Remicade lyophilisate solution for infusion 100mg vials, 1pc

Composition

Active ingredient: infliximab 100 mg

Pharmacological action

Remicade – immunosuppressive.

It interacts with soluble and transmembrane forms of human tumor necrosis factor alpha (a broad biological cytokine) and reduces its functional activity due to the formation of a stable complex.

Indications

Rheumatoid arthritis (active form), Crohn’s disease (active form).

Use during pregnancy and lactation

Remicade is contraindicated during pregnancy, lactation, and children under 17 years of age

Contraindications

Hypersensitivity (including to other mouse proteins), sepsis, clinically expressed infectious disease or abscess, pregnancy, breast-feeding.

Side effects

Nervous system disorders: headache, dizziness, fainting, depression, psychosis, anxiety, amnesia, apathy, nervousness, drowsiness.

From the cardiovascular system: “hot flashes” of blood to the skin of the face, increased or decreased blood pressure, petechiae, thrombophlebitis, bradycardia, palpitations, vascular spasm, cyanosis, peripheral circulatory disorders, arrhythmia.

From the digestive system: nausea, diarrhea, abdominal pain, dyspepsia, constipation, gastroesophageal reflux, cheilitis, diverticulitis, liver dysfunction, cholecystitis.

From the urinary system: urinary tract infections, pyelonephritis.

From the genitourinary system: vaginitis.

Musculoskeletal disorders: myalgia, arthralgia.

Hematopoietic disorders: anemia, leukopenia, lymphadenopathy, lymphocytosis, lymphopenia, neutropenia, thrombocytopenia.

From the respiratory system: upper respiratory tract infections, bronchitis, pneumonia, shortness of breath, sinusitis, nosebleeds, bronchospasm, pleurisy.

From the sensory organs: conjunctivitis, keratoconjunctivitis, endophthalmitis.

From the skin and subcutaneous fat: urticaria, increased sweating, dry skin, eczema, seborrhea, periorbital edema, hyperkeratosis, skin pigmentation disorder, alopecia, bullous rash.

Allergic reactions (delayed type): myalgia and / or arthralgia with fever, urticaria, pruritus, swelling of the face, lips, hands, dysphagia, headache.

Other: autoantibody formation, lupus syndrome, excessive fatigue, chest pain, edema, infusion syndrome; viral infections (flu, herpes), abscess, sepsis, bacterial and fungal infections (erysipelas, warts, furunculosis, onychomycosis, phlegmon).

Interaction

In patients with rheumatoid arthritis and Crohn’s disease, concomitant use of methotrexate or other immunomodulators reduces the formation of antibodies to Remicade and increases the concentration of the latter in plasma.

CORTICOSTEROIDS have virtually no effect on the pharmacokinetics of Remicade.

It is not recommended to combine treatment Remicade and anakinra.

There are no data on interactions between infliximab and other drugs.

Pharmaceutical interaction

When conducting an infusion, mix the solution Remicade with other medications should not be used.

How to take, course of use and dosage

Remicade is administered intravenously, for 2 hours at a rate of no more than 2 ml / min, using an infusion system with a built-in sterile pyrogen-free filter with low protein-binding activity. In rheumatoid arthritis, treatment is given in combination with methotrexate. The initial single dose of infliximab is 3 mg / kg; after 2 and 6 weeks, it is re-administered at the same dose, then every 8 weeks (the total number of injections is 5-6). In Crohn’s disease (severe course) – once 5 mk/kg. In Crohn’s disease with fistula formation-a single dose of 5 mg / kg, re-administered 2 and 6 weeks after the first injection. If the disease recurs, the drug can be prescribed again within 14 weeks after the last dose is administered. To prepare the infusion solution, the contents of the vial are dissolved in 10 ml of water for injection and the total volume is adjusted to 250 ml with 0.9% NaCl solution. The resulting solution should be colorless or light yellow in color and opalescent; it may contain a small amount of small translucent particles (a solution with dark particles or with a changed color is not used). Due to the lack of preservative in the preparation, the infusion solution should be started as soon as possible and no later than 3 hours after its preparation. The unused portion of the infusion solution is not subject to further use.

Special instructions

Repeated treatment with Remicade with an interval of more than 15 weeks is not recommended, women of reproductive age during treatment with Remicade and then for 6 months should use reliable methods of contraception

Form of production

Lyophilizate for preparation of solution for infusions.

Storage conditions

At a temperature of 2-8 °C (do not freeze)

Shelf life

3 years

Active ingredient

Infliximab

Conditions of release from pharmacies

By prescription

Dosage form

infusion solution