Vivitrol - instructions for use, dose, side effects, contraindications

Powder: naltrexone encapsulated in a copolymer of lactic and glycolic acid (polymer: 75:25 DL JN1). The vial contains 430 mg of naltrexone (an excess of 12.9%).

Solvent: carmellose sodium (sodium carboxymethylcellulose), polysorbate 20, sodium chloride, water for injection. The vial contains 4.0 ml of solvent.

Description:

Sterile powder and sterile solvent for suspension preparation for intramuscular administration of prolonged action.

Powder from white or almost white to light-yellow-brown color, without visible foreign inclusions; is easily suspended in a solvent without the formation of agglomerates.

Solvent: clear, colorless liquid.

Reduced suspension from white to white with a slightly yellowish-brown tinge of color; must pass through the needle (supplied) with little resistance or no resistance. There should be no solvent release without suspension.

Pharmacotherapeutic group:Drugs for the treatment of alcohol dependence

ATX: & nbsp

N.07.B.B.04 Naltrexone

Pharmacodynamics:

Pharmacodynamic properties

Naltrexone is an opioid receptor antagonist with the greatest affinity for opioid mu receptors.

In addition to the blockade of opioid receptors, the drug does not have other pharmacological activity.

The use of the drug for unknown reasons can cause a narrowing of the pupil.

The use of Vivitrol is not addictive or addictive.

In patients with physical opioid dependence, the administration of the drug causes withdrawal symptoms.

The neurobiological mechanisms responsible for reducing alcohol consumption observed in patients treated with alcohol dependence naltrexone are not fully clear, but it is assumed that the mechanism of action affects the endogenous opioid system.

Naltrexone blocks the effects of opioids by competitively binding to opioid receptors. The blockade of action of naltrexone can be eliminated by the introduction of high doses of opioids, which can lead to an increase in the release of histamine with a characteristic clinical picture. Binding to opioid receptors can block the effects of endogenous opioid peptides.

Vivitrol is not an aversive therapy and does not cause a disulfiram-like reaction when taking opiates or alcohol.

Pharmacokinetics:

Suction

Vivitrol is a prolonged-release drug intended for intramuscular injection every 4 weeks or once a month.

After intramuscular administration, the change in naltrexone concentration in the blood plasma is characterized by an initial peak with a maximum of about 2 hours after administration and a second peak after 2-3 days. Starting from about the 14th day after the administration of the drug, its concentration in the plasma gradually decreases, but the measurable concentration persists for more than 1 month.

The maximum concentration (C_m_Oh) and the area under the concentration-time curve of naltrexone and its main metabolite, 6-beta-naltrexol, in plasma is proportional to the administered dose of Vivitrol.The total exposure of naltrexone after a single injection of 380 mg of Vivitrol is 3-4 times higher than its oral intake in an amount of 50 mg for 28 days. After the first injection, the equilibrium concentration is reached at the end of the inter-dose interval. After repeated administration of Vivitrol, minimal cumulation (less than 15%) of naltrexone or 6-beta naltrexol is observed.

Distribution

Naltrexone weakly binds to blood plasma proteins in vitro (21%).

Metabolism

Naltrexone is subject to active metabolism in the body. The main metabolite, 6-beta-naltrexol, is formed by the cytosolic enzyme dihydrodialdehydrogenase.

Enzymes of the cytochrome P450 system do not participate in the metabolism of naltrexone. Other metabolites are 2-hydroxy-3-methoxy-6-beta-naltrexol and 2-hydroxy-3-methoxy- naltrexone. Naltrexone and its metabolites form conjugates with glucuronic acid.

With intramuscular introduction of Vivitrol in comparison with oral, much less 6-beta-naltrexol is formed, which is caused by a reduced pre-systemic metabolism in the liver.

Excretion from the body

Naltrexone and its metabolites are excreted mainly in the urine, and the minimum amount of the drug is unchanged;

The half-life of naltrexone is 5-10 days and depends on the degree of degradation of the polymer. The half-life of 6-beta-naltrexol is 5-10 days.

Pharmacokinetics in patients with renal and hepatic impairment

Liver failure

Vivitrol pharmacokinetics does not change in patients with mild to moderate liver function disorder (Child-Pugh classes A and B). Such a patient does not need a dose adjustment. In patients with severe impairment of liver function, the pharmacokinetics of Vivitrol have not been studied.

Renal insufficiency

The results of pharmacokinetic analyzes indicate that mild renal insufficiency (creatinine clearance 50-80 ml / min) has almost no effect on the pharmacokinetics of Vivitrol and there is no need to correct the dose of the drug. In patients with mild and severe renal insufficiency, the pharmacokinetics of Vivitrol have not been studied.

Effect of sex

A study conducted with the participation of healthy patients of both sexes (18 women and 18 men) showed that the sex of the patients does not affect the pharmacokinetics of Vivitrol.

The influence of age and race

The pharmacokinetics of Vivitrol have not been studied in elderly patients, children and representatives of different races.

Indications:

1.The drug is indicated for the treatment of alcohol dependence in patients who can refrain from drinking alcohol before starting treatment. Patients should not actively consume alcohol at the beginning of Vivitrol treatment.

2. The drug is indicated to prevent the recurrence of opioid dependence after opioid detoxification.

Opioid-dependent patients, including patients who receive treatment for alcohol dependence, should not take opioids at the beginning of treatment with the drug. Treatment with the drug should be part of an appropriate addiction program, including psychosocial support.

Children and elderly patients

Data on the safety and efficacy of the drug in children are absent.

In the clinical trials of Vivitrol, an inadequate number of patients older than 65 years was included to compare the effect of treatment in elderly patients and in younger patients.

Contraindications:

Vivitrol is contraindicated:

- patients taking narcotic analgesics;

- PWhen taking opioids against the background of drug treatment;

- bacute in the state of acute withdrawal of opioids (opioid withdrawal syndrome);

- ban oligophagy who has not undergone a provocative naloxone test or who has a positive test for the presence of opioids in the urine;

- bwith hypersensitivity to the active substance of the preparation, or to any of its excipients and solvent components;

- Pserious violations of liver function (including acute hepatitis and liver failure);

- Pin pregnancy and lactation;

- dUp to 18 years of age.

Carefully:

Application for liver failure

Patients with mild or moderate liver function disorder (Child-Pugh classes A and B) do not need dose adjustment. In patients with severe impairment of liver function, the pharmacokinetics of Vivitrol have not been studied. In such patients, Vivitrol, like all other intramuscular injections, should be administered with caution because of the risk associated with intramuscular injection (eg, with thrombocytopenia and coagulation disorders).

Application for renal failure

Patients with mild renal insufficiency (creatinine clearance 50-80 ml / min) do not need dose adjustment. In patients with moderate to severe renal failure, the pharmacokinetics of Vivitrol have not been studied. Due to the fact that naltrexone and its primary metabolite are excreted from the body mainly with urine, it is recommended that Vivitrol be administered with caution in patients with moderate or severe renal insufficiency.

Pregnancy and lactation:

Pregnancy

The effects of Vivitrol on pregnant women have not been studied. Prescribe Vivitrol during pregnancy should only be if the potential benefit to the mother from its use exceeds the potential risk to the fetus.

Lactation

When naltrexone was orally taken, naltrexone and 6-beta-naltrexol were isolated from breast milk. Because of potential carcinogenicity and the likelihood of serious side effects in infants, stop Vivitrol medication during breastfeeding or stop breastfeeding during treatment with the drug, depending on the importance of therapy for the mother.

Dosing and Administration:

Vivitrol should only be administered by qualified medical personnel using the components available in the package.

Do not replace the packaging components.

The recommended dose of Vivitrol is 380 mg IM once every 4 weeks or once everymonth. The drug should be injected into the gluteus muscle, alternating the buttocks.

Vivitrol can not be administered intravenously and subcutaneously!

If the patient misses the next dose, the next injection should be done as quickly as possible. Before using Vivitrol, oral naltrexone is not required.

Renewal of treatment after a break

There is no data on the resumption of treatment after the break.

Transfer of patients with alcohol dependence with oral naltrexone to Vivitrol

There is no systematic data on the transfer of patients with oral naltrexone to Vivitrol.

Instructions for preparing a suspension

To prepare the suspension, use only the supplied solvent. Enter the drug should only be supplied with a needle. All components of the package - a bottle of powder, a bottle of solvent, a needle for the preparation of a suspension and an injection needle with a protective cap - are necessary for the administration of the drug. The kit also contains a spare needle for injection with a protective cap. Do not replace the supplied components. To ensure accurate dosing, it is necessary to follow the instructions for preparing and administering the preparation. Observe the rules of asepsis.

The set includes:

1 bottle with powder;

1 bottle with a solvent;

1 disposable syringe;

1 short needle for the preparation of suspension;

2 needles for injection with a protective cap;

Instructions for use

1. Before use, remove the package from the refrigerator and allow it to warm to room temperature (approximately 45 minutes).

2. To facilitate mixing, tap the bottom of the powder vial on a hard surface to loosen the powder.

3. Remove the aluminum covers from both bottles. Do not use if the bottle cap is damaged or missing.

4. Wipe the neck of the vials with an alcoholic napkin.

5. Put short needle for suspension on the syringe and Collect 3.4 ml of the solvent from the vial with the solvent. Some of the solvent will remain in the vial.

Enter 3.4 ml of solvent into the vial of powder.

Stir the solvent and powder by vigorously shaking the vial for about 1 minute. Before proceeding, make sure that the suspension is homogeneous. Correctly mixed suspension should be milk-white, without lumps and freely flow along the walls of the bottle.

1.Immediately after preparation, take 4.2 ml of the suspension into the syringe using a needle to prepare the suspension.

2. Remove this needle and put the injection needle on the syringe.

Before injection, tap on the syringe to release air bubbles, then gently push the plunger until 4 ml of the suspension is left in the syringe.

The suspension is ready for immediate introduction.

1. The needle of the syringe is inserted deep into the gluteus muscle. After that, the piston is checked to see if the needle has entered the vessel (if any, the blood is thrown into the syringe). When blood appears, repeat the procedure, after replacing the needle with a spare one.

2. The drug is injected smoothly deep into the gluteus muscle. Suspension is introduced alternately into different buttocks.

3. Vivitrol can not be administered intravenously and subcutaneously.

After the administration of the drug, close the needle with a protective cap, pressing it with one hand to a hard surface and holding it away from you. The use of a protective cap prevents splashing of the liquid, which can remain on the needle after the injection. Discard used and unused packaging components.

Side effects:

In clinical studies lasting up to 6 months, 9% of patients with alcohol dependence who were treated with Vivitrolum discontinued treatment due to side effects. In the group of patients who received placebo, 7% of the patients stopped treatment due to adverse events. The most common reasons for refusing Vivitrol treatment were at the injection site (3%), nausea (2%), pregnancy (1%), headache (1%) and suicidal behavior (0.3%). In the group receiving placebo, only 1% of patients discontinued treatment because of the occurrence of reactions at the site of administration.

In clinical studies of up to 6 months, 2% of patients with opioid dependence who were treated with Vivitrol were discontinued due to side effects. In the group of patients who received placebo, 2% of patients discontinued treatment due to side effects.

The following are side effects, patients with alcohol dependence, occurring in clinical trials in more than 5% of cases (frequent), the severity of these side effects was characterized as mild and moderate.

From the gastrointestinal tract:

Nausea, vomiting, diarrhea, frequent urge to defecate, gastrointestinal upset, frequent loose stools, abdominal pain, stomach discomfort, dry mouth, anorexia, decreased appetite, and a loss of appetite.

From the respiratory system:

Infections of the upper respiratory tract, laryngitis, sinusitis, pharyngitis (including streptococcal), nasopharyngitis.

General disorders and reactions at the site of administration:

Pain, soreness, tightness, swelling, itching, hemorrhage, asthenia, lethargy, lethargy.

From the musculoskeletal system:

Arthritis, joint pain, joint stiffness, back pain, pain in the limbs, muscle spasm, muscle twitching, stiffness of muscles.

From the skin and subcutaneous tissues:

Rash, papular rashes, sweating.

Co hand nervous system:

Headache, migraine, dizziness, fainting, drowsiness, anxiety, sedation.

Adverse events in patients with opioid dependence were, basically, the same as in patients with alcohol dependence.

The following are side effects in patients with opioid dependence,occurring in clinical trials in more than 2% of cases (frequent), the severity of these side effects was characterized as mild and moderate.

Laboratory indicators:

Increased activity of alanine aminotransferase, aspartate aminotransferase and gamma-glutamyltransferase.

From the respiratory system:

Nasopharyngitis, influenza.

Co hand nervous system:

Insomnia, headache.

From the cardiovascular system:

Increase in blood pressure.

General disorders and reactions at the site of administration:

Pain.

Co hand gastrointestinal tract:

Toothache.

Side effects revealed during pre-registration studies of the drug:

Co hand gastrointestinal tract:

Perversion of taste, increased appetite, reflux-esophagitis, constipation, flatulence, hemorrhoids, colitis, gastrointestinal bleeding, paralytic ileus, pararectal abscess, gastroenteritis, tooth abscess, abdominal discomfort, acute pancreatitis.

General disorders and reactions at the site of administration:

Increased fever, lethargy, chest pain, tightness in the chest, increased or decreased body weight, trembling, chills, swelling of the face.

Mental disorders:

Irritability, sleep disturbance, alcohol withdrawal syndrome, agitation, euphoria, delirium.

From the nervous system:

Violation of attention, migraine, decreased mental activity, convulsions, ischemic stroke, aneurysms of the cerebral arteries, paresthesia.

From the sense organs:

Blurred vision, conjunctivitis.

Co hand musculoskeletal system:

Pain in the extremities, muscle spasm, stiffness in the joints, myalgia.

Co hand skin and subcutaneous tissues:

Intensive sweating, including at night, itching.

From the respiratory system:

Sore throat, shortness of breath, nasal congestion, obstructive bronchitis, bronchitis, pneumonia, laryngitis, sinusitis, upper respiratory tract infections.

From the side of metabolism:

Heat stroke, dehydration, hypercholesterolemia.

Co hand of cardio-vascular system:

"Tides", deep vein thrombosis, pulmonary thrombosis, heart palpitations, atrial fibrillation, myocardial infarction, angina pectoris, unstable angina, chronic heart failure, coronary artery atherosclerosis.

From the side of the blood and lymphatic system:

Lymphadenopathy, including inflammation of the cervical lymph nodes, an increase in the content of leukocytes in the blood.

Co hand immune system:

Seasonal allergies, hypersensitivity reactions, including angioedema and urticaria, the induction of HIV infection in HIV-infected patients.

Co hand genitourinary system:

Spontaneous abortion, decreased libido, urinary tract infection.

Co hand hepatobiliary system:

Chololithiasis, increased activity of alanine aminotransferase and aspartate aminotransferase, acute cholecystitis.

Overdose:

Data on overdose are very limited. Single doses of 784 mg were administered to 5 healthy volunteers. They did not have any serious side effects. The most common adverse events were reactions at the injection site, nausea, abdominal pain, drowsiness and dizziness. There was no significant increase in the number of hepatic enzymes.

In case of an overdose, appropriate supportive treatment should be given.

Interaction:

The interaction of Vivitrol with other drugs has not been studied.

Naltrexone is an antagonist of opioid-containing medicines (eg, drugs for cough, cold, antidiarrheal drugs and opioid analgesics).

Because the naltrexone is not a substrate of enzymes of the cytochrome system, inducers or inhibitors of these enzymes are unlikely to affect the clearance of Vivitrol.

Studies to assess the clinical significance of the effects of other drugs on the metabolism of Vivitrol has not been carried out, so caution should be exercised and the potential risk and potential benefit in the appointment of Vivitrol together with other drugs should be assessed.

The safety indices of the use of Vivitrol together with and without antidepressants are the same.

Special instructions:

Hepatotoxicity

Taking excessive doses of naltrexone can lead to hepatocellular impairment.

Naltrexone is contraindicated in acute hepatitis and liver failure. The administration of Vivitrol to patients with acute liver disease should be carefully thought out and justified, taking into account the risk of liver function abnormalities. The relationship between a safe dose of naltrexone and a dose that causes hepatic impairment ≤ 5 times.

When used in recommended doses, Vivitrol is not hepatotoxic. Patients should be warned about the risk of liver damage and advise you to seek medical help in case of symptoms of hepatitis.If such symptoms occur, treatment with Vivitrolum should be discontinued.

Eosinophilic pneumonia

In the course of clinical trials, one case of occurrence and one case of suspicion of eosinophilic pneumonia. In both cases, patients required hospitalization, treatment was performed with antibiotics and glucocorticosteroids.

The possibility of developing eosinophilic pneumonia in a patient receiving Vivitrol should be considered and counseling patients when symptoms such as progressive dyspnoea and hypoxia appear, seek medical help immediately.

Physicians should consider the possibility of developing eosinophilic pneumonia in patients resistant to antibiotics.

Hypersensitivity reactions

When taking the drug Vivitrol can develop such side effects as urticaria, angioedema, anaphylaxis. Patients should be warned that if hypersensitivity reactions develop, you should immediately consult a doctor and stop further treatment drug.

An overdose of opioids after trying to overcome their blockade

After opioid detoxification in patients, tolerance to opioids is usually reduced. Vivitrol blocks the effects of exogenous opioids for 28 days, but there have been reports of fatal opioid overdoses in patients who took opioids before the introduction of a new dose of Vivitrol or in the case of missing the next Vivitrol injection.

Patients treated with Vivitrol may be sensitive to lower doses of opioids than before treatment. This can cause potentially life-threatening opioid intoxication (respiratory failure or respiratory arrest, collapse, etc.). Patients should be warned that after the cessation of treatment with Vivitrolum, they may be sensitive to lower doses of opioids.

It is important to remember the decrease in tolerance to opioids at the end of the dosing interval, that is, about a month after the injection of the drug and in the case of missing the next injection. Patients and their families should be warned about hypersensitivity to opioids and the risk of opioid overdose.

Despite the fact that Vivitrol is a strong antagonist of opioid receptors with a long pharmacological effect, the blockade caused by it can be overcome.Patients attempting to overcome this blockade by administering large doses of exogenous opioids risk taking a lethal dose of opioids and endangering their lives. The concentration of opioids in the plasma immediately after they are taken may be sufficient to overcome the competitive blockade of opioid receptors, and as a consequence, the patient can immediately develop a life-threatening opioid intoxication manifested by respiratory depression and collapse. Patients should be aware of the seriousness of the consequences of trying to overcome the blockade of opioid receptors.

Effect of the drug on the duration of labor and labor

The effect of the drug on the duration of labor and delivery is unknown.

Effect of the drug on laboratory blood counts

In patients receiving treatment Vivitrol, there was an increase in the content of eosinophils in the blood, but after several months of treatment the content of eosinophils normalized.

In patients receiving high doses of the drug, a decrease in platelet count was observed on average by 17.8 x 10³ / RTI & gt; However, in the course of randomized controlled trials, the effect of Vivitrol on the increase in bleeding is not proven.

In patients with opioid dependence, who received treatment with the drug for 24 weeks, there was a decrease in platelet count by an average of 62.8 x 10³ / RTI & gt; In patients in the placebo group, the platelet count decreased on average by 39.9 x 10³/ RTI & gt; However, in the course of randomized controlled trials, the effect of Vivitrol on the increase in bleeding is not proven.

The increase in activity of aspartate aminotransferase in the blood during the treatment with Vivitrol was the same as in the treatment with oral naltrexone and was 1.5% compared with 0.9% in the group receiving placebo.

In clinical studies of up to 6 months with the participation of patients with opioid dependence, 89% of patients were diagnosed with hepatitis C, 41% of patients with HIV infection. The study often observed an increase in the activity of "hepatic" enzymes (alanine aminotransferase, aspartate aminotransferase and gamma-glutamyltransferase). These adverse events were more frequent in the group of patients receiving Vivitrol 380 mg than in the placebo group.

Patients with alanine aminotransferase or aspartate aminotransferase activity exceeding the upper limit of the norm more than three times were not included in the study.

In patients treated with Vivitrol, an increase in the activity of transaminases more than 3 times compared with the upper limit of the norm and requiring immediate treatment, was observed more often than in patients receiving placebo. This increase in enzyme activity was observed in 20% of patients treated with Vivitrol, compared with 13% of patients in the placebo group.

The increase in activity of aspartate aminotransferase more than three times compared with the upper limit of the norm was also more frequent in the group of patients treated with Vivitrol (14%), compared with patients in the placebo group (11%).

In patients with opioid dependence treated with Vivitrol, the activity of alanine aminotransferase increased by an average of 61 IU / L, in patients in the placebo group, an average of 48 IU / L.

In patients with opioid dependence treated with Vivitrol, aspartate aminotransferase activity increased by an average of 40 IU / L, in patients in the placebo group, an average of 31 IU / L.

In clinical trials in patients receiving Vivitrol, there was an increase in activity of creatine phosphokinase, usually 1-2 times compared with the upper limit of the norm. A similar increase in the activity of creatine phosphokinase is also observed in the treatment with oral naltrexone.However, there are cases of a 4-fold and even 35-fold increase in the activity of this enzyme in a group of patients receiving oral naltrexone and Vivitrol, respectively.

In 39% of patients with opioid dependence, treated with Vivitrol, there was an increase in activity of creatine phosphokinase above normal values, in the group of patients receiving placebo, an increase in activity of creatine phosphokinase was observed in 32% of patients.

In some cases, in patients receiving placebo, the activity of creatine phosphokinase increased 41.8 times compared with the upper limit of the norm; in the group of patients treated with Vivitrol, cases of increase in the activity of creatine phosphokinase were found to be 22.1 times higher than the upper limit of the norm.

When carrying out some immunoassay tests of urine, false-positive results may appear on a number of drugs, especially opioids. For further information, refer to the specific test instructions.

Warnings and Precautions

Elimination of the Vivitrol blockade

In an emergency situation in the case of patients receiving Vivitrol treatment,The proposed method of pain relief is regional analgesia, sedation with benzodiazepine and the use of non-narcotic analgesics or general anesthesia.

In situations requiring the use of narcotic analgesia, the required dose of opioids may be higher than normal, as a result of which respiratory depression may be deeper and longer.

Preferably the use of a high-speed narcotic analgesic, which reduces the duration of respiratory depression. The amount of analgesic administered should be determined in accordance with the needs of the patient. There may occur receptor-mediated phenomena (eg, facial edema, itching, generalized erythema, or bronchospasm), presumably because of the secretion of histamine.

Regardless of the remedy chosen to eliminate the Vivitrol blockade, the patient should be carefully monitored by appropriate qualified medical personnel in a specially equipped intensive care unit.

Depression and suicidal behavior

During Vivitrol's controlled clinical trials, adverse suicidal events (suicidal thoughts, suicide attempts, committed suicides) were infrequent,however, were found in the group of patients receiving Vivitrol treatment more often than in the group receiving placebo (1% vs. 0). In some cases, suicidal thoughts and behavior appeared in the patient after completion of the study, but were a consequence of the depression that developed during drug treatment. There were two committed suicides, in both cases, patients were treated with Vivitrol.

The discontinuation of the drug, associated with the manifestation of depression, occurred more often in the group of patients taking Vivitrol (1%) than in the placebo group (0).

In a 24-week placebo-controlled study, adverse events associated with depressive moods were observed in 10% of patients treated with Vivitrol at a dose of 380 mg, and in the group receiving placebo injections in 5%.

It should be closely monitored for the appearance of signs of depression or suicidal thoughts in patients with alcohol dependence, including patients receiving Vivitrol treatment. Family members and caregivers should be warned about the need to closely monitor the occurrence of symptoms of depression or suicidal behavior and immediately report the occurrence of such symptoms to the treating physician.

Reactions at the injection site

Injections of Vivitrol may be accompanied by pain, soreness, tightness, swelling, erythema and pruritus. During clinical trials, one patient developed a compaction that, 4 weeks after the injection, continued to increase, followed by the development of necrosis, which required surgical removal for removal. During post-registration observations, other cases of reactions at the injection site, including abscess, sterile abscess, compaction and necrosis, were noted, some of which required surgical intervention. Patients should be warned about the need to inform the attending physician of any reaction at the injection site.

Alcohol withdrawal

The use of Vivitrol not only does not exclude, but also does not reduce the manifestation of symptoms associated with the abolition of alcohol intake.

Retinal occlusion

Occlusion of the retinal artery after injection of another drug containing a copolymer of lactic and glycolic acid was very rare in post-research studies, and occurred in the presence of an abnormal arteriovenous anastomosis.During the clinical and postregistration studies of Vivitrol, no cases of retinal artery obstruction were noted. Vivitrol should be used as an injection in the gluteus muscle and avoid accidental ingestion into the blood vessel.

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

During treatment with Vivitrol, dizziness may occur. In case of dizziness, you should refrain from managing transport, as well as working with machinery.

Form release / dosage:

Powder for the preparation of suspension for intramuscular administration of prolonged action, 380 mg.

Packaging:

Powder: The amount of powder containing 430 mg of naltrexone (excess 12.9%) is placed in a 5 ml glass vial sealed with a rubber stopper and covered with an aluminum cap with a plastic cover, facilitating the opening.

Solvent: 4 ml of the solvent is placed in a 5 ml glass vial sealed with a rubber stopper and covered with an aluminum cap with a plastic cover that facilitates opening.

One vial of powder, one vial with 4 ml of solvent, one 5 ml syringe, one short needle for suspension,two needles for injection with a protective cap, in a pack carton along with instructions for medical use.

Storage conditions:

In the refrigerator at a temperature of 2 ° C to 8 ° C.

At a temperature of no higher than 25 ° C, not more than 7 days.

Do not expose to temperatures above 25 ° C.

Keep out of the reach of children.

Do not freeze.

Shelf life:

Shelf-life of powder - 3 years.

Shelf life of the solvent - 4 years.

Expiration date of the kit is indicated for the shortest period of time of the components (powder, solvent) included in the kit.

Vivitrol should be used immediately after the preparation of the suspension. It is intended for single use only.

Do not use after expiration. shelf life.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006057/08

Date of registration:31.07.2008 / 07.04.2016

Expiration Date:Unlimited

The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia

Manufacturer: & nbsp

ALKERMES, Inc. USA

BAXTER PHARMACEUTICAL SOLUTIONS, LLC USA

Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia

Information update date: & nbsp09.01.2017

Illustrated instructions

Instructions

Vivitrol (Vivitrol)