Fendivia ™ (Fendivia ™)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceFentanylFentanyl
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    • Dosage form: & nbsptransdermal therapeutic system
    Composition:

    Active component:

    Fendivia ™ 12.5 μg / hr: each TTS contains 1.38 mg of fentanyl in a plaster area of ​​4.2 cm2 and releases fentanyl at a rate of 12.5 μg / h.

    Fendivia ™ 25 μg / h: each TTS contains 2.75 mg of fentanyl in a patch measuring 8.4 cm2 and releases fentanyl at a rate of 25 μg / h.

    Fendivia ™ 50 μg / h: each TTS contains 5.50 mg of fentanyl in a 16.8 cm patch2 and releases fentanyl at a rate of 50 μg / h.

    Fendivia ™ 75 mcg / hr: each TTS contains 8.25 mg of fentanyl in a 25.2 cm patch2 and releases fentanyl at a rate of 75 μg / h.

    Fendivia ™ 100 μg / h: each TTS contains 11.0 mg of fentanyl in a patch of 33.6 cm2 and releases fentanyl at a rate of 100 μg / h.

    Excipients:

    1) External protective film:

    - polyethylene terephthalate film;

    2) Tank layer:

    - silicone adhesive layer;

    - dimethicone (E 900);

    3) Micro-tanks containing the active component:

    - dipropylene glycol;

    - giprolose (E 463);

    4) Release membrane:

    - ethylene and vinyl acetate copolymer;

    5) Dermal-adhesive layer:

    - silicone adhesive layer;

    - dimethicone (E 900);

    6) Protective removable film:

    - polyester film with fluorine-containing polymer coating.

    Description:

    Rectangular translucent patch with rounded edges on removable transparent protective film. The protective film is larger in size than the adhesive. Sinusoidal section divides the removable protective film into two parts.

    The following inscriptions are marked on the plaster by means of color printing:

    1) Fendivia ™ 12.5 μg / h, adhesive tape with a width of 18 ± 0.5 mm, length of 24 ± 0.5 mm: - "Fentanyl 12.5 μg / hour" - brown print;

    2) Fendivia ™ 25 mcg / hr, a patch with a width of 24.6 ± 0.5 mm, a length of 37 ± 0.5 mm: - "Fentanyl 25 μg / hour" - red print;

    3) Fendivia ™ 50 μg / hr, plaster width of 34 ± 0.5 mm, length 51.3 ± 0.5 mm: - "Fentanyl 50 μg / hour" - green print;

    4) Fendivia ™ 75 mcg / hr, plaster width 42 ± 0,5 mm, length 61,7 ± 0,5 mm: - "Fentanyl 75 μg / hour" - light blue printing;

    5) Fendivia ™ 100 μg / h, adhesive tape with a width of 49 ± 0.5 mm, length 70 ± 0.5 mm: - "Fentanyl 100 μg / hour" - gray print.

    Pharmacotherapeutic group:analgesic narcotic
    ATX: & nbsp

    N.01.A.H.01   Fentanyl

    Pharmacodynamics:

    Fendivia ™ is a transdermal patch that provides a constant systemic intake of fentanyl for 72 hours. Fentanyl is an opioid analgesic with an affinity, mainly to the opiate central nervous system (CNS) receptors, the spinal cord and peripheral tissues. Increases the activity of the antinociceptive system, increases the threshold of pain sensitivity. The drug mainly has analgesic and sedative effects. Fentanyl has a depressing effect on the respiratory center, slows the heart rate, excites the centers n.vagus and vomiting center, increases the tone of the smooth muscles of the bile ducts, sphincters (including the urethra, bladder and sphincter of Oddi), improves the absorption of water from the gastrointestinal tract (GIT). Reduces blood pressure (BP), intestinal peristalsis and renal blood flow.Increases the concentration of amylase and lipase in the blood; reduces the concentration of somatotropic hormone, catecholamines, adrenocorticotropic hormone, cortisol, prolactin. Promotes the onset of sleep (mainly in connection with the removal of the pain syndrome). Causes euphoria. The rate of development of drug dependence and tolerance to analgesic effect has significant individual differences. Unlike other opioid analgesics, histamine reactions are much less likely to occur.

    Pharmacokinetics:

    The minimum effective analgesic concentration in the blood in patients who did not previously use opioid analgesics is 0.3-1.5 ng / ml.

    Suction: after the first patch application, the fentanyl concentration in the serum increases gradually, leveling usually between 12 and 24 hours, and then remains relatively constant for the remaining 72-hour period of time. To the second 72-hour patch application achieves a constant concentration of the drug in the serum, which persists with subsequent patches of the same size patch. The concentration of fentanyl in the blood is proportional to the size TTFROM. Absorption of fentanyl may differ slightly depending on the site of application. A slightly reduced absorption of fentanyl (approximately 25%) was observed in studies conducted with healthy volunteers during the application of the patch on the chest in comparison with the upper arm and back.

    Distribution: fentanyl binds to plasma proteins by 84%, penetrates the blood-brain barrier, the placenta and into breast milk.

    Biotransformation: fentanyl possesses linear biotransformation kinetics and is metabolized, first of all, in the liver by means of enzymes CYP3A4. The main metabolite of fentanyl is norfentanil, which is not active.

    Elimination: after removing the patch containing fentanyl, its serum concentrations decrease gradually. The half-life of fentanyl after the application of TTS is 17 hours (13-22 hours) for a single application and 17-30.8 hours after 5 applications for a duration of 72 hours. Continued absorption of fentanyl in transdermal administration causes a slower withdrawal of the drug from the serum as compared to intravenous the introduction.

    Fentanyl is excreted by the kidneys (75% in the form of metabolites and 10% in unchanged form) and with bile (9% - in the form of metabolites).

    Special patient groups

    Violation of the liver or kidney function can cause an increase in serum fentanyl concentration. In elderly patients, debilitated or debilitated patients, a decrease in fentanyl clearance may occur, which may lead to a longer half-life of the substance.
    Indications:

    Chronic pain syndrome of strong and moderate severity, requiring analgesia with narcotic analgesics:

    - pain caused by an oncological disease;

    - pain syndrome of non-oncological genesis, requiring repeated anesthesia with narcotic analgesics (for example, neuropathic pains, arthritis and arthrosis, phantom pain after limb amputation).

    Contraindications:

    - Hypersensitivity to the active substance or excipients;

    - depression of the respiratory center, including acute respiratory depression;

    - irritated, irradiated or damaged skin at the place of application;

    - diarrhea against pseudomembranous colitis caused by cephalosporins, lincosamides, penicillins;

    - toxic dyspepsia;

    - age to 18 years;

    - the drug should not be used for the treatment of acute or postoperative pain due to the inability to select a dose in a short period of time and the likelihood of life-threatening respiratory depression;

    - severe lesions of the central nervous system;

    - simultaneous use of monoamine oxidase (MAO) inhibitors or admission within 14 days after their withdrawal.

    Carefully:Pchronic lung diseases; intracranial hypertension; brain tumors; craniocerebral trauma; bradyarrhythmias; arterial hypotension; renal and hepatic insufficiency; in patients with hepatic or renal colic, including in the anamnesis; cholelithiasis; hypothyroidism; in elderly, emaciated and weakened patients; acute surgical diseases of the abdominal cavity before diagnosis; general severe condition; benign prostatic hypertrophy; strictures of the urethra; drug dependence; alcoholism; suicidal tendencies; hyperthermia; simultaneous administration of insulin, glucocorticosteroids, hypotensive drugs.
    Pregnancy and lactation:

    Safety of transdermal patches containing fentanyl, with pregnancy is not established.

    Fentanyl during pregnancy should be used only in case of emergency. Long-term treatment during pregnancy can cause withdrawal syndrome in newborns.

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

    Fentanyl is secreted into milk and can cause sedative effects and respiratory depression in a breast-fed baby. Therefore, if it is necessary to prescribe the drug during lactation, breastfeeding should be stopped (for the entire duration of use and 72 hours after the last application).

    Dosing and Administration:

    Transdermal patches containing fentanyl, the active substance is released for 72 hours. The release rate of fentanyl is 12.5; 25; 50; 75 and 100 μg / h, and the area of ​​the corresponding active surface is 4.2; 8.4; 16.8; 25.2 and 33.6 centimeters2.

    The required dosage of fentanyl is selected individually and should be evaluated regularly after each use.

    Mode of application

    The drug is used transdermally.

    A patch containing fentanyl, should be applied to the flat surface of intact and unirradiated skin of the trunk or shoulder. For application it is recommended to choose a place with a minimal hair cover (preferably without hair). Before application, the hair should be cut at the application site (do not shave!). If the application site needs to be cleaned before applying the patch, it should be done with clean water. Do not use soap, lotions, oils, alcohol or other products. they can cause skin irritation or change its properties. Before application, the skin should be absolutely dry.

    Since the transdermal patch is protected by a waterproof outer protective film, it can be removed without a brief stay in the shower.

    A transdermal patch comprising fentanyl, should be applied immediately after removal from the heat-seal bag. After removing the protective film, the transdermal patch should be pressed firmly with the palm of the hand in place of the application for approximately 30 seconds. It should be ensured that the patch is tight against the skin, especially around the edges. Additional patch fixation may be required.The drug should be worn continuously for 72 hours, after which it must be changed to a new patch. A new transdermal patch should always be applied to another area of ​​the skin, without seizing the place of the previous application. At the same place of application the plaster can be applied again not earlier than 7 days later.

    The transdermal patch should not be divided or cut (see section "Special instructions").

    Selection of initial dosage

    The level of dosing of fentanyl is determined depending on the level of opioid intake in the previous period, as well as taking into account the possible development of tolerance, concomitant drug treatment, the general health of the patient and the severity of the disease.

    If the nature of the response to opioids for this pain syndrome is not fully understood, the initial dosage should not exceed 25 μg / h.

    Transition from taking other opioids

    When a patient passes from oral or parenteral opioids to fentanyl treatment, the initial dosage is calculated as follows:

    1) It is necessary to determine the number of analgesics required in the last 24 hours;

    2) The amount should be transferred to the appropriate oral dose of morphine with using Table 1;

    3) The appropriate dose of fentanyl should be determined using Table 2.

    Table 1: Dosages of drugs equivalent to analgesia efficacy

    All intramuscular (IM) and oral (p / o) doses presented in the table are equivalent to the analgesic effect of 10 mg of morphine administered intramuscularly.

    Name of the medicinal product

    Equal-effective dose (mg)

    in / m *

    by

    Morphine

    10

    30 (with regular administration) **

    60 (with a single or intermittent administration)

    Hydromorphone

    1,5

    7,5

    Methadone

    10

    20

    Oxycodone

    10-15

    20-30

    Levorphanol

    2

    4

    Oxymorphine

    1

    10 (rectally)

    Diamorphine

    5

    60

    Pethidine

    75

    -

    Codeine

    -

    200

    Buprenorphine

    0,4

    0.8 (sublingually)

    Ketobemidone

    10

    30

    * Based on the results of studies obtained after a single administration of drugs, with / m the administration of each drug was compared with morphine in order to achieve equivalent efficacy. Oral doses are the doses recommended for switching from a parenteral route of administration to an oral route of administration.

    ** The morphine efficacy ratio for intramuscular / oral administration is 3: 1, which is based on the results of the studies,received in the treatment of patients with chronic pain.

    Table 2: Recommended initial dose of the drug Fendivia ™, depending on the daily oral dose of morphine

    The oral daily dose of morphine (mg / day)

    The dose of the drug Fendivia ™ (transdermal patch), mcg / hr

    < 135

    25

    135-224

    50

    225-314

    75

    315-404

    100

    405-494

    125

    495 - 584

    150

    585 -674

    175

    675 - 764

    200

    765 - 854

    225

    855 - 944

    250

    945 - 1034

    275

    1035 - 1124

    300

    Initial assessment of the maximal analgesic effect of the drug Fendivia™ can be conducted no earlier than 24 hours after the application. This restriction is due to the fact that the increase in serum fentanyl concentration in the first 24 hours after application is gradual. Therefore, when switching from one drug to another, the previous analgesic therapy should be canceled gradually after the initial dose of Fendivia ™ is applied until its analgesic effect stabilizes.

    Dose selection and maintenance therapy

    The transdermal patch should be replaced every 72 hours. The dose is selected individually to achieve the required level of anesthesia. If 48-72 hours after the application of the initial dose occurs a significant reduction in the analgesic effect, then the replacement of the patch may be required after 48 hours.A dose of 12.5 μg / hr is usually sufficient to select a dose in the lower dosage range. If anesthesia was not sufficient by the end of the first application period, the dose can be increased after 3 days until the desired effect is obtained.

    Usually, at one time, the dose increases by 12.5 μg / hour or 25 μg / h, however, the patient's condition and the need for additional anesthesia must be taken into account. To achieve a dose of more than 100 mcg / h, several patches can be used at the same time. In the event of "breakthrough" pain, patients may occasionally need additional doses of short-acting analgesics. If the dose of Fendivia ™ is more than 300 μg / h, additional or alternative methods of analgesia or alternative methods for administering opioid analgesics should be considered.

    When switching from long-term morphine treatment to transdermal administration of fentanyl, withdrawal may occur, despite adequate analgesic effects. When there is a withdrawal syndrome, it is recommended that short-acting morphine is administered to patients in low doses.

    Discontinuation of treatment with Fendivia™

    If it is necessary to interrupt the use of the transdermal patch, the substitution for any other opioids should be gradually started from a low dose and slowly increased. This is due to the fact that the fentanyl content in the blood serum decreases gradually after removal of the patch; to reduce serum fentanyl concentration 50% at least, 17 hours. There is a general rule: the abolition of opioid analgesia should be carried out gradually to prevent the occurrence of withdrawal syndrome (nausea, vomiting, diarrhea, anxiety and muscle tremor).

    Use in children

    The use of Fendivia ™ transdermal patch for the treatment of children is not recommended.

    Side effects:

    To describe the frequency of unwanted effects, the following terms are used:

    Very frequent (> 1/10), Frequent (> 1/100, <1/10), Infrequent (> 1/1000, <1/100), Rare (> 1 / 10,000, <1/1000), Very rare (<1 / 10,000), including individual messages.

    The most dangerous side effect is respiratory depression.

    Mental disorders

    Very frequent: drowsiness;

    Frequent: sedation, confusion, depression, anxiety, nervousness, hallucinations, anorexia nervosa;

    Infrequent: euphoria, amnesia, insomnia, agitation;

    Very rare: delirium, asthenia, sexual dysfunction.

    From the nervous system

    Very frequent: hypersomnia, headache, dizziness;

    Frequent: involuntary muscle contraction, hypoesthesia;

    Infrequent: tremor, paresthesia, speech disorders;

    Very rare: ataxia, myoclonic cramps.

    Disorders of eye function

    Rare: amblyopia.

    From the side of the cardiovascular system

    Frequent: palpitation;

    Infrequent: bradycardia, tachycardia, hypotension, arterial hypertension;

    Rare: arrhythmia, vasodilation.

    From the respiratory system

    Frequent: yawning, rhinitis;

    Infrequent: dyspnea, hypoventilation;

    Very rare: respiratory depression (including respiratory failure, apnea and bradypnoea), hemoptysis, obstructive pulmonary disease, pharyngitis, laryngospasm.

    From the digestive system

    Very frequent; nausea, vomiting, constipation;

    Part: pain in the abdomen, xerostomia, indigestion;

    Infrequent: diarrhea;

    Rare: hiccough;

    Very rare: intestinal obstruction, painful flatulence.

    From the immune system

    Infrequent: itching;

    Very rare: anaphylactic shock, anaphylactic reactions, anaphylactoid reactions, rash.

    From the skin and subcutaneous tissues

    Very frequent: sweating, itching;

    Frequent: skin reaction at the place of application (change in skin appearance, peeling, exudation, petechial erosion, microcracks, scab);

    Infrequent: a rash, erythema. The rash, erythema and itching at the site of application in most cases disappear within one day after removing the patch.

    From the side of the kidneys and urinary system

    Infrequent: retention of urine, urinary tract infection;

    Very rare: oliguria, pain in the bladder, spasm of the ureters.

    General disorders

    Rare: swelling, a feeling of cold.

    Other side effects

    Infrequent: conjunctivitis, fatigue, malaise, flu-like symptoms.

    With long-term administration of fentanyl, tolerance, physical and mental dependence, short-term stiffness of the muscles (including those of the chest) may develop.

    When replacing previously prescribed opioid analgesics with a transdermal patch containing fentanyl, or in the event of a sudden cessation of therapy, withdrawal can occur, including, for example, nausea, vomiting, diarrhea, anxiety and shivering.

    Overdose:

    Symptoms

    The following symptoms may develop: retardation, coma, oppression of the respiratory center with Chain-Stokes breathing and / or cyanosis.Other symptoms may include hypothermia, decreased muscle tone, bradycardia, arterial hypotension. Signs of toxicity are - deep sedation, ataxia, miosis, convulsions and respiratory depression (is the main symptom).

    Treatment

    Removal of the plaster, the introduction of a specific antagonist - naloxone, physical or verbal effects on the patient; symptomatic and supportive of vital functions of therapy (including the introduction of muscle relaxants, artificial ventilation of the lungs, with bradycardia - the introduction of atropine, with a pronounced decrease in blood pressure - replenishment of the circulating blood volume).

    The recommended initial dose for: adults is 0.4-2 mg of naloxone intravenously. If necessary, you can give the same dose every 2-3 minutes or appoint a long-term administration of 2 mg of the drug dissolved in 500 ml of 0.9% sodium chloride solution or 5% dextrose solution (0.004 mg / ml). The rate of administration should be adjusted to accommodate previous bolus infusions and individual patient response. If intravenous administration is not possible, then naloxone can be administered intramuscularly or subcutaneously.After intramuscular or subcutaneous administration of naloxone, the onset of action will be slower compared to intravenous administration. Intramuscular administration gives a more prolonged effect than intravenous administration. Respiratory depression due to an overdose may persist longer than the effect of an opioid antagonist. Removing the narcotic effect can lead to an increase in acute pain and the release of catecholamines. If necessary, the patient should be treated in the intensive care unit.

    Interaction:

    The simultaneous administration of barbituric acid derivatives should be avoided, since they can enhance the effect of respiratory depression of fentanyl.

    Concomitant administration of other CNS suppressing agents, including opioids, anxiolytics, tranquilizers, hypnotics, general anesthetics, phenothiazine derivatives, muscle relaxants, antihistamines with sedative action, alcohol, can cause additive sedative effects; hypoventilation, hypotension, deep sedation, or coma may occur. Therefore, taking any of the above means requires monitoring the patient.

    Dinitrogen oxide increases muscle rigidity; effect reduces buprenorphine. MAO inhibitors increase the effect of narcotic analgesics, especially in patients with heart failure. Therefore, do not take fentanyl during the entire period of application of MAO inhibitors, and also within 14 days after their cancellation. Fentanyl It has a high clearance, it is rapidly and largely metabolized, mainly by cytochrome CYP3A4.

    Simultaneous reception strong inhibitors CYP3A4 (eg, ritonavir, ketoconazole, itraconazole, macrolide antibiotics) with fentanyl administered transdermally, can lead to an increase in fentanyl concentrations in the plasma. This can enhance or prolong both the therapeutic effect and side effects that can cause severe respiratory depression. In such situations, intensive care should be provided and more careful monitoring of the patient should be carried out. The combined administration of ritonavir or another potent inhibitor CYP3A4 with transdermal administration of fentanyl is not recommended unless careful monitoring of the patient is performed.

    Enhances the effect of antihypertensive drugs.

    Buprenorphine, nalboufine, pentazocine, naloxone, naltrexone reduce the analgesic effect of fentanyl, eliminate its depressing effect on the respiratory center and can induce the syndrome, withdrawal in patients with opioid dependence.

    It is necessary to reduce the dose of fentanyl with simultaneous use with insulin, glucocorticosteroids and antihypertensive drugs.

    Muscle relaxants prevent or eliminate muscle rigidity; muscle relaxants with vagolytic activity (including pancuronium bromide) reduce the risk of bradycardia and arterial hypotension (especially when using beta-blockers and other vasodilators) and may increase the risk of tachycardia and hypertension; muscle relaxants that do not have vagolytic activity (including succinylcholine) do not reduce the risk of bradycardia and arterial hypotension (especially in the background of an aggravated cardiological history) and increase the risk of serious side effects from the cardiovascular system.

    Special instructions:

    The drug should be used as part of a comprehensive treatment of pain in patients, provided adequate medical, social and psychological evaluation of their condition.After severe adverse effects, the patient should be monitored within 24 hours after removal of the transdermal patch containing fentanyl, due to the long half-life of fentanyl.

    Both unused and used transdermal patches containing fentanylshould be kept out of the reach of children.

    Transdermal patches should not be used: split or cut to pieces, since the quality, effectiveness and safety of the patch, divided into parts, has not been established.

    Inhibition of respiration

    As with other potent opioids, when using a transdermal patch containing fentanyl, some patients may develop respiratory depression, and therefore patients should be monitored. Respiratory depression may persist after removal of the patch. The frequency of manifestations of respiratory depression increases with an increase in the dose of fentanyl. Neurotropic drugs can enhance the effect of respiratory depression (see section "Interaction with other drugs"). Patients with symptoms of respiratory depression fentanyl should be administered with extreme caution and only in small doses.

    If the patient has to undergo procedures that completely relieve the pain (for example, regional analgesia), it is advisable to envisage the possibility of developing respiratory depression. Before these procedures, you should reduce the dosage of fentanyl or replace it with a drug of the opioid series of fast or short-acting.

    Chronic lung diseases

    In patients with chronic obstructive or other lung diseases fentanyl can cause more dangerous side effects. In such patients, opioids can reduce respiratory function and increase airway resistance.

    Drug addiction

    With the regular administration of opioids, tolerance, physical and mental dependence may develop, but they are rarely found in the treatment of pain associated with tumors.

    Increased intracranial pressure

    The drug Fendivia ™ should be used with caution in patients who may be particularly sensitive to increased CO levels2. These patients are those who have experienced increased intracranial pressure, impaired consciousness or coma. Fentanyl should be administered with caution to patients with a diagnosed brain tumor.

    Heart Disease

    Fentanyl can cause a bradycardia. Therefore, in patients with bradyarrhythmia, the drug Fendivia ™ should be administered with caution.

    Opioids can cause arterial hypotension especially in patients with hypovolemia. Therefore, it is necessary to take precautions in the treatment of patients with arterial hypotension and / or hypovolemia.

    Impaired liver function

    Fentanyl is metabolized in the liver, thus, in patients with liver disease, delayed elimination is possible. Patients with impaired liver function should be monitored, and if necessary, the dose of the drug for such patients should be reduced.

    Impaired renal function

    Less than 10% of fentanyl is excreted by the kidneys unchanged, and unlike morphine, there are no active metabolites released by the kidneys. Data obtained by intravenous administration of fentanyl to patients with renal insufficiency indicate that the volume of fentanyl distribution may vary with dialysis. This can affect the serum concentrations of the drug.If patients with impaired renal function receive fentanyl transdermally, they should be carefully observed for signs of fentanyl toxicity, and if necessary, the dose of the drug for such patients should be reduced.

    Use in patients with elevated body temperature / exposed to external heat sources

    Patients with elevated body temperature require particularly careful observation for the presence of side effects of opioids, and, if necessary, correction of the dosage of fentanyl. Patients should also be advised to avoid exposure to the transdermal patch application site containing fentanyl, direct external heat sources, such as hot water bottles, hot water bottles, heated blankets, heating lamps, hot tubs, whirlpools, as there is a probability of a temperature-dependent increase in the release of fentanyl from the plaster.

    Before visiting the sauna, the transdermal patch should always be removed from the skin. Reception of a sauna is possible only when replacing the transdermal patch (at intervals of 72 hours). The new plaster should be applied to the cold and absolutely dry area of ​​the skin.

    Use in elderly patients

    The results of studies on the intravenous use of fentanyl show that in elderly patients the clearance decreases, the half-life increases, 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.

    Use in depleted and debilitated patients

    Due to the fact that depleted and weakened patients have decreased clearance and the half-life of fentanyl increases, such patients need careful observation to identify symptoms of a possible fentanyl overdose, and if necessary they should lower the dose of the drug.

    Other

    There may be myoclonic cramps.

    In the treatment of patients with myasthenia gravis should take precautions.

    Removal of TTS

    Even after use in transdermal patches, large quantities of fentanyl remain. For safety and ecological purity, the used transdermal patches, as well as unused patches, should be removed.The used transdermal patches should be folded with sticky surfaces inwards to ensure that the release membrane is completely closed and returned to medical or pharmaceutical personnel. Unused transdermal patches should be returned to medical or pharmaceutical personnel.

    Effect on the ability to drive transp. cf. and fur:

    Transdermal patches containing fentanylmay affect the mental and / or physical functions necessary to carry out potentially dangerous work, such as driving a vehicle or working with machinery. Mostly, this should be expected at the beginning of treatment, as well as with any change in dosage.

    There is no need to impose restrictions on patients who constantly take an individually selected dose of the drug. Therefore, patients should consult their physician if they are authorized to operate the vehicle or equipment.

    During the treatment period it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

    It is not recommended to drink alcohol.

    Form release / dosage:The transdermal therapeutic system is 12.5 μg / hr, 25 μg / hr, 50 μg / hr, 75 μg / hr, 100 μg / hr.
    Packaging:

    Each TTS is packaged in a heat-sealing bag consisting of paper, aluminum and polyacrylonitrile (PAN).

    For 5 packs, along with instructions for use, put in a cardboard box.

    Storage conditions:

    At a temperature of 15 to 25 ° C.

    Keep out of reach of children, even after use.

    Shelf life:

    3 years.

    The drug can not be used after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-005232/09
    Date of registration:30.06.2009
    The owner of the registration certificate:Takeda Pharma A / STakeda Pharma A / S Denmark
    Manufacturer: & nbsp
    Representation: & nbspTakeda Pharmaceuticals Ltd.Takeda Pharmaceuticals Ltd.
    Information update date: & nbsp22.09.2015
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