DEXAMETHASONE MEDOCHEMIE 4 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Dexametasona Medochemie 4 mg/ml Solution for Injection and Infusion EFG

dexametasona phosphate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Dexametasona Medochemie and what is it used for
2. What you need to know before you are given Dexametasona Medochemie
3. How Dexametasona Medochemie will be given to you
4. Possible side effects
5. Storage of Dexametasona Medochemie
6. Contents of the pack and further information

1. What is Dexametasona Medochemie and what is it used for

Dexametasona is a synthetic glucocorticoid(adrenocortical hormone) with effects on metabolism, electrolyte balance, and tissue function.

Dexametasona Medochemie is used in

Diseases that require treatment with glucocorticoids. Depending on the type and severity, these include:

Systemic use:

• Brain swelling caused by brain tumors, brain surgery, brain abscess, bacterial inflammation of the brain lining.
• Shock states after severe injuries, for the prophylactic treatment of pulmonary shock.
• Severe acute asthma attack.
• Initial treatment of some extensive, acute, and severe skin disorders, such as erythroderma, pemphigus vulgaris, acute eczema.
• Treatment of systemic rheumatic diseases (rheumatic diseases that can affect internal organs) such as systemic lupus erythematosus.
• Active rheumatic inflammation of the joints (rheumatoid arthritis) with a severe progressive course, for example, forms that rapidly lead to joint destruction, and/or where tissue outside the joints is affected.
• Severe infectious diseases with conditions similar to poisoning (e.g., in tuberculosis, typhoid fever, brucellosis); only in addition to appropriate anti-infective therapy.
• Supportive treatment in malignant tumors.
• Prevention and treatment of post-surgical or chemotherapy-induced vomiting.
• Dexametasona is used as treatment for coronavirus disease 2019 (COVID-19) in adult and adolescent patients (from 12 years with a body weight of at least 40 kg) with difficulty breathing and need for oxygen therapy.

Local use:

• Intra-articular injection: persistent inflammation of one or several joints after general treatment of chronic inflammatory joint diseases, activated osteoarthritis, acute forms of painful shoulder syndrome.
• Infiltration therapy (only if strictly indicated): non-bacterial inflammation of tendons or bursa (a fluid-filled sac that forms under the skin, usually over the joints), inflammation around a joint, tendon disorder.
• Ocular therapy: injection under the conjunctival sac in non-infectious inflammation of various parts of the eye (cornea and conjunctiva, chorion inflammation, iris and ciliary body inflammation), inflammation of the middle part of the eye (uveitis).

2. What you need to know before you are administered Dexametasona Medochemie

You should not be administered Dexametasona Medochemie

• If you are allergic to dexamethasone or to any of the other components of this medication (included in section 6).

Severe allergic reactions (anaphylactic reactions) with circulatory collapse, cardiac arrest (heart stops beating), arrhythmia (abnormal heart rhythm), lack of breathing (bronchospasm) and/or fall or increase in blood pressure during isolated cases during the use of dexamethasone.

Injection into the joints is contraindicated in:

• Infections in or in the immediate vicinity of the joint to be treated.
• Bacterial arthritis.
• Instability of the joint to be treated.
• Bleeding tendency (spontaneous or due to anticoagulants).
• Calcifications in the vicinity of the joints.
• Avascular osteonecrosis (disease in which bone tissue dies when there is no blood supply to the bone).
• Tendon rupture.
• Charcot's joint (loss of sensation in the joint).

Infiltration should not be performed without additional causal therapy in the case of infections at the administration site; the same applies to subconjunctival administration in eye diseases caused by viruses, bacteria, and fungi and in corneal injuries and ulcers.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before you start taking this medication.

You should not stop taking any other steroid medication unless your doctor has given you instructions to do so.

General precautions regarding the use of steroids in specific diseases, masking of infection, medications used at the same time, etc. in line with current recommendations.

If particular situations of physical stress (accident, surgery, childbirth, etc.) occur during therapy with this medication, it may be necessary to temporarily increase the dose.

This medication may mask signs of infection and, therefore, prevent the diagnosis of existing or developing infections. Latent infections may be reactivated.

In the following diseases, treatment with this medication should only be initiated if your doctor considers it essential. If necessary, medications that act against the pathogens should also be taken:

• Acute viral infections (hepatitis B, chickenpox, shingles, herpes simplex infections, corneal inflammation caused by herpes viruses).
• Chronic active hepatitis positive for HBSAG (infectious liver inflammation).
• Approximately 8 weeks before and 2 weeks after vaccinations with attenuated pathogens (live vaccine).
• Acute and chronic bacterial infections.
• Fungal infections with internal organ involvement.
• Certain diseases caused by parasites (amebic infections, worms). In patients with suspected or confirmed worm infection (nematodes), this medication may lead to the activation and massive proliferation of these parasites.
• Poliomyelitis (infection caused by a virus).
• Lymph node disease after tuberculosis vaccination.
• In the case of a history of tuberculosis, use only in combination with tuberculosis medications.

The following diseases must be specifically monitored during treatment with this medication and treated according to the requirements:

• Gastrointestinal ulcers.
• Bone loss (osteoporosis).
• High blood pressure that is difficult to control.
• Diabetes that is difficult to control.
• Mental disorders (psychological) (also in the past), including suicidal tendencies. In this case, neurological or psychiatric monitoring is recommended.
• Increased intraocular pressure (narrow-angle and wide-angle glaucoma); Close monitoring and treatment by an ophthalmologist and complementary therapy are recommended.
• Corneal injuries and ulcers; Close monitoring and treatment by an ophthalmologist and complementary therapy are recommended.

Contact your doctor if you experience blurred vision or other visual disturbances.

Due to the risk of intestinal perforation, dexamethasone can only be taken if there are compelling medical reasons and with adequate monitoring:

• In severe colon inflammation (ulcerative colitis) with threatened perforation, with abscesses or purulent inflammation, possibly without peritoneal irritation.
• In inflamed pouches in the intestinal wall (diverticulitis).
• After certain intestinal surgeries (enteroanastomosis), immediately after surgery.

Signs of peritoneal irritation after gastrointestinal perforation may be absent in patients receiving high doses of glucocorticoids.

In patients with diabetes, metabolism should be regularly verified; the possibility of an increased need for diabetes medications (insulin, oral antidiabetics) should be taken into account.

Patients with severe hypertension and/or severe heart failure should be carefully monitored due to the risk of deterioration. High doses may lead to a slowing of the heart rate.

Severe anaphylactic reactions (exaggerated immune system reaction) may occur.

The risk of tendon disorders, tendon inflammation, and tendon rupture increases when fluoroquinolones (certain antibiotics) and this medication are administered together.

During treatment of a particular form of muscular paralysis (myasthenia gravis), symptoms may worsen at first.

Generally, vaccinations with killed pathogen vaccines (inactivated vaccines) are possible. However, it should be noted that the immune response and, therefore, the vaccine may be compromised at higher doses of corticosteroids.

Especially with prolonged treatment with high doses of this medication, sufficient potassium intake (such as vegetables, bananas) and limited salt intake should be ensured. Your doctor will monitor your blood potassium levels.

Viral diseases (such as measles, chickenpox) can be very severe in patients treated with this medication. Patients with a compromised immune system who have not had measles or chickenpox yet are particularly at risk. If these patients have contact with people infected with measles or chickenpox during treatment with this medication, they should contact their doctor immediately, who will introduce preventive treatment if necessary.

Symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, visual loss or disturbances, and shortness of breath, in case you suffer from hematological malignancy (blood cancers).

If you have or suspect you have pheochromocytoma (a tumor of the adrenal glands), talk to your doctor before taking this medication.

Treatment with dexamethasone can cause pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare tumor of the adrenal glands. The crisis can occur with the following symptoms: headaches, sweating, palpitations, and high blood pressure. Contact your doctor immediately if you experience these signs.

Intravenous administration (in a vein) should be performed by slow injection (over 2-3 minutes), as side effects such as unpleasant itching or paresthesia may occur if injected too quickly.

This medication is intended for short-term use. If used incorrectly for a longer period, additional warnings and precautions should be considered, as described for long-term administration of medications containing glucocorticoids.

Possible systemic side effects and interactions should be taken into account after local administration.

Administration of this medication in the joint increases the risk of joint infections. Long-term administration and repeated injections of glucocorticoids in weight-bearing joints may exacerbate joint changes related to wear and tear. This is probably due to the overload of the affected joints after pain or other symptoms have been relieved.

Local use in eye diseases

Inform your doctor if you experience swelling and weight gain around the trunk and in the face, as these are generally the first manifestations of a syndrome called Cushing's syndrome. Suppression of adrenal gland function may develop after stopping intensive long-term treatment with this medication. Consult your doctor before stopping treatment yourself. These risks are especially important in children and patients treated with a medication called ritonavir or cobicistat (medications used to treat HIV).

Children and adolescents

Routine use of dexamethasone is not recommended in premature infants with lung problems.

This medication should only be administered to children if necessary, as it may slow down the growth of children. During long-term treatment with this medication, growth in height should be regularly monitored.

If dexamethasone is given to a premature newborn, the heart function and structure should be monitored.

Elderly patients

A special risk-benefit assessment should be carried out due to the increased risk of osteoporosis.

Use in athletes

Athletes are informed that this medication contains a component that may produce a positive result in doping tests.

Other medications and Dexametasona Medochemie

Inform your doctor or pharmacist if you are using, have recently used, or could use any other medication.

Inform your doctor if you are taking any of the following medications, as they may interact with the effect of this medication:

• Medications that accelerate decomposition in the liver, such as certain sleep medications (barbiturics), medications used to treat convulsions (phenytoin, carbamazepine, primidone), and certain medications for tuberculosis (rifampicin), may reduce the effect of corticosteroids.
• Medications that slow down decomposition in the liver, such as certain medications for fungal infections (ketoconazole, itraconazole), may increase the effect of corticosteroids.
• Certain female sex hormones, for example for pregnancy prevention (the pill): the effect of this medication may be increased.
• Ephedrine (such as medications for low blood pressure, chronic bronchitis, asthma attacks, medications used to reduce swelling of the mucous membranes in rhinitis, and appetite suppressants may contain ephedrine): through accelerated decomposition in the body, the effectiveness of this medication may be reduced.

Inform your doctor if you are using ritonavir or cobicistat (medications used to treat HIV), as this may increase the amount of dexamethasone in the blood.

Inform your doctor if you are taking any of the following medications, as dexamethasone may influence the effect of these medications:

• During concomitant use with certain medications for reducing blood pressure (ACE inhibitors),
• Dexamethasone may increase the risk of changes in blood count.
• Dexamethasone may increase the effect of heart-strengthening medications (cardiac glycosides) due to potassium deficiency.
• This medication may increase potassium excretion by diuretics (saluretics) or laxatives.
• Dexamethasone may decrease the glucose-lowering effect of oral antidiabetics and insulin.
• Dexamethasone may weaken or increase the effects of medications that reduce blood coagulation (oral anticoagulants, coumarin). Your doctor will decide whether a dose adjustment of the anticoagulant is necessary.
• During concomitant use of anti-inflammatory and anti-rheumatic medications (salicylates, indomethacin, and other NSAIDs), dexamethasone may increase the risk of stomach ulcers and gastrointestinal bleeding.
• Dexamethasone may prolong the muscle relaxation effect of certain medications (non-depolarizing muscle relaxants).
• This medication may enhance the intraocular effect (within the eye) of certain medications (atropine and other anticholinergics) that increase pressure.
• Dexamethasone may decrease the effect of medications for worm diseases (praziquantel).
• During concomitant use of medications for malaria and rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine), dexamethasone may increase the risk of muscle diseases or cardiac muscle diseases (myopathies, cardiomyopathies).
• Dexamethasone may reduce the increase of thyroid-stimulating hormone (TSH) after administration of protirelin (TRH, a midbrain hormone).
• If used in combination with medications that suppress the body's immune system (immunosuppressants), dexamethasone may increase susceptibility to infections and worsen existing infections that have not yet appeared.
• Additionally, for cyclosporin (a medication used to suppress the body's immune system): dexamethasone may increase the concentration of cyclosporin in the blood and, therefore, the risk of convulsions (seizures).
• Fluoroquinolones, a certain group of antibiotics, may increase the risk of tendon ruptures.

Effect on investigation methods

Glucocorticoids may suppress skin reactions in allergy tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Dexamethasone crosses the placental barrier. During pregnancy, especially in the first three months, the medication should only be used after a careful benefit-risk assessment. Therefore, women should inform their doctor if they are already pregnant or become pregnant.

During long-term treatment with glucocorticoids during pregnancy, growth disorders in the fetus cannot be excluded. If glucocorticoids are administered towards the end of pregnancy, there is a risk of subactive adrenal cortex in the newborn, which may require replacement therapy that should be gradually reduced.

Newborns of mothers who received dexamethasone near the end of pregnancy may experience low blood sugar levels after birth.

Breastfeeding

Glucocorticoids, including dexamethasone, are excreted in breast milk. So far, no harm to breastfed infants has been reported. However, the need for treatment during breastfeeding should be carefully examined. If the disease requires higher doses, breastfeeding should be interrupted. Contact your doctor immediately.

Consult your doctor or pharmacist before taking/using any medication.

Driving and using machines

To date, there is no evidence that this medication affects the ability to drive or use machines, or work without secure restraint.

Dexametasona Medochemie contains sodium.

This medication contains 3.12 mg of sodium (main component of table/cooking salt) in 1 ml of ampoule. This is equivalent to 0.15% of the maximum recommended daily dietary intake of sodium for an adult.

This medication contains 6.24 mg of sodium (main component of table/cooking salt) in 2 ml of ampoule. This is equivalent to 0.30% of the maximum recommended daily dietary intake of sodium for an adult.

3. How Dexametasona Medochemie will be administered to you

Your doctor will decide how long you should take dexametasona. The doctor will determine your individual dose. Follow the instructions so that this medication has the proper effect.

In case of doubt, consult your doctor or pharmacist.

Method of administration

This medication will be administered to you by a qualified healthcare professional. It will be administered as an injection into a vein. It can also be administered into a muscle, directly into a joint or soft tissue.

This medication must be administered by slow intravenous injection (over 2-3 minutes) (into the vein), but it can also be administered by intramuscular route (into the muscle) if problems occur with venous access and blood circulation is adequate.

This medication can also be used intra-articularly (into a joint), intralesionally (into a lesion or into the skin), or subconjunctivally (into the eyelid).

Direct intravenous administration or injection into an IV line should be administered before perfusion, if possible.

The daily dose should be administered as a single dose in the morning, if possible. However, in conditions that require high-dose therapy, multiple doses are often required throughout the day to achieve maximum effect.

The duration of treatmentdepends on the underlying disease and the course of the disease. Your doctor will specify a treatment schedule, which you must follow strictly. Once a satisfactory treatment result is achieved, the dose will be reduced to a maintenance dose or the treatment will be completed.

Sudden discontinuation of treatment after approximately 10 days may cause acute adrenocortical insufficiency; therefore, the dose should be reduced slowly if treatment is to be discontinued.

In cases of hypothyroidism or liver cirrhosis, your doctor may prescribe low doses of this medication or your dose may be reduced.

When high doses are needed in a single treatment, it should be considered to take medications containing dexametasona at a higher resistance/quantity.

Unless your doctor prescribes otherwise, the recommended dose is:

Systemic use

• Cerebral edema: initially, in acute conditions, depending on the cause and severity, 8-10 mg (up to 80 mg) into a vein (i.v.), then 16-24 mg (up to 48 mg) daily, divided into 3-4 (up to 6) individual doses for 4-8 days.
• Cerebral edema due to bacterial meningitis:
• • Use in adults: 0.15 mg/kg body weight every 6 hours for 4 days;
  • Use in children: 0.4 mg/kg body weight every 12 hours for 2 days, starting before the first antibiotics.
• Shock after severe injury:
• • Use in adults: initially 40-100 mg i.v., repeated dose after 12 hours or 16-40 mg every 6 hours for 2-3 days.
  • Use in children: initially 40 mg i.v., repeated dose after 12 hours or 16-40 mg every 6 hours for 2-3 days.
• Severe asthma exacerbations:
• • Use in adults: 8-20 mg i.v. as soon as possible, if necessary, another dose of 8 mg every 4 hours may be repeated.
  • Use in children: 0.15-0.3 mg/kg body weight, or 1.2 mg/kg body weight i.v. as a bolus, then 0.3 mg/kg every 4-6 hours.
• Severe skin diseases: depending on the nature and extent of the disease, daily doses of 8-40 mg i.v., in individual cases up to 100 mg. Followed by treatment with decreasing doses of tablets.
• Systemic lupus erythematosus: 6-16 mg/day.
• Severe progressive forms of rheumatoid arthritis, for example, forms that rapidly lead to joint destruction: 12-16 mg/day, when tissue outside the joints is affected: 6-12 mg/day.
• Severe cases with conditions similar to poisoning: 4-20 mg i.v. daily, for a few days, only in conjunction with adequate anti-infective therapy; in individual cases (e.g., typhoid) initial doses of up to 200 mg i.v., then gradually reduced.
• Supportive treatment in malignant tumors: initially 8-16 mg/day, during long-term treatment 4-12 mg/day.
• Prevention and treatment of chemotherapy-induced vomiting in antiemetic regimens: 10-20 mg i.v. before starting chemotherapy, then 4-8 mg two to three times a day for 1-3 days as needed (moderately emetogenic chemotherapy) or up to 6 days (highly emetogenic chemotherapy).
• Prevention and treatment of postoperative vomiting:
• • Use in adults: a single dose of 8-20 mg i.v. before the start of surgery;
  • Use in children over 2 years: 0.15-0.5 mg/kg body weight (max. up to 16 mg).
• Treatment of Covid-19:
• • It is recommended that adult patients receive 7.2 mg i.v. of dexametasona phosphate (equivalent to 6 mg dexametasona i.v.) once a day for up to 10 days.
  • Adolescents 12 years or older: it is recommended that they receive 7.2 mg dexametasona phosphate/dose i.v. (equivalent to 6 mg dexametasona) once a day for up to 10 days.

Local use

Local infiltration and general injection therapy are usually performed with 4-8 mg; 2 mg dexametasona phosphate sodium is sufficient if injected into small joints or administered by subconjunctival injection.

If you have been administered more Dexametasona Medochemie than you should

Generally, dexametasona is well tolerated even with short-term use of large quantities. A doctor or nurse will administer this medication to you. It is unlikely that you will be given too much or too little, however, inform your doctor or nurse if you have any doubts.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you missed a dose of Dexametasona Medochemie

The missed dose can be administered on the same day and the next day the dose prescribed by your doctor should be administered as usual. If several doses are not administered, this may lead to a recurrence or worsening of the disease. In such cases, you should talk to your doctor, who will review the treatment and adjust it if necessary.

Do not take a double dose to make up for a missed dose.

If you stop treatment with Dexametasona Medochemie

Always follow the dosage indicated by your doctor. Do not stop receiving this medication suddenly, as it could be dangerous. Your doctor will indicate how the treatment will be gradually reduced. This medication should not be discontinued without permission, particularly because long-term treatment can lead to a decrease in the production of glucocorticoids in the body. A highly stressful situation without adequate glucocorticoid production can be fatal.

If you have any further questions about the use of this medication, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

Talk to your doctor or pharmacist if you notice any of the side effects mentioned or other side effects during treatment with dexametasona. Never stop treatment on your own.

The risk of undesirable effects is low during short-term treatment with dexametasona, with the exception of high-dose parenteral therapy where changes in electrolytes, swelling, possible increase in blood pressure, cardiac arrest, cardiac rhythm disorders, or convulsions may occur, and clinical manifestations of infections during short-term treatment may also be observed. Attention should be paid to possible gastric and intestinal ulcers (often stress-induced), as corticosteroid treatment can reduce their symptoms and decrease glucose tolerance.

If any of the following situations occur, inform your doctor immediately:

• Severe allergic reactions that can lead to anaphylactic shock (very rare cases). You may experience a sudden rash with itching (urticaria), swelling of hands, feet, ankles, face, lips, mouth, or throat (which can cause difficulty swallowing or breathing), and you may feel like you are going to faint.
• Discomfort in the stomach or intestine, back pain, shoulder or hip area, psychological problems, abnormal fluctuations in blood sugar (in diabetics).

During long-term treatment with this medication, especially with high doses, side effects of various degrees can be expected regularly (the frequency cannot be estimated from the available data).

Infections and infestations

Masking of infections, occurrence, and worsening of viral, fungal, bacterial, and parasitic infections or opportunistic infections, activation of worm infection.

Blood and lymphatic system disorders

Changes in blood count (increased number of white blood cells or all blood cells, decreased number of certain white blood cells).

Immune system disorders

Hypersensitivity reactions (e.g., drug rash), severe anaphylactic reactions, such as cardiac rhythm disorders, bronchospasm (smooth muscle spasm of the bronchi), high or low blood pressure, circulatory collapse, cardiac arrest, weakening of the immune system.

Endocrine disorders

Cushing's syndrome (typical signs include moon face, central obesity, and flushing), reduced or decreased adrenal gland function.

Metabolic and nutritional disorders

Weight gain, high blood sugar levels, diabetes, increased lipid levels in the blood (cholesterol and triglycerides), increased sodium levels with swelling (edema), potassium deficiency due to increased potassium excretion (can cause cardiac rhythm disorders), increased appetite.

Psychiatric disorders

Depression, irritability, euphoria, increased impulse, psychosis, mania, hallucinations, mood changes, anxiety, sleep disorders, suicidal tendencies.

Nervous system disorders

Increased intracranial pressure, appearance of previously unrecognized epilepsy, more frequent seizures in pre-existing epilepsy.

Eye disorders

Increased intraocular pressure (glaucoma), clouding of the lens (cataract), worsening of corneal ulcers, increased occurrence or worsening of eye inflammation caused by viruses, bacteria, or fungi; worsening of bacterial corneal inflammation, drooping eyelid, pupil dilation, conjunctival swelling, perforation of the eyeball, visual disturbances, vision loss. Rare cases of reversible exophthalmos (bulging of the eye), and after subconjunctival administration, also with herpes simplex keratitis, corneal perforation in existing keratitis, blurred vision.

Cardiac disorders

Thickening of the heart muscle (hypertrophic cardiomyopathy) in premature infants, which usually returns to normal after treatment is discontinued.

Vascular disorders

High blood pressure, increased risk of atherosclerosis and thrombosis (blood clot in the vein), inflammation of blood vessels (also as withdrawal syndrome after long-term treatment), increased fragility of blood vessels.

Gastrointestinal disorders (stomach and intestine)

Gastrointestinal ulcers, gastrointestinal bleeding, pancreatitis, stomach upset, hiccups.

Skin and subcutaneous tissue disorders

Stretch marks on the skin, thinning of the skin ("parchment skin"), enlargement of skin blood vessels, tendency to bruise, bleeding of the skin in points or patches, increased body hair, acne, inflammatory changes in the skin of the face, especially around the mouth, nose, and eyes, changes in skin pigmentation.

Musculoskeletal, connective tissue, and bone disorders

Muscle diseases, muscle weakness, and wasting, bone loss (osteoporosis) are related to the dose and are possible even with short-term use, other forms of bone death (osteonecrosis), tendon disorders, tendinitis (tendon inflammation), tendon rupture, fat deposits in the spine (epidural lipomatosis), growth inhibition in children.

Note: Too rapid reduction of the dose after long-term treatment can cause a withdrawal syndrome with symptoms such as muscle and joint pain.

Reproductive system and breast disorders

Disorders of sex hormone secretion (consequently: irregular or absent menstruation (amenorrhea), male body hair in women (hirsutism), impotence).

General disorders and administration site conditions

Delayed wound healing.

Local use

Local irritation and hypersensitivity reactions may occur (burning sensation, persistent pain), especially when applied to the eye. Skin atrophy and subcutaneous tissue atrophy at the injection site cannot be excluded if corticosteroids are not carefully injected into the joint cavity.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Dexametasona Medochemie

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the packaging after CAD. The expiration date is the last day of that month.

Store below 25°C. Store the ampoules in the outer packaging to protect them from light.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Container Contents and Additional Information

Composition of Dexametasona Medochemie

• The active ingredient is dexamethasone phosphate.

Each 1 ml ampoule contains 4 mg of dexamethasone phosphate (as sodium phosphate dexamethasone).

Each 2 ml ampoule contains 8 mg of dexamethasone phosphate (as sodium phosphate dexamethasone).

• The other components are: sodium citrate (E331), disodium edetate (E386), creatinine, water for injectable preparations, sodium hydroxide (E524), concentrated hydrochloric acid (E507).

Appearance of the Product and Container Contents

Transparent, colorless to slightly yellowish solution. pH 7.0 to 8.5. Osmolality: 160 to 230 mOsm/Kg.

Type I (Ph.Eur), 2 ml capacity transparent glass ampoule.

Boxes of 5, 10, or 100 ampoules are available.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Medochemie Limited,

1-10 Constantinoupoleos,

3011 Limassol,

Cyprus

Manufacturer

Medochemie Ltd. Ampoule Injectable Facility

48 Iapetou, Agios Athanassios Industrial Area,

4101 Agios Athanassios,

Cyprus

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Local Representative:

Medochemie Iberia S.A., Branch in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:February 2023.

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

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This information is intended only for healthcare professionals:

Dexametasona Medochemie injectable and infusion solution is for intravenous, intramuscular, intra-articular, intralesional, or subconjunctival use.

Method of Administration

Dexametasona Medochemie should be administered by slow intravenous injection (over 2-3 minutes) or by infusion, but it can also be administered intramuscularly if there are problems with venous access and blood circulation is adequate. This medicinal product can also be administered by infiltration and by intra-articular or subconjunctival injection. The duration of treatment depends on the indication.

In hypothyroidism or liver cirrhosis, low doses may be sufficient or a dose reduction may be necessary.

Intra-articular injection should be considered an open joint procedure and performed under strict aseptic conditions. A single intra-articular injection is usually sufficient for effective symptom relief. If a repeat injection is necessary, it should not be administered before 3-4 weeks. No more than 3-4 injections should be used in a joint. Medical monitoring of the joint is required, especially after repeated injections.

Infiltration: The area of greatest pain or tendon junction is infiltrated with this medicinal product. Caution, do not inject into the tendon! Frequent injections should be avoided and strict aseptic precautions should be observed.

Suitability for Use

Only clear solutions should be used. The contents of the ampoule are intended for a single withdrawal. Any remaining injectable solution should be discarded.

Instructions for Use and Handling

Dexametasona Medochemie 4 mg/ml injectable and infusion solution is preferably administered by direct intravenous injection or injected into the infusion tube. The solution for injection/infusion is compatible with the following infusion solutions and is designed to be used within 24 hours:

• Isotonic saline solution
• Ringer's solution
• 5% glucose solution
• 10% glucose solution
• 5% dextrose solution

Incompatibilities

When used in combination with infusion solutions, the information provided by each supplier on their infusion solutions, including information on compatibility, contraindications, adverse effects, and interactions, should be taken into account.

Precautions for Storage in Use

Chemical and physical stability in use has been demonstrated for 24 hours at 25 °C and 2-8 °C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2-8 °C, unless the reconstitution/dilution has been carried out under controlled and validated aseptic conditions.