Urbason 8 mg powder and solvent for solution for injection

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Urbason 8 mg powder and solvent for injectable solution

metilprednisolone

Read the entire leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Urbason is and what it is used for
2. What you need to know before using Urbason
3. How to use Urbason
4. Possible adverse effects
5. How to store Urbason
6. Contents of the pack and other information

1. What Urbason is and what it is used for

Methylprednisolone belongs to a group of medicines called corticosteroids (it acts at the cellular level by reducing the production of substances that cause inflammation or allergic reactions).

Due to its rapid onset of action, it is especially indicated in severe cases requiring immediate acute treatment or when administration of Urbason tablets is not possible, including:

• Severe asthma attacks.
• Anaphylactic shock (severe allergic reaction) and life-threatening clinical conditions such as angioedema (generalized urticaria accompanied by swelling of feet, hands, throat, lips, and airways), laryngeal edema (swelling of the throat area due to fluid accumulation).
• Accidental poisonings, such as insect bites, snake bites, to prevent anaphylactic shock.
• Cerebral edema (brain inflammation due to fluid accumulation) and spinal cord injuries (provided treatment is initiated within 8 hours after the injury has occurred).
• Addisonian crisis (a disorder affecting the adrenal glands, located just above each of the two kidneys, which requires immediate medical treatment) and shock secondary to adrenocortical insufficiency.
• Acute relapses of multiple sclerosis.
• As an adjunct in chemotherapy.
• Treatment of acute organ transplant rejection.

2. What you need to know before using Urbason

Do not use Urbason

• if you are allergic (hypersensitive) to the active substance, to other glucocorticoids, or to any of the other components of this medicine (listed in section 6),

• except in replacement or emergency treatments, do not use Urbason 8 mg in the following cases:

• if you have gastric or duodenal ulcers,

• if you have severe bone demineralization (osteoporosis),

• if you have a history of psychiatric disorders, consult your doctor about the appropriateness of using this medicine,

• if you have closed-angle or open-angle glaucoma (an eye disease),

• if you have herpetic keratitis (an eye disease),

• if you have lymphadenopathy (swollen lymph nodes) after tuberculosis vaccination,

• if you have an infection caused by amoebae (a type of infectious agent),

• if you have systemic mycosis (a fungal infection spread throughout the body),

• in patients with poliomyelitis (a spinal cord disease),

• if you have certain viral infections (such as chickenpox, herpes, herpes zoster) (see section “Warnings and precautions”),

• if you have tuberculosis, or if it is only suspected,

• 8 weeks before vaccination and 2 weeks after vaccination.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Urbason:

• if you have or have recently had intestinal diseases due to the risk of intestinal perforation with peritonitis, such as severe ulcerative colitis (with risk of perforation, abscesses, or purulent inflammation), diverticulitis, or intestinal anastomoses,
• Urbason may cause gas in the intestinal wall, a condition called intestinal pneumatosis (frequency not known, see section 4. “Possible side effects” below). The course of intestinal pneumatosis varies from a benign condition requiring no treatment to severe conditions that may require immediate treatment. If you experience symptoms such as “nausea, vomiting, and abdominal pain” that persist or become severe, you must consult your doctor immediately. Your doctor will decide whether further diagnostic measures or treatment are needed,
• if you have any infection, as it may reduce your body's defenses, leading to new infections or reactivation of existing ones. In severe infections, Urbason should only be used alongside treatment for the infection,
• contact your doctor if you experience blurred vision or other visual disturbances,
• in patients treated with high-dose intravenous pulses of Urbason, cardiac arrhythmias and cardiac arrest may occur, even in patients without known cardiac abnormalities,
• except for patients who have already had chickenpox, avoid contact with people who have, for example, chickenpox or herpes zoster. If during treatment with Urbason you are exposed to these infections, contact a doctor immediately, even if you do not have symptoms,
• if you are using Urbason, it is recommended that you do not get vaccinated,
• if you have tested positive in the tuberculin test (a test to detect tuberculosis), inform your doctor,
• if you have myasthenia gravis, particularly if you are receiving high-dose glucocorticoid treatment, a low initial dose of Urbason should be used and gradually increased,
• if you have hypothyroidism or hepatic cirrhosis. In both cases, relatively low doses may be sufficient and dose reduction may be necessary. Your doctor will perform regular monitoring,
• if you have overactivity of the thyroid gland (hyperthyroidism).

Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, and stiffness while using methylprednisolone. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with overactive thyroid (hyperthyroidism) treated with methylprednisolone. You may need additional treatment to relieve this condition,

• treatment should not be stopped abruptly, but gradually tapered. Do not stop using this medicine without consulting your doctor (see section 4. “Possible side effects”),
• if you are diabetic, or have heart failure or very high blood pressure, your doctor will perform regular checks,
• during long-term treatment, ensure adequate potassium intake, limit sodium intake, and monitor blood potassium levels. Additionally, your doctor will perform regular checks to prevent eye complications,
• long-term treatment with corticosteroids may cause osteopor游戏副本

3. How to use Urbason

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Urbason 8 mg can be administered by intravenous or intramuscular injection.

The dose will be individual for each patient and may be adjusted by your doctor depending on the severity of the condition and the patient's response. The recommended dose is 20 to 40 mg per day in adults and 8 to 16 mg per day in children.

In severe cases, if a sufficient therapeutic effect has not been achieved within half an hour, injections may be repeated up to a maximum recommended dose of 80 mg. The intervals between injections will range from 30 minutes to 24 hours, depending on the severity of the patient's condition.

If you feel that the effect of Urbason is too strong or too weak, inform your doctor or pharmacist.

In life-threatening situations, treatment should be initiated with single doses of 250 to 1000 mg of methylprednisolone in adults and 4 to 20 mg/kg of body weight in children. For this purpose, other injectable presentations of Urbason (20 mg, 40 mg, or 250 mg) may need to be used.

The following are the recommended doses according to different indications:

Acute asthma exacerbations: 30 to 90 mg per day. In status asthmaticus, 250 to 500 mg of methylprednisolone is recommended.

Anaphylactic shock and other immediately life-threatening situations: 250 to 500 mg of methylprednisolone.

Cerebral edema: 250 to 500 mg of methylprednisolone.

Addisonian crises: 16 to 32 mg by infusion, followed by another 16 mg over 24 hours. In these crises and in Waterhouse-Friderichsen syndrome, simultaneous administration of mineralocorticoids is indicated.

Acute relapses of multiple sclerosis: generally 1 g per day intravenously for 3 to 5 days.

Rejection crises: up to 30 mg of methylprednisolone/kg of body weight.

In cases of cerebral edema, status asthmaticus, and immunological crises, treatment should be continued with oral Urbason tablets, gradually reducing the dose.

Urbason is used as an adjunct to standard therapy (e.g., fluid volume replacement, cardiac and circulatory treatment, administration of antibodies, analgesia, etc.).

Prolonged treatment with Urbason, particularly at relatively high doses, should not be stopped abruptly, but should be tapered gradually (and, if necessary, under additional treatment with adrenocorticotropic hormone, ACTH).

If you use more Urbason than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 91 562 04 20, stating the medicine and the amount ingested or administered.

Overdose may cause anxiety, depression, mental confusion, gastrointestinal spasms or hemorrhages, increased glucose levels (hyperglycemia), elevated blood pressure (hypertension), and edema.

If you forget to use Urbason

Do not use a double dose to make up for missed doses.

If you stop using Urbason

Do not stop using this medicine without consulting your doctor.

After prolonged use of Urbason, if you need to discontinue treatment, follow your doctor's advice. Your doctor may instruct you to gradually reduce the amount of medicine you are taking until you stop completely.

Sudden discontinuation of treatment may cause:

• corticosteroid withdrawal syndrome (see section 4)
• adrenal insufficiency (low cortisol levels), or
• a recurrence (return) of the underlying condition being treated.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Urbason can cause adverse effects, although not everyone will experience them.

The following frequency definitions have been used for classification:

Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: cannot be estimated from available data.

The following adverse effects have been observed during treatment with Urbason:

Metabolism and nutrition disorders

Common: abnormal fat distribution, obesity, increased blood sugar levels, changes in blood fat levels (such as cholesterol or triglycerides), absence of menstrual periods, increased body hair growth, weight gain.

Rare: impotence, adrenal cortex problems (glands located above the kidneys that produce hormones), growth retardation in children, increased protein metabolism, elevated blood urea levels.

Very rare: reversible accumulation of fat in the epidural canal or thoracic cavity.

Frequency not known: localized accumulation of adipose tissue in certain parts of the body. Cases of tumor lysis syndrome have been reported in patients with malignant hematological neoplasms. Tumor lysis syndrome may be detected by your doctor based on blood test changes such as increased levels of uric acid, potassium, or phosphate and decreased calcium levels, and may cause symptoms such as muscle cramps, muscle weakness, confusion, visual loss or disturbances, difficulty breathing, seizures, irregular heartbeat, or renal failure (reduced urine output or darkening of urine). If you experience any of these symptoms, you must inform your doctor immediately (see section "Warnings and precautions").

Cardiac disorders

Frequency not known: myocardial disease (hypertrophic cardiomyopathy) in premature infants, arrhythmias and cardiac arrest associated with high-dose intravenous pulse therapy.

Vascular disorders

Common: sodium and water retention, increased potassium excretion, and possibly hypokalaemia.

In patients with heart failure, pulmonary congestion may increase and hypertension may develop.

Blood vessel disorders including vasculitis (allergic inflammation of blood vessels), increased intracranial pressure with optic nerve inflammation.

Frequency not known: increased blood clotting.

Other effects include a tendency towards increased platelet count (thrombocytosis) and increased risk of thrombosis.

Skin and subcutaneous tissue disorders

Common: skin changes (atrophy, stretch marks, acne, purplish-red spots due to accumulation of small amounts of blood under the skin, small red spots).

Rare: allergic reactions (skin rash), including shock in rare cases after parenteral administration, especially in patients with bronchial asthma or after kidney transplantation.

Blood and lymphatic system disorders

Common: delayed wound healing.

Frequency not known: elevated white blood cell count, thrombocytopenia (reduced platelet count).

Musculoskeletal and connective tissue disorders

Common: osteoporosis, which in severe cases may lead to fractures.

Rare: muscle weakness (reversible). In patients with myasthenia gravis, it may cause reversible worsening of weakness, potentially leading to a myasthenic crisis.

Also, a serious muscle disease (acute myopathy) due to concomitant administration of non-depolarizing muscle relaxants.

Very rare: bone tissue death in the head of the femur or humerus, tendon rupture (in individuals with prior tendon injury, diabetes, or high blood uric acid levels). When Urbason is administered at very high doses over a long period, muscle disorders may occur.

Renal and urinary disorders

Frequency not known: scleroderma renal crisis in patients who already have scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include elevated blood pressure and reduced urine output.

Gastrointestinal disorders

Rare: stomach or duodenal ulcers, and if these perforate, peritonitis (serious gastrointestinal infection), pancreatitis (inflammation of the pancreas), or abdominal discomfort.

Frequency not known: gas in the intestinal wall (intestinal pneumatosis).

Hepatobiliary disorders

Frequency not known: methylprednisolone may damage your liver: cases of hepatitis and elevated liver enzymes, cholestasis, and cellular-level liver damage have been reported, which may include acute liver failure (see section "Warnings and precautions").

Endocrine disorders

Frequency not known: pheochromocytoma crisis (see section "Warnings and precautions").

The following adverse effects have been observed after abrupt withdrawal of Urbason following prolonged use, although not everyone will experience them:

• symptoms such as fever, loss of appetite, nausea, weakness, restlessness, joint pain, skin peeling, low blood pressure, and weight loss (corticosteroid withdrawal syndrome).

Eye disorders

Rare: eye damage: opaque lens, increased eye pressure, cataracts, glaucoma (an eye disease that may lead to vision loss).

Frequency not known: retinal and choroidal disease, blurred vision.

Immune system disorders

Uncommon: decreased body defenses and increased risk of infection. If you have a viral disease such as chickenpox, simple herpes, or shingles, your condition may worsen, sometimes seriously endangering your health.

Nervous system disorders

Rare: cerebral seizures.

Frequency not known: dizziness, headache, and sleep disturbances.

Psychiatric disorders

Rare: development or worsening of pre-existing psychiatric problems (euphoria, mood swings, personality changes, depression, psychosis).

General disorders and administration site conditions

Skin atrophy may occur when injected into fatty tissue.

If treatment with Urbason is stopped abruptly (not gradually) after long-term use, muscle pain, joint pain, breathing problems, anorexia, nausea, vomiting, fever, low blood pressure, low blood sugar levels, and even death due to acute adrenal insufficiency may occur (see section "Warnings and precautions").

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage instructions for Urbason

Keep out of the sight and reach of children.

Store the ampoules in the outer packaging to protect them from light.

Do not use Urbason 8 mg after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Once reconstituted, the solution must be used immediately.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and unused medicines. This way, you will help protect the environment.

6. Package contents and other information

Composition of Urbason 8 mg powder and solvent for injectable solution

• The active substance is sodium metilprednisolone hemisuccinate. Each vial contains 10.61 mg, equivalent to 8 mg of methylprednisolone.
• The other components are: disodium phosphate dihydrate, monosodium phosphate monohydrate, and water for injections.

Appearance of the product and contents of the pack

The pack contains:

• 1 glass vial with lyophilisate and 1 glass vial of 2 ml with solvent.

The lyophilisate vial contains a white or almost white powder and the solvent vial contains a clear, colourless, and transparent liquid.

Marketing Authorization Holder and Manufacturer

Fidia farmaceutici S.p.A.

Via Ponte della Fabbrica, 3/A

35031 Abano Terme (PD) - Italy

Further information on this medicine can be requested from the local representative of the Marketing Authorization Holder

Local representative:

Laboratorios Fidia Farmacéutica S.L.U.

Parque Empresarial de la Moraleja - Edificio Torona

Avenida de Europa, 24 - Edificio A - 1 B

28108 Alcobendas - Madrid

(Spain)

This information is intended exclusively for physicians or healthcare professionals

Urbason 8 mg may be administered by intravenous or intramuscular injection.

The intravenous injection must be given slowly (each vial over 1 or 2 minutes).

Your doctor or nurse will dissolve the contents of one vial of injectable Urbason in 2 ml of water for injections, provided in the solvent vial.

Concomitant administration of reconstituted solutions of injectable Urbason with other medicines in the same syringe should be avoided, as precipitation may occur. Mixing with infusion solutions may also result in cloudiness or formation of precipitates.

Reconstituted solutions for injection should be used as soon as possible.

Date of latest review of this leaflet: August 2022

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/