DESAMETASONE 4 мг/мл Инъекционный раствор

Содержание инструкции

1. Desametasone hameln 4 mg/ml injectable solution
   1. What is Desametasone hameln and what is it used for
   2. What you need to know before you are given Desametasone hameln
2. Desametasone hameln may increase potassium excretion caused by these medications.
   1. How to use Desametasone hameln
   2. Possible side effects
   3. How to store Desametasone hameln
   4. Package contents and other information

Desametasone hameln 4 mg/ml injectable solution

Desamethasone phosphate

Equivalent medicinal product

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, even those not listed in this leaflet, tell 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 is Desametasone hameln and what is it used for

Desametasone hameln is a synthetic glucocorticoid (adrenal hormone) with an effect on
metabolism, electrolyte balance and tissue function.
Desametasone hameln is used to treat diseases that require glucocorticoid therapy.
Depending on their nature and severity, these include:

By systemic use

• Cerebral edema, caused by brain tumor, neurosurgical interventions, brain abscess, bacterial meningitis.
• Shock following severe trauma, to prevent acute respiratory distress syndrome (ARDS).
• Treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years and over with a body weight of at least 40 kg) with breathing difficulties and requiring oxygen therapy.
• Severe acute asthma attack.
• Initial treatment of extensive skin diseases in acute and severe form, such as erythroderma, pemphigus vulgaris, acute eczema.
• Systemic rheumatic diseases (rheumatic diseases that can affect internal organs), such as systemic lupus erythematosus.
• Active rheumatic joint diseases (rheumatoid arthritis), severe and progressive, for example forms that rapidly lead to destruction of the joints and/or tissue outside the joints is affected.
• Severe infectious diseases with states similar to poisoning (e.g. tuberculosis, typhoid fever; only in addition to the corresponding therapy for treating the infection). Prevention and treatment of vomiting after surgery or in case of cytostatic therapy.

Supportive treatment of malignant tumors, as sometimes desametasone can be
administered by injection or infusion into a vein or under the skin (subcutaneously) to
relieve certain symptoms, including pain, fatigue, weight loss, nausea and
vomiting.

By local use

• Injection into joints: persistent inflammation in one or more joints after general treatment of chronic inflammatory joint diseases, activated osteoarthritis, acute forms of scapulo-humeral periarthritis.
• Infiltration therapy (where strictly indicated): non-bacterial tenovaginitis and bursitis, periarthropathy, insertion endopathy.

2. What you need to know before you are given Desametasone hameln

Desametasone hameln must not be given:

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

In individual cases, hypersensitivity reactions have been observed with the use of Desametasone hameln

severe (anaphylactic reactions), with circulatory failure, heart attack, cardiac arrhythmias,

difficulty breathing (bronchospasm), and/or a decrease or increase in blood pressure.
Injections into the joints may not be given 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 should not be undertaken without prior additional anti-infective treatment
if there is an infection in the area intended for the administration of
dexamethasone.
You must not stop taking any other steroid medicine unless your doctor
tells you to.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Desametasone
hameln.
If you experience particular physical stress during treatment with Desametasone hameln
(accident, surgery, childbirth, etc.), it may be necessary to temporarily increase
the dose.
Desametasone hameln can mask the signs of an infection and thus hinder the attempt to
identify an ongoing or developing infection. Latent infections may be reactivated.
General precautions regarding the use of steroids for specific diseases, masking of
infections, concomitantly taken medicines, etc., in line with current recommendations.
Treatment with Desametasone hameln should only be considered if it is strictly necessary with
other medicines taken at the same time, targeting the pathogens that cause the following diseases:

• Acute viral infections (hepatitis B, chickenpox, Herpes Zoster, Herpes simplex infections, corneal inflammation caused by Herpes viruses)
• Active chronic hepatitis HBsAg-positive (liver infectious disease)
• Approximately 8 weeks before and up to 2 weeks after immunizations with live vaccines
• Acute and chronic bacterial infections
• Systemic fungal infections
• Some diseases caused by parasites (amoebae, worm infections). In patients with suspected or confirmed nematode infection (Strongyloides), Desametasone hameln may lead to activation and large-scale multiplication of the parasites
• Poliomyelitis
• Lymph node disease following vaccination against tuberculosis
• Tuberculosis present in the medical history

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

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

If you experience blurred vision or other visual disturbances, consult your doctor.
Due to the risk of perforation of the intestinal wall, Desametasone hameln can only be used
in the presence of valid medical reasons and with corresponding monitoring:

• Severe inflammation of the colon (ulcerative colitis) with risk of perforation, with abscesses or with purulent inflammation, possibly even without peritonitis
• Inflamed intestinal diverticula (diverticulitis)
• Immediately after some intestinal surgery (enteroanastomoses).

Signs of peritonitis following perforation of a gastrointestinal ulcer may be absent
in patients receiving high doses of glucocorticoids.
In patients with diabetes mellitus, blood glucose levels must be checked regularly
because an increased need for medicines used to treat diabetes mellitus (insulin, oral antidiabetics) must be taken into account.
Patients with very high blood pressure and/or severe heart failure must be
monitored carefully as there is a risk of worsening.
A decrease in heart rate may occur with the administration of high doses.
Severe anaphylactic reactions (hyper-reaction of the immune system) are possible.
The risk of tendon-related symptoms, tendinitis and tendon rupture increases with the concomitant administration of fluoroquinolones (some antibiotics) and Desametasone hameln.
In the treatment of a particular form of muscle paralysis (myasthenia gravis), symptoms may
worsen at the beginning.
In principle, immunizations with vaccines derived from killed pathogens (inactivated vaccines) are possible. However, it must be taken into account that the immune response, and therefore the good outcome
of the immunization, may be compromised with the use of higher doses of corticosteroids.
In particular, during long-term treatment with high doses of Desametasone hameln, patients
must be monitored to ensure an adequate intake of potassium (e.g. vegetables,
bananas). Salt intake may need to be limited, 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
compromised immunity who have never had measles or chickenpox before are particularly at risk. If these
patients come into contact with people suffering from 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 malignancy.
For intravenous administration, the injection must be administered slowly over
2-3 minutes. Following too rapid administration, temporary and essentially harmless side effects may occur, in the form of unpleasant tingling or paresthesia, with a maximum duration
of 3 minutes.
Desametasone hameln is a medicine intended for short-term use. However, if it is used
for a rather long period, further warnings and precautions must be considered, as
occurs with medicines containing glucocorticoids 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.
Longer-term and repeated use of glucocorticoids within the weight-bearing joints can
lead to a deterioration of wear-and-tear lesions, due to possible overloading
of the joint after reduction of pain or other symptoms.

Children and adolescents
Dexamethasone should not be used routinely in premature infants 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, in
particular 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 giving them this medicine, especially if they are using other medicines
containing propylene glycol or alcohol.

Patients with hepatic or renal impairment
Desametasone hameln contains propylene glycol.
If you have a liver or kidney disease, this medicine should not be given to you unless
it has been recommended by your doctor, who may perform further checks while you are
given this medicine.

Elderly
In elderly patients, a special assessment of the benefit/risk ratio must be performed
due to the increased risk of osteoporosis.

Note on doping
The use of Desametasone hameln may lead to positive doping tests.

Other medicines and Desametasone hameln
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription. This is particularly important in the case
of the following medicines, as they may interact with Desametasone hameln.

Other medicines that can affect the effect of Desametasone hameln:

• Medicines that accelerate metabolism in the liver, such as some sleeping pills (barbiturates), medicines used to treat seizures (phenytoin, carbamazepine, primidone) and some medicines used to treat tuberculosis (rifampicin) can reduce the cortisone effect.
• Medicines that slow down metabolism in the liver, such as some medicines used to treat fungal diseases (ketoconazole, itraconazole) can increase the effect of corticosteroids.
• Certain female sex hormones, for example those for preventing pregnancy (birth control pill): the effect of Desametasone hameln may be increased.
• Ephedrine (in medicines used to treat hypotension, chronic bronchitis, asthma attacks and to reduce swelling of the mucous membranes in case of colds, and as a component of appetite suppressants): due to the accelerated metabolism in the body, the effectiveness of Desametasone hameln may be reduced.
• Some medicines for HIV: ritonavir, cobicistat, as they may increase the effect of Desametasone hameln, and your doctor may want to monitor you closely if you take these medicines.

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

• Medicines used to lower blood pressure (ACE inhibitors). When Desametasone hameln is used at the same time, it can increase the risk of changes in blood count.
• Medicines used to strengthen the heart (cardiac glycosides), as Desametasone hameln can increase their effects due to potassium deficiency.
• Medicines that promote salt loss with urination (diuretics) or laxatives, as

Desametasone hameln may increase potassium excretion caused by these medications.

• Oral antidiabetics and insulin, as Desametasone hameln may reduce their antidiabetic effect (ineffectiveness in reducing blood glucose levels).
• Medicines used to inhibit blood clotting (oral anticoagulants, coumarin). Their effect may be weakened or potentiated by Desametasone hameln. The doctor will decide if an adjustment of the anticoagulant dose is necessary.
• Medicines used to treat inflammation and rheumatism (salicylates, indometacin and other non-steroidal anti-inflammatory drugs) as Desametasone hameln, if used simultaneously with such 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 pressure inside the eye (atropine and other anticholinergics), as their effect may be increased by Desametasone hameln.
• Medicines used to treat diseases caused by worms (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 diseases affecting the muscles of the body or the heart muscle (myopathies, cardiomyopathies) if they are used simultaneously with Desametasone hameln.
• Protirelin (TRH, a hormone produced in the diencephalon) as, following its administration, Desametasone hameln may reduce the increase in thyroid-stimulating hormone (TSH).
• Medicines used to suppress the body's immune system (immunosuppressants). If used with Desametasone hameln, there is an increased susceptibility to infections and worsening of ongoing infections that may not yet have become symptomatic.
• Cyclosporine (a medicine used to suppress the body's immune system), as Desametasone hameln may increase the level of cyclosporine and consequently the risk of seizures.
• Fluoroquinolones, a specific group of antibiotics, may increase the risk of tendon rupture.

Impact on methods for diagnostic tests:
Glucocorticoids can suppress skin reactions to allergy tests.
Due to interactions with these drugs, the doctor may need to adjust the dose of
the medicine you are taking.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before you are given this
medicine.
At that point, the doctor will decide if the medicine is suitable for you and may perform further checks
while you are taking this medicine.
Desamethasone crosses the placenta. During pregnancy, particularly in the first trimester, treatment should only occur after careful evaluation of the benefit/risk ratio.
When desamethasone is administered for prolonged or repeated periods during
pregnancy, there may be an increased risk of delayed growth of the newborn. If
glucocorticoids are used at the end of pregnancy, adrenal insufficiency may occur, which may require gradual reduction/replacement therapy in the newborn.
Glucocorticoids, including desamethasone, are excreted in breast milk. No adverse effects on the infant have been reported, however, if higher doses are necessary
breastfeeding should be discontinued.

Driving and operating machinery
There is no evidence that Desametasone hameln reduces the ability to drive vehicles or operate
machinery. The same applies to work performed in 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 (the main component of table
salt) per maximum single dose (350 mg for a person weighing 70 kg). This
is equivalent to 2.15% of the recommended maximum daily intake with the diet for an adult.

3. How to use Desametasone hameln

The nurse or doctor will administer this medicine to you. The doctor will decide the correct dose for
you, and how and when the medicine will be administered.
This medicine is a solution for intravenous (i.v.), into a muscle (i.m.) or under the skin
(s.c.) or tissue injection.
Desametasone hameln must be administered slowly into a vein (within 2-3 minutes). If
intravenous administration is not possible, and if circulatory function is not impaired,
Desametasone hameln can also be administered into a muscle. Sometimes Desametasone
hameln may also be administered by injection or continuous infusion under the skin (subcutaneously).
The administration of Desametasone hameln is also possible with infiltration or injection into
a joint.
Intra-articular injection must be administered under strictly aseptic conditions.
Generally, a single intra-articular injection is sufficient to relieve symptoms. If a further
injection is considered necessary, it must be administered not before 3-4 weeks have elapsed.
The number of injections per joint should be limited to 3-4. In particular, after each consecutive
injection, a medical examination of the joint is indicated.
Desametasone hameln can also be administered in the area of maximum pain or at the insertion
points of tendons, but not directly into the tendon itself. Injections at short intervals should be avoided,
and strict aseptic precautions must be ensured.
If high doses are required for a single treatment, the use of medicines
containing desamethasone in higher doses/volumes should be considered.

Systemic use

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

Local use
As a rule, the doses for infiltration and local injection therapies are 4-8 mg. For injection into
a small joint, 2 mg are sufficient.
If possible, the daily dose should be administered in the morning as a single dose. However, for
the treatment of diseases requiring higher doses, more than a single
dose in the morning is often necessary to achieve maximum effect.
The duration of treatment is established based on the underlying disease and its course. The doctor
establishes a treatment schedule, which you must strictly adhere to. As soon as a satisfactory result of the treatment is obtained, the dose will be reduced to a maintenance dose, or terminated.
Abrupt discontinuation of the medicine administered for more than about 10 days can lead to
the onset of acute adrenal insufficiency, therefore the dose must be reduced gradually before discontinuation.
In case of a hypoactive adrenal gland or liver cirrhosis, relatively low doses may be sufficient, or a dose reduction may be necessary.

If you think you have been given too much Desametasone hameln, or if you have
forgotten a dose
Since this medicine will be administered by the doctor or nurse, it is unlikely that you will receive too much, or forget a dose. If this worries you, contact the doctor or
nurse.
In general, Desametasone hameln is well tolerated in high quantities, even
during short-term use. No special measures are necessary. If you observe more
serious or unusual side effects, you should contact the doctor.
If a dose is missed, it may still be administered on the same day and the dose prescribed by the doctor
can continue to be administered as usual from the following day. If more than one
dose is missed, a relapse or worsening of the treated disease is possible.
Consult the 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 dosage schedule prescribed by the doctor. Desametasone hameln should never be stopped on your own, because, in particular, relatively prolonged treatment can
lead to suppression of glucocorticoid production by the body (adrenal insufficiency). A situation of marked physical stress without adequate glucocorticoid production can be potentially fatal.
If you have any doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

The risk of side effects is low during short-term therapy with desametasone. However,
in case of short-term parenteral therapy and at high doses, the risk of
electrolyte changes, edema, possible increase in blood pressure, heart failure, cardiac arrhythmias or convulsive crises must be considered, and clinical manifestations
of infection must also be anticipated. Doctors must be aware of the possibility of gastrointestinal ulcers,
which are often related to stress, and which may be relatively asymptomatic during
treatment with corticosteroids, as well as a reduction in glucose tolerance.
Desametasone hameln may cause allergic reactions, including anaphylactic shock in very rare cases.
In particular, if high doses are used for a longer period of time, it is expected that
side effects will occur regularly and with varying severity.
Like all medicines, this medicine can cause side effects, although not all
people will experience them.
Side effects may include:
Frequency not known (the frequency cannot be defined based on available data)

Infections and infestations:
Masking of infections, onset, recurrence and worsening of viral, fungal and
bacterial infections and parasitic and opportunistic infections, activation of nematode infection.

Blood and lymphatic system disorders:
Changes in blood count (proliferation of white blood cells or all blood cells,
reduction of some white blood cells).

Immune system disorders:
Hypersensitivity reactions (e.g. drug-induced rash), severe anaphylactic reactions, such as arrhythmias, bronchospasm (spasm of the smooth muscles of the bronchi), excessively high or excessively low blood pressure, circulatory collapse, cardiac arrest,
weakening of the immune system.

Endocrine disorders:
Development of Cushing's syndrome (typical symptoms include a 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 can lead to
cardiac arrhythmias), increased appetite.

Psychiatric disorders:
Depression, irritability, euphoria, increased drives, psychosis, mania, hallucinations, emotional lability, feeling of anxiety, sleep disorders, risk of suicide.

Nervous system disorders:
Increased pressure inside the skull, onset of previously unnoted seizures (epilepsy), increased occurrence of seizures in previously
diagnosed epilepsy.

Eye disorders:
Increased pressure inside the eye (glaucoma), clouding of the lens (cataract),
worsening of corneal ulcers, increased risk, or worsening, of eye inflammation caused by viruses, bacteria or fungi; worsening of bacterial inflammation of the cornea, drooping eyelid, dilated pupils, swelling of the conjunctiva, perforation of the sclera, visual disturbances,
loss of vision.
In rare cases, reversible protruding eyeball.

Vascular disorders:
High blood pressure, increased risk of arteriosclerosis and thrombosis, inflammation of the
blood vessels (also as withdrawal syndrome after long-term therapy), increased
fragility of blood vessels.

Gastrointestinal disorders:
Ulcers of the stomach and intestines, gastric and intestinal bleeding, pancreatitis, symptoms affecting the stomach.

Skin and subcutaneous tissue disorders:
Stretch marks, thinning of the skin, dilation of blood vessels, tendency to develop bruises,
spots or areas of skin bleeding, increased hair growth on the body, acne, inflammatory skin lesions
of the face, especially around the mouth, nose and eyes, changes in skin pigmentation.

Musculoskeletal and connective tissue disorders:
Muscle diseases, muscle weakness and muscle loss and thinning of the bones
(osteoporosis) occur in a dose-dependent manner and are possible during short-term use only; other forms of bone loss (bone necrosis), symptoms related to tendons, tendinitis, tendon rupture, fat deposits in the spine (epidural lipomatosis), inhibition of growth in
children.
If the dose is reduced too quickly after long-term treatment, symptoms of withdrawal may occur, which may manifest as muscle and
joint pain.

Reproductive system and breast disorders:
Disorders in the secretion of sex hormones (causing irregular menstrual cycles or cessation
of menstrual cycles (amenorrhea), growth of body hair with a male pattern in women (hirsutism),
impotence).

General disorders and conditions related to the site of administration:delayed wound healing.

Local use:
Local irritation and intolerance (feeling of warmth, relatively persistent pain) are possible. Thinning of the skin or subcutaneous tissue (atrophy) may occur at the
injection site if corticosteroids are not injected carefully into the joint cavity.
If you experience any of the following symptoms, seek immediate medical attention:

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

It is important to remember notto abruptly stop taking this medicine
(even if you suffer from a side effect), unless your doctor tells you to do so (see
paragraphs 2 and 3).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
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 can help provide more information on the safety of
this medicine.

5. How to store Desametasone hameln

Store at a temperature below 25°C. Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the vial label and on the
package 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 in wastewater. Ask your pharmacist how to dispose of medicines
that you no longer use. This will help protect the environment.

6. Package contents and other information

What Desametasone hameln contains

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

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

• The other ingredients are propylene glycol, disodium edetate, sodium hydroxide (for pH adjustment) and water for injections.

Description of the appearance of Desametasone hameln and package contents
Desametasone hameln (injection) is a clear and colorless 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 authorised in the Member States of the European Economic Area under the
following denominations: