with congestive heart failure. Therefore, fentanyl should not take over the entire period of use of inhibitors of MAO, as well as for 14 days after their cancellation.

Fentanyl has a high clearance, it is rapidly and largely metabolized, primarily, via cytochrome CYP3A4. Simultaneous treatment with strong CYP3A4 inhibitors (eg, Ritonavir, ketoconazole, itraconazole, macrolide antibiotics) with fentanilom, vvodimыm transdermalyno, It can lead to increased plasma concentrations of fentanyl. This may increase or prolong both the therapeutic effect, and adverse reactions, which can cause severe respiratory depression. In such situations should be given intensive care and to conduct a more careful monitoring of patients. Combined receiving ritonavir or other potent CYP3A4 inhibitor with transdermal fentanyl is not recommended, if not carried out a careful observation of the patient.

Fentanyl while the application increases the effect of antihypertensive drugs.

Buprenorphine, nalʙufin, pentazocin, Naloxone, naltrexone snizhayut analygeziruyushtiy эffekt fentanyl, eliminate its depressing effect on the respiratory center and may induce withdrawal symptoms in patients with opioid dependence.

It is necessary to reduce the dose of fentanyl while the use of insulin, Valium and antihypertensive drugs.

Muscle relaxants, while the use of fentanyl, prevents or eliminates muscle rigidity; muscle relaxants with vagolytic activity (incl. pankuroniya bromide) reduce the risk of bradycardia and hypotension (especially against the use of beta-blockers, and other vasodilators) and can increase the risk of tachycardia and hypertension; muscle relaxants, non-vagolytic activity (incl. succinylcholine) does not reduce the risk of bradycardia and hypotension (especially against the background of aggravated cardiac history) and increase the risk of severe side effects from the cardiovascular system.

Conditions of supply of pharmacies

The drug is released under the prescription. It refers to a Schedule II narcotic drugs.

Conditions and terms

The drug should be stored out of reach of children, even after use at a temperature of from 15 ° to 25 ° C.. Shelf life – 2 year.