Analgin 500 mg 2 ml N10 Ampoule (Belarus)

Analgin

Analgin composition

10 mg per kilogram of body weight is recommended in the first 3 months; the use of Analgin in children is not recommended—use other available dosage forms for young children. For patients from 3 months to 1 year, metamizole is administered only intramuscularly; the table includes the recommended single doses and maximum doses. Single dose Maximum dose ml (50-0.4-0.8 100 mg metamizole 400 mg ml (200 sodium) only intranatrium) only oral (body weight) 3-11 0.1-0.2 (5-8 kg) 1-3 years (9-15 kg) 0.2-0.5 250 mg sodium) 0.3-0.8 1-5 days when used—1-3 days, including death—decrease in the number of white blood cells (agranulocytosis) or decrease in platelets (thrombocytopenia); These reactions may occur as a result of the body’s immune system; if metamizole is tolerated without complications previously, they may also occur; if used for more than a week, there may be an increased risk of agranulocytosis. Anecdotal evidence suggests that fever, chills, sore throat, difficulty swallowing, and inflammation in the mouth, nose, throat, genital organs, or anal area (medicines used to treat bacterial infections) may be mild. The erythrocyte sedimentation rate (ESR) increases significantly and lymph nodes usually become slightly enlarged or generally enlarge. Typical signs of a decrease in the number of platelets are: increased tendency to bleed and precise identification of bleeding in the skin and mucous membranes; widespread skin blisters and peeling of the skin (Stevens-Johnson syndrome or toxic epidermal necrolysis); acute worsening of kidney function, in some cases absence or decrease of urine output, presence of blood proteins in urine; acute renal failure; inflammation of the kidneys (acute interstitial nephritis). Sudden circulatory failure as a result of a severe allergic reaction (anaphylactic shock) of unknown severity (cannot be estimated from available data); heart attack as part of an allergic reaction (Kounis syndrome); anemia with simultaneous dysfunction of bone marrow (aplastic anemia); decrease in the number of leukocytes, erythrocytes, and platelets (pancytopenia), including no fatal outcome. Signs of these blood changes include: general malaise, infection, persistent fever, bruising, bleeding, and paleness.

inflammation of the liver, yellowing of the skin or the whites of the eyes, increased levels of liver enzymes in the blood; gastrointestinal bleeding; stop using the medicine and contact your doctor immediately if you notice any of the following serious adverse reactions: reddish, non-blanching, target-shaped or round patches on the trunk, frequent central blisters, skin peeling, and sores in the mouth, throat, nose, genital organs, or eyes. Before these serious rashes, fever and flu-like symptoms may occur (Stevens-Conson syndrome, toxic epidermal necrolysis); widespread rash, high body temperature, and swelling of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). A harmless breakdown product of metamizole may cause the urine to turn red; injection site pain and local reactions may occur, and very rarely—phlebitis (inflammation of the veins).

Contraindications

decrease in the number of white blood cells (leukopenia); rash (e.g., maculopapular exanthema). Very rarely (may affect up to 1 in 10,000 people) a marked decrease in granulocytes—Analgin must not be used in the following cases: allergy to metamizole or other pyrazolones (e.g., phenazone, propiphenazone) or pyrazolidines (e.g., phenylbutazone, oxyphenbutazone); This also includes patients who have had a marked decrease in certain white blood cells (agranulocytosis) after using metamizole. “I have this product contains any component (listed in section 6.1); I have intolerance to painkillers and asthma or intolerance to analgesics, e.g., angioedema, urticaria); This applies to patients who react to analgesics such as salicylates, paracetamol, diclofenac, ibuprofen, indometacin, or naproxen with spasmodic narrowing of the lower airways or other reactions, and hypersensitivity such as urticaria with blisters, runny nose, swelling (urticaria, rhinitis, angioedema); dysfunctions of bone marrow, including after treatment with certain anticancer medicines; blood diseases; inherited disease with risk of destruction of red blood cells (congenital glucose-6-phosphate dehydrogenase deficiency); inherited disease with impaired formation of red blood pigment (acute intermittent hepatic porphyria); low blood pressure or poor circulation; shortness of breath with asthma, especially if you have nasal polyps or inflammation of the HOC and paranasal sinuses; long-lasting urticaria; hypersensitivity to dyes (e.g., tartrazine) or preservatives (e.g., benzoates); intolerance to alcohol; If even a small amount of alcohol causes sneezing, watering of the eyes, and severe redness on your face, this may still be a sign of intolerance to analgesics not yet recognized (see section 21, “ ”).”

In patients with a high risk of developing hypersensitivity reactions, Analgin should be used only after careful assessment of the benefits and risks (also see section 2.1). In such cases, if Analgin is used, the patient must be under close medical supervision and ready for emergency care. Shock may occur, especially in sensitive patients (see section 4). Severe hypersensitivity reactions Severe skin reactions including drug reactions with severe skin reactions associated with metamizole treatment and eosinophilia and systemic symptoms (DRESS), such as Stevens-Conson syndrome, toxic epidermal necrolysis, eosinophilia and systemic symptoms, have been reported.

Stop using metamizole and contact your doctor immediately if you experience any of the reactions described above in section 4. If you have had serious skin reactions, you should never restart treatment with Analgin (see section 4). Liver disorders In patients taking metamizole, inflammation of the liver has been observed with symptoms developing within a few days or within a few months after starting treatment: feeling unwell (good or bad), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or the whites of the eyes, itching—if symptoms of liver disease occur, stop using Analgin and contact your doctor.

Pain in the upper abdomen may be related to liver function; if you have previously used metamizole, it is retained and you have a problem. A drop in blood pressure Analgin may cause a decrease in blood pressure (also see section 4). This occurs not orally, but with parenteral administration.

This risk increases further in the following cases: - injecting the medicine into a vein too quickly (see section 3); low blood pressure, dehydration, poor circulation or circulatory failure (e.g., in heart attack or severe injury); high temperature should be used only under careful monitoring of circulatory function; especially during severe coronary heart disease and narrowing of cerebral blood vessels, it is necessary to prevent a decrease in blood pressure. To minimize the risk of a severe drop in blood pressure and to stop the intravenous injection immediately at the first signs of anaphylactic or anaphylactoid reaction, the intravenous administration of Analgin must be very slow, i.e., no more than 1 ml per minute (or 0.5 g metamizole sodium) and/or in case of liver failure. If you have impaired kidney or liver function, Analgin should be used only after careful assessment of the benefit-risk and with appropriate precautions (see.

section 3, “Patients with severe liver or kidney failure”). Analgin should not be used together with other medicines except in cases of mixing. 2.3. Use in children Analgin should not be used in newborns and in children under 3 months or weighing less than 5 kg (no information available about use).

For children aged 3 to 11 months, Analgin can be used only intramuscularly—see the section “What you need to know before using Analgin”. 2.4. Use of Analgin with other medicinal products If you are taking any other medicines, have taken them recently, or intend to take them, tell your doctor or pharmacist.

In particular, tell your doctor about the following medicines, because their blood levels may decrease and their effectiveness may decrease: bupropion, a medicine used to treat depression and help you quit smoking; efavirenz, a medicine used to treat HIV/AIDS; methadone, a medicine used to treat drug dependence (called opioids); valproate, a medicine used to treat epilepsy or bipolar disorder; cyclosporine, a medicine used to suppress the body’s immune system; tacrolimus, a medicine used in transplant patients to prevent organ rejection; sertraline, a medicine used to treat depression. You must monitor the effectiveness and/or concentration of medicines in the blood. Tell your doctor about the following medicines that should be avoided when combined with Analgin: methotrexate, a medicine used to treat cancer or rheumatic diseases. Avoid use in the elderly at the same time because it may cause liver damage.

Acetylsalicylic acid in doses to protect the heart; concomitant use of acetylsalicylic acid and chlorpromazine used for mental disorders; Concomitant use may interact with some to reduce body temperature (it is not known to what extent the mother is involved in this interaction): anticoagulants taken; captopril, a medicine used for high blood pressure and other conditions; lithium-containing medicines and treatment of mental disorders—diuretics, such as medicines that lower blood pressure. 2.5. Effects on research methods Before performing laboratory tests, inform your doctor about the condition based on the results of certain laboratory tests such as fats in the blood, HDL cholesterol, or mo 2.6.

Use together with Analgin If possible, do not drink while using Analgin. 2.7. Pregnancy, breastfeeding and f If you are pregnant or breastfeeding, or if you are planning pregnancy, consult your doctor before taking this medicine. 2.7.1. Pregnancy Available data on use during the first three months of pregnancy do not show that it harms the embryo.

In some cases, without other treatment options, metamizole may be taken in the first and second trimesters after the doctor or pharmacist, and after considering the risks/benefits of use, metamizole use is usually in the first and second trimesters for a few months, because there are no severe complications for the mother and child: only for a newborn whose important vessel called the ductus is closed prematurely after birth. 2.7.2. During breastfeeding metamizole breakdown products enter the breast and this may pose a risk to the baby during breastfeeding, and repeated use of metamizole for feeding.

If you use only metamizole, it is recommended that mothers discard breast milk after using it. 2.8. Driving and operating machinery Works within the recommended dosage range

Use during pregnancy and breastfeeding

breastfeeding period; 2.2. Special warnings and precautions Before using Analgin, consult your doctor. Metamizole is contained and may cause rare but life-threatening adverse reactions: - sudden circulatory failure; agranulocytosis (a serious condition characterized by a sharp decrease in certain white blood cells in the blood). If you experience any of the following symptoms that may indicate possible agranulocytosis, stop using Analgin and contact your doctor immediately: unexpected deterioration of general health (e.g., fever, chills, sore throat, difficulty swallowing); fever that does not go away or does not return, painful changes in the mucous membranes, especially in the mouth, nose and throat, or in the genital or anal area (“See section Possible additional reactions”).

If you notice signs of a decrease in the number of all types of blood cells (pancytopenia) (e.g., general malaise, infection or persistent fever, bruising, bleeding and paleness) or of platelets (thrombocytopenia) (e.g., increased tendency to bleed, precisely identify bleeding in the skin), contact your doctor immediately and stop using the mucous membrane. 4 “Possible adverse reactions”). Your doctor should regularly monitor blood tests and stop treatment when certain changes occur. If you have an allergic or other reaction of the immune system to Analgin (e.g., agranulocytosis), you are at risk of the same reaction to other pyrazolones and pyrazolidines (chemically related substances), and to analgesics (phenazone, propiphenazone, phenylbutazone, but not sensitive to veroxisazone).

Allergic or other reactions caused by the immune system reacting to other pyrazolones (pyrazolidines) mean that when choosing the route of administration, it must be taken into account that parenteral administration (into a muscle or vein) is associated with a higher risk of hypersensitivity reactions. or compared with medicines containing metamizole in suppository form, hypersensitivity reactions. Hypersensitivity reactions Severe hypersensitivity reactions The risk of severe hypersensitivity reactions increases significantly in the following cases: intolerance to analgesics and antirheumatic medicines, including.

severe urticaria with itching and blisters or swelling; In this case, Analgin cannot be used—see section 2.1 for information.

Use in children

children under 3 months or with body weight less than 5 kg (no information available about use); age of children 3 to 11 months for intravenous administration.

How to use Analgin and dosage

Analgin solution can be administered intravenously or intramuscularly. In infants (3-11 months)—only intramuscularly. The temperature of the injection solution should be close to body temperature. The injection solution can be mixed with or diluted using 5% glucose solution, 0.9% saline solution, or Ringer lactate solution. Due to limited stability of these solutions, they must be used immediately.

Due to potential incompatibility, it is not recommended to use the Analgin solution together with other medicines in the same syringe or in an intravenous infusion system. 3.3. Duration of treatment When used as an anesthetic, the duration of treatment

Special warnings and precautions

If you are given a higher dose of Analgin than you should. When an overdose of Analgin is taken, various functional disorders of the body may occur: nausea, vomiting, abdominal pain; decreased kidney function up to acute renal failure, dizziness, drowsiness, loss of consciousness; convulsions; decreased blood pressure up to circulatory failure. Due to breakdown products of metamizole, urine may turn red. Disorders require medical supervision and appropriate treatment. If no specific antidote is known, the airways must be cleared and circulation restored.

For convulsions, patients who have lost consciousness should be hospitalized and treated with barbiturates or diazepam administered intravenously, and its metabolites can be removed from the body by hemodialysis, hemofiltration, hemoperfusion, or plasma filtration. If you have any additional questions about use, contact your doctor.

4. Possible adverse reactions Like all medicines, this medicine can cause adverse reactions, even if not everybody gets them. The use of this medicine should be stopped immediately if serious adverse reactions occur, and if any of the adverse reactions listed occur suddenly or develop rapidly, you should contact a doctor as soon as possible.

Some additional reactions (e.g., severe hypersensitivity reactions, Stevens-Conson syndrome or toxic epidermal necrolysis, severe skin reactions such as agranulocytosis, pancytopenia) can be life-threatening. In such a case, Analgin should not be continued without medical supervision. If signs of pancytopenia or thrombocytopenia occur (see below and section 2.2 “Special warnings and precautions”), Analgin intake must be stopped immediately and a blood test must be checked by a doctor, including a differential blood test. Do not delay stopping treatment until results are obtained.

Stop using Analgin and contact your doctor immediately if you notice any of the following symptoms: feeling unwell (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or the whites of the eyes, itching in the upper abdomen, rash or pain. These symptoms may be signs of liver damage (also see section 2.2 “Special warnings and precautions”). Other possible additional reactions. Often (may affect up to 1 in 100 people) skin rash from violet to dark red, sometimes with blisters (fixed drug eruption related to the medicine); decreased blood pressure that may be directly related to the effect of the medicine and not accompanied by other signs of hypersensitivity. This reaction rarely causes a sharp decrease in blood pressure. If you have a high fever, the risk of low blood pressure may also increase.

Typical signs of a sudden decrease in arterial blood pressure include: tachycardia, pallor, chills, dizziness, nausea and fainting (may affect up to 1 in 1,000 people). Severe hypersensitivity reactions (anaphylactoid or anaphylactic reactions). Signs of mild reactions include: burning eyes, cough, runny nose, sneezing, tightness in the chest, redness of the skin, especially on the face and head, hives and swelling on the face; less commonly: nausea and abdominal cramps. Burning, itching and a feeling of warmth on the tongue and under it, especially on the palms of the hands and the soles of the feet.

These milder reactions may progress to more severe forms: severe urticaria, severe angioedema (swelling in the throat area), severe spasmodic narrowing of the lower airways, rapid heartbeat, sometimes very slow heartbeat, cardiac arrhythmia, decreased blood pressure, sometimes a decrease in blood pressure in advance, increased circulatory failure. These reactions may occur especially after intravenous administration and can be serious or life-threatening, and in some cases fatal. They can also occur after repeated use without complications in patients with a syndrome. In some asthma patients, hypersensitivity reactions usually present as asthma attacks (see section 2.1 “