Methilprednisolone Sopharma

Leaflet accompanying the packaging: information for the user

Methylprednisolone Sopharma, 40 mg, powder and solvent for solution for injection

for injection

Methylprednisolone Sopharma, 250 mg, powder and solvent for solution for injection

Methylprednisolone

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Methylprednisolone Sopharma and what is it used for
• 2. Important information before using Methylprednisolone Sopharma
• 3. How to use Methylprednisolone Sopharma
• 4. Possible side effects
• 5. How to store Methylprednisolone Sopharma
• 6. Contents of the pack and other information

1. What is Methylprednisolone Sopharma and what is it used for

The active substance of Methylprednisolone Sopharma, methylprednisolone, belongs to a group of medicines called glucocorticosteroids. Glucocorticosteroids penetrate cell membranes and bind to specific receptors located in the cytoplasm. These complexes then enter the cell nucleus, stimulating further synthesis of various enzymes, which are probably responsible for the numerous actions of glucocorticosteroids observed after general use. In addition to their significant effect on inflammatory and immune processes, glucocorticosteroids also affect carbohydrate, protein, and fat metabolism. They also act on the cardiovascular system, skeletal muscles, and the central nervous system.

Methylprednisolone Sopharma is used as symptomatic treatment, except in cases of endocrine disorders, when it is used as substitution therapy, in the following diseases:

Endocrine disorders

primary or secondary adrenal cortex insufficiency (in certain circumstances in combination with mineralocorticosteroids)

• acute adrenal cortex insufficiency (may require administration in combination with mineralocorticosteroids) treatment of shock caused by adrenal cortex insufficiency, or shock not responding to conventional treatment, in cases where adrenal cortex insufficiency is confirmed or suspected (in cases where mineralocorticosteroid administration is contraindicated)

before surgical procedures and in cases of severe illness or injury, in patients diagnosed with adrenal cortex insufficiency or decreased adrenal hormone levels

congenital adrenal hyperplasia

subacute thyroiditis

hypercalcemia in cancer

Rheumatic diseases

Supportive treatment for short-term use during episodes of exacerbation or deterioration of the condition in:

post-traumatic degenerative joint disease

synovial membrane inflammation in degenerative joint disease

rheumatoid arthritis, including juvenile rheumatoid arthritis

acute and subacute bursitis

epicondylitis

acute non-specific tendon sheath inflammation

acute gouty arthritis

psoriatic arthritis

ankylosing spondylitis

Systemic diseases of connective tissue

During exacerbation or as maintenance treatment in:

systemic lupus erythematosus (and kidney inflammation in lupus)

acute rheumatic myocarditis

systemic polymyositis and dermatomyositis

giant cell arteritis

Goodpasture's syndrome

Dermatological diseases

pemphigus

severe form of erythema multiforme (Stevens-Johnson syndrome)

exfoliative dermatitis

severe form of psoriasis

bullous pemphigoid

severe form of seborrheic dermatitis

granulomatous dermatitis

Allergic diseases

Treatment of severe allergic diseases, when other treatment methods are ineffective:

bronchial asthma

contact dermatitis (contact eczema)

atopic dermatitis

psoriasis

seasonal or perennial allergic rhinitis

drug hypersensitivity reaction

transfusion-related urticaria

acute non-inflammatory laryngeal edema (epinephrine is the first-choice drug)

Ophthalmic diseases

Severe, acute, and chronic allergic and inflammatory processes affecting the eye and its appendages, such as:

ophthalmic zoster

uveitis, uveitis and ciliary body inflammation

retinal and choroidal inflammation

diffuse choroidal and retinal vascular inflammation and uveitis

optic neuritis

sympathetic ophthalmia

inflammation of the anterior segment of the eye

allergic conjunctivitis

allergic marginal corneal ulcers

keratitis

Gastrointestinal diseases

As systemic treatment during exacerbation of:

ulcerative colitis

Crohn's disease

Respiratory diseases

sarcoidosis

berylliosis

fulminant or disseminated pulmonary tuberculosis, simultaneously with appropriate antitubercular chemotherapy

Loeffler's syndrome not responding to other treatments

aspiration pneumonia

moderate or severe pneumonia caused by Pneumocystis carinii in patients with AIDS (as supportive treatment, when administered within the first 72 hours of initial treatment against Pneumocystis)

Hematological diseases

acquired (autoimmune) hemolytic anemia

idiopathic thrombocytopenic purpura in adults (only intravenous administration; intramuscular administration is contraindicated)

secondary thrombocytopenia in adults

erythroblastopenia in the bone marrow

congenital hypoplastic anemia

Oncological diseases

Palliative treatment:

leukemia and lymphoma in adults

acute leukemia in children

improving the quality of life of patients with advanced cancer

Edema

to induce diuresis or remission of proteinuria in nephrotic syndrome, without uremia

Nervous system

brain edema associated with the presence of a primary or metastatic tumor and (or) related to surgical treatment or radiation therapy

exacerbation in multiple sclerosis

acute spinal cord injuries. Treatment should be started within eight hours of the injury.

Other indications

tuberculous meningitis with subarachnoid block or in a situation threatening subarachnoid block, along with appropriate antitubercular therapy

trichinosis with involvement of the nervous system or heart muscle

organ transplantation

prevention of nausea and vomiting associated with cancer chemotherapy

2. Important information before using Methylprednisolone Sopharma

When not to use Methylprednisolone Sopharma

• if the patient is allergic to methylprednisolone or any of the other ingredients of this medicine (listed in section 6)
• if the patient has systemic fungal infections
• for intrathecal administration
• for epidural administration.
• in premature infants and newborns.

Administration of live or live attenuated vaccines is contraindicated during treatment with Methylprednisolone Sopharma at doses that cause immunosuppressive effects.

Warnings and precautions

In patients with the following diseases, treatment with Methylprednisolone Sopharma should be as short as possible and they require special medical care during the use of Methylprednisolone Sopharma.

Before starting and during treatment with Methylprednisolone Sopharma, the patient should inform the doctor if they have:

infectious diseases,such as tuberculosis and certain viral diseases (herpes and zoster with eye symptoms).

The use of Methylprednisolone Sopharma in active tuberculosis should be limited to cases of fulminant or disseminated pulmonary tuberculosis, in which Methylprednisolone Sopharma is used in combination with antitubercular therapy. During long-term treatment with Methylprednisolone Sopharma in patients with latent tuberculosis or a positive tuberculin test, careful observation is necessary, as the disease may recur.

In patients with ocular herpes simplex infection, who are given Methylprednisolone Sopharma, there is a risk of corneal perforation.

diabetes

Treatment with Methylprednisolone Sopharma may cause symptoms of latent diabetes, increased insulin requirements, or oral hypoglycemic agents.

hypertension

Treatment with Methylprednisolone Sopharma may exacerbate hypertension.

psychiatric disorderscurrently or in the past

Methylprednisolone Sopharma may exacerbate existing emotional instability or psychotic tendencies. During treatment, psychiatric disorders may occur, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to severe psychotic disorders.

severe stress

In patients exposed to severe stress, it may be necessary to increase the dose of rapidly acting glucocorticosteroids before, during, and after the stress-causing situation.

allergyto any medicines

If an allergic reaction occurred after taking any medicine, the doctor should be informed before starting treatment with Methylprednisolone Sopharma.

hypothyroidism

The effect of Methylprednisolone Sopharma is stronger in patients with hypothyroidism.

liver cirrhosis

The effect of Methylprednisolone Sopharma is stronger in patients with liver cirrhosis.

head injury

nonspecific ulcerative colitis,in case of possible perforation, abscess, or other purulent infection

diverticulitis

recent intestinal anastomosis

active or latent gastric ulcer

renal failure

osteoporosis

myasthenia gravis(acquired, chronic disease characterized by rapid fatigue and weakness of skeletal muscles).

Immunosuppressive effect, increased susceptibility to infections

Methylprednisolone Sopharma may increase susceptibility to infections and may mask some symptoms of infection. During its use, new infections may develop. During the use of Methylprednisolone Sopharma, there may be decreased immunity and inability to limit the development of infection. The risk of infections with pathogens such as viruses, bacteria, fungi, protozoa, or parasites increases with increasing dose.

Patients using Methylprednisolone Sopharma are more susceptible to infections than healthy individuals, e.g., in children with immunodeficiency or in adults using Methylprednisolone Sopharma, chickenpox and measles can have a more severe course or even be fatal.

During treatment with Methylprednisolone Sopharma at doses that cause immunosuppressive effects, it is contraindicated to administer certain vaccines. Inactivated vaccines may be administered, but the response to them may be limited or they may be ineffective. Patients receiving Methylprednisolone Sopharma at doses that do not have an immunosuppressive effect may undergo all required vaccinations.

In patients treated with Methylprednisolone Sopharma, Kaposi's sarcoma has been observed. Discontinuation of treatment may lead to remission of the disease.

Effect on the immune system

In patients, allergic reactions may occur. In patients taking Methylprednisolone Sopharma, skin reactions and anaphylactic or pseudo-anaphylactic reactions have rarely occurred.

Endocrine disorders

During long-term treatment with Methylprednisolone Sopharma, adrenal insufficiency may occur, which may persist for several months after discontinuation of treatment.

The doctor may also decide to gradually reduce the dose of Methylprednisolone Sopharma.

Patients should inform their doctor about any stressful situations that occur during this period. The doctor will consider initiating hormone therapy and (or) increasing the amount of salt and (or) mineralocorticoids consumed.

Sudden discontinuation of Methylprednisolone Sopharma may cause acute adrenal cortex insufficiency leading to death.

After sudden discontinuation of Methylprednisolone Sopharma, a "steroid withdrawal syndrome" may also occur. This syndrome includes symptoms such as loss of appetite, nausea, vomiting, lethargy, headache, fever, joint pain, peeling, muscle pain, weight loss, and (or) hypotension.

Methylprednisolone Sopharma may cause or exacerbate Cushing's syndrome, so patients with Cushing's disease should not use it.

In patients with hypothyroidism, the effect of Methylprednisolone Sopharma is increased.

Psychiatric disorders

During treatment with Methylprednisolone Sopharma and after its discontinuation, psychiatric disorders may occur. They usually occur within a few days or weeks of starting treatment with Methylprednisolone Sopharma. Most of them disappear after reducing the dose or discontinuing Methylprednisolone Sopharma. Patients and their caregivers should consult a doctor if the patient develops psychological symptoms, especially if they suspect depressive mood or suicidal thoughts. Patients and their caregivers should pay special attention to psychiatric disorders that may occur during treatment, immediately after dose reduction, or after discontinuation of Methylprednisolone Sopharma.

Effect on the nervous system

Methylprednisolone Sopharma should be used with caution in patients with seizure disorders.

In patients using Methylprednisolone Sopharma, usually with long-term use of high doses, cases of supratentorial lipomatosis have been reported.

Effect on the eyes

In patients using Methylprednisolone Sopharma for a long time, posterior subcapsular cataract and nuclear cataract (especially in children) may develop, as well as exophthalmos or increased intraocular pressure, which can cause glaucoma with potential optic nerve damage. In patients using Methylprednisolone Sopharma, secondary fungal and viral eye infections may also occur more frequently.

The use of Methylprednisolone Sopharma is associated with the development of central serous retinopathy, which can lead to retinal detachment.

Effect on the heart

In cases of high-dose and long-term treatment with Methylprednisolone Sopharma in patients with cardiovascular risk factors, it should be administered with caution and with additional monitoring of the cardiovascular system if necessary. The frequency of complications associated with the use of Methylprednisolone Sopharma can be reduced by using low doses and administering the drug every other day.

After rapid intravenous administration of high doses of Methylprednisolone Sopharma, cardiac arrhythmias and (or) circulatory collapse and (or) cardiac arrest may occur.

In patients with congestive heart failure, Methylprednisolone Sopharma should be administered with caution and only if necessary.

Effect on the stomach and intestines

Treatment with Methylprednisolone Sopharma may mask symptoms of peptic ulcers, so perforation or bleeding may occur without significant pain. In combination with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), the risk of developing gastric and intestinal ulcer disease increases.

Effect on the liver and bile ducts

After the use of high doses of Methylprednisolone Sopharma, acute pancreatitis may occur.

Effect on the musculoskeletal system

During the use of high doses of Methylprednisolone Sopharma, acute myopathy may occur, especially in patients with impaired neuromuscular transmission (e.g., in myasthenia gravis) or in patients treated simultaneously with anticholinergic drugs, including neuromuscular blockers (e.g., pancuronium). Myopathy may affect the eye muscles and respiratory muscles and lead to quadriparesis. Increased creatine kinase activity may occur. Improvement in clinical condition or complete recovery after discontinuation of Methylprednisolone Sopharma may occur after several weeks or even years.

Diagnostic tests

In patients using medium and high doses of Methylprednisolone Sopharma, blood pressure, sodium and water retention, and potassium excretion may increase. In this regard, it may be necessary to limit salt in the diet and supplement potassium. All glucocorticosteroids, including Methylprednisolone Sopharma, increase calcium excretion.

Methylprednisolone Sopharma should not be used as a routine treatment for head injuries.

Other

Complications of glucocorticosteroid therapy depend on the dose and duration of treatment. The doctor will decide on the dosage and duration of treatment individually for each patient.

Patients should be careful when using acetylsalicylic acid and nonsteroidal anti-inflammatory drugs (NSAIDs) with Methylprednisolone Sopharma.

After the administration of Methylprednisolone Sopharma, a breakthrough in the course of a pheochromocytoma has been reported, sometimes fatal. In patients suspected of having a pheochromocytoma, the doctor will decide on the use of Methylprednisolone Sopharma only after a thorough assessment of the benefit-risk ratio.

Use in children

In children who are treated with long-term Methylprednisolone Sopharma in divided daily doses, growth retardation may occur. The use of this treatment regimen should be limited to the most severe indications, and treatment with Methylprednisolone Sopharma should be as short as possible. Patients should be under close medical supervision.

Infants and children taking Methylprednisolone Sopharma for a long time are particularly susceptible to increased intracranial pressure.

After the administration of high doses of Methylprednisolone Sopharma in children, pancreatitis may develop.

Other warnings

Corticosteroid therapy affects the results of many tests and biological parameters (e.g., skin tests, thyroid hormone levels).

Methylprednisolone Sopharma should not be administered by injection into the shoulder muscle due to the frequent occurrence of subcutaneous atrophy.

Use of Methylprednisolone Sopharma in patients with liver function disorders

The effect of Methylprednisolone Sopharma is particularly strong in patients with liver cirrhosis.

Caution should be exercised when using Methylprednisolone Sopharma in patients with liver function disorders.

Use of Methylprednisolone Sopharma in patients with hypothyroidism

The effect of Methylprednisolone Sopharma is particularly strong in patients with hypothyroidism.

Methylprednisolone Sopharma and other medicines

Patient should tell their doctor about all medicines they are currently taking or have recently taken, including those obtained without a prescription.

It may be necessary to adjust the dose of Methylprednisolone Sopharma during concurrent use with the following medicines:

antibacterial drugs: isoniazid

antitubercular antibiotic: rifampicin

• anticoagulant drugs (oral). Concurrent use with Methylprednisolone Sopharma may decrease or increase the effect of anticoagulant drugs. It is necessary to monitor blood coagulation parameters to ensure adequate anticoagulant effect
• antiepileptic drugs: carbamazepine, phenobarbital, phenytoin
• anticholinergic drugs: neuromuscular blockers. During concurrent use of high doses of Methylprednisolone Sopharma and anticholinergic drugs, cases of acute myopathy have been reported
• muscle relaxants, e.g., pancuronium, vecuronium: Methylprednisolone Sopharma may partially inhibit the neuromuscular blockade caused by muscle relaxants
• anticholinesterases: Methylprednisolone Sopharma may reduce the effect of anticholinesterases in patients with myasthenia gravis
• antidiabetic drugs: in diabetic patients, it may be necessary to adjust the dose of antidiabetic drugs, as Methylprednisolone Sopharma may increase blood glucose levels
• antiemetic drugs: aprepitant, fosaprepitant
• antifungal drugs: itraconazole, ketoconazole
• antiviral drugs - HIV protease inhibitors: indinavir and ritonavir
• aromatase inhibitor: aminoglutethimide
• calcium channel blocker: diltiazem
• oral contraceptives: ethinylestradiol/norethindrone
• grapefruit juice
• immunosuppressive drugs: cyclosporine. When cyclosporine and Methylprednisolone Sopharma are used concurrently, there is mutual inhibition of metabolism, which may increase the concentration of one or both drugs in the blood. Therefore, there is a possibility that the risk of adverse reactions associated with the use of one of the drugs may increase during concurrent administration. During concurrent use, cases of seizures have been reported
• immunosuppressive drugs: cyclophosphamide, tacrolimus
• macrolide antibacterial drugs: clarithromycin, erythromycin, troleandomycin
• nonsteroidal anti-inflammatory drugs (NSAIDs): high doses of aspirin (acetylsalicylic acid). Concurrent use of NSAIDs with Methylprednisolone Sopharma may increase the frequency of bleeding and ulceration of the gastrointestinal tract. Caution should be exercised when using aspirin in combination with Methylprednisolone Sopharma
• potassium-lowering drugs. During concurrent use of Methylprednisolone Sopharma with potassium-lowering drugs (e.g., diuretics), patients should be monitored for the development of hypokalemia (a condition in which the potassium ion concentration in the blood is below the laboratory norm). During concurrent use of Methylprednisolone Sopharma with amphotericin B, xanthines, or beta2 agonists, the risk of hypokalemia increases
• certain medications may enhance the effect of Methylprednisolone Sopharma, and the doctor may want to closely monitor the patient's condition when taking such medications (including some HIV medications: ritonavir, cobicistat)

Pregnancy, breastfeeding, and fertility

Pregnancy

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine. Methylprednisolone Sopharma should be used in pregnant women only when absolutely necessary.

Methylprednisolone Sopharma crosses the placenta. Although adrenal cortex insufficiency in newborns who were exposed to Methylprednisolone Sopharma in utero is rare, children born to mothers who took high doses of Methylprednisolone Sopharma during pregnancy should be carefully monitored and evaluated for adrenal cortex insufficiency.

In infants born to mothers who were treated with Methylprednisolone Sopharma for a long time during pregnancy, cataract development has been observed.

The effect of Methylprednisolone Sopharma on the course of labor is not known.

Breastfeeding

Before using the medicine, the patient should consult a doctor. Methylprednisolone Sopharma passes into breast milk.

In children who are breastfed, Methylprednisolone Sopharma, which has passed into the mother's milk, may inhibit growth and affect the production of endogenous glucocorticosteroids. Methylprednisolone Sopharma should be administered to breastfeeding mothers only when the expected benefit to the mother outweighs the potential risk to the child.

Fertility

In animal studies, it has been shown that methylprednisolone has a fertility-reducing effect.

Driving and using machines

The effect of Methylprednisolone Sopharma on the ability to drive and use machines has not been studied.

Patients who experience dizziness, visual disturbances, and fatigue during treatment with Methylprednisolone Sopharma should not drive or operate machines.

Methylprednisolone Sopharma contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Methylprednisolone Sopharma

This medicine should be used as directed by the doctor, who will adjust the dose individually for the patient. In case of doubts, the patient should consult a doctor.

During treatment with Methylprednisolone Sopharma, as well as in case of discontinuation of long-term treatment, the patient should be under close medical supervision.

Methylprednisolone Sopharma can be administered by intravenous or intramuscular injection, or by intravenous infusion. The recommended dosing is presented in the table below. The dose may be reduced in infants and children, but it should be based on the patient's condition and response to treatment, rather than age or body weight (it should not be less than 0.5 mg/kg body weight/24 hours).

During prolonged therapy, routine laboratory tests should be performed regularly, such as urinalysis, postprandial glucose levels, blood pressure, body weight, and chest X-ray. Radiographic examination of the upper gastrointestinal tract is required in patients with a history of ulcers or significant dyspepsia.

If the patient feels that the effect of Methylprednisolone Sopharma is too strong or too weak, they should consult a doctor.

Use of a higher than recommended dose of Methylprednisolone Sopharma

In case of overdose, the patient should immediately consult a doctor or pharmacist. There are no clinical signs of acute overdose of Methylprednisolone Sopharma. Chronic overdose causes typical symptoms of Cushing's syndrome. Dialysis is an effective method of removing Methylprednisolone Sopharma from the body.

Missing a dose of Methylprednisolone Sopharma

The patient should not take a double dose to make up for a missed dose.

Discontinuation of Methylprednisolone Sopharma

In case of any further doubts about the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Methylprednisolone Sopharma can cause side effects, although not everybody gets them.

The following side effects have been reported for the following routes of administration:

intrathecal/epidural: meningitis, gastrointestinal and urinary tract disorders, headache, meningitis, transverse paralysis/paresis, seizures, sensory disturbances. The frequency of these events is not known.

The following side effects have also been reported:

Frequency not known (cannot be estimated from available data)

• opportunistic infections, infections
• leukocytosis (increased white blood cell count)
• hypersensitivity reactions (including anaphylactic or anaphylactoid reactions)
• Cushing's syndrome, hypopituitarism, "steroid withdrawal syndrome"
• fat accumulation in certain parts of the body, sodium retention, fluid retention, hypokalemic alkalosis, dyslipidemia, impaired glucose tolerance, increased insulin requirements (or oral hypoglycemic agents in diabetic patients), negative nitrogen balance (due to protein catabolism), increased urea levels in the blood, increased appetite (which may lead to weight gain)
• affective disorders (including depressive mood, euphoric mood, emotional instability, drug dependence, suicidal thoughts), psychotic disorders (including manic excitement, delusions, hallucinations, and schizophrenia), mental disorders, personality changes, confusion, anxiety, mood swings, abnormal behavior, insomnia, irritability
• increased intracranial pressure (with papilledema [benign intracranial hypertension]), seizures, amnesia, cognitive function disorders, dizziness, headache
• retinal and choroidal disorders, cataract, glaucoma, exophthalmos
• congestive heart failure (in patients with increased risk), arrhythmia
• hypotension, hypertension
• hiccups
• peptic ulcers (with possible subsequent perforation and bleeding), perforation of the intestine, gastrointestinal bleeding, pancreatitis, peritonitis, esophagitis, esophageal ulceration, abdominal distension, abdominal pain, diarrhea, dyspepsia, nausea
• angioedema, peripheral edema, hirsutism, purpura, ecchymosis, skin atrophy, flushing, excessive sweating, striae, rash, pruritus, urticaria, acne, skin discoloration
• muscle weakness, muscle pain, myopathy, muscle atrophy, osteoporosis, bone necrosis, pathological fractures, neuropathic arthropathy, arthralgia, growth retardation
• irregular menstruation
• impaired wound healing, fatigue, malaise, injection site reactions
• increased urinary calcium excretion, hypokalemia, impaired carbohydrate tolerance, increased intraocular pressure, increased creatine kinase activity

aminotransferase elevation, increased alkaline phosphatase activity in the blood, inhibition of skin test responses

• vertebral compression fractures, tendon rupture
• methylprednisolone may cause liver damage. Cases of hepatitis and increased liver enzyme activity have been reported
• increased white blood cell count in the blood
• increased blood coagulability

5. How to Store Methylprednisolone Sopharma

Vials with powder for solution for injection:
Store at a temperature below 25°C. Store the vials in the outer packaging to protect them from light.
Vials with solvent:
Store at a temperature below 25°C. Store the vials in the outer packaging. Do not freeze.
Store in a place out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton after: (EXP). The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Methylprednisolone Sopharma Contains

• The active substance of the medicinal product is methylprednisolone sodium succinate, equivalent to 40 mg or 250 mg of methylprednisolone.
• The other ingredients of the medicinal product are: disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate.
• Each vial with solvent contains 1 ml or 5 ml of water for injections.

What Methylprednisolone Sopharma Looks Like and What the Package Contains

White or almost white lyophilized powder.
Each package contains a colorless glass vial with powder for solution for injection, with a colored dot marking the place of opening, and a colorless glass vial (with a colored dot marking the place of opening) with solvent, and an information leaflet in a cardboard box.
Methylprednisolone Sopharma, 40 mg – 10 vials with powder for solution for injection and 10 vials containing 1 ml of water for injections in PVC foil blisters;
Methylprednisolone Sopharma, 250 mg – 5 vials with powder for solution for injection and 5 vials containing 5 ml of water for injections in PVC foil blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sopharma Warszawa Sp. z o.o.
Al. Jerozolimskie 136, 02-305 Warsaw

Manufacturer

Sopharma AD
16 Iliensko Shosse str., 1220 Sofia, Bulgaria

Date of Last Update of the Leaflet:

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Information Intended for Healthcare Professionals Only

Full information on the medicinal product can be found in the Summary of Product Characteristics
Method of administration:intravenously, intravenously as an infusion, and intramuscularly. The preferred method of initial administration in emergency situations is intravenous injection.
Reconstitution of the solution
Add the solvent from the second vial supplied with the kit to the vial with powder for solution for injection. If the medicinal product is to be administered as an infusion, add the prepared solution to the desired amount of infusion solution - 5% glucose solution, 0.9% sodium chloride solution, or 5% glucose solution in 0.9% sodium chloride solution.
The prepared solution should be used immediately. If the solution is not used immediately after preparation, the user is responsible for maintaining the appropriate storage time and conditions, i.e., no longer than 24 hours at a temperature of 2–8°C, unless the solution was prepared or reconstituted under controlled and validated sterile conditions.

Do Not Mix with Other Medicinal Products in the Same Syringe!

Before use, check the color and clarity of the solution for parenteral administration!