​​Betaferon 50mcg/ 1ml powder for injection solution, 15 sets

Description

The drug Betaferon is a type of drug known as interfenone, it contains a powder and a solvent to prepare a solution for injection. Betaferon is used to treat multiple sclerosis. Interferons are proteins produced by the body that make it easier to defend against attacks on the immune system, such as viral infections.

Composition

Recombinant interferon beta-1b ≈ 250 micrograms (8.0 million IU) in 1 ml of the prepared solution.

Betaferon contains 300 micrograms (9.6 million IU) of recombinant interferon beta-1b in 1 vial.

Excipients: vial (with powder for solution preparation for injection): human albumin, mannitol. Solvent (sodium chloride solution with a concentration of 5.4 mg / ml (0.54% i/v)): sodium chloride, water for injection.

Dosage

This medicine should always be used as directed by a doctor. If in doubt, contact your doctor, pharmacist, or nurse.

The dosage is determined by the doctor individually for the patient.

Recommended dose: 1 ml of the prepared betaferon solution is administered subcutaneously every other day (once every two days). This corresponds to a dose of 250 micrograms (8.0 million IU) of interferon beta-1b.

At the beginning of treatment, Betaferon is best tolerated when we gradually increase the dose, for example, starting with a 0.25 ml dose and increasing it every third injection to, sequentially, first to 0.5 ml, then to 0.75 ml, ending with the full dose (1 ml). The doctor, in consultation with the patient, may decide to change the time intervals in which the dose is increased, depending on the side effects that may occur at the beginning of treatment. To make it easier for the patient to gradually increase the dose during the first 12 injections, a new package was introduced containing 4 triple packs with different colors containing specially labeled syringes and detailed instructions for the patient.

Before injection, it is necessary to prepare a solution of betaferon. To do this, 1.2 ml of solvent in the ampoule is added to the contents of the vial with Betaferon preparation in powder form. Injections can be performed by a doctor or nurse, or independently by a patient who has been carefully trained.

Detailed information on how to make subcutaneous injections of betaferon yourself is provided in the leaflet. it is attached to the drug.

Action

Multiple sclerosis (MS) is a chronic disease affecting the central nervous system (CNS), affecting, in particular, the functioning of the brain and spinal cord. In multiple sclerosis, the inflammatory process destroys the protective membrane (called myelin) around the nerves of the central nervous system and prevents the nerves from functioning properly. This phenomenon is called demyelination. The exact cause of MS is unknown. It is believed that an abnormal reaction of the body's immune system plays an important role in the process that damages the central nervous system. Damage to the central nervous system can occur during an attack of multiple sclerosis (throw). This can cause temporary disability, such as difficulty walking. The symptoms may disappear completely or partially. Interferon beta-1b has been shown to alter the immune system's response and help reduce disease activity. Interferon beta-1b has both antiviral and immune regulatory properties.

One clinical episode indicating a high risk of developing multiple sclerosis: the drug Betaferon has been shown to delay the progression to complete multiple sclerosis. People with a remitting, recurrent form of MS sometimes have seizures or outbreaks of the disease, during which the symptoms become noticeably worse. The drug Betaferon has been shown to limit the number of seizures and reduce their severity. The drug reduces the frequency of hospital stays caused by illness and prolongs the time without outbreaks. Secondary progressive form of multiple sclerosis: In some cases, people with a remitting, recurrent form of multiple sclerosis experience an increase in symptoms and a transition to the next form, called secondary progressive form of multiple sclerosis. In this form, patients experience a progressive deterioration in physical fitness, regardless of whether they have or do not have an outbreak of the disease. Betaferon can reduce the number and severity of seizures and slow the progression of disability.

Indications

Betaferon is used to treat: patients with a single focus of demyelination with an active inflammatory process that is sufficiently acute and requires treatment with intravenous corticosteroids if alternative diagnoses are excluded and if patients have a high risk of developing clinically apparent multiple sclerosis; patients with a remitting, recurrent form of multiple sclerosis who have had at least two years in recent years. at least two outbreaks of the disease; patients with a secondarily progressive form of multiple sclerosis in the active stage of the disease, confirmed by outbreaks.

Contraindications

Do not use the drug in case of: hypersensitivity to the active substance or any component of the drug; severe depression and / or suicidal thoughts; decompensated liver disease.

Side effects

Like any medicine, this medicine can cause side effects, although not everyone has them.

Tell your doctor immediately and stop taking betaferon if you experience symptoms such as: itching of the whole body, swelling of the face and/or tongue, or sudden shortness of breath; suicidal thoughts; unusual bruising, excessive bleeding after injury or frequent infections; loss of appetite, fatigue, nausea, repeated vomiting, and especially when you notice itching of a significant area of the skin, Yellowing of the skin or whites of the eyes, or slight bruising; irregular heartbeat, swelling, for example, of the ankles or shins, or shortness of breath; abdominal pain radiating to the back, and/or nausea or fever.

Side effects that occur very frequently (may occur in more than 1 in 10 users): decreased white blood cell count, headache, sleep disorders (insomnia), abdominal pain, the concentration of a specific liver enzyme (alanine aminotransferase or Alat) may be increased (this will be seen in blood tests), rash, muscle pain disorders (myalgia), muscle rigidity (hypertension), joint pain (arthralgia), urge to bladder, injection site reaction (including redness, swelling, discoloration, inflammation, pain, infection, allergic reactions) (hypersensitivity), flu-like symptoms, pain, fever, chills, fluid accumulation in the arm or leg (peripheral edema), lack/loss of strength (asthenia).

Additional information is provided in the booklet attached to the drug.

Warnings and precautions

Before starting taking betaferon, discuss with your doctor if you have: monoclonal gammopathy (a disorder of the immune system in which an abnormal protein is found in the blood); he has depression or had suicidal thoughts in the past; he has ever had seizures or taken medication for epilepsy; he has serious problems with kidneys.

Tell your doctor immediately if you experience: itching of the whole body, swelling of the face and/or tongue, or sudden shortness of breath; noticeable periods of greater sadness and hopelessness than before starting treatment with Betaferon, or suicidal thoughts; any unnatural bruising, excessive bleeding after injury, or frequent infections; loss of appetite,loss of appetite, etc. fatigue, feeling of nausea (Nausea), periodic vomiting, and especially when observing generalized itching, yellowing of the skin or the white membrane of the eyes, and slight bruising; irregular heartbeat or swelling, such as in the ankles or lower legs, or shortness of breath; abdominal pain radiating to the back, and/or nausea or fever.

During the use of the drug Betaferon, it will be necessary to take blood tests, an examination of the thyroid gland, an examination that checks the functioning of the kidneys.

The drug Betaferon contains human albumin, so there is a risk of transmission of viral diseases. The risk of transmission of Creutzfeldt-Jakob disease (CJD) cannot be excluded.

Pallor, yellowing of the skin, or dark urine color may occur during treatment, which may be accompanied by unusual dizziness, fatigue, or shortness of breath. These may be symptoms of red blood cell breakdown.

During treatment, the patient may develop blood clots in small blood vessels. These clots can affect kidney function. This can happen several weeks or even several years after starting treatment with Betaferon. For this reason, the doctor may recommend measuring the patient's blood pressure, blood count (platelet count), and kidney function.

Use of other medications

Tell your doctor about all the medications you are currently or recently taking, as well as the medications you plan to take, including those that are available without a prescription.

Information is especially important if you are taking or have recently taken: medications that require a system of liver enzymes (called the cytochrome P450 system) to remove from the body, for example, medications used to treat epilepsy (for example, phenytoin); medications that affect the production of blood cells.

Betaferon is not recommended to be used with other drugs that alter the immune system's response, with the exception of anti-inflammatory drugs called corticosteroids or adrenocorticotropic hormone (ACTH).

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, assume that she may be pregnant, or when she plans to have a baby, she should consult a doctor or pharmacist before using this medicine.

The decision on the use of the drug during pregnancy and lactation is made by the doctor.

Use of the drug in children and adolescents