Leaflet: information for the user

Dexametasona Kalceks 4 mg/ml injectable solution and for infusion EFG

dexamethasone phosphate

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Dexametasona Kalceks and how it is used

2. What you need to know before Dexametasona Kalceks is administered

3. How Dexametasona Kalceks will be administered

4. Possible side effects

5. Storage of Dexametasona Kalceks

6. Contents of the pack and additional information

This medication contains the active ingredient dexamethasone phosphate (also known as dexamethasone). Dexamethasone is a synthetic glucocorticoid (adrenal cortical hormone). It reduces the symptoms of inflammation and intervenes in essential metabolic processes.

Systemic route (affects the entire body)

This medication is often used after an emergency treatment initiated at high doses:

• Treatment and prophylaxis of cerebral edema (brain swelling) in brain tumors (after surgical intervention and radiation with X-rays) and after spinal cord trauma.
• Shock due to an allergic reaction called anaphylactic shock (for example, due to a contrast medium reaction).
• Shock states after severe injuries, prevention of acute respiratory distress syndrome.
• Severe persistent symptoms of an asthma attack.
• Initial treatment of some extensive, acute, and severe skin disorders, such as pemphigus vulgaris or erythrodermia.
• Severe blood diseases (for example, acute thrombocytopenic purpura or hemolytic anemia, as part of leukemia treatment).
• As a second-line treatment in patients with reduced or absent adrenocortical activity (adrenal insufficiency, Addisonian crisis).

This medication is used as a treatment for coronavirus disease 2019 (COVID-19) in adult and adolescent patients (at least 12 years old, with a body weight of at least 40 kg) with breathing difficulties and a need for oxygen therapy.

Local route (affects a limited part of the body)

• Injection near the joints (periarticular) and treatment that penetrates the tissue (infiltrative), for example, for shoulder joint inflammation (periarthritis), elbow joint inflammation (epicondylitis), joint capsule inflammation (bursitis), tendon sheath inflammation (tendovaginitis), and wrist inflammation (styloiditis).
• Injection into a joint (intraarticular), for example, in rheumatoid arthritis, if individual joints are affected or do not respond adequately to systemic treatment, accompanying inflammatory reactions in degenerative joint disease (rheumatoid arthritis).

Do not administer Dexametasona Kalceks

• If you are allergic to dexamethasone or any of the other components of this medication (listed in section6).
• If you have a body-wide infection, including one that could have been caused by a fungus (such as candidiasis) that is not being treated with antibiotics.
• The injection into a joint should not be administered in the following cases: infections within or near the joint being treated; bacterial arthritis (inflammation of the joint caused by bacteria); instability of the joint being treated; a tendency to bleed (spontaneous or due to anticoagulants); calcium deposits near the joint (periarticular calcification); localized death of bone tissue, especially in the head of the humerus and femur (avascular necrosis of the bone); tendon rupture; joint disease due to syphilis (Charcot joint).
• Unilateral infiltration without additional treatment of the cause is contraindicated in the presence of infections within the area of administration.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to administer this medication, as special care is required if:

• You have an acute or chronic bacterial infection.
• You have had tuberculosis.
• You have a fungal disease that affects internal organs.
• You have a parasitic disease (such as amoebiasis or tapeworm infection).
• You have an acute viral infection (hepatitis B, herpes infection, varicella).
• You (or your child) have been or will be vaccinated (see "Other medications and Dexametasona Kalceks"). Inform your doctor especially if you have not yet had measles or chickenpox or if your child's immune system is weakened.
• You have stomach or intestinal ulcers.
• You have osteoporosis (bone tissue decomposition). Your doctor may want to determine your bone density before starting long-term treatment. Your doctor may prescribe calcium supplements, vitamin D, and/or medications to reduce bone density if necessary. In patients with advanced osteoporosis, this medication will only be used in life-threatening situations or for short periods.
• You have uncontrolled high blood pressure.
• You have diabetes.
• You have a history of mental illness, including the risk of suicide.
• You have increased pressure in the eye (glaucoma of closed and open angles), eye injuries, or ulcers (as close monitoring and treatment by an ophthalmologist are required).
• You have heart or kidney disorders.
• You have myasthenia gravis (a muscle disease), as symptoms may worsen initially after dexamethasone administration; the initial dose should be selected with caution.
• You have a tumor of the adrenal glands (pheochromocytoma).

If you are unsure whether the above applies to you, consult your doctor or pharmacist.

Inform your doctorif you notice any of the following symptoms while being treated with this medication:

• Muscle cramps, muscle weakness, confusion, deterioration or loss of vision, and difficulty breathing, in the case of cancer in the blood. These may be symptoms of tumor lysis syndrome.
• Blurred vision or other visual disturbances.

Concurrent use of corticosteroids

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

General precautions related to the use of corticosteroids in specific diseases, masking of infections, concurrent medications, etc., should be adjusted according to current recommendations.

Severe allergic reactions

Severe allergic reactions, including anaphylaxis (a potentially life-threatening reaction), may occur with symptoms such as irregular heartbeats, constriction of respiratory muscles, decreased or increased blood pressure, circulatory failure, or cardiac arrest.

Adrenocortical insufficiency

Stopping treatment abruptly for more than 10days may cause acute adrenocortical insufficiency. Therefore, the dose should be reduced gradually if you anticipate stopping treatment. Depending on the dose and duration of treatment, adrenocortical insufficiency caused by glucocorticoid treatment may persist for several months and, in individual cases, for more than a year after treatment has been discontinued.

If you experience specific physical stress situations during treatment, such as a fever, accident, or surgical intervention, inform your doctor or emergency physician immediately about the ongoing dexamethasone treatment. You may need to temporarily increase your daily dexamethasone dose. Glucocorticoid administration may also be necessary in physical stress situations if adrenocortical insufficiency persists after treatment has been discontinued.

Risk of infection

Dexamethasone at doses higher than those required for maintenance treatment is associated with an increased risk of infection, possible worsening of an existing infection, and possible activation of a latent infection. The anti-inflammatory effect may mask infection symptoms until the infection reaches a higher level.

Gastrointestinal disorders

Due to the risk of intestinal wall perforation with peritonitis (inflammation of the peritoneum), this medication will only be used if there are medical reasons to do so, along with adequate control, in the following cases:

• Severe inflammation of the colon (ulcerative colitis) with impending perforation;
• abscesses or purulent infections (filled with pus);
• diverticulitis (inflammation of diverticula in the colon wall);
• after certain types of intestinal surgery (intestinal anastomosis) immediately after the intervention.

Patients receiving high doses of glucocorticoids may not have signs of peritoneal irritation after a stomach or intestinal ulcer perforation.

Prolonged treatment

During prolonged treatment, regular medical check-ups (including ophthalmological check-ups every three months) are indicated; at comparably high doses, ensure adequate potassium intake (e.g., with vegetables or bananas) and restrict sodium (salt) intake, and monitor blood potassium levels. A careful watch is also recommended in patients with severe heart failure (heart inability to provide the necessary amount of blood for metabolism, during effort or even at rest).

Warnings related to specific administration methods

• The medication will be injected slowly (2‑3minutes) into a vein, as a too rapid injection may cause temporary unpleasant tingling or abnormal skin sensations that may last up to 3minutes. These effects are harmless in themselves.
• Glucocorticoid administration into a joint increases the risk of joint infections. Prolonged and repeated use of glucocorticoids in weight-bearing joints may lead to worsening of degenerative changes within the joint. A possible cause is the overloading of the affected joint after regression of pain or other symptoms.

Other warnings

• At high doses, it may cause a decrease in heart rate.
• The risk of tendon disorders, inflammation, and rupture increases when fluoroquinolones (antibiotics) are used concurrently with dexamethasone.
• Principally, vaccination with inactivated vaccines is possible. However, it should be remembered that higher doses may compromise the immune response and, therefore, the success of vaccination.
• In elderly patients, the doctor will carefully weigh the benefits and risks and pay attention to side effects, such as osteoporosis (bone tissue rupture).
• If dexamethasone is administered to a premature baby, careful monitoring of heart function and structure is necessary.

Children and adolescents

Dexamethasone should not be used routinely in premature neonates with respiratory problems.

In children and adolescents, treatment should only be administered if there are medical reasons to do so, due to the risk of growth delays. Whenever possible, intermittent therapy should be pursued during long-term treatment.

Other medications and Dexametasona Kalceks

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Some medications may increase the effects of dexamethasone, and your doctor may want to closely monitor you if you are using these medications (including HIV medications: ritonavir, cobicistat).

Inform your doctor or pharmacist if you are taking any of the following medications:

• Medications to treat heart failure or asthma (cardiac glycosides);
• Medications used to increase urine production;
• Medications to reduce blood sugar levels (antidiabetic medications);
• Medications to prevent blood clots/anticoagulants (cumarin derivatives);
• Ephedrine (used for asthma and poor circulation);
• Rifampicin (used to treat tuberculosis);
• Medications to treat seizures and epilepsy (phenytoin, carbamazepine, primidone);
• Barbiturates (medications to help you sleep);
• Ketoconazole, itraconazole (used to treat fungal infections);
• Medications to treat infections (macrolide antibiotics, such as erythromycin, or fluoroquinolones, such as ciprofloxacin);
• Analgesics and anti-inflammatory/antirheumatic medications (e.g., salicylates and indomethacin);
• Contraceptives containing estrogens;
• A medication to treat intestinal parasitic infestations (praziquantel);
• Medications to treat high blood pressure and some heart diseases (ACE inhibitors or angiotensin-converting enzyme inhibitors);
• Antimalarial medications (chloroquine, hydroxychloroquine, mefloquine);
• Growth hormone (somatropin);
• Laxatives;
• Atropine and other anticholinergic medications (medications that block the action of a specific neurotransmitter in the brain);
• Medications to relax muscles;
• Medications that weaken the immune system (ciclosporin);
• Bupropion (a smoking cessation aid).

The medication may suppress skin reactions to allergy tests. Interactions may occur with a medication used in thyroid tests (protirelina: may reduce the increase in TSH that occurs when protirelina is administered).

If dexamethasone treatment is carried out 8weeks before and up to 2weeks after active preventive vaccination, it can be expected that the efficacy of the vaccination will be reduced or abolished.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Dexamethasone crosses the placental barrier. During pregnancy, especially in the first three months, it should only be used after careful evaluation of the benefits and risks. Therefore, women should inform their doctor if they are or become pregnant. During long-term treatment in pregnancy, the possibility of growth disorders in the fetus cannot be ruled out. If glucocorticoids are administered at the end of pregnancy, there is a risk of hypoadrenalism in the newborn, which may require gradual substitution treatment in the neonate, which will be gradually reduced. Newborns of mothers who received Dexametasona Kalceks near the end of pregnancy may present with low blood sugar levels after birth.

Lactation

Glucocorticoids are excreted in human milk. To date, no harm to the suckling infant has been reported. However, they should only be used when strictly indicated during lactation. If higher doses are required, lactation should be interrupted.

Fertility

No fertility studies have been conducted.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery.

Dexametasona Kalceks contains sodium

This medication contains approximately 3mg of sodium (main component of table salt/for cooking) in each ml of solution. This corresponds to 0.15% of the maximum daily sodium intake recommended for an adult.

This medication should be used only as directed by your doctor. Your doctor will decide how long you should use dexamethasone. If you are unsure, consult your doctor or pharmacist again.

This medication can be administered through a vein, muscle, or joint, as well as in the form of an injection into soft tissues.

The dosage depends on the indication, the severity of symptoms, the individual response of the patient, and in the case of injection into a joint, the size of the joint.

Glucocorticoids should be used only for the time and at the lowest dose necessary to achieve and maintain the desired effect. The duration of use is determined by the indication. Prolonged use of dexamethasone should not be stopped abruptly, but rather the dose should be gradually reduced according to the doctor's instructions.

For the treatment of COVID-19‑19

Adult patientsare recommended to be administered 6mg through a vein, once a day, for a maximum of 10días.

Use in adolescents:It is recommended that pediatric patients (adolescents from 12years of age with a body weight of at least 40kg) be administered 6mg through a vein, once a day, for a maximum of 10días.

Renal insufficiency

No dose adjustment is necessary.

Liver insufficiency

In patients with severe liver disease, a dose adjustment may be necessary.

Children and adolescents

In children up to 14years of age, during long-term treatment, an interval of 4días without treatment should be introduced after each period of 3días of treatment due to the risk of growth alterations.

If you have been administered more Dexametasona Kalceks than you should have

No cases of acute intoxication with dexamethasone have been reported. In the event of an overdose, an increase in side effects is expected. If you believe you have been administered an excessive amount of this medication, inform your doctor immediately.

If you interrupt treatment with Dexametasona Kalceks

Treatment should not be interrupted or stopped abruptly, unless instructed by a doctor. If you decide to stop treatment on your own, for example, due to side effects that occur or because you feel better, not only will you be putting your treatment at risk, but you will also be exposing yourself to significant risks. In particular, after a prolonged period of treatment, you should never stop this medication on your own. Always consult your doctor first.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

In short-term treatment with dexamethasone, the risk of side effects is low. The following side effects may occur:

• Stomach ulcers or duodenal ulcers;
• Reduction of the body's defenses against infections;
• Increased blood sugar levels (reduced glucose tolerance).

The following side effects may occur, which to a large extent depend on the dose and duration of treatment, and whose frequency is therefore unknown (cannot be estimated from available data):

Infections and infestations

Masking of infections, fungal, viral, and other (opportunistic) infections that favor the development or worsening, activation of worms (see section2, "Warnings and precautions").

Blood and lymphatic system disorders

Alterations in the blood count or hemogram (moderate leukocytosis, lymphocytopenia, eosinopenia, polycythemia).

Immune system disorders

Hypersensitivity reactions (e.g., exanthema), weakening of the immune system, allergic reactions, and even anaphylaxis (potentially fatal allergic reaction), with symptoms such as irregular heartbeats, constriction of respiratory muscles, decreased or increased blood pressure, circulatory failure, or cardiac arrest.

Endocrine system disorders

Cushing's syndrome (e.g., moon face, upper body obesity), adrenocortical inactivity or atrophy.

Metabolism and nutrition disorders

Retention of sodium in the body with accumulation of water in tissues, increased potassium excretion (precaution: possible cardiac rhythm disorders), weight gain, increased blood sugar levels (reduced glucose tolerance), diabetes, increased blood fat levels (cholesterol and triglycerides), increased appetite.

Mental disorders

Psychosis, depression, irritability, euphoria (excessive joy), sleep disorders, instability, anxiety, mania, hallucinations, suicidal thoughts.

Nervous system disorders

Pseudotumor cerebri ("false" brain tumor), first appearance of epilepsy in patients with latent epilepsy (previously "inactive") and increased susceptibility to seizures in pre-existing epilepsy (attacks).

Eye disorders

Glaucoma, cataracts, worsening of corneal ulcer symptoms, promotion of eye inflammation due to viruses, fungi, and bacteria; worsening of bacterial inflammation of the cornea, drooping eyelid (ptosis), dilated pupils, conjunctival edema, iatrogenic perforation of the sclera (induced by the doctor), alteration or loss of vision, blurred vision. In rare cases, reversible protrusion of the eyeball (exophthalmos).

Cardiac disorders

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

Vascular disorders

High blood pressure, increased risk of atherosclerosis (alteration of blood vessel walls) and thrombosis (obstruction of blood vessels by a clot), inflammation of blood vessels and lymphatics (vasculitis, also as withdrawal syndrome after prolonged treatment), fragility of blood vessel walls (capillary fragility).

Gastrointestinal disorders

Abdominal discomfort, gastrointestinal ulcers, digestive bleeding, inflamed pancreas, risk of intestinal perforation in ulcerative colitis (severe inflammation of the large intestine).

Skin and subcutaneous tissue disorders

Striae, skin thinning, localized small hemorrhages under the skin, hematomas, steroid acne, inflammation of the skin around the mouth, dilation of superficial blood vessels, excessive body hair, changes in skin pigmentation.

Musculoskeletal and connective tissue disorders

Muscle weakness, muscle atrophy, inflammatory muscle disease, tendon disorders, inflammation, or rupture, bone decomposition (osteoporosis), growth delay in children, aseptic bone necrosis (death of bone tissue without microbial presence), increased fatty tissue in the spinal canal.

Reproductive and mammary system disorders

Sex hormone secretion disorders, such as amenorrhea, excessive hair growth with a male pattern in women, impotence.

General disorders and administration site conditions

Delayed wound healing.

Local use

Irritation and signs of intolerance (sensations of heat, prolonged pain) are possible, especially in eye use. A tissue wear cannot be ruled out if dexamethasone is not injected carefully into the joint cavity.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above30°C.

Store the ampoules inthe outer packagingto protect them from light.

After opening the ampoule: Once opened, the medication must be used immediately.

Period of validity after dilution

The chemical and physical stability in use has been demonstrated for 48hours at 25°C (protected from light) and 2‑8°C.

From a microbiological point of view, the diluted solution must be used immediately. If not used immediately, the storage times in use and the conditions prior to use are the responsibility of the user and should normally not exceed 24hours at a temperature of 2to 8°C, unless the dilution was made in controlled and validated aseptic conditions.

Do not use this medication after the expiration date that appears on the boxand on the ampoule after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Dexamethasone Kalceks

• The active principle is dexamethasone phosphate.

Cada ampolla de 1ml contiene fosfato sódico de dexametasona, equivalente a 4mg de dexametasona fosfato.

• The other components are: creatinina, citrato sódico, edetato disódico, hidróxido sódico and water for injectable preparations.

Aspect of Dexamethasone Kalceks and packaging content

Transparent and colorless solution, without visible particles.

1ml type I glass ampoules, transparent, colorless with a cutting point.

The ampoules are marked with a ring code of a specific color.

The ampoules are placed in trays. The trays are packaged in cardboard boxes.

Packaging sizes:

3, 10, 25, 50 or 100ampoules of 1ml.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible for Manufacturing

AS KALCEKS

Krustpils iela 71E,

Riga, LV‑1057,

Latvia

Tel.: +37167083320

E‑mail:[email protected]

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

EVER Pharma Therapeutics Spain SL

c/ Toledo 170

28005 Madrid

Spain

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

EstoniaDexamethasone Kalceks

Austria, GermanyDexamethasone Kalceks 4 mg/ml Injektions-/Infusionslösung

CroatiaDeksametazon Kalceks 4 mg/ml otopina za injekciju/infuziju

Czech Republic, PolandDexamethasone Kalceks

Denmark, NorwayDexamethasone phosphate Kalceks

FinlandDexalcex 4 mg/ml injektio-/infuusioneste, liuos

FranceDEXAMETHASONE KALCEKS 4 mg/1 mL, solution injectable/pour perfusion

HungaryDexamethasone Kalceks 4 mg/ml oldatos injekció vagy infúzió

IrelandDexamethasone phosphate 4 mg/ml solution for injection/infusion

ItalyDesametasone Kalceks

LatviaDexamethasone Kalceks 4mg/ml škidums injekcijam/infuzijam

LithuaniaDexamethasone Kalceks 4 mg/ml injekcinis ar infuzinis tirpalas

NetherlandsDexamethasonfosfaat Kalceks 4 mg/mloplossing voor injectie/infusie

PortugalDexametasona Kalceks

SloveniaDeksametazon Kalceks 4 mg/ml raztopina za injiciranje/infundiranje

SpainDexametasona Kalceks 4 mg/ml soluci?n inyectable y para perfusi?n EFG

SwedenDexalcex

Last review date of this leaflet:January 2022.

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

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This information is intended only for healthcare professionals:

Dosage and administration

In case of the need for high doses in a particular treatment, consider the use of medicinal products containing dexamethasone with higher concentration/volume.

1. Systemic route

For thetreatment and prophylaxis of cerebral edema associated with brain tumors (in the postoperative period and after radiation with X-rays) and after spinal cord trauma

Depending on the cause and severity, the initial dose is8‑10mg (up to80mg), administered intravenously, followed by16‑24mg (up to48mg)/day, divided into3‑4(6) single intravenous doses over4‑8días. During radiation therapy and in the conservative treatment of inoperable brain tumors, long-term administration of lower doses of dexamethasone phosphate may be necessary.

Foranaphylactic shock, first administer intravenous adrenaline, then intravenous dexamethasone phosphate 40‑100mg (children 40mg) as needed.

Shock polytrauma/prophylaxis of post-traumatic pulmonary shock

Initially, 40‑100mg (children 40mg) intravenously, with repetition of the dose after 12hours, or every 6hours 16‑40mg for 2‑3días.

Forsevere exacerbations of asthma, administer 8‑40mg intravenously as soon as possible; if necessary, repeat injections of 8mg every 4hours.

Foracute severe dermatitis and severe blood diseases, initial treatment with 20‑40mg of dexamethasone phosphate intravenously, followed by treatment according to the severity of the case, with the same daily dose or lower doses in the first days and switching to oral therapy.

For the treatment ofacute adrenal insufficiency(Addisonian crisis), initiate treatment with 4‑8mg of dexamethasone phosphate intravenously.

For the treatment of COVID-19

Adult patients:6mg intravenously once a day for a maximum of 10días.

Older adults, renal insufficiency, hepatic insufficiency [low-dose treatment (6mg daily) and short duration]:No dose adjustment is necessary.

Pediatric population:For pediatric patients (adolescents from 12years old with a body weight of at least 40kg), recommend the use of 6mg intravenously once a day for a maximum of 10días.

The duration of treatment should be guided by clinical response and individual patient requirements.

2. Local route

For local infiltrative treatment, periarticular and intraarticular, in strictly aseptic conditions, inject 4mg or 8mg of dexamethasone phosphate. For injection into a small joint, 2mg of dexamethasone phosphate is sufficient. According to the severity of the disease, no more than 3‑4infiltrations or 3‑4injections per joint should be performed. The interval between injections should not be less than 3‑4weeks.

Administration form

Intravenous, intramuscular, intraarticular or local (infiltration).

This medicinal product is generally administered intravenously slowly (2‑3minutes) in acute diseases, by injection or infusion. However, it can also be administered intramuscularly (only in exceptional cases), as local infiltration or intraarticular injection.

Instructions for use, disposal and other manipulations

For single use.

Once the ampoule is opened, the medicinal product should be used immediately. Dispose of any remaining content.

Inspect the ampoule visually before use. It should only be used if the solution is transparent and free of particles.

pH of the solution between7,0-8,5

This medicinal product should not be mixed with other medicinal products, except for those mentioned below.

This medicinal product should be administered preferably by direct intravenous injection or injected into the infusion tube. However, the injectable solutions are compatible with the following infusion solutions (250ml and 500ml):

• 0.9% sodium chloride solution
• 5% glucose solution
• Ringer's solution

When combined with infusion solutions, the information provided by the respective manufacturers on their infusion solutions, including compatibility data, contraindications, undesirable effects and interactions, should be taken into account.

Instructions for opening the ampoule:

1)Hold the ampoule with the color point upwards. If there is any solution left in the upper part of the ampoule, gently tap it with your finger to allow all the solution to flow to the lower part of the ampoule.

2)Use both hands to open it and while holding the lower part of the ampoule with one hand, use the other hand to break the upper part of the ampoule in the opposite direction to the color point (see the images below).

The disposal of unused medicinal product and all materials that have come into contact with it will be carried out in accordance with local regulations.