Dexamethasone Hameln

Package leaflet: Information for the patient

Desametasone hameln 4 mg/ml solution for injection

Dexamethasone phosphate
Generic medicine
Please read this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Desametasone hameln is and what it is used for
2. What you need to know before you are given Desametasone hameln
3. How Desametasone hameln is administered
4. Possible side effects
5. How to store Desametasone hameln
6. Contents of the pack and other information

1. What Desametasone hameln is and what it is used for

Desametasone hameln is a synthetic glucocorticoid (adrenocortical hormone) with effects on
metabolism, electrolyte balance, and tissue function.
Desametasone hameln is used to treat diseases requiring glucocorticoid therapy.
Depending on their nature and severity, these include:
By systemic use

• Cerebral oedema caused by brain tumour, neurosurgical procedures, brain abscess, bacterial meningitis.
• Shock following severe trauma, for prevention of acute respiratory distress syndrome (ARDS).
• Treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years and older with body weight at least 40 kg) who have respiratory difficulty and require oxygen supplementation.
• Severe acute asthma attack.
• Initial treatment of extensive, acute and severe skin diseases such as erythroderma, pemphigus vulgaris, acute eczema.
• Systemic rheumatic diseases (rheumatic diseases that may affect internal organs), such as systemic lupus erythematosus.
• Active, severe and progressive rheumatic joint diseases (rheumatoid arthritis), for example forms that rapidly lead to joint destruction and/or extra-articular tissue involvement.
• Severe infectious diseases with toxic-like conditions (e.g. tuberculosis, typhoid fever; only as adjunct to appropriate anti-infective therapy). Prevention and treatment of vomiting after surgery or during cytostatic therapy.

Supportive treatment of malignant tumours, since desamethasone may sometimes be
administered by intravenous or subcutaneous injection or infusion to
relieve certain symptoms, including pain, fatigue, weight loss, nausea, and
vomiting.
By local use

• Intra-articular injection: persistent inflammation in one or more joints following general treatment of chronic inflammatory joint diseases, activated osteoarthritis, acute forms of scapulohumeral periarthritis.
• Infiltration therapy (where strictly indicated): non-bacterial tenosynovitis and bursitis, periarticular disorders, insertion endopathies.

2. What you should know before being given Desametasone hameln

Desametasone hameln must not be administered:

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

In individual cases, severe hypersensitivity reactions (anaphylactic reactions) have been observed with the use of Desametasone hameln, including circulatory failure, heart attack, cardiac arrhythmias, breathing difficulties (bronchospasms), and/or a drop or rise in blood pressure.
Joint injections should not be administered if you have any of the following conditions:

• Infections within the joint to be treated, or in a nearby area
• Bacterial joint infections
• Unstable joint
• Abnormal bleeding (spontaneous or caused by anticoagulants)
• Calcifications near the joints
• Avascular bone necrosis
• Tendon rupture
• Charcot joint

Local infiltrative therapy must not be initiated without prior additional anti-infective treatment if there is an infection in the area intended for administration of dexamethasone.
You must not stop taking any other steroid medicine unless your doctor has instructed you to do so.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Desametasone hameln.
If you experience situations of particular physical stress during treatment with Desametasone hameln (e.g., accident, surgery, childbirth, etc.), a temporary increase in dose may be necessary.
Desametasone hameln may mask the signs of infection and thus hinder the identification of an existing or developing infection. Latent infections may be reactivated.
General precautions regarding steroid use in specific diseases, masking of infections, concomitant medications, etc., in accordance with current recommendations.
Treatment with Desametasone hameln should only be considered if strictly necessary when other medicines are taken simultaneously, targeting pathogens causing the following conditions:

• Acute viral infections (hepatitis B, chickenpox, herpes zoster, herpes simplex infections, corneal inflammations caused by herpes viruses)
• Chronic active hepatitis HBsAg-positive (infectious liver disease)
• Approximately 8 weeks before and up to 2 weeks after immunizations with live vaccines
• Acute and chronic bacterial infections
• Systemic fungal infections
• Certain parasitic diseases (amoebiasis, worm infections). In patients with suspected or confirmed nematode infection (Strongyloides), Desametasone hameln may lead to activation and widespread multiplication of the parasites
• Poliomyelitis
• Lymph node disease following tuberculosis vaccination
• Tuberculosis in medical history

Treatment with Desametasone hameln must be specifically monitored in patients with pre-existing medical conditions requiring treatment, such as:

• Gastrointestinal ulcers
• Thinning of the bones (osteoporosis)
• Poorly controlled blood pressure
• Poorly controlled diabetes mellitus
• Mental illnesses (including those in medical history), including risk of suicide. Neurological or psychiatric monitoring is recommended.
• Increased intraocular pressure (narrow-angle and open-angle glaucoma). Ophthalmological monitoring and concomitant therapy are recommended.
• Corneal lesions and ulcers. Ophthalmological monitoring and concomitant therapy are recommended.

If you experience blurred vision or other visual disturbances, consult your doctor.
Due to the risk of intestinal wall perforation, Desametasone hameln may only be used when there are valid medical reasons and with appropriate monitoring:

• Severe inflammation of the colon (ulcerative colitis) with risk of perforation, with abscesses or purulent inflammations, possibly even in the absence of peritonitis
• Inflamed intestinal diverticula (diverticulitis)
• Immediately after certain intestinal surgeries (enteroanastomosis).

Signs of peritonitis following gastrointestinal ulcer perforation may be absent in patients receiving high doses of glucocorticoids.
In patients with diabetes mellitus, blood glucose levels must be regularly monitored, as an increased need for diabetes medications (insulin, oral antidiabetics) may occur.
Patients with very high blood pressure and/or severe heart failure must be closely monitored, as there is a risk of worsening.
With administration of high doses, a decrease in heart rate may occur.
Severe anaphylactic reactions (overreaction of the immune system) are possible.
The risk of tendon-related symptoms, tendinitis, and tendon rupture increases with concomitant administration of fluoroquinolones (a certain group of antibiotics) and Desametasone hameln.
In the treatment of a specific form of muscle paralysis (myasthenia gravis), symptoms may initially worsen.
In principle, immunizations with vaccines derived from killed pathogens (inactivated vaccines) are possible. However, it should be noted that the immune response, and thus the success of immunization, may be compromised when higher doses of corticosteroids are used.
In particular, during long-term treatment with high doses of Desametasone hameln, patients must be monitored to ensure adequate potassium intake (e.g., vegetables, bananas). Salt intake may need to be restricted, and blood potassium levels must be monitored.
Viral diseases (e.g., measles, chickenpox) may have a particularly severe course in patients treated with Desametasone hameln. Patients with impaired immunity who have never had measles or chickenpox are at particular risk. If these patients come into contact with people affected by measles or chickenpox during treatment with Desametasone hameln, they must contact their doctor immediately, who may initiate preventive treatment.
Symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, loss or disturbances of vision, and shortness of breath, if you suffer from hematological malignancies.
For intravenous administration, the injection must be administered slowly over 2–3 minutes. Undesirable temporary and essentially harmless effects may occur following too rapid administration, in the form of unpleasant tingling or paresthesia, lasting up to 3 minutes.
Desametasone hameln is a medicine intended for short-term use. However, if it is used for a relatively long period, additional warnings and precautions must be considered, as with glucocorticoid-containing medicines intended for long-term use.
With local use, possible systemic side effects and interactions must be considered.
Intra-articular administration of glucocorticoids increases the risk of joint infections.
Long-term and repeated use of glucocorticoids in weight-bearing joints may lead to deterioration of wear-related lesions due to possible overloading of the joint after reduction of pain or other symptoms.
Children and adolescents
Dexamethasone should not routinely be used in preterm neonates with respiratory problems.
In children, Desametasone hameln should only be used for valid medical reasons due to the risk of inhibition/delay of growth. Growth must be monitored regularly, especially if the medicine is used for long-term treatment.
Desametasone hameln contains propylene glycol. If your child is under 5 years of age, consult your doctor or pharmacist before administering this medicine, particularly if using other medicines containing propylene glycol or alcohol.
Patients with hepatic or renal impairment
Desametasone hameln contains propylene glycol.
If you have liver or kidney disease, this medicine must not be administered unless recommended by your doctor, who may perform additional monitoring while you are receiving this medicine.
Elderly patients
In elderly patients, a special benefit-risk assessment must be performed due to the increased risk of osteoporosis.
Note on doping
Use of Desametasone hameln may lead to positive results in anti-doping tests.
Other medicines and Desametasone hameln
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without prescription. This is particularly important for the following medicines, as they may interact with Desametasone hameln.
Other medicines that may affect the effect of Desametasone hameln:

• Medicines that accelerate metabolism in the liver, such as certain sleeping pills (barbiturates), medicines used to treat seizures (phenytoin, carbamazepine, primidone), and certain medicines used to treat tuberculosis (rifampicin), may reduce the corticosteroid effect.
• Medicines that slow down metabolism in the liver, such as certain medicines used to treat fungal diseases (ketoconazole, itraconazole), may increase the effect of corticosteroids.
• Certain female sex hormones, e.g., those used for pregnancy prevention (oral contraceptives): the effect of Desametasone hameln may be increased.
• Ephedrine (in medicines used to treat hypotension, chronic bronchitis, asthma attacks, and to reduce mucosal swelling in colds, and as a component of appetite suppressants): due to accelerated metabolism in the body, the effectiveness of Desametasone hameln may be reduced.
• Certain HIV medicines: ritonavir, cobicistat, as they may increase the effect of Desametasone hameln, and your doctor may want to monitor you closely if you are taking these medicines.

Desametasone hameln may affect the effect of other medicines such as:

• Medicines used to lower blood pressure (ACE inhibitors). When Desametasone hameln is used simultaneously, it may increase the risk of changes in blood counts.
• Medicines used to strengthen the heart (cardiac glycosides), as Desametasone hameln may increase their effects due to potassium deficiency.
• Medicines that promote salt loss through urination (saluretics) or laxatives, as Desametasone hameln may increase potassium excretion caused by these medicines.
• Oral antidiabetics and insulin, as Desametasone hameln may reduce their antidiabetic effect (ineffectiveness in lowering blood glucose levels).
• Medicines used to inhibit blood clotting (oral anticoagulants, coumarins). Their effect may be weakened or enhanced by Desametasone hameln. Your doctor will decide whether a dose adjustment of the anticoagulant is necessary.
• Medicines used to treat inflammation and rheumatism (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs), as Desametasone hameln, when used concurrently with these medicines, may increase the risk of gastric ulcers and gastrointestinal bleeding.
• Non-depolarizing muscle relaxants, as their muscle-relaxing effect may be prolonged by Desametasone hameln.
• Certain medicines used to increase intraocular pressure (atropine and other anticholinergics), as their effect may be increased by Desametasone hameln.
• Medicines used to treat worm infections (praziquantel), as Desametasone hameln may reduce their effect.
• Medicines used to treat malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine). There is an increased risk of muscle diseases (myopathies, cardiomyopathies) if used simultaneously with Desametasone hameln.
• Protirelin (TRH, a hormone produced in the diencephalon), as Desametasone hameln may reduce the increase in thyroid-stimulating hormone (TSH) following its administration.
• Medicines used to suppress the body's immune system (immunosuppressants). When used with Desametasone hameln, there is an increased susceptibility to infections and worsening of existing infections that may not yet have become symptomatic.
• Cyclosporine (a medicine used to suppress the body's immune system), as Desametasone hameln may increase cyclosporine levels and thus the risk of seizures.
• Fluoroquinolones, a certain group of antibiotics, may increase the risk of tendon ruptures.

Impact on diagnostic test methods:
Glucocorticoids may suppress skin reactions in allergy tests.
Due to interactions with these medicines, your doctor may need to adjust the dose of the medicine you are receiving.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before being given this medicine.
Your doctor will then decide whether the medicine is suitable for you and may perform additional monitoring while you are receiving this medicine.
Dexamethasone crosses the placenta. During pregnancy, particularly in the first trimester, treatment should only occur after careful benefit-risk assessment.
When dexamethasone is administered for prolonged or repeated periods during pregnancy, there may be an increased risk of fetal growth retardation. If glucocorticoids are used at the end of pregnancy, adrenal cortical insufficiency may occur, which may require gradual reduction/replacement therapy in the newborn.
Glucocorticoids, including dexamethasone, are excreted in breast milk. There have been no reports of harmful effects on the infant; however, if higher doses are required, breastfeeding must be discontinued.
Driving and using machines
There is no evidence that Desametasone hameln impairs the ability to drive vehicles or operate machinery. The same applies to work performed under hazardous conditions.
Desametasone hameln contains propylene glycol
This medicine contains 20 mg of propylene glycol in 1 ml of solution.
Desametasone hameln contains sodium
This medicine contains up to 43 mg (1.9 mmol) of sodium (main component of table salt) per maximum single dose (350 mg for a person weighing 70 kg). This corresponds to 2.15% of the maximum daily dietary intake recommended for an adult.

3. How to use Desametasone hameln

This medicine will be administered to you by a nurse or doctor. The doctor will determine the correct dose for you and how and when the medicine will be administered.
This medicine is a solution for intravenous (i.v.), intramuscular (i.m.), or subcutaneous (s.c.) injection into the skin or tissue.
Desametasone hameln must be administered slowly intravenously (over 2–3 minutes). If intravenous administration is not possible, and if circulatory function is not impaired, Desametasone hameln may also be administered intramuscularly. Occasionally, Desametasone hameln may also be administered via subcutaneous injection or continuous subcutaneous infusion.
Administration of Desametasone hameln is also possible via infiltration or intra-articular injection.
Intra-articular injection must be performed under strictly aseptic conditions.
Generally, a single intra-articular injection is sufficient to relieve symptoms. If a further injection is considered necessary, it should not be administered earlier than 3–4 weeks after the previous one. The number of injections per joint should be limited to 3–4. In particular, a medical examination of the joint should be performed after each consecutive injection.
Desametasone hameln may also be administered into the area of maximum pain or at tendon insertions, but not directly into the tendon itself. Frequent repeated injections at short intervals must be avoided, and strict aseptic precautions must be ensured.
If high doses are required for a single treatment, consideration should be given to using medicines containing desametasone in higher doses/volumes.

Systemic use

• Brain swelling: in acute cases, depending on cause and severity, initially 8–10 mg (up to 80 mg) i.v., followed by 16–24 mg (up to 48 mg)/day divided into 3–4 (up to 6) individual doses i.v. over 4–8 days.
• Cerebral oedema due to bacterial meningitis: 0.15 mg/kg body weight every 6 hours over 4 days; in children: 0.4 mg/kg body weight every 12 hours over 2 days, starting before initial administration of antibiotics.
• Shock following severe trauma: initially 40–100 mg (children 40 mg) i.v., repeat dose after 12 hours or every 6 hours 16–40 mg i.v. over 2–3 days.
• Treatment of COVID-19: for adult patients, administration of 6 mg i.v. once daily for up to 10 days is recommended. For paediatric patients (adolescents aged 12 years or older), administration of 6 mg i.v. once daily for up to 10 days is recommended.
• Severe acute asthma attack: as soon as possible, 8–20 mg i.v., with repeated 8 mg injections every 4 hours if necessary. Children: 0.15–0.3 mg/kg body weight or 1.2 mg/kg body weight i.v. as a bolus, then 0.3 mg/kg every 4–6 hours.
• Acute skin diseases: daily doses of 8–40 mg i.v., depending on the nature and extent of the disease; up to 100 mg in individual cases. Subsequently, further oral treatment with gradually decreasing doses.
• Systemic lupus erythematosus: 6–16 mg.
• Active rheumatoid arthritis with severe progressive course, e.g. forms leading rapidly to joint destruction: 12–16 mg; when tissue outside the joint is affected: 6–12 mg.
• Severe infectious diseases with poisoning-like symptoms: 4–20 mg/day i.v. over several days, only in addition to appropriate therapy to treat the infection; in individual cases (e.g. typhoid fever) initial doses up to 200 mg i.v., followed by gradual reduction.
• Prophylaxis and treatment of vomiting after surgery: individual dose of 8–20 mg before the start of the procedure; children from 2 years of age: 0.15–0.5 mg/kg body weight (maximum 16 mg).
• Supportive therapy in malignant tumours: initially 8–16 mg/day; in longer-term treatment, 4–12 mg/day.
• Prevention and treatment of vomiting during cytostatic therapy within certain regimens: 10–20 mg i.v. before initiation of chemotherapy, then, if necessary, 2–3 times daily 4–8 mg over 1–3 days (moderately emetogenic chemotherapy) or up to 6 days (highly emetogenic chemotherapy).
• In palliative care and for prevention and treatment of nausea and vomiting induced by chemotherapy (CINV), standard doses range from 4.82 mg to 19.3 mg s.c. over 24 hours, considering local clinical guidelines, and should be titrated according to response.

Local use
Typically, doses for infiltration and local injection therapies are 4–8 mg. For injection into a small joint, 2 mg is sufficient.
If possible, the daily dose should be administered in the morning as a single dose. However, for treatment of diseases requiring higher doses, more than one single morning dose is often necessary to achieve maximum effect.
The duration of treatment is determined based on the underlying disease and its course. Your doctor will establish a treatment regimen, which you must follow strictly. As soon as a satisfactory treatment outcome is achieved, the dose will be gradually reduced to a maintenance dose or discontinued.
Abrupt discontinuation of the medicine after administration for approximately more than 10 days may lead to the development of acute adrenal insufficiency; therefore, the dose must be gradually reduced before stopping.
In cases of adrenal hypofunction or hepatic cirrhosis, relatively low doses may be sufficient, or dose reduction may be required.

If you think you have been given more Desametasone hameln than you should have, or if you have missed a dose
Since this medicine will be administered by your doctor or nurse, it is unlikely that you will receive too much or miss a dose. If you are concerned, speak to your doctor or nurse.
In general, Desametasone hameln is well tolerated in high quantities without complications, even during short-term use. No special measures are required. If you experience more severe or unusual side effects, you must contact your doctor.
If a dose is missed, it may be administered on the same day, and the prescribed dose can continue to be administered as usual from the next day. If more than one dose is missed, a relapse or worsening of the condition being treated may occur. Consult your doctor, who will review the treatment and adjust the dose if necessary.
Do not take a double dose to make up for a missed dose.

If you stop using Desametasone hameln
Always follow the dosing schedule prescribed by your doctor. Desametasone hameln must never be stopped on your own, as, in particular, relatively prolonged treatment can lead to suppression of the body's own glucocorticoid production (adrenal hypofunction). A situation of significant physical stress without adequate glucocorticoid production can be potentially fatal.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

The risk of side effects is low during short-term desamethasone therapy. However,
in the case of short-term parenteral therapy with high doses, the risk of
electrolyte imbalances, edema, possible increase in blood pressure, heart
failure, cardiac arrhythmias or convulsive seizures should be considered, and
clinical signs of infection must also be anticipated. Physicians should be aware of the possibility of gastrointestinal ulcers,
which are often stress-related and may be relatively asymptomatic during
treatment with corticosteroids, as well as reduced glucose tolerance.
Desametasone hameln may cause allergic reactions, including anaphylactic shock in very rare cases.
In particular, if high doses are used over a prolonged period, side effects are expected to occur regularly and with varying severity.
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Possible side effects may include:
Frequency not known (frequency cannot be estimated from the available data)
Infections and infestations:
Masking of infections, onset, recurrence, and worsening of viral, fungal, and bacterial infections, as well as parasitic and opportunistic infections, activation of nematode infection.
Blood and lymphatic system disorders:
Changes in blood cell counts (increased white blood cells or all blood cells, reduction in certain white blood cells).
Immune system disorders:
Hypersensitivity reactions (e.g. drug-induced rash), severe anaphylactic reactions such as arrhythmias, bronchospasms (spasms of the smooth muscles of the bronchi), excessively high or low blood pressure, circulatory collapse, cardiac arrest, weakening of the immune system.
Endocrine disorders:
Development of Cushing's syndrome (typical symptoms include rounded face, abdominal obesity, and facial flushing), suppression or loss of adrenal cortex function.
Metabolism and nutrition disorders:
Weight gain, increased blood sugar levels, diabetes mellitus, increased blood lipid levels (cholesterol and triglycerides), increased sodium levels with tissue swelling (edema), 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, emotional lability, anxiety, sleep disturbances, risk of suicide.
Nervous system disorders:
Increased intracranial pressure, onset of previously unknown convulsive seizures (epilepsy), increased frequency of seizures in pre-existing epilepsy.
Eye disorders:
Increased intraocular pressure (glaucoma), lens opacity (cataract), worsening of corneal ulcers, increased risk or worsening of eye inflammation caused by viruses, bacteria, or fungi; worsening of bacterial corneal inflammation, drooping eyelid, dilated pupils, conjunctival swelling, scleral perforation, visual disturbances, loss of vision.
In rare cases, reversible protrusion of the eyeball.
Vascular disorders:
Elevated blood pressure, increased risk of atherosclerosis and thrombosis, inflammation of blood vessels (including withdrawal syndrome after long-term therapy), increased fragility of blood vessels.
Gastrointestinal disorders:
Stomach and intestinal ulcers, gastrointestinal and intestinal bleeding, pancreatitis, stomach-related symptoms.
Skin and subcutaneous tissue disorders:
Stretch marks, thinning of the skin, dilation of blood vessels, tendency to bruise easily, petechiae or areas of skin bleeding, increased body hair, acne, inflammatory skin lesions on the face, particularly around the mouth, nose, and eyes, changes in skin pigmentation.
Musculoskeletal and connective tissue disorders:
Muscle disorders, muscle weakness and muscle loss, and bone thinning (osteoporosis) occur in a dose-dependent manner and are possible even during short-term use; other forms of bone loss (bone necrosis), tendon-related symptoms, tendinitis, tendon ruptures, fat deposits in the spine (epidural lipomatosis), growth suppression in children.
If the dose is reduced too rapidly after long-term treatment, withdrawal symptoms may occur, including muscle and joint pain.
Reproductive system and breast disorders:
Disorders in the secretion of sex hormones (causing irregular menstrual cycles or cessation of menstruation (amenorrhea), growth of body hair in a male pattern in women (hirsutism), impotence).
General disorders and administration site conditions: delayed wound healing.
Local use:
Local irritation and intolerance (sensation of warmth, relatively persistent pain) are possible. Thinning of the skin or subcutaneous tissue (atrophy) at the injection site may occur if corticosteroids are not carefully injected into the joint cavity.
If you experience any of the following symptoms, contact your doctor immediately:

• gastrointestinal symptoms,
• back, shoulder, or hip pain,
• mood disturbances,
• marked fluctuations in blood sugar levels in diabetic patients.

Please remember it is very important not to stop taking this medicine abruptly
(even if you are experiencing a side effect), unless your doctor tells you to do so (see
sections 2 and 3).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Desametasone hameln

Store below 25°C. Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the packaging after Exp. The expiry date refers to the last day of that month.
This product is for single use only. Any unused solution must be discarded.
Do not use this medicine if you notice visible particles in the solution.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Desametasone hameln contains

• The active substance is dexamethasone sodium phosphate. Each vial containing 1 ml of solution contains 4 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).

Each vial containing 2 ml of solution contains 8 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).

• The other components are propylene glycol, disodium edetate, sodium hydroxide (to adjust pH), and water for injections.

Description of the appearance of Desametasone hameln and package contents
Desametasone hameln (injection) is a clear, colourless solution free from visible particles.
Desametasone hameln is available in packs of 5 or 10 vials; each vial contains 1 ml or 2 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorization Holder
hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany

Manufacturer
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
HBM Pharma s.r.o.
Sklabinská 30
03680 Martin
Slovak Republic
hameln rds s.r.o.
Horná 36
90001 Modra
Slovak Republic

This medicinal product is authorized in the European Economic Area countries under the following names: