Elox-solofarm injection 10mg / ml 1.5ml amp.pl. 5 pieces


Elox-solofarm injection 10mg / ml 1.5ml amp.pl. 5 pieces



Active substance:
1 ml of solution
Meloxicam – 10.0 mg.
Tetrahydrofurfuryl macrogol (glycofurol) – 100.0 mg Poloxamer 188 – 50.0 mg, Meglumin – 6.25 mg Glycine – 5.0 mg Sodium chloride – 3.0 mg, 10 M sodium hydroxide solution to pH 8, 2-8,9, Water for injection – up to 1.0 ml.
Transparent yellow or greenish-yellow liquid.
ATC code: M01AS06.
Product form:
A solution for intramuscular injection of 10 mg / ml.
1.5 ml ampoules of low density polyethylene or polypropylene, or into ampoules of a colorless or colored glass.
5 vials of low density polyethylene or polypropylene together with instructions for use in a stack of cardboard.
– Hypersensitivity to the active ingredient and the auxiliary components of the drug to aspirin or other NSAIDs. – full or partial combination of asthma, recurrent nasal polyposis, and paranasal sinuses, urticaria or angioedema caused by intolerance to acetylsalicylic acid or other NSAIDs due to the existing probability of cross-sensitivity (including history). – Erosive and ulcerative lesions of the stomach and duodenum in the acute stage or recently transferred. – Inflammatory bowel disease – Crohn’s disease or ulcerative colitis in the acute stage. – Severe liver and heart failure. – Severe renal insufficiency (unless hemodialysis, creatinine clearance less than 30 mL / min), progressive renal disease, including hyperkalemia confirmed. – Active liver disease. – active gastrointestinal bleeding, cerebrovascular bleeding recently transferred or established diagnosis of diseases of the blood coagulation system. – Age 18 years. – Treatment of perioperative pain during coronary artery bypass. – Concomitant treatment with anticoagulants, as there is a risk of intramuscular hematoma.
10 mg / ml
Initial therapy and short-term symptomatic treatment of osteoarthritis (arthrosis, degenerative joint disease), rheumatoid arthritis, ankylosing spondylitis, other inflammatory and degenerative diseases of the musculoskeletal system such as arthropathies, dorsopathies (e.g., sciatica, low back pain, shoulder periarthritis and other ), accompanied by pain.
Interaction with other drugs
– other inhibitors of prostaglandin synthesis, including glucocorticoids and salicylates – simultaneous with meloxicam increases the risk of formation of ulcers in the gastrointestinal tract and gastrointestinal bleeding (due to synergistic actions). Simultaneous treatment with other NSAIDs is not recommended. – Anticoagulants for oral administration for systemic use heparin, thrombolytic agents – simultaneous with meloxicam increases the risk of bleeding. In the case of simultaneous application of careful monitoring of the blood coagulation system. – Antiplatelet agents, serotonin reuptake inhibitors – a simultaneous reception with meloxicam increases the risk of bleeding due to inhibition of platelet function. In the case of simultaneous application of careful monitoring of the blood coagulation system. – lithium Formulations – NSAIDs increase the level of lithium in the plasma, by reducing its excretion by the kidneys. The simultaneous use of meloxicam with lithium therapy is not recommended. If necessary, the simultaneous use recommended careful control of the concentration of lithium in the plasma during the course of application of drugs lithium. – Methotrexate – methotrexate NSAIDs reduce the secretion by the kidneys, thereby increasing its concentration in plasma. The simultaneous use of meloxicam and methotrexate (in a dose of 15 mg per week) did not recommended. In the case of simultaneous use of careful monitoring of renal function and blood formula. Meloxicam may enhance methotrexate hematologic toxicity, particularly in patients with impaired renal function. – Contraception – there is evidence that NSAIDs may reduce the effectiveness of intrauterine contraceptive devices, but this is not proven. – Diuretics – the use of NSAIDs in the case of dehydration of patients with a risk of developing acute renal failure. – Antihypertensive agents (beta-blockers, ACE inhibitors, vasodilators, diuretics). NSAIDs reduce the effect of antihypertensive agents by inhibiting prostaglandins having vasodilating properties. – Antagonists of angiotensin-II receptors, as well as inhibitors of angiotensin-converting enzyme inhibitor, when combined with NSAIDs decreased glomerular filtration increase, thereby, may lead to the development of acute renal failure, especially in patients with impaired renal function. – Kolestiramin, linking meloxicam in the gastrointestinal tract, leading to its more rapid removal. – Pemetrexed – while the use of meloxicam and pemetrexed in patsien- comrade with a creatinine clearance of 45 to 79 ml / min should stop reception of meloxicam 5 days prior to beginning of the reception and pemetrexed may resume after 2 days after admission. If there is a need for joint use of meloxicam and pemetrexed, such patients should be carefully monitored, especially in respect of myelosuppression and the occurrence of side effects from the gastrointestinal tract. In patients with a creatinine clearance less than 45 mL / min reception meloxicam together with pemetrexed is not recommended.
NSAIDs, exerting effects on renal prostaglandins may enhance nefrotoksich- NOSTA cyclosporin.
When used in conjunction with meloxicam drugs which have a certain ability to inhibit SYP2S9 and / or SYP3A4 (or metabolized by the participation of these enzymes), such as derivatives of sulphonylurea or probenecid, should take into account the possibility of a pharmacokinetic interaction.
When combined with anti-diabetic agents for oral administration (e.g., sulfonylureas, nateglinide) possible interactions mediated SYP2S9 which may lead to increased concentrations of both of these drugs, and meloxicam in blood. Patients taking concomitant meloxicam with sulfonylurea or nateglinide should carefully monitor blood sugar levels due to the possibility of hypoglycemia.
With simultaneous use of antacids, cimetidine, furosemide and digoxin, significant pharmacokinetic interactions have been identified.
Symptoms include nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, liver failure, respiratory arrest, asystole, lethargy, drowsiness, high blood pressure, coma, convulsions, cardiovascular collapse, cardiac arrest, anaphylactoid reactions .
Treatment: the specific antidote is available. In the case of drug overdose symptomatic therapy. Forced diuresis, urinary alkalization, hemodialysis – are ineffective due to high drug connection with blood proteins.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug (NSAID).
Meloxicam -nesteroidny anti-inflammatory drug having analgesic, antiinflammatory and antipyretic action. Refers to a class of oxicams, enolievoy acid derivatives. The anti-inflammatory action due to inhibition of the enzymatic activity of COX-2, involved in the biosynthesis of prostaglandins in inflammation. To a lesser extent meloxicam acts on cyclooxygenase-1, which participates in the synthesis of prostaglandin, which protects mucosa of the gastrointestinal tract and participate in the regulation of renal blood flow.
The relative bioavailability of approximately 100%. After intramuscular administration at a dose of 15 mg maximum drug concentration in plasma (Cmax) was 1.62 g / ml and is attained within about 60 minutes.
Meloxicam well bound to plasma proteins, particularly albumin (99%).
Penetrates into the synovial fluid, synovial fluid concentration is about 50% of plasma concentrations. The volume of distribution is low, approximately 11 liters. Interindividual differences account for 30-40%.
Meloxicam is almost completely metabolized in the liver to form four pharmacologically inactive metabolites. The main metabolite, 5-karboksimeloksikam (60% of the dose), formed by oxidation of an intermediate metabolite of 5-gidroksimetilmeloksikama which is also excreted, but to a lesser extent (9% of the dose). In vitro studies have shown that this metabolic transformation plays an important role of CYP2C9 isoenzyme, additional important isoenzyme CYP3A4. The formation of two other metabolites (components, respectively, 16% and 4% of the dose) participates peroxidase activity which probably varies individually.
Derived equally from feces and urine, mainly as metabolites. In an unmodified form with the faeces derived at least 5% of the daily dose in the urine as unchanged drug is detected only in trace amounts. The average half-life of meloxicam is 20 hours. Plasma clearance is an average of 8 ml / min. Meloxicam exhibits linear pharmacokinetics in doses of 7.5-15 mg when administered intramuscularly. There are reports that the oral administration of meloxicam is characterized for enterohepatic recirculation. When receiving dosage forms for oral administration of meloxicam median time to reach maximum plasma concentration of drug in blood plasma (TSmax) is 5-6 hours, with a violation by any reason enterohepatic recycling may increase the elimination of meloxicam and reduce its half-life of up to 13 hours or more (by ingestion).
Lack of liver and / or kidney
Deficiency of liver function, as well as mild to moderate renal insufficiency significant effect on the pharmacokinetics of meloxicam has not. When ESRD increase in the volume of distribution can result in higher concentrations of free meloxicam, so these patients the daily dose should not exceed 7.5 mg.
Elderly patients
In elderly patients the mean plasma clearance between the equilibrium state pharmacokinetics is slightly lower than in younger patients.
Pregnancy and breast-feeding
The drug is contraindicated in pregnancy.
If necessary, the appointment during lactation, breast-feeding should be discontinued.
We do not recommend the use of meloxicam in women planning pregnancy and women involved in the study of infertility or birth control.
Safety of use during pregnancy, this drug has not been proved.
The effect of delay on embryogenesis prostaglandin synthesis during the first two trimesters of pregnancy is not clear. In the last trimester of pregnancy, the mechanism of action of meloxicam is characterized by the inhibition of labor, premature closure of the Ductus arteriosus Botalli the fetus, increased susceptibility to bleeding in the mother and baby and increases the risk of edema formation in the mother. Meloxicam penetrates in small quantities in mother’s milk, and in the case of breastfeeding meloxicam can be detected in the blood plasma of an infant.
As a drug that inhibits the synthesis of cyclooxygenase / prostaglandin, meloxicam may have an impact on fertility, and is therefore not recommended for women who have difficulty conceiving. Therefore, in women undergoing a survey on the subject, we recommend removal of the drug.
Conditions of supply of pharmacies
side effects
The following describes the side effects, whose connection with the use of the preparation was regarded as possible. Side effects recorded during post-marketing use, whose connection with the drug intake was regarded as possible are marked with *.
Inside the system-organ classes uses the following categories in the incidence of side effects: very common (> 1/10), common (> 1/100, 1/1000, 1/10000,
Disturbances in the blood and lymphatic systems rarely, leukopenia, thrombocytopenia, changes in the number of blood cells, including changes in leukocyte counts.
Violations by the immune system
Infrequently – other reactions of immediate type hypersensitivity *; not found – anaphylactic shock * * anaphylactoid reactions.
mental disorders
Rarely – mood changes *; not set – confusion *, disorientation *.
Disorders of the nervous system
Often -Head pain; rarely – dizziness, drowsiness.
Violations by the organs of vision, hearing and labyrinth disorders
Infrequently – vertigo; rarely -konyunktivit *, visual disturbances, including blurred vision *, tinnitus.
Violations of the heart and blood vessels
Infrequently -increase in blood pressure, feeling “high tide” of blood to the face; rarely, palpitations.
Violations of the respiratory system
Rarely – asthma patients with allergies to aspirin and NSAIDs dru- GIM.
Disorders of the gastrointestinal tract
Often – abdominal pain, dyspepsia, diarrhea, nausea, vomiting; infrequently – the hidden and obvious gastrointestinal bleeding, gastritis *, stomatitis, constipation, bloating, belching; rarely – gastroduodenal ulcers, colitis, esophagitis; very rarely -perforatsiya gastrointestinal tract.
Disorders of the liver and biliary tract
Infrequently – transient changes in liver function (e.g., increase in transaminases or bilirubin); very rarely, hepatitis *.
Violations of the skin and subcutaneous tissue
Infrequently -angiootek *, itching, skin rash; seldom – toxic epidermal necrolysis *, Stevens-Johnson Syndrome, urticaria; very rarely, bullous dermatitis *, erythema multiforme *; not found – photosensitivity.
Violations of the kidneys and the urinary tract
Infrequently – change indicators of renal function (increased creatinine and / or urea in blood serum), urination disorders, including acute urinary retention *; very rarely, acute renal failure *.
Violations by the genitals and mammary glands
Infrequently – late ovulation *; not found – infertility in women. *
General disorders and injection site
Often, pain and swelling at the injection site; Infrequent – edema.
The combined use of drugs, depressing the bone marrow (e.g., methotrexate) may provoke cytopenia.
Gastrointestinal hemorrhage, ulcer or perforation can be fatal.
As with other NSAIDs do not exclude the possibility of interstitial nephritis, glomerulonephritis, renal medullary necrosis, nephrotic syndrome.
special instructions
Patients suffering from diseases of the gastrointestinal tract should be monitored regularly. In the event of gastrointestinal ulceration or gastrointestinal bleeding medication should be abolished.
Ulcers of the gastrointestinal tract, perforation or bleeding may occur during the use of NSAIDs at any time, as in the presence of warning signs or information about serious gastrointestinal complications in history, and in the absence of these signs. The consequences of these complications are generally more serious in the elderly.
In applying the drug can develop such serious skin reactions as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. Therefore, you should pay special attention to patients reporting of adverse events by the skin and mucous membranes, as well as hypersensitivity reactions to the drug, especially if such reactions were observed during the previous courses of treatment. The development of such reactions occur usually within the first month of treatment. In the case of the first signs of skin rash, mucosal changes or other signs of hypersensitivity should be considered the question of terminating the application of the drug. There are cases when taking NSAIDs increase the risk of serious cardiovascular thrombosis, myocardial infarction, angina, possibly fatal. This risk increases with prolonged use of the drug, as well as in patients with the above diseases in history and predisposed to such diseases.
NSAIDs inhibit the renal synthesis of prostaglandins, which are involved in the maintenance of renal perfusion. The use of NSAIDs in patients with reduced renal blood flow or a reduced amount of circulating blood can lead to hidden flowing decompensation of kidney failure. After the cancellation of NSAIDs renal function is usually restored to its original level. The greatest risk for this reaction is subject to elderly patients, patients who have marked dehydration, congestive heart failure, liver cirrhosis, nephrotic syndrome, or acute renal dysfunction, patients simultaneously receiving diuretics, angiotensin-converting enzyme inhibitors, angiotensin-II receptors, as well as patients who have undergone major surgery, leading to hypovolemia. In these patients at initiation of therapy should be carefully monitored urine output and renal function. The use of NSAIDs in conjunction with diuretics may lead to sodium retention, potassium and water, as well as to reduce the action of natriuretic diuretics. As a result, in predisposed patients may increase symptoms of heart failure or hypertension. Therefore, careful monitoring of the status of these patients, as well as their adequate hydration should be maintained. Prior to the beginning of treatment should be a study of kidney function. В случае проведения комбинированной терапии следует также контролировать функцию почек. При использовании мелоксикама (также, как и большинства других НПВП) возможно эпизодическое повышение активности трансаминаз в сыворотке крови или других показателей функции печени. В большинстве случаев это повышение было небольшим и преходящим. Если выявленные изменения существенны или не уменьшаются со временем, препарат следует отменить и проводить наблюдение за выявленными лабораторными изменениями. Ослабленные или истощенные пациенты могут хуже переносить нежелательные явления, в связи с чем такие пациенты должны тщательно наблюдаться. Подобно другим НПВП, мелоксикам может маскировать симптомы основного инфекционного заболевания. Применение мелоксикама, как и других препаратов, ингибирующих синтез циклооксигеназы/простагландина, может влиять на фертильность, поэтому не рекомендуется женщинам, имеющим трудности с зачатием.
У пациентов со слабой или умеренной почечной недостаточностью (клиренс креатинина более 25 мл/мин) коррекция дозы не требуется. У пациентов с циррозом печени (компенсированным) коррекция дозы не требуется.
The effect on the ability of control of vehicles and mechanisms
В период лечения из-за возможных побочных эффектов со стороны сердечно-сосудистой и нервной системы необходимо соблюдать осторожность при управлении транспортными средствами и занятии другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Storage conditions
Store at a temperature not higher than 25 C. Keep out of reach of children.
Dosing and Administration
Препарат вводится посредством глубокой внутримышечной инъекции.
Препарат нельзя вводить внутривенно.
Остеоартрит с болевым синдромом: 7,5 мг в сутки. При необходимости эта доза может быть увеличена до 15 мг в день.
Ревматоидный артрит: 15 мг в сутки. В зависимости от лечебного эффекта эта доза может быть снижена до 7,5 мг в день.
Анкилозирующий спондилит: 15 мг в сутки. В зависимости от лечебного эффекта эта доза может быть снижена до 7,5 мг в день.
У пациентов с повышенным риском побочных реакций (заболевания ЖКТ в анамнезе, наличие факторов риска сердечно-сосудистых заболеваний) рекомендуется начинать лечение с дозы 7,5 мг в день.
У пациентов с выраженной почечной недостаточностью, находящихся на гемодиализе, доза не должна превышать 7,5 мг в день.
Максимальная рекомендуемая суточная доза – 15 мг.
You should not use the drug in conjunction with other NSAIDs.
Суммарная суточная доза препарата Мелоксикам, применяемого в виде разных лекарственных форм, не должна превышать 15 мг.
Внутримышечное введение препарата показано только в течение первых нескольких дней терапии. В дальнейшем лечение продолжают с применением пероральных лекарственных форм. Рекомендуемая доза составляет 7,5 мг или 15 мг 1 раз в сутки, в зависимости от интенсивности болей и тяжести воспалительного процесса.
Учитывая возможную несовместимость, препарат не следует смешивать в одном шприце с другими лекарственными средствами.
Working with the polymer vial: 1. Take a vial and shake it, holding it by the neck. 2. Сдавить ампулу рукой, при этом не должно происходить выделение препарата, и вращаю- щими движениями повернуть и отделить клапан. 3. Through the hole immediately connect a syringe with an ampoule. 4. Turn the vial and syringe dial slowly in its contents. 5. Push the needle on the syringe.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg

Grotex Ltd.

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