Prospect: Information for the Patient

Dexamethasone Medochemie 4 mg/ml Injectable Solution and for Infusion EFG

dexamethasone phosphate

Read this prospect carefully before starting to use this medication, because it contains important information for you.

−Keep this prospect, as you may need to read it again.

−If you have any doubts, consult your doctor, pharmacist, or nurse.

−If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

Dexamethasone is a synthetic glucocorticoid (adrenocortical hormone) with effects on metabolism, electrolyte balance, and tissue functions.(hormona adrenocortical) with effect on metabolism, electrolyte balance, and tissue functions.

Dexamethasone Medochemie is used for

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

Systemic use:

• Swelling of the brain caused by brain tumors, brain surgery, brain abscess, bacterial inflammation of the brain's meninges.
• States of shock after severe injuries, for prophylactic treatment of pulmonary edema.
• Acute severe asthma attack.
• Initial treatment of some extensive, acute, and severe skin disorders, such as erythrodermia, 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 progressive severe 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 vomiting after surgery or in cytostatic treatment.
• Dexamethasone 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.
• Therapeutic infiltration (only strictly indicated): non-bacterial inflammation of tendons or bursa (a sac filled with fluid that forms under the skin, usually over joints), inflammation around a joint, tendon disorder.
• Ocular therapy: injection under the conjunctival sac in non-infectious inflammation of several parts of the eye (cornea and conjunctiva, corneal inflammation, iritis, and ciliary body inflammation), inflammation of the middle part of the eye (uveitis).

Do not administer Dexametasona Medochemie

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

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

The injection into the joints is contraindicated in:

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

Do not perform the infiltration 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 lesions and ulcers.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to administer this medication.

Do not stop taking any other steroid medication unless your doctor has instructed you to do so.

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

If situations of particular 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 thus prevent the diagnosis of existing or developing infections. Latent infections may reactivate.

Initiate treatment with this medication only if your doctor considers it essential in the following diseases. If necessary, also take medications that act against pathogens:

• Acute viral infections (hepatitis B, varicella, measles, herpes simplex infections, inflammation of the cornea caused by herpes viruses).
• Active chronic hepatitis positive for HBSAG (infectious liver inflammation).
• Approximately 8 weeks before and 2 weeks after vaccination with attenuated pathogens (live vaccine).
• Acute and chronic bacterial infections.
• Fungal infections involving internal organs.
• Certain diseases caused by parasites (amebic infections, worms). In patients with suspected or confirmed worm infections, this medication may lead to the activation and massive proliferation of these parasites.
• Polio (infection caused by a virus).
• Lymph node disease after tuberculosis vaccination.
• In the case of a history of tuberculosis, use only in conjunction with tuberculosis medications.

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

• Ulcers of the gastrointestinal tract.
• Bone loss (osteoporosis).
• Difficult-to-control high blood pressure.
• Difficult-to-control diabetes.
• Mental disorders (psychological disorders) (also in the past), including suicidal tendencies. In this case, neurological or psychiatric monitoring is recommended.
• Increased intraocular pressure (angle-closure and wide-angle glaucoma); close follow-up and treatment by an ophthalmologist and complementary therapy are recommended.
• Corneal lesions and ulcers of the eye; close follow-up 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 convincing medical reasons and adequate control:

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

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

In patients with diabetes, metabolism must be checked regularly; the possibility of increased need for diabetes treatment medications (insulin, oral antidiabetic drugs) must be taken into account.

Patients with severe hypertension and/or severe heart failure must be closely monitored due to the risk of deterioration. High doses may lead to bradycardia.

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 used together.

During treatment of a particular type of muscle paralysis (myasthenia gravis), symptoms may worsen initially.

Generally, vaccinations with inactivated pathogens (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 must be ensured. Your doctor will monitor your blood potassium levels.

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

Symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision loss, or respiratory distress, in the case of hematological malignancy (blood cancers).

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

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

Intravenous administration (through a vein) should be performed slowly (over 2-3 minutes), as it may cause unpleasant itching or paresthesia if administered 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 the long-term administration of medications containing glucocorticoids.

The possible systemic effects and interactions must be taken into account after local administration.

Administration of this medication into the joint increases the risk of joint infections. Long-term administration and repeated injections of glucocorticoids into the joints may exacerbate joint-related changes. This is likely due to the overloading of the affected joints after the pain and other symptoms have been alleviated.

Local use in eye diseases

Inform your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first manifestations of a syndrome called Cushing's syndrome. Suppression of adrenal 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 babies with respiratory problems.

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

If dexamethasone is given to a premature baby, the heart function and structure must be closely monitored.

Older patients

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

Use in athletes

Inform athletes that this medication contains a component that may produce a positive result in doping control tests.

Other medications and Dexametasona Medochemie

Inform your doctor or pharmacist if you are using, have used recently, or may 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 liver breakdown, such as certain sleep medications (barbiturates), medications used to treat seizures (phenytoin, carbamazepine, primidone), and certain tuberculosis medications (rifampicin), may reduce the effect of corticosteroids.
• Medications that slow down liver breakdown, such as certain antifungal medications (ketoconazole, itraconazole), may increase the effect of corticosteroids.
• Certain female sex hormones, for example, for preventing pregnancy (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 mucous membranes in rhinitis, and appetite suppressants may contain ephedrine): through accelerated breakdown 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:

Effect on research methods

Glucocorticoids may suppress skin reactions in allergy tests.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you suspect 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 ruled out. If glucocorticoids are administered towards the end of pregnancy, there is a risk of subactive adrenal cortex in the newborn, which may require gradual reduction of replacement therapy.

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

Lactation

Glucocorticoids, including dexamethasone, are excreted in breast milk. To date, no damage to the infant 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 operating machines

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

Dexametasona Medochemie contains sodium.

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

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

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

In case of doubt, consult your doctor or pharmacist.

Administration method

This medication will be administered 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 should be administered by slow intravenous injection (over 2-3 minutes) (into the vein), but it can also be administered by intramuscular injection (into the muscle) if there are problems with access to the vein and the blood circulation is adequate.

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

Direct intravenous administration or injection into an I.V. route should be administered before a preferred infusion.

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.

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

Abruptly interrupting treatment after approximately 10 days may cause acute adrenocortical insufficiency; therefore, the dose should be reduced gradually 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, consider taking medications containing dexamethasone with increased resistance/quantity.

Unless your doctor prescribes otherwise, the recommended dose is:

Systemic use

• Cerebral edema: initially, in acute states, depending on the cause and severity, 8-10 mg (up to 80 mg) intravenously (i.v.), then 16-24 mg (up to 48 mg) daily, divided into 3-4 (up to 6) individual doses over 4-8 days.
• Cerebral edema due to bacterial meningitis:
• • Use in adults: 0.15 mg/kg of body weight every 6 hours for 4 days;
  • Use in children: 0.4 mg/kg of 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., a repeated dose after 12 hours or 16-40 mg every 6 hours for 2-3 days.
  • Use in children: initially 40 mg i.v., a repeated dose after 12 hours or 16-40 mg every 6 hours for 2-3 days.
• Severe exacerbations of asthma:
• • Use in adults: 8-20 mg i.v. as soon as possible, if necessary, another dose of 8 mg every 4 hours should be repeated.
  • Use in children: 0.15-0.3 mg/kg of body weight, or 1.2 mg/kg of 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 tablets at decreasing doses.
• SLE: 6-16 mg/day.
• Progressively severe form of rheumatoid arthritis, for example, those that lead quickly to joint destruction: 12-16 mg/day, when tissue outside the joints is affected: 6-12 mg/day.
• Severe cases with similar conditions to intoxication: 4-20 mg i.v. daily for a few days, only in combination with adequate anti-infective therapy; in individual cases (e.g., typhoid fever) 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 twice 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 of body weight (max. up to 16 mg).
• Treatment of COVID-19:
• • Adult patients are recommended to receive 7.2 mg i.v. of dexamethasone phosphate (equivalent to 6 mg i.v. dexamethasone) once a day for up to 10 days.
  • Adolescents 12 years or older: it is recommended that they receive 7.2 mg of dexamethasone phosphate/dose i.v. (equivalent to 6 mg of dexamethasone) once a day for up to 10 days.

Local use

Local infiltration and injection therapy are usually carried out with 4-8 mg; 2 mg dexamethasone sodium phosphate is sufficient if injected into small joints or administered subconjunctivally.

If you have been given more Dexametasona Medochemie than you should

Dexamethasone is generally tolerated without complications even with the short-term use of large quantities. A doctor or nurse will administer this medication. 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 forgot to administer Dexametasona Medochemie

You can administer the missed dose on the same day and the prescribed dose for the next day should be administered as usual. If multiple doses are missed, this may lead to recurrence or worsening of the disease. In such cases, you should speak with your doctor, who will review the treatment and adjust it if necessary.

Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Dexametasona Medochemie

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

The risk of undesirable effects is low during short-term treatment with dexamethasone, except for high-dose parenteral therapy, where changes in electrolytes, swelling, possible increased blood pressure, cardiac arrest, arrhythmias, or seizures may occur, and clinical manifestations of infections may also be observed during short-term treatment. Be aware of possible gastric and intestinal ulcers (often induced by stress), 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 may lead to anaphylactic shock (very rare cases). You may experience sudden hives (urticaria), swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing), and may feel like you are going to faint.
• Discomfort in the stomach or intestines, back pain, shoulder or hip area, psychological problems, abnormal fluctuations in blood sugar (in diabetics).

During long-term treatment with this medicine, especially at high doses, you can expect secondary effects of various degrees 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 or opportunistic infections, activation of tapeworm infection.

Blood and lymphatic system disorders

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

Immune system disorders

Hypersensitivity reactions (e.g., drug rash), severe anaphylactic reactions, such as arrhythmias, bronchospasm (bronchial muscle spasm), high or low blood pressure, circulatory collapse, cardiac arrest, or immunosuppression.

Endocrine disorders

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

Metabolism and nutrition disorders

Weight gain, elevated blood sugar, diabetes, increased blood lipids (cholesterol and triglycerides), increased sodium levels with swelling (edema), potassium deficiency due to increased potassium excretion (which may cause arrhythmias), increased appetite.

Mental disorders

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

Nervous system disorders

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

Eye disorders

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

Cardiac disorders

Cardiac muscle hypertrophy (hypertrophic cardiomyopathy) in premature babies, which usually returns to normal after treatment is stopped.

Vascular disorders

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

Gastrointestinal disorders (stomach and intestines)

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

Skin and subcutaneous tissue disorders

Stretch marks on the skin, skin thinning ("leather skin"), skin vessel enlargement, tendency to bruising, skin bleeding in spots or patches, increased body hair, acne, inflammatory skin changes on the face, especially around the mouth, nose, and eyes, skin pigmentation changes.

Musculoskeletal, connective tissue, and bone disorders

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

Note: Rapid dose reduction after long-term treatment may cause withdrawal syndrome with symptoms such as muscle and joint pain.

Reproductive and breast disorders

Hormonal secretion disorders (resulting in 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), particularly when applied to the eye. Skin atrophy and subcutaneous tissue atrophy at the injection site cannot be ruled out if corticosteroids are not injected carefully into the joint cavity.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines that you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition of Dexamethasone Medochemie

• The active ingredient is dexamethasone phosphate.

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

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

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

Appearance of the product and contents of the package

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

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

Available in boxes of 5, 10 or 100 ampoules.

Only some package sizes may be marketed.

Marketing Authorization Holder

Medochemie Limited,

1-10 Constantinoupoleos,

3011 Limassol,

Cyprus

Responsible for manufacturing

Medochemie Ltd. Ampoule Injectable Facility

48 Iapetou, Agios Athanassios Industrial Area,

4101 Agios Athanassios,

Cyprus

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Local Representative:

Medochemie Iberia S.A., Sucursal en España

Avenida de las Águilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

SPAIN

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

Last review date of this leaflet:February 2023.

The detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended solely for healthcare professionals:

Dexametasona Medochemie solution for injection and infusion 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 by intramuscular injection if venous access problems occur and blood circulation is adequate. This medication 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 should be performed in strict aseptic conditions. A single intra-articular injection is usually sufficient for effective relief of symptoms. 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 control of the joint, especially after repeated injections, is required.

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

Idoneity for use

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

Instructions for use and handling

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

• Sodium chloride isotonic solution
• Ringer's solution
• Glucose 5% solution
• Glucose 10% solution
• Dextrose 5% solution

Incompatibilities

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

Precautions for storage in use

Chemical and physical stability has been demonstrated in use 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, storage times in use and pre-use conditions are the responsibility of the user and will normally not exceed 24 hours at 2–8 °C, unless reconstitution/dilution has been performed in controlled and validated aseptic conditions.