COVEXAN

Package leaflet: Information for the patient

Covexan, 4 mg/ml solution for injection/infusion
Dexamethasoni phosphas
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Covexan is and what it is used for

Dexamethasone is a synthetic glucocorticoid (a corticosteroid hormone of the adrenal cortex)
affecting metabolism, electrolyte balance, and tissue function.
Covexan is used
in the treatment of diseases requiring glucocorticoid therapy. Depending on symptoms
and severity, these include, among others:
Systemic administration:

• Treatment of acute, life-threatening conditions requiring glucocorticoid administration (e.g. shock of various etiologies, cerebral edema, acute allergic reactions, severe bronchial spasms, i.e. status asthmaticus);
• Clinical situations requiring glucocorticoid use for treatment and (or) symptom relief of the underlying disease or its complications;
• Initial stage of parenteral treatment of extensive, severe skin diseases, such as erythroderma, pemphigus vulgaris, acute eczema;
• Initial stage of parenteral treatment of autoimmune 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;
• Adjunctive treatment of malignant tumors;
• Severe infectious diseases with signs of intoxication (e.g. tuberculosis, typhoid fever, brucellosis), only in combination with anti-infective treatment;
• Prevention and treatment of postoperative or chemotherapy-induced vomiting;
• Covexan is used in the treatment of COVID-19 in adult and adolescent patients (aged 12 years and older, weighing at least 40 kg) who require oxygen therapy.

Local administration:

• Intra-articular injection: persistent inflammation of one or more joints following systemic treatment of chronic inflammatory joint diseases, active degenerative joint disease, acute forms of painful shoulder syndrome;
• Tendon sheath injection (only when strictly indicated): non-bacterial inflammation of tendons or tendon sheaths (a fluid-filled sac forming under the skin, usually above joints), periarthritis, tendon disorders involving tendon insertions;
• Subconjunctival administration: subconjunctival injection in non-infectious inflammation of various eye parts (cornea and conjunctiva, scleritis (excluding necrotizing scleritis), iridocyclitis), intermediate uveitis (inflammation of the eye's vascular layer).

2. Information before using Covexan

When not to use Covexan

• if the patient is allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).

There are no contraindications to Covexan in acute, life-threatening conditions, especially
when the drug is expected to be used for a short period (24–36 hours).
Intra-articular injection is contraindicated in the case of:

• infection at or near the joint to be treated,
• bacterial arthritis,
• joint instability requiring treatment,
• bleeding tendency (spontaneous or caused by anticoagulant drugs),
• calcifications around the joints,
• avascular necrosis of bone,
• tendon rupture,
• Charcot joint.

Infiltration must not be administered without additional causal treatment if there is
an infection at the site of administration. Similarly, subconjunctival administration must not be used
in the presence of bacterial, viral, or fungal eye diseases or corneal injuries and ulcers.
Warnings and precautions
Before starting treatment with Covexan, discuss this with your doctor or pharmacist.
Do not stop taking any other corticosteroid medications unless instructed by your doctor.
General precautions regarding the use of corticosteroid drugs in specific diseases, masking of infections, concomitant medications, etc., should be followed according to current guidelines.
Dexamethasone should not be administered 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 status in this patient group.
If the patient is being treated for COVID-19 infection, do not discontinue any other corticosteroid
medications unless otherwise advised by the doctor.
If unusual physical stress occurs during treatment with Covexan (e.g., accident, surgery, childbirth, etc.), temporary dose increase may be necessary.
Covexan may mask symptoms of existing or developing infections, making diagnosis difficult.
Inactive infections may reactivate.
In the following circumstances, treatment with Covexan should only be initiated if the treating
physician considers it necessary. If required, additional antimicrobial therapy should also be used:

• acute viral infections (hepatitis B, chickenpox, shingles, herpes simplex virus infections, herpes virus-induced keratitis),
• chronic active hepatitis with positive HBsAg test (infectious hepatitis),
• from approximately 8 weeks before to 2 weeks after vaccination with live attenuated microorganisms (live vaccine),
• 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 helminths (nematodes), Covexan may lead to activation and massive proliferation of these parasites,
• Heine-Medin disease (poliomyelitis),
• lymph node disorders after tuberculosis vaccination,
• if the patient has previously had tuberculosis, the drug should only be used concurrently with anti-tuberculosis medications.

During treatment with Covexan, the following conditions should be carefully monitored and appropriate treatment initiated:

• 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 injuries and ulcers; ophthalmological supervision and appropriate treatment are recommended.

Treatment with this drug may cause a so-called "pheochromocytoma crisis," which may lead to death. Pheochromocytoma is a rare hormone-dependent adrenal tumor. Possible symptoms of crisis include headache, sweating, palpitations, and high blood pressure (hypertension). If the patient experiences any of these symptoms, medical advice should be sought immediately. Before starting treatment with Covexan, discuss this with your doctor if the patient suspects or knows they have a pheochromocytoma (adrenal tumor).
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
Due to the risk of intestinal perforation, Covexan should only be used in emergencies and under appropriate monitoring:

• in severe colitis (ulcerative colitis) with risk of perforation, with ulcerative or suppurative inflammation, which may occur without peritoneal irritation,
• in inflammation of intestinal diverticula (diverticulitis),
• after certain intestinal surgeries (intestinal anastomosis), immediately post-operatively. Signs of peritoneal irritation after gastrointestinal perforation may not occur in patients receiving high doses of glucocorticosteroids.

In patients with diabetes, 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 careful observation.
During treatment with high doses of the drug, pulse rate may be lower than usual.
Severe anaphylactic reactions (immune system hypersensitivity) may occur. In isolated cases, severe hypersensitivity reactions (anaphylactic reactions) with circulatory collapse, cardiac arrest, arrhythmia, dyspnea (bronchospasm), and/or decreased or increased blood pressure have been observed during treatment with Covexan.
The risk of tendon diseases, tendonitis, and tendon rupture increases in patients treated simultaneously with fluoroquinolones (a type of antibiotic) and Covexan.
During treatment of a specific type of muscle paralysis (myasthenia gravis), symptoms may initially worsen.
Vaccination with vaccines containing killed pathogenic microorganisms (inactivated vaccines) is generally possible. However, it should be remembered that after administration of high doses of corticosteroids, immunological response and thus vaccine efficacy may be weakened.
Particular attention should be paid during prolonged treatment with high doses of Covexan to ensure adequate potassium intake (e.g., vegetables, bananas) and restriction of salt intake. The doctor will monitor blood potassium levels.
In patients treated with Covexan, viral diseases (e.g., measles, chickenpox) may have a particularly severe course, especially in immunocompromised children and individuals who have never had measles or chickenpox. If these patients come into contact with individuals suffering from measles or chickenpox during treatment with Covexan, 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 dyspnea, in case the patient has a hematological malignancy.
Due to the possibility of transient adverse effects during too rapid administration, such as unpleasant tingling or sensory disturbances (paresthesia), intravenous injection should be administered slowly (over 2–3 minutes).
Covexan is intended for short-term use. In case of inappropriate long-term use, additional warnings and precautions regarding long-term therapy with glucocorticosteroid-containing drugs should be reviewed.
After local administration, adverse effects and interactions similar to those after systemic administration should be considered.
Intra-articular administration of Covexan increases the risk of joint infections. Long-term and repeated use of glucocorticosteroids within weight-bearing joints may lead to worsening of degenerative joint changes. One possible cause is overuse of the affected joint after pain or other symptoms subside. During intra-articular administration, the doctor should take special care to minimize the risk of bacterial infection. The patient should not overload affected joints, even if pain is absent.
Subconjunctival administration
Contact a doctor if the patient develops swelling or accumulation of fatty tissue on the face and trunk, as these are usually the first signs of a condition called Cushing's syndrome. After discontinuation of prolonged and intensive treatment with Covexan, adrenal suppression may occur. Consult a doctor before stopping the drug independently. The risk of developing Cushing's syndrome and/or adrenal suppression is particularly high in children and patients treated with ritonavir or cobicistat (drugs used in HIV treatment).
Children and adolescents
Routine use of dexamethasone is not recommended in premature infants with lung disorders.
This drug should only be used in children when necessary, due to the risk of growth retardation. During prolonged treatment, the child's growth should be monitored regularly.
If dexamethasone is administered to a prematurely born infant, cardiac function and structure must be monitored.
Elderly patients
Due to the increased risk of osteoporosis, the doctor will assess the benefit-risk ratio of using the drug in elderly patients.
Effects after use for doping purposes
Use of Covexan may lead to positive results in doping tests.
Covexan and other medicines
Inform your doctor or pharmacist about all medicines currently or recently used, as well as any medicines the patient plans to use.
Inform the doctor if the patient is taking any of the following medicines, as they may affect the action of Covexan:

• Medicines that accelerate its metabolism in the liver, such as certain sedatives (barbiturates), anticonvulsants (phenytoin, carbamazepine, primidone), and certain anti-tuberculosis drugs (rifampicin), may weaken the effect of corticosteroids.
• Medicines that slow down corticosteroid metabolism in the liver, such as certain antifungal drugs (ketoconazole, itraconazole), may enhance the effect of corticosteroids. Also inform the doctor if the patient is using ritonavir or cobicistat (drugs used in HIV treatment), as this may increase blood levels of dexamethasone.
• Certain female sex hormones, e.g., oral contraceptives: the effect of Covexan may be increased.
• Ephedrine (e.g., drugs used to treat low blood pressure, chronic bronchitis, asthma attacks, nasal decongestants for colds, and appetite suppressants): the effectiveness of Covexan may be reduced due to accelerated metabolism of glucocorticosteroids.

Effect of Covexan on other medicines:

• Concomitant use with certain blood pressure-lowering drugs (ACE inhibitors) may increase the risk of blood count changes.
• Covexan may enhance the effects of cardiac-strengthening drugs (cardiac glycosides) due to potassium deficiency.
• Covexan may enhance potassium loss caused by diuretics (saluretics) or laxatives.
• Covexan may weaken the glucose-lowering effect of oral antidiabetic drugs and insulin.
• Covexan may weaken or enhance the effect of anticoagulant drugs (oral anticoagulants, coumarins). The doctor will decide whether a dose adjustment of the anticoagulant is necessary.
• When used concomitantly with anti-inflammatory and anti-rheumatic drugs (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs), Covexan may increase the risk of gastric ulcers and gastrointestinal bleeding.
• Covexan may prolong the muscle-relaxing effect of certain drugs (non-depolarizing muscle relaxants).
• Covexan may enhance the effect of drugs increasing intraocular pressure (atropine and other anticholinergics).
• Covexan 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), Covexan may increase the risk of muscle or heart diseases (myopathies and cardiomyopathies).
• Covexan may reduce the increase in thyrotropin (TSH) activity after administration of protirelin (TRH, a hormone produced by the hypothalamus).
• Concomitant use of Covexan with immunosuppressive drugs may increase susceptibility to infections and worsen the course of an existing but not yet apparent infection.
• Additionally, with cyclosporine (an immunosuppressive drug): Covexan may increase blood levels of cyclosporine and thus the risk of seizures.
• Fluoroquinolones, a group of antibiotics: may increase the risk of tendon rupture.

Effect on diagnostic tests
Glucocorticosteroids may suppress skin reactions in allergy tests.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans 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 drug should only be used after careful assessment of benefit versus risk. Therefore, if the patient is pregnant or becomes pregnant, she should inform her doctor. In case of prolonged use of glucocorticosteroids during pregnancy, growth disorders in the unborn child cannot be excluded. When glucocorticosteroids are used in late pregnancy, newborns may develop adrenal insufficiency. This may require replacement therapy, which should be gradually discontinued.
Newborns of mothers who received Covexan near the end of pregnancy may have low blood sugar levels after birth.
Breastfeeding
Glucocorticosteroids, including dexamethasone, pass into breast milk. Harmful effects on the infant have not been reported so far. However, the necessity of treatment during breastfeeding should be carefully considered. If high doses are required due to illness, breastfeeding should be discontinued and medical advice sought immediately.
Before taking/using any medicine, consult a doctor or pharmacist.
Driving and operating machinery
There is currently no evidence that dexamethasone affects the ability to drive vehicles or operate machinery or perform tasks requiring balance.
Covexan contains sodium
The medicine contains 3.12 mg of sodium (main component of table salt) in 1 ml of solution. This corresponds to 0.16% of the maximum recommended daily sodium intake in the adult diet.
The medicine contains 6.24 mg of sodium (main component of table salt) in 2 ml of solution. This corresponds to 0.31% of the maximum recommended daily sodium intake in the adult diet.
The medicine may be diluted – see below "Instructions for administration and preparation of the medicine for use". The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared diluted solution. For precise information on sodium content in the solution used for dilution, refer to the leaflet of the diluent used.

3. How to use Covexan

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
The doctor will decide how long the patient should receive dexamethasone. The doctor will determine the
appropriate dose for the individual patient. Follow the instructions carefully, as otherwise the effect of
Covexan may not be optimal.

Administration method
This medicine will be administered by trained medical personnel.
The medicine will be given as an intravenous injection or infusion, but may also be administered as an
intramuscular injection, intra-articular (directly into the joint), or subconjunctival injection.
Covexan should be administered slowly (over 2–3 minutes) as an intravenous injection (into a vein). The
medicine may be given intramuscularly (into the muscle) if intravenous access is difficult but circulation is
adequate.
Whenever possible, the daily dose should be given as a single morning dose. However, in conditions
requiring high-dose treatment, multiple doses throughout the day are often necessary to achieve optimal
effect.
The duration of treatment depends on the underlying disease and its course. The physician will determine
the treatment regimen, which must be strictly followed. After achieving a satisfactory therapeutic response,
the dose will be reduced to a maintenance level or treatment will be discontinued.
Abrupt discontinuation of treatment after approximately 10 days of use may lead to exacerbation or
relapse of the underlying disease, acute adrenal insufficiency, and/or corticosteroid withdrawal syndrome.
Therefore, if treatment needs to be stopped, the dose should be tapered gradually.
In patients with hypothyroidism or liver cirrhosis, the physician may prescribe lower doses or reduce the
dose accordingly.

General dosing guidelines
Unless otherwise prescribed, the recommended dose is 4 to 16 mg per day; exceptionally up to 32 mg per
day. Typically, a single dose is 4 to 8 mg. If necessary, the dose may be repeated at appropriate intervals,
several times per day.
However, in life-threatening emergencies (e.g. anaphylactic shock, acute asthma attack), significantly higher
doses may be required.
Unless otherwise directed by the physician, the recommended dose is:
Systemic administration

• Cerebral edema:
• Adults: depending on the cause and severity of the disease, initial dose of 8 to 10 mg (up to 80 mg in justified cases) intravenously, followed by 16 to 24 mg (up to 48 mg in justified cases) per day intravenously, divided into 3–4 (up to 6) single doses, for 4–8 days.
• Cerebral edema due to bacterial meningitis:
• Adults: 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.
• Traumatic shock/prophylaxis of traumatic shock lung syndrome:
• Adults: initial dose of 40 to 100 mg intravenously, repeated after 12 hours, or 16 to 40 mg every 6 hours for 2–3 days.
• Children: initial dose of 40 mg intravenously, repeated after 12 hours, or 16 to 40 mg every 6 hours for 2–3 days.
• Anaphylactic shock:
• Adults: initial intravenous administration of adrenaline, followed by 40 to 100 mg dexamethasone intravenously; repeat injection if necessary.
• Children: initial intravenous administration of adrenaline, followed by 40 mg dexamethasone intravenously; repeat injection if necessary.
• Severe acute asthma attack:
• Adults: 8 to 20 mg intravenously, administered as rapidly as possible, with repeated 8 mg injections every 4 hours if needed.
• Children: initially 0.15 to 0.3 mg/kg body weight intravenously or 1.2 mg/kg body weight as a bolus, followed by 0.3 mg/kg body weight every 4–6 hours.
• Acute skin diseases depending on type and severity, daily doses ranging from 8 to 40 mg intravenously, and up to 100 mg in severe cases. Treatment should then be continued with gradually decreasing doses.
• Systemic lupus erythematosus: 6 to 16 mg per day.
• Severe, progressive rheumatoid arthritis, e.g. rapidly progressive forms leading to joint damage: 12 to 16 mg per day; in cases with extra-articular tissue damage: 6 to 12 mg per day.
• Severe infectious diseases with signs of intoxication (e.g. tuberculosis, typhoid fever; only in combination with anti-infective therapy): 4 to 20 mg per day intravenously, only in combination with appropriate anti-infective therapy; in individual cases (e.g. typhoid fever), initial dose up to 200 mg intravenously.
• Adjunctive treatment of malignant tumors: initially 8 to 16 mg per day; 4 to 12 mg per day for long-term therapy.
• Prevention and treatment of vomiting induced by cytostatic agents as antiemetic therapy:
• 10 to 20 mg intravenously before starting chemotherapy, followed by 4 to 8 mg, 2 to 3 times per day for 1 to 3 days (moderately emetogenic chemotherapy) or up to 6 days (highly emetogenic chemotherapy).
• Prevention and treatment of postoperative nausea and vomiting:
• Adults: single dose of 8 to 20 mg intravenously before surgery;
• Children (children over 2 years of age): 0.15 to 0.5 mg/kg body weight (maximum 16 mg).
• Treatment of COVID-19:
• Adults: recommended dose is 7.2 mg dexamethasone sodium phosphate (equivalent to 6 mg dexamethasone) intravenously once daily for up to 10 days.
• Adolescents aged 12 years and older: 7.2 mg dexamethasone sodium phosphate (equivalent to 6 mg dexamethasone) intravenously once daily for up to 10 days is recommended.
• Elderly patients, patients with renal impairment, patients with hepatic impairment: Dose adjustment is not required.

Local administration
Treatment involving local injection or infiltration usually requires a dose of 4 to 8 mg. A dose of 2 mg of dexamethasone sodium phosphate is sufficient for injection into small joints or subconjunctival injection.

Overdose of Covexan
Dexamethasone is generally well tolerated, even when large amounts are administered for a short period. This medicine will be administered by a doctor or nurse, so it is unlikely that a patient will receive too high or too low a dose. If in doubt, consult your doctor or nurse.

Missed dose of Covexan
A missed dose may be taken on the same day. The next day, resume the usual dosing schedule. If multiple doses are missed, symptoms of the disease may recur or worsen. In such a case, contact your doctor, who will assess and possibly adjust the treatment.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Covexan
Follow the doctor's dosing instructions exactly. Do not stop taking the medicine abruptly, as this may be dangerous. The doctor will inform the patient how the dose should be gradually reduced. Never discontinue Covexan independently, especially since long-term use may suppress the body's natural production of glucocorticoids. Severe stress could then become life-threatening.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse effects occur in a patient during treatment with Covexan, a doctor or pharmacist should be informed. Never stop treatment on your own.
During short-term treatment with dexamethasone, the risk of adverse effects is low. The only exception is parenteral treatment with high doses, which may lead to electrolyte disturbances, development of edema, possible increase in blood pressure, cardiac arrest, cardiac arrhythmias, or seizures; clinical signs of infections may also be observed, even during short-term use.
Particular attention should be paid to the possibility of gastric and duodenal ulcers (often stress-related), as corticosteroid treatment may mask their symptoms and reduce glucose tolerance.
If any of the following situations occur in a patient, immediate medical advice must be sought:

• Severe allergic reaction (rare adverse effect). This may include sudden itchy rash (urticaria), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and a feeling of impending fainting.
• Gastrointestinal discomfort, back pain, pain in the shoulder and hip areas, psychiatric disturbances, abnormal fluctuations in blood glucose levels (in patients with diabetes).

During long-term treatment with this medicine, adverse effects of varying severity may occur regularly (frequency cannot be estimated from available data).

• Masking of infection symptoms, occurrence or worsening of viral, fungal, bacterial, parasitic or opportunistic infections, reactivation of tuberculosis infection.
• Changes in blood morphology (increased number of white blood cells or all blood cells, decreased number of certain white blood cells).
• Hypersensitivity reactions (e.g. drug rash), severe anaphylactic reactions such as cardiac arrhythmias, bronchospasm (constriction of bronchial smooth muscles), excessively high or low blood pressure, circulatory collapse, cardiac arrest, immunosuppression.
• Cushing's syndrome (typical symptoms: moon face, central obesity, facial flushing), adrenal insufficiency or adrenal cortex atrophy.
• Weight gain, increased blood glucose concentration, diabetes, increased blood lipid levels (cholesterol and triglycerides), increased sodium concentration with tissue edema, potassium deficiency due to increased potassium excretion (which may lead to cardiac arrhythmias), increased appetite.
• Depression, irritability, euphoria, increased drive, psychosis, mania, hallucinations, mood changes, anxiety, sleep disturbances, suicidal tendencies.
• Pseudotumor cerebri, manifestation of latent epilepsy, increased susceptibility to seizures in symptomatic epilepsy.
• Increased intraocular pressure (glaucoma), lens opacity (cataract), worsening of corneal ulcers, increased frequency or severity of viral, bacterial or fungal eye infections; worsening of bacterial keratitis, eyelid ptosis, pupil dilation, conjunctival edema, perforation of the sclera (white part of the eyeball), visual disturbances, vision loss. Rarely transient exophthalmos, and after subconjunctival administration also herpetic keratitis, corneal perforation in case of pre-existing corneal inflammation, blurred vision.
• Thickening of the heart muscle (hypertrophic cardiomyopathy) in premature infants, which usually resolves after discontinuation of treatment.
• High blood pressure, increased risk of atherosclerosis and thrombosis, vasculitis (including withdrawal syndrome after long-term treatment), increased capillary fragility.
• Gastrointestinal ulcers, gastrointestinal bleeding, pancreatitis, gastrointestinal discomfort, hiccups.
• Skin striae, decreased skin thickness ("parchment skin"), skin vessel dilation, tendency to bruising, pinpoint or extensive skin hemorrhages, hirsutism, acne, inflammatory skin lesions of the face, particularly around the mouth, nose and eyes, skin pigmentation changes.
• Muscle disorders, muscle weakness and atrophy, loss of bone mass (osteopor游戏副本

5. How to store Covexan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and outer packaging. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and the abbreviation Lot indicates the batch number.
Store below 25°C. Keep ampoules in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Covexan contains

• The active substance is dexamethasone sodium phosphate. Each ml of solution contains 4 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).
• The other ingredients are: sodium citrate; disodium edetate; creatinine; water for injections; sodium hydroxide (for pH adjustment); hydrochloric acid, concentrated (for pH adjustment).

What Covexan looks like and contents of the pack
Clear, colourless to slightly yellowish solution.
Type I colourless glass ampoules containing 1 ml and 2 ml of solution for injection/infusion,
on a PVC tray, in a PE film, in a cardboard box.
5 or 10 ampoules of 1 ml
5 or 10 ampoules of 2 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Medochemie LTD (Ampoule Injectable Facility)
48 Iapetou Street, Agios Athanassios Industrial Area,
4101 Agios Athanassios, Limassol, Cyprus

Information intended exclusively for medical professionals:

Covexan, solution for injection/infusion is intended for intravenous,
intramuscular, intra-articular, intralesional or subconjunctival administration.
Method of administration
Covexan should be administered by slow (lasting 2-3 minutes) intravenous injection or infusion,
but may also be given intramuscularly if there are difficulties with venous access but circulation
is normal. Covexan may also be administered by infiltration, as an intra-articular or subconjunctival
injection. The duration of treatment depends on the indication.
If high single doses are required, consideration should be given to using a medicinal product
containing dexamethasone with higher potency per unit volume.
In hypothyroidism or liver cirrhosis, lower doses may be sufficient or dose reduction may be
necessary.
Intra-articular injection should be treated as a procedure performed on an open joint and carried out
exclusively under sterile conditions. A single intra-articular injection is usually sufficient to
effectively relieve symptoms. If further 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 examination of joints is recommended, particularly after repeated
injections.
Infiltration administration: Covexan is administered by infiltration into the most painful areas or
areas of tendon insertion. Caution: do not inject into the tendon! Frequent injections should be
avoided and strict aseptic conditions must be maintained.
Suitability for use
Only a clear solution should be used. The contents of the ampoule are intended for single use.
Any unused solution remaining after injection must be discarded.
Instructions for administration and preparation for use
Covexan 4 mg/ml, solution for injection/infusion should be administered as a direct
intravenous injection or injected into an infusion line.
The solution for injection/infusion is compatible with the following infusion solutions, for use
within 24 hours:

• isotonic sodium chloride solution
• Ringer's solution
• 5% glucose solution
• 10% glucose solution

Pharmaceutical incompatibilities
When using with other infusion solutions, consider information provided by the manufacturer
regarding the specific infusion solution, including information on compatibility, contraindications,
adverse reactions and interactions.
Precautions during storage
Physical and chemical stability of the medicinal product has been demonstrated for 24 hours
during storage at 25°C and 2-8°C.
From a microbiological point of view, the product should be used immediately unless the method
of dilution excludes the risk of microbiological contamination. If the product is not used
immediately, the user is responsible for conditions and duration of storage prior to use.
Typically, storage should not exceed 24 hours at 2-8°C, unless reconstitution/dilution was
performed under controlled and validated aseptic conditions.