Package leaflet: Information for the patient

Dexamethasone phosphate SF, 4 mg/ml, solution for injection
Dexamethasoni phosphas
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

What Dexamethasone phosphate SF is and what it is used for
Important information before using Dexamethasone phosphate SF
How to use Dexamethasone phosphate SF
Possible side effects
How to store Dexamethasone phosphate SF
Contents of the pack and other information

1. What Dexamethasone phosphate SF is and what it is used for

Dexamethasone phosphate SF solution for injection contains dexamethasone phosphate. Dexamethasone is a synthetic glucocorticoid (a type of corticosteroid hormone) that affects metabolism, electrolyte balance, and tissue function. Dexamethasone phosphate SF is used in clinical situations requiring glucocorticoid therapy. Depending on symptoms and severity, these include, among others:
Systemic administration:

Cerebral oedema caused by brain tumour, neurosurgical intervention, brain abscess, or bacterial meningitis;
Shock following severe trauma, for prophylactic treatment of shock lung;
Severe acute asthma attack;
Initial stage of treatment of extensive, severe skin diseases such as erythroderma, pemphigus vulgaris, and acute eczema;
Treatment of systemic rheumatic diseases (rheumatic diseases that may affect internal organs), such as systemic lupus erythematosus;
Severe progressive course of active rheumatoid arthritis, e.g. rapidly progressing forms leading to joint and/or extra-articular tissue damage;
Severe infectious diseases with signs of intoxication (e.g. tuberculosis, typhoid fever, brucellosis), only in combination with anti-infective treatment;
Palliative treatment of malignant tumours;
Prevention and treatment of postoperative or cytostatic-induced vomiting;
Dexamethasone phosphate SF is indicated in the treatment of COVID-19 in adult patients and adolescents (aged 12 years and older with body weight of at least 40 kg) who have difficulty breathing and require oxygen therapy.

Local administration:

Intra-articular injection: persistent inflammation of one or more joints following systemic treatment of chronic inflammatory joint diseases, activated osteoarthritis (progressive phase), acute forms of painful shoulder syndrome;
Infiltrative administration (only when strictly indicated): non-bacterial tenosynovitis or bursitis (a fluid-filled sac that forms under the skin, usually over joints), periarticular inflammation, tendon disorders.

2. Important Information Before Using Dexamethasone phosphate SF

When not to use Dexamethasone phosphate SF:

if the patient is allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6). In isolated cases during the use of Dexamethasone phosphate SF, severe hypersensitivity reactions (anaphylactic reactions) have been observed, including circulatory collapse, cardiac arrest, cardiac arrhythmia, dyspnoea (bronchospasm), and (or) decreased or increased arterial blood pressure. Intra-articular injection is contraindicated in cases of: infections at or near the joint requiring treatment, bacterial arthritis, joint instability requiring treatment, bleeding tendency (spontaneous or drug-induced due to anticoagulants), calcifications around the joint, avascular necrosis of bone, tendon rupture, or Charcot joint.

Do not administer intralesionally without additional causal treatment in the presence of infections at the site of administration.

Warnings and precautions

Before starting treatment with Dexamethasone phosphate SF, discuss this with your doctor, pharmacist, or nurse.

Do not discontinue any other steroid medications unless otherwise advised by your doctor.

General precautions regarding the use of steroid medications in specific diseases, masking of infections, concomitant medications, etc., should be followed according to current guidelines.

Dexamethasone should not be used in COVID-19 disease in patients who do not require oxygen supplementation or mechanical ventilation, due to lack of therapeutic benefit and risk of worsening health in this patient group.

If unusual physical stress occurs during treatment with Dexamethasone phosphate SF (e.g., accident, surgery, childbirth, etc.), temporary dose increase may be necessary.

Dexamethasone phosphate SF may mask symptoms of existing or developing infections, making diagnosis difficult. Dormant infections may reactivate.

Treatment with Dexamethasone phosphate SF should only be initiated under the supervision of a physician in the following circumstances. Concomitant antimicrobial therapy may also be required:

acute viral infections (chickenpox, shingles, herpes virus infections, herpes keratitis),
chronic active hepatitis with positive HBsAg test (infectious hepatitis),
approximately 8 weeks before and up to 2 weeks after vaccination with live vaccines,
acute and chronic bacterial infections,
fungal infections involving internal organs,
certain parasitic diseases (infection with amoebae or worms). In case of infection or suspected infection with roundworms, Dexamethasone phosphate SF may lead to activation and massive proliferation of these parasites,
Heine-Medin disease (poliomyelitis),
lymph node disorders following tuberculosis vaccination,
if the patient has a history of tuberculosis, the medicine should only be used concomitantly with anti-tuberculosis agents.

During treatment with Dexamethasone phosphate SF, the following conditions should be carefully monitored and appropriately treated:

gastric or intestinal ulcers,
bone mass loss (osteoporosis),
hypertension difficult to control,
diabetes difficult to control,
psychiatric disorders (including past history), including suicidal tendencies. In such cases, supervision by a neurologist or psychiatrist is recommended,
increased intraocular pressure (closed-angle or open-angle glaucoma); ophthalmological supervision and appropriate treatment are recommended,
corneal damage and ulcers; ophthalmological supervision and appropriate treatment are recommended.

Use of this medicine may cause a pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare adrenal gland tumor. A pheochromocytoma crisis may present with headache, excessive sweating, palpitations, and elevated blood pressure. If any of these symptoms occur, the patient should contact a doctor immediately.

Before starting treatment with Dexamethasone phosphate SF, discuss with your doctor if pheochromocytoma (adrenal gland tumor) is suspected or has been diagnosed.

If the patient experiences blurred vision or other visual disturbances, medical advice should be sought immediately.

Due to the risk of intestinal perforation, Dexamethasone phosphate SF should only be used when there are strong medical reasons and under appropriate monitoring:

in severe colitis (ulcerative colitis) with perforation risk, with ulcerative or suppurative inflammation that may occur without peritoneal irritation,
in diverticulitis (inflammation of intestinal diverticula),
after certain intestinal surgeries (intestinal anastomosis), immediately post-operatively.

Signs of peritoneal irritation following gastrointestinal perforation may not appear in patients receiving high doses of glucocorticoids.

In diabetic patients, metabolism should be monitored regularly, and increased requirements for antidiabetic medications (insulin, oral antidiabetic drugs) should be considered.

Due to the risk of exacerbating symptoms, patients with very high blood pressure and (or) severe heart failure should remain under close observation.

During high-dose treatment, heart rate may be lower than usual.

If dexamethasone is administered to a premature infant, cardiac function and structure must be monitored.

Severe anaphylactic reactions (immune system hypersensitivity) may occur.

The risk of tendon disorders, tendonitis, and tendon rupture increases in patients receiving concomitant fluoroquinolones (a type of antibiotic) and Dexamethasone phosphate SF.

In the treatment of a specific type of muscle paralysis (myasthenia gravis), symptoms may initially worsen.

Vaccination with inactivated vaccines (containing killed pathogenic microorganisms) is generally possible. However, it should be noted that after administration of high-dose corticosteroids, the immune response and thus vaccine efficacy may be reduced.

Particular attention should be paid during long-term, high-dose treatment with Dexamethasone phosphate SF to ensure adequate potassium intake and restriction of salt consumption. The doctor will monitor blood potassium levels.

Viral diseases (e.g., measles, chickenpox) may have a particularly severe course in patients treated with Dexamethasone phosphate SF, especially in immunocompromised children and individuals who have not previously had measles or chickenpox. If such individuals come into contact with measles or chickenpox patients during treatment with Dexamethasone phosphate SF, they should immediately consult a doctor, who may initiate preventive treatment if necessary.

Consult a doctor if the patient develops symptoms of tumor lysis syndrome, such as: muscle cramps, muscle weakness, confusion, visual disturbances or loss of vision, and shallow breathing, particularly if the patient has a hematological malignancy.

Due to the possibility of transient adverse effects from too rapid administration, such as unpleasant tingling or sensory disturbances (paresthesias), which are harmless and last up to 3 minutes, intravenous injection should be administered slowly (over 2–3 minutes).

Dexamethasone phosphate SF is intended for short-term use. In case of prolonged inappropriate use, additional warnings and precautions regarding long-term therapy with glucocorticoid-containing medicines should be observed.

After local administration, adverse effects and interactions similar to those of systemic administration should be considered.

Intra-articular administration of Dexamethasone phosphate SF increases the risk of joint infections.

Long-term and repeated intra-articular use of glucocorticoids in weight-bearing joints may lead to worsening degenerative joint changes. One possible reason is overuse of the affected joint after pain or other symptoms subside.

When administering intra-articularly, the physician must exercise special caution to minimize the risk of bacterial infection. Patients should avoid stressing affected joints, even if they do not feel pain.

Children and adolescents

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

This medicine should only be used in children when absolutely necessary due to the risk of growth retardation. During long-term treatment, the child's growth should be monitored regularly.

Elderly patients

Due to increased risk of osteoporosis, the physician will evaluate the benefit-risk ratio before prescribing the medicine to elderly patients.

Effects related to doping

Use of Dexamethasone phosphate SF may result in positive doping test results.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

Dexamethasone crosses the placenta. During pregnancy, especially in the first three months, the medicine should only be used after careful benefit-risk assessment. If the patient is pregnant or becomes pregnant, she should inform her doctor. With prolonged use of glucocorticoids during pregnancy, impaired fetal growth cannot be excluded. When glucocorticoids are used late in pregnancy, neonatal adrenal insufficiency may occur. This may require replacement therapy, which should be gradually withdrawn.

Breastfeeding

Glucocorticoids, including dexamethasone, pass into breast milk. Harmful effects on the infant have not been reported to date. However, the necessity of treatment during breastfeeding should be carefully considered. If high doses are required due to illness, breastfeeding should be discontinued and the doctor contacted immediately.

In newborns of mothers who received Dexamethasone phosphate SF near the end of pregnancy, low blood sugar levels may occur after birth.

Driving and operating machinery

There is currently no evidence that Dexamethasone phosphate SF affects the ability to drive or operate machinery or perform tasks requiring balance.

Dexamethasone phosphate SF and other medicines

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.

Inform your doctor if the patient is taking any of the following medicines,
as they may affect the action of Dexamethasone phosphate SF:

Medicines that accelerate its metabolism in the liver, such as certain sleeping pills (barbiturates), anticonvulsants (phenytoin, carbamazepine, primidone), and some anti-tuberculosis drugs (rifampicin), may reduce the effect of corticosteroids.
Medicines that slow corticosteroid metabolism in the liver, such as certain antifungal drugs (ketoconazole, itraconazole), may enhance the effect of corticosteroids.
Certain female sex hormones, e.g., oral contraceptives: the effect of Dexamethasone phosphate SF may be increased.
Ephedrine (a component of, e.g., medications used to treat low blood pressure, chronic bronchitis, asthma attacks, nasal decongestants for colds, and appetite suppressants): the effectiveness of Dexamethasone phosphate SF may be reduced due to accelerated metabolism of glucocorticoids.

Effect of Dexamethasone phosphate SF on other medicines

Concomitant use with certain antihypertensive drugs (ACE inhibitors) may increase the risk of blood morphology changes.
Dexamethasone phosphate SF may enhance the effects of cardiac glycosides due to hypokalemia.
Dexamethasone phosphate SF may enhance potassium loss caused by diuretics or laxatives.
Dexamethasone phosphate SF may reduce the glucose-lowering effect of oral antidiabetic drugs and insulin.
Dexamethasone phosphate SF may weaken or strengthen the effect of anticoagulant drugs (oral anticoagulants, coumarins). The doctor will decide whether a dose adjustment of the anticoagulant is necessary.
If Dexamethasone phosphate SF is used concomitantly with anti-inflammatory and antirheumatic drugs (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs), the risk of gastric ulcers and gastrointestinal bleeding may increase.
Dexamethasone phosphate SF may prolong the muscle-relaxing effect of certain non-depolarizing neuromuscular blocking agents.
Dexamethasone phosphate SF may enhance the effect of drugs increasing intraocular pressure (e.g., atropine and other anticholinergic drugs).
Dexamethasone phosphate SF may reduce the effectiveness of drugs used to treat worm infestations (praziquantel).
When used concomitantly with drugs used to treat malaria and rheumatic diseases (chloroquine, hydroxychloroquine, and mefloquine), Dexamethasone phosphate SF may increase the risk of muscle or heart disorders (myopathy and cardiomyopathy).
Dexamethasone phosphate SF may reduce the increase in thyroid-stimulating hormone (TSH) activity after protirelin (TRH, a hormone produced by the hypothalamus) administration.
Concomitant use of Dexamethasone phosphate SF with immunosuppressive drugs may increase susceptibility to infections and worsen the course of existing but not yet apparent infections.
Cyclosporine (an immunosuppressive drug): Dexamethasone phosphate SF may increase cyclosporine blood levels and thus the risk of seizures.
Fluoroquinolones (a group of antibiotics): may increase the risk of tendon rupture.

Effect on diagnostic tests

Glucocorticoids may suppress skin reactions in allergy tests.

Dexamethasone phosphate SF contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, meaning it is considered "sodium-free".

Dexamethasone phosphate SF contains propylene glycol

Dexamethasone phosphate SF contains 20 mg of propylene glycol in the 1 ml ampoule and 40 mg in the 2 ml ampoule, corresponding to 20 mg/ml.

Before administering the medicine to a child under 5 years of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

Women who are pregnant or breastfeeding should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.

Patients with impaired liver or kidney function should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.

3. How to use Dexamethasone phosphate SF

This medicine should always be used exactly as directed by the physician. The physician will decide how long
dexamethasone should be administered and will determine the appropriate dose for the individual patient. You must
follow these instructions precisely, as otherwise the effect of Dexamethasone phosphate SF may not be
optimal. If in doubt, consult your doctor or pharmacist.
Route of administration
The medicine will be administered by intravenous injection, but may also be given by intramuscular,
intralesional, or intra-articular injection.
Dexamethasone phosphate SF should be administered slowly (over 2–3 minutes) by intravenous injection (into a vein). The medicine may be administered intramuscularly (into the muscle) if venous access is difficult but circulation is normal.
Intra-articular injections are considered procedures involving open joints and must be performed only under sterile conditions. A single intra-articular injection is usually sufficient to effectively relieve symptoms. If a subsequent injection is necessary, it should not be administered earlier than 3–4 weeks after the previous one. The number of injections into a single joint should be limited to 3–4. Medical evaluation of joints is recommended, especially after repeated injections.
Dexamethasone phosphate SF is administered intralesionally in areas of most intense pain or tendon insertions. Warning: do not inject directly into tendons. Repeated injections in close succession should be avoided. Strict aseptic technique is mandatory.
Suitability for use
Only a clear, transparent solution should be used. The contents of the ampoule are intended for single use only. Any unused solution remaining after injection must be discarded.
Immediately before administration, the ampoule contents should be diluted in isotonic sodium chloride solution or 5% glucose solution when administered by infusion.
Unless otherwise directed by the physician, the following doses should be used:
Systemic administration:

Cerebral edema: initially in acute conditions, depending on the cause and severity of the disease, the initial dose is 8 to 10 mg (up to 80 mg) intravenously, followed by 16 to 24 mg (up to 48 mg) per day, divided into 3–4 (up to 6) individual doses for 4–8 days.
Cerebral edema due to bacterial meningitis: 0.15 mg/kg body weight every 6 hours for 4 days. Children: 0.4 mg/kg body weight every 12 hours for 2 days, starting before the first dose of antibiotic.
Shock following severe trauma: initial dose of 40 to 100 mg (40 mg in children) intravenously, repeated after 12 hours, or 16 to 40 mg every 6 hours for 2–3 days.
Severe acute asthma attack: Adults: 8 to 20 mg intravenously, administered as rapidly as possible. If necessary, repeat injections of 8 mg every 4 hours. Children: 0.15 to 0.3 mg/kg body weight, or oral dexamethasone, or initially 1.2 mg/kg body weight as a bolus, followed by 0.3 mg/kg body weight every 4 to 6 hours. Aminophylline and secretolytic agents may also be administered.
Acute skin diseases: depending on the type and extent of the disease, daily doses of 8 to 40 mg intravenously, up to 100 mg in severe cases. Subsequently, switch to tablet treatment with gradually decreasing doses.
Systemic lupus erythematosus: 6 to 16 mg.
Severe, progressive rheumatoid arthritis, e.g. rapidly progressive forms leading to joint damage: 12 to 16 mg; in cases with extra-articular tissue damage: 6 to 12 mg.
Severe infectious diseases with symptoms resembling intoxication: 4 to 20 mg/day intravenously for several days, only in combination with appropriate anti-infective therapy; in individual cases (e.g. typhoid fever), initially up to 200 mg intravenously, followed by gradually decreasing doses.
Palliative treatment of malignant tumors: initially 8 to 16 mg/day; 4 to 12 mg/day for long-term therapy.
Prevention and treatment of vomiting induced by cytostatic agents as antiemetic therapy: 10 to 20 mg intravenously before initiation of chemotherapy, followed, if necessary, by 4 to 8 mg 2–3 times daily for 1–3 days (moderately emetogenic chemotherapy) or for 6 days (highly emetogenic chemotherapy).
Prevention and treatment of postoperative nausea and vomiting: single dose of 4 to 8 mg intravenously before surgery; children over 2 years of age: 0.15–0.5 mg/kg body weight (maximum 16 mg).
Treatment of COVID-19: adults are recommended to receive 6 mg intravenously once daily for up to 10 days. Use in adolescents Children and adolescents (aged 12 years and older) are recommended to receive 6 mg intravenously once daily for up to 10 days.

Local administration:
Treatment involving intralesional or local injection usually requires a dose of 4 to 8 mg; for injection into small joints, a dose of 2 mg of dexamethasone sodium phosphate is sufficient.
Method of administration
The duration of treatment depends on the type and course of the disease. The physician will determine the treatment plan, which must be strictly followed. As soon as a satisfactory treatment response is achieved, the dose will be reduced to a maintenance level or treatment will be discontinued.
Abrupt discontinuation of treatment after approximately 10 days may cause acute adrenal insufficiency; therefore, if treatment needs to be stopped, the dose should be tapered gradually.
In patients with hypothyroidism or liver cirrhosis, relatively low doses may be sufficient, or dose reduction may be necessary.
Use of a higher than recommended dose of Dexamethasone phosphate SF
Dexamethasone phosphate SF is generally well tolerated, even when large doses are used for a short period. No special precautions are required. If the patient experiences severe or unusual adverse effects, medical advice should be sought.
Missed dose of Dexamethasone phosphate SF
A missed dose may be taken on the same day. On the following day, resume the usual dosing schedule. If several doses are missed, disease symptoms may recur or worsen. In such cases, consult your doctor, who will assess and, if necessary, adjust the treatment.
Do not take a double dose to make up for a missed dose.
Stopping Dexamethasone phosphate SF
Follow your doctor's dosing instructions exactly. Never discontinue Dexamethasone phosphate SF treatment on your own, especially since prolonged use of the medicine may suppress the body's natural production of glucocorticosteroids. In such cases, significant physiological stress could become life-threatening.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
During short-term treatment with dexamethasone, the risk of adverse reactions is low. However, short-term treatment with high doses requires monitoring for electrolyte imbalances, development of oedema, possible increase in blood pressure, heart failure, cardiac arrhythmias, or seizures, and clinical signs of infection should also be anticipated. Monitoring is also required for reduced glucose tolerance, as well as for the occurrence of gastric and intestinal ulcers (often stress-related), which may be less apparent due to corticosteroid treatment. In very rare cases, Dexamethasone phosphate SF may cause allergic reactions, even anaphylactic shock.
However, during prolonged administration, especially of high doses, adverse reactions of varying severity may be expected.

Infections and parasitic infestations
Masking of infections, occurrence or worsening of viral, fungal, bacterial, and parasitic infections, including those caused by opportunistic pathogens; activation of intestinal roundworm infection.

Blood and lymphatic system disorders
Changes in blood morphology (increased white blood cell count or increased count of all blood cells, decreased count of certain types of white blood cells).

Immune system disorders
Hypersensitivity reactions (e.g. drug rash), severe anaphylactic reactions such as cardiac arrhythmias, bronchospasm (constriction of smooth muscles in the bronchi), excessively high or low blood pressure, circulatory collapse, cardiac arrest, immunosuppression.

Endocrine disorders
Development of so-called Cushing's syndrome (typical symptoms include moon face, central obesity, and facial flushing), impaired function or atrophy of the adrenal cortex.

Metabolism and nutrition disorders
Increased body weight, increased blood glucose concentration, diabetes, increased blood lipid levels (cholesterol and triglycerides), increased sodium levels with tissue oedema, potassium deficiency due to increased potassium excretion (which may lead to cardiac arrhythmias), increased appetite.

Psychiatric disorders
Depression, irritability, euphoria, increased drive, psychosis, mania, hallucinations, mood changes, feeling of anxiety (anxiety), sleep disturbances, suicidal thoughts (suicide risk).

Nervous system disorders
Increased intracranial pressure, onset of symptoms of previously undiagnosed epilepsy, increased frequency of seizures in patients with diagnosed epilepsy.

Eye disorders
Increased intraocular pressure (glaucoma), cataract, worsening of corneal ulcers, onset or worsening of viral, fungal, and bacterial eye infections, worsening of bacterial corneal infection, ptosis (drooping eyelid), dilatation of the pupil, conjunctival oedema, scleral perforation (white part of the eye), visual disturbances, loss of vision; in rare cases, reversible ocular proptosis (exophthalmos), blurred vision.

Cardiac disorders
Myocardial hypertrophy (hypertrophic cardiomyopathy) in preterm infants, which usually resolves after discontinuation of treatment (frequency unknown).

Vascular disorders
Hypertension, increased risk of atherosclerosis and thrombosis, vasculitis (including withdrawal syndrome after prolonged treatment), increased capillary fragility.

Respiratory, thoracic and mediastinal disorders
Hiccups

Gastrointestinal disorders
Gastric and intestinal ulcers, gastrointestinal bleeding, pancreatitis, epigastric discomfort.

Skin and subcutaneous tissue disorders
Striae, thinning of the skin ("parchment skin"), telangiectasia (dilated blood vessels), tendency to bruising, petechiae (very small or superficial haemorrhages), hirsutism (excessive hair growth), acne, inflammatory skin changes on the face, especially around the mouth, nose, and eyes, skin pigmentation changes.

Musculoskeletal and connective tissue disorders
Muscle disorders, muscle weakness, muscle atrophy, and osteoporosis, which are dose-dependent and may also occur during short-term treatment; other forms of bone degeneration (bone necrosis), tendon disorders, tendonitis, tendon rupture, fat accumulation in the spine (subcapsular lipomatosis), growth suppression in children.

Note:
Withdrawal syndrome, manifesting among others as muscle pain and joint pain, may occur if the dose is reduced too quickly after prolonged treatment.

Reproductive system and breast disorders
Disturbances in sex hormone secretion leading to irregular menstrual bleeding or amenorrhea (absence of menstruation), hirsutism (male-pattern hair growth) in women, impotence.

General disorders and administration site conditions
Delayed wound healing.

Local administration:
Local irritation and intolerance symptoms (feeling of warmth, prolonged pain) may occur. Skin and subcutaneous tissue atrophy at the injection site cannot be excluded if corticosteroids are not injected precisely into the joint cavity.

Management
If any adverse reactions occur, whether listed in this leaflet or not, consult a doctor or pharmacist. Do not discontinue treatment without consulting a doctor.
If gastrointestinal or joint disorders, back or shoulder pain, hip joint area pain, psychiatric disorders, noticeable changes in blood glucose levels (in diabetic patients), or any other disturbances occur, contact a doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dexamethasone phosphate SF

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not store in a refrigerator or freeze.
Store in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Dexamethasone phosphate SF contains

The active substance is dexamethasone phosphate (in the form of dexamethasone sodium phosphate). 1 ml of solution contains 4 mg of dexamethasone phosphate.
The other components are: edetate disodium, propylene glycol, sodium chloride, sodium hydroxide, water for injections.

What Dexamethasone phosphate SF looks like and contents of the pack
Dexamethasone phosphate SF is available in colourless ampoules containing 1 ml or 2 ml of a clear, colourless or almost colourless solution for injection, packed in a cardboard box.
Pack sizes:
1, 5 or 10 ampoules with 1 ml of solution.
1 or 10 ampoules with 2 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
tel. +48 22 350 66 69

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Information intended exclusively for healthcare professionals:

Each 1 ml ampoule contains 4 mg of dexamethasone phosphate (as sodium dexamethasone phosphate).
Each 2 ml ampoule contains 8 mg of dexamethasone phosphate (as sodium dexamethasone phosphate).
Route of administration:
Dexamethasone phosphate SF should be administered as a slow (lasting 2–3 minutes) intravenous injection or infusion, but may also be given intramuscularly if venous access is difficult but circulation is adequate. Dexamethasone phosphate SF may also be administered via infiltration or intra-articular injection. The duration of treatment depends on the indication.
In cases of hypothyroidism or liver cirrhosis, low doses may be sufficient or dose reduction may be required.
An intra-articular injection should be treated as a procedure involving an open joint and must be performed exclusively under sterile conditions. A single intra-articular injection is usually sufficient to effectively relieve symptoms. If a subsequent injection is necessary, it should not be administered earlier than 3–4 weeks after the previous one. The number of injections into a single joint should be limited to 3–4. Medical evaluation of joints is recommended, especially after repeated injections.
Infiltration administration: Dexamethasone phosphate SF is administered via infiltration into the most painful areas or tendon insertion sites. Caution: do not inject into tendons! Repeated infiltrations at short intervals should be avoided. Strict aseptic technique must be maintained.
Guidelines on solution suitability
Only a clear, transparent solution should be used. The contents of an ampoule are intended for single use only. Any unused portion of the solution must be discarded.
Immediately before intravenous infusion, the contents of the ampoule should be diluted in isotonic sodium chloride solution or 5% glucose solution.
Storage conditions:
See section 5 "How to store Dexamethasone phosphate SF".
After opening: use immediately.
After dilution in infusion fluids, chemical and physical stability has been demonstrated for 24 hours at 25°C. Do not store in a refrigerator. For microbiological reasons, the product should be used immediately unless the method of opening/dilution prevents microbial contamination. If the product is not used immediately, the responsibility for storage conditions and duration lies with the user.

Dexamethasone phosphate sf