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Arthrocol 2.5% 45 g gel in tube

Instructions for medical use of the drug Artrocol Trade name Artrocol International nonproprietary name Ketoprofen Dosage form Gel 2.5% 45 g Composition 100 g of gel contain the active substance - ketoprofen 2.5 g, excipients: carbomer 980, trolamine, ethanol 96%, methyl parahydroxybenzoate , purified water. Description Homogeneous transparent gel Pharmacotherapeutic group Preparations for local treatment of diseases of the musculoskeletal system. Non-steroidal anti-inflammatory drugs for topical use. Ketoprofen Code ATX M02AA10 Pharmacological actions Pharmacokinetics When applied topically in the form of a gel, it is absorbed extremely slowly and practically does not accumulate in the body. The bioavailability of ketoprofen in gel form is about 5%, which determines the local nature of its effect on the body and the absence of systemic effects. Pharmacodynamics Ketoprofen is a non-steroidal anti-inflammatory drug, a derivative of the propionic acid group. The mechanism of action is associated with inhibition of prostaglandin synthesis. It has a local analgesic, anti-inflammatory, anti-exudative effect. Indications for use - disease of the musculoskeletal system (articular syndrome with exacerbation of gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of various localizations, osteochondrosis, inflammatory damage to the ligaments, tendons, bursitis, sciatica, lumbago) - myalgia of rheumatic and non-rheumatic origin - post-traumatic inflammation of soft tissues and the musculoskeletal system (symptomatic treatment of uncomplicated injuries, including sports, dislocations, sprains or ruptures of ligaments and tendons, bruises, post-traumatic pain) Method of administration and dosage The drug is intended for external use. A small amount of gel (a column 3–5 cm long) should be applied to painful and inflamed areas 1–2 times a day, rubbed into the skin for several minutes. The duration of treatment without consulting a doctor should not exceed 7 days. Side effects Often: - minor allergic reactions and redness of the skin, skin rash, - photosensitivity Very rarely: - nausea, vomiting, constipation, abdominal pain - gastrointestinal bleeding, peptic ulcer, diarrhea - exacerbation of previous renal failure, interstitial nephritis - severe inflammatory reaction of the skin (contact dermatitis), bullous dermatitis - headaches, dizziness, drowsiness - asthma attack (aspirin asthma) - skin eczema - purpura If any side effects occur, stop using the drug and consult a doctor. Contraindications - individual hypersensitivity to the components of the drug, acetylsalicylic acid or other NSAIDs (including a history of) - children under 15 years of age - pregnancy and lactation - a history of allergic reactions to taking salicylates or a predisposition to allergic diseases and bronchial asthma - the gel should not be applied to damaged skin (eczema, weeping dermatitis, open or infected wound) - solar or ultraviolet irradiation (during treatment or within 2 weeks after its cessation) Drug interactions There have been no reports of interaction of the gel with other drugs . However, careful monitoring of patients taking coumarin drugs is recommended, since non-steroidal anti-inflammatory drugs may increase the hypoprothrombinemic effect and risk of bleeding when used together with oral anticoagulants. Special instructions The gel should not be applied to areas of skin with pathological changes, such as eczema or acne; or infected skin areas or open wounds. Avoid getting the gel on mucous membranes or eyes. After applying the gel, you should immediately wash your hands. The drug is not recommended for use with occlusive (airtight) dressings. Despite the fact that the plasma concentration after using ketoprofen in gel form is much lower than when taken orally, caution must be exercised when prescribing the drug to patients with a history of gastrointestinal ulcers, renal and liver failure, and those receiving coumarin anticoagulants. The appearance of skin rashes after applying the drug is grounds for stopping its use. During treatment and for 2 weeks after treatment, direct sunlight, including solariums, should be avoided. Pregnancy and lactation The drug is contraindicated for use during pregnancy, since NSAIDs can cause prolongation of the gestational period, premature closure of the ductus Botallus and pulmonary hypertension in the newborn and during lactation. Features of the effect of the drug on the ability to drive vehicles and potentially dangerous mechanisms There is no data on the effect of the drug on the ability to drive vehicles and control mechanisms. Overdose Symptoms: irritation, erythema, itching. Treatment: rinse the skin thoroughly under running water, discontinue the drug, symptomatic treatment. Release form and packaging 45 g in aluminum tubes with an internal varnish coating. Each tube, along with instructions for medical use in the state and Russian languages, is placed in a cardboard pack. Storage conditions Store at temperatures from 150 C to 250 C. Keep out of the reach of children! Shelf life: 3 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription, Boulevard Theodor Pallady No. 44C, sector 3, Bucharest, Romania SC “Slavia Pharm SRL”, Theodor Pallady 44C, district 3, Bucharest, Romania. The owner of the trademark and registration certificate is Great Britain (“WORLD MEDICINE”, Great Britain). Address of the organization that accepts claims from consumers on the quality of products (goods) of the Republic of Kazakhstan on the territory of the Republic of Kazakhstan, Almaty, st. Suyunbaya 222 B Tel/fax: 8(7272)529090

Texared injection

INSTRUCTIONS for the use of the medicinal product for medical use TEXARED

Registration number: LS-000295 Trade name of the drug: Texared International nonproprietary name (INN): Tenoxicam Dosage form: lyophilisate for the preparation of solution for injection 20 mg. Chemical name: 4-hydroxy-2-methyl-1,1-dioxo-N-(2-pyridyl)-1,2-dihydro-1λ6-thieno[2,3-e][1,2]-thiazine-3 -carboxamide

Compound:

1 bottle contains:

Active substance:
Tenoxicam	20.00 mg	Eur.F.
Auxiliary components:
Mannitol	57.33 mg	Eur.F.
Sodium hydroxide	3.28 mg	Eur.F.
Trometamol	3.00 mg	Eur.F.
Sodium metabisulfite	2.00 mg	Eur.F.
Disodium edetate	0.20 mg	Eur.F.

Description:

Lyophilized powder of yellow color with a greenish tint.

Pharmacotherapeutic group: Nonsteroidal anti-inflammatory drug

(NSAID)

ATX code: [M01AC02]

Pharmacodynamics

Tenoxicam, a thienothiazine derivative of oxicam, is a non-steroidal anti-inflammatory drug. In addition to anti-inflammatory, analgesic and antipyretic effects, the drug also prevents platelet aggregation. Tenoxicam exerts its anti-inflammatory effect by inhibiting the activity of cyclooxygenase isoenzymes involved in the metabolism of arachidonic acid, and thus inhibits the synthesis of prostaglandins. Tenoxicam has no effect on the activity of lipoxygenases. In addition, tenoxicam inhibits some functions of leukocytes, including phagocytosis, histamine release and reduces the content of active radicals at the site of inflammation.

Pharmacokinetics

The drug is quickly absorbed from the gastrointestinal tract unchanged. Cmax is reached 2 hours after taking the drug. When taking the drug after meals or together with antacids, the rate, but not the extent of its absorption, decreases. The average half-life is 70 hours. Tenoxicam is completely absorbed, its bioavailability is 100%. In the blood, the drug is 99% protein bound. The drug penetrates well into the synovial fluid, is characterized by low systemic clearance and a long half-life, which allows tenoxicam to be taken once a day. Two-thirds of the dose taken is excreted in the urine, 1/3 in feces. With long-term use, accumulation of tenoxicam is not observed; The serum content of the drug is 10-15 mcg/ml.

Indications for use:

Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, articular syndrome with exacerbation of gout, bursitis, tenosynovitis; pain syndrome (weak and moderate intensity): arthralgia, myalgia, neuralgia, migraine, toothache and headache, algomenorrhea; pain from injuries, burns.

For inflammatory and degenerative diseases of the musculoskeletal system, accompanied by pain, such as sciatica, lumbago, epicondylitis. Intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Contraindications:

Hypersensitivity, erosive and ulcerative lesions of the gastrointestinal tract (including a history), gastrointestinal bleeding (including a history), severe gastritis; complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to ASA or other NSAIDs (including a history); hemophilia, hypocoagulation, liver and/or renal failure (creatinine clearance less than 30 ml/min), inflammatory diseases of the gastrointestinal tract, progressive kidney disease, active liver disease, condition after CABG; confirmed hyperkalemia, hearing loss, pathology of the vestibular apparatus, glucose-6-phosphate dehydrogenase deficiency; blood diseases, pregnancy, lactation.

Directions for use and dosage:

Intramuscularly, intravenously. Texared injections are prescribed for short-term treatment - 20 mg per day, for long-term treatment - 20 mg per day, for long-term use - 10 mg per day. For gouty arthritis, 40 mg per day is prescribed for 1-2 days, and 20 mg per day for the next 3-5 days. The prescribed dose should be taken in one dose.

Carefully:

CHF, edema, arterial hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular diseases, dyslipidemia/hyperlipidemia, peripheral arterial diseases, smoking, chronic renal failure (creatinine clearance 30-60 ml/min), presence of H. pylori infection, long-term use of NSAIDs, alcoholism, severe somatic diseases, simultaneous use of oral corticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram , fluoxetine, paroxetine, sertraline), old age.

Overdose:

In case of drug overdose, symptomatic treatment is necessary.

Special instructions:

During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys, the prothrombin index (against the background of indirect anticoagulants), and the concentration of glucose in the blood (against the background of oral hypoglycemic drugs). If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. A few days before surgery, the drug is discontinued. It is necessary to take into account the possibility of Na+ and water retention in the body when prescribing diuretics to patients with arterial hypertension and CHF.

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used for the shortest possible short course.

Side effects:

Adverse events that may occur during the use of Texared in film-coated tablets include the following:

Digestive system disorders (11.4% of cases):

Burning sensation in the stomach, stomach pain, vomiting, nausea, diarrhea, constipation, flatulence, etc. NSAID gastropathy, abdominal pain, stomatitis, anorexia, liver dysfunction. With long-term use in large doses - ulceration of the mucous membrane of the gastrointestinal tract of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), perforation of the intestinal walls.

From the cardiovascular system:

heart failure, tachycardia, increased blood pressure.

Central nervous system disorders (2.6% of cases):

Headache, dizziness, drowsiness, depression, agitation, hearing loss, tinnitus, eye irritation, blurred vision.

Disorders of the skin and subcutaneous tissue (2.5% of cases):

Rash, itching, erythema and urticaria. Photodermatitis, Stevens-Johnson syndrome, and Leila syndrome were extremely rare.

From the urinary system (1-2%):

Increased levels of urea nitrogen and creatinine in the blood.

Disorders of the hematopoietic organs (1-2%):

Agranulocytosis, leukopenia, rarely anemia, thrombocytopenia.

Hepatobiliary system disorders (1-2%):

Increased activity of ALT, AST, gamma-GT and serum bilirubin levels.

Laboratory indicators:

Hypercreatininemia, hyperbilirubinemia, increased concentration of urea nitrogen and activity of “liver” transaminases, prolongation of bleeding time.

Adverse effects observed from hematopoiesis include a decrease in hemoglobin levels and granulocytopenia. These adverse events were observed extremely rarely.

During treatment, mental disorders (1.7%) and metabolic disorders (1%) may be observed.

Drug interactions:

Reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics, side effects of MCS and GCS, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics; enhances the hypoglycemic effect of sulfonylurea derivatives.

Increases the concentration of Li+ and methotrexate in the blood. Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites.

Antacids and cholestyramine reduce absorption.

Dr. NSAIDs carry a risk of side effects, especially from the gastrointestinal tract.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

>Use during pregnancy and lactation:

Tenoxicam is contraindicated during pregnancy and breastfeeding.

Impact on the ability to drive vehicles and operate machinery

One of the undesirable effects of the drug is dizziness; this should be taken into account in situations that require close attention of the patient, for example, when driving a vehicle or complex technical devices.

PACKAGE

Primary packaging.

The lyophilized powder containing 20 mg of the active substance is placed in a type 3 clear glass vial, sealed with a bromobutyl rubber stopper, crimped with an aluminum ring or an aluminum flip-off cap with a plastic disk or plastic cap on top of the aluminum one.

Solvent (water for injection): 2 ml per clear glass ampoule.

Secondary packaging:

1 bottle of the drug and 1 ampoule of solvent are placed in a polyvinyl chloride cassette; 1 cassette along with instructions for use is placed in a cardboard box.

1 bottle of the drug and 1 ampoule of solvent, along with instructions for use, are placed in a cardboard box.

50 bottles of the drug are placed in a cardboard box (for hospitals) with instructions for use; 50 ampoules with solvent are placed in a separate cardboard box (for hospitals).

Storage conditions:

In a dry place, protected from light, at a temperature not exceeding 25°C.

Keep out of reach of children.

Best before date:

3 years.

Do not use the drug after the expiration date indicated on the package.

Conditions for dispensing from pharmacies:

On prescription.

Legal entity in whose name the registration certificate was issued

Dr. Reddy's Laboratories Ltd., India

Manufacturer

Mustafa Nevzat Ilach Sanai A.Sh.

Pak Ish Merkezi, prof. Dr. Bulent, Tarkan Sokak No. 5/1, 34349 Gairettepe, Istanbul, Türkiye.

Tel. / fax: (+90212) 3373800 / (+90212) 2757956 www.mn.com.tr

Send information about complaints and adverse drug reactions to:

Representative office:

115035, Moscow, Ovchinnikovskaya embankment, 20, building 1

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