Blockium B12 amp No. 5

Diclofenac is a nonsteroidal anti-inflammatory drug whose mechanism of action is similar to that of NSAIDs and is not fully understood. It inhibits prostaglandin synthesis—this is part of its pharmacological action. Betamethasone is a glucocorticoid that suppresses inflammation through several mechanisms, inhibiting the formation of various inflammatory response factors, including vasoactive and chemotactic factors. It reduces the secretion of lipophilic and proteolytic enzymes, reduces the influx of leukocytes to damaged sites, and reduces fibrosis. Finally, it also influences the number and immune responses that depend on lymphocytes. Vitamin B12 is essential for cell growth and reproduction. Its derivative, methylcobalamin, is required for the formation of methionine and S-adenosylmethionine from homocysteine. Vitamin B12 deficiency can cause irreversible damage to the nervous system, with progressive neuronal tumors, demyelination, and neural death.

Diclofenac is eliminated by metabolism in the liver. It is excreted in urine (65%) and bile (35%) as sulfur- or glucuronide-conjugated metabolites. No changes in pharmacokinetics were observed in geriatric patients or in patients with hepatic or renal impairment. Betamethasone circulates bound to plasma proteins (64%), and its half-life is 5.6 hours. Vitamin B12 is primarily distributed in liver parenchyma cells, which constitute its primary storage site.

Acute inflammatory rheumatism crisis. Inflammation in the lumbar region. Neuralgia in the cervical region and multiple neuroradicals.

intramuscular injection of 3-6 ml (1 or 2 vials dissolved in solvent) daily, through deep intramuscular injection.

Blokium B12 may cause various adverse reactions in the following systems: Gastrointestinal: epigastric pain, nausea, vomiting, diarrhea, abdominal distension, gastric bleeding, gastric or duodenal ulcer with or without hemorrhage or perforation. Central nervous system: convulsions, increased intracranial pressure, dizziness, migraine, and drowsiness.
Liver: Occasional: increased transaminase levels and, rarely, hepatitis with or without jaundice.
Skin: Occasional: erythema and skin rash. Rarely, urticaria. Isolated cases of Stevens-Johnson syndrome, erythema multiforme, and toxic epidermolysis have been described. Delayed wound healing, skin fragility, petechiae and ecchymoses, and facial flushing may occur. Some adverse reactions are related to its parenteral administration: hyperpigmentation or hypopigmentation, cutaneous and subcutaneous atrophy, abscess.
Kidney: Isolated cases of acute renal failure, hematuria and proteuria.
Hematopoietic system: Isolated cases of leukopenia, hemolytic anemia, and agranulocytosis.
Cardiovascular system: Arterial hypertension, heart failure, and palpitations.
Fluor and electrolyte disturbances: Sodium retention, edema, potassium loss, and hypokalemic alkalosis.
Musculoskeletal system: Muscle weakness, steroid myopathy, muscle loss, osteoporosis, vertebral compression fractures, femoral head necrosis, and/or pathological fractures of long bones. Endocrine system: menstrual irregularities, Itsenko-Cushing's disease, growth retardation in children, adrenal insufficiency, especially in cases of trauma, surgery, and systemic diseases. Decreased carbohydrate tolerance and increased need for insulin and oral hypoglycemic agents in diabetics.
Sensory organs: subcapsular cataracts, increased intraocular pressure, glaucoma, pain in bright light, and tinnitus.
Metabolism: negative nitrogen balance due to protein catabolism.

- hypersensitivity to the active ingredients. - hypersensitivity to aspirin and other NSAIDs. - active gastroduodenal ulcer,
- severe renal failure,
- severe liver failure,
- decompensatory heart failure, severe hypertension,
- systemic mycosis,
- active tuberculosis,
- gout,
- hepatitis A, B, non-A, non-B, and other viral diseases,
- treatment with anticoagulants,
- pregnancy and breastfeeding.

Concomitant use of Blokium B12 with other systemic nonsteroidal anti-inflammatory drugs may result in adverse effects. Close monitoring of coagulation parameters is recommended in patients taking oral anticoagulants. Blokium B12 may inhibit the pharmacological action of diuretics. It may also increase potassium retention due to diuretic inhibition.
The drug should be administered with caution, 24 hours before or after a dose of methotrexate, as this may increase its blood levels and toxicity.
Concomitant use of Blokium B12 and lithium salts may increase lithium blood levels without signs of overdose.
Blokium B12 contains a steroid (betamethasone), so this should be taken into account in subsequent administration. Contraindications: IV erythromycin, astemizole, bepridil, halofantrine, pentamidine, terfenadine, sultopride, and vincamine carry a risk of torsades de pointes and ventricular fibrillation (hypokalemia, bradycardia, and prolongation of the QT interval increase the risk of developing this arrhythmia).
Associations that require cautious use include antiarrhythmic drugs that predispose to the development of torsades de pointes and ventricular fibrillation, such as amiodarone, britelium, disopyramide, quinidine, and sotalol. Digitalis increase the risk of toxic effects in case of hypokalemia. Substances that cause hypokalemia when administered intravenously include amphotericin B, thiazide diuretics, and laxatives.
Acetylsalicylic acid and corticosteroids increase the excretion of salicylate. Therefore, there is a risk of salicylate overdose after discontinuing corticosteroid therapy. It is recommended to adjust the salicylate dose after discontinuing corticosteroid therapy.
In these cases, increased patient monitoring is recommended for oral anticoagulants and parenteral heparin, as corticosteroids increase the risk of hemorrhage. This effect may be noticeable when high doses of corticosteroids are administered for periods longer than ten days.
Insulin, metformin, and sulfonamides, which lower blood glucose, are recommended in these cases. In these cases, increased glucose monitoring is recommended, and the dose of antidiabetic medications should be adjusted during and after corticosteroid therapy.
Isoniazid: Blood levels of isoniazid decrease when isoniazid is administered concomitantly with corticosteroids. In these cases, clinical and microbiological monitoring is recommended. Phenobarbital, phenytoin, primidone, carbamazepine, rifabutin, and rifampin are all enzyme inducers that reduce the effectiveness of corticosteroids. Therefore, it is recommended to adjust the drug dosage during and after treatment with these medications.
Associations to consider
Antihypertensive drugs and corticosteroids reduce their therapeutic effects.
Alpha interferon and corticosteroids may interrupt its therapeutic effect.
Vaccines with reduced viable microorganisms carry a risk of developing systemic diseases, which can ultimately be fatal. The risk is greater in patients who are pre-immune, as a consequence of the underlying disease. Vaccines with inactive microorganisms are preferable. Pregnancy and breastfeeding: Blokium B12 should not be prescribed during pregnancy unless there are compelling reasons, especially during the last three months of pregnancy, as diclofenac may inhibit uterine contractions and cause early closure of the arterial canal. Corticosteroids are partially excreted in breast milk.

Blokium B12 contains diclofenac and should be used with caution in patients with renal, cardiac, or hepatic impairment, as well as in patients who have undergone major surgery or have decreased circulating blood volume. Diclofenac may exacerbate symptoms in patients with hepatic porphyria and may also exacerbate symptoms in patients with bronchial asthma. Medical supervision is necessary in patients with duodenal ulcers, ulcerative colitis, or Crohn's disease. Patients with bleeding disorders or those taking oral anticoagulants should also be monitored.
Blokium B12 also contains betamethasone and should be used with caution in patients with diverticulitis, intestinal anastomosis, gastric ulcers, ulcerative colitis, abscesses or other purulent diseases, hypertension, osteoporosis, and myasthenia gravis. It should also be used with caution in patients with ocular herpes simplex, emotional instability or psychotic tendencies, and hyperthyroidism.
With long-term therapy with Blokium B12, blood, renal, and liver function tests are necessary.
Elderly patients should take the lowest effective dose of Blokium B12.
Blokium B12 contains diclofenac, and like any other nonsteroidal anti-inflammatory drug, it can cause gastrointestinal bleeding at any time during treatment. This is most likely to occur in elderly patients. Diclofenac rarely causes a serious anaphylactic or anaphylactoid allergic reaction. *
Betamethasone may mask some signs of infection.
Patients treated with Blokium B12 should not undergo immunization procedures due to altered immune response. It should also be used with caution in patients with suspected strangyloidosis infection, as it may predispose to dissemination of symptoms and may be life-threatening.
Patients with latent tuberculosis or tuberculin reactivity should be closely monitored, as the disease may develop. These patients should receive chemoprophylaxis during long-term treatment.
Corticosteroid therapy for more than two weeks carries a risk of adrenal insufficiency due to ACTH inhibition, which can lead to adrenal atrophy. In these cases, adrenal insufficiency may be caused by stress (surgery, serious trauma, severe infections) or as a consequence of abrupt discontinuation of steroid therapy. In these situations, prompt administration of corticosteroids will prevent adrenal insufficiency. If long-term corticosteroid treatment must be interrupted, it is recommended to gradually reduce the dose.

In case of overdose, the stomach should be emptied by inducing vomiting or performing gastric lavage. Activated charcoal should be administered to reduce absorption or interrupt the intrahepatic cycle of diclofenac. Antiacids or other urinary alkalinizers, such as difunisal or sulindac, enhance the excretion of nonsteroidal anti-inflammatory drugs. Hemodialysis, which is necessary in some cases of renal inflammation secondary to NSAID intoxication, may accelerate the elimination of diclofenac. If convulsions occur, diazepam or other benzodiazepines should be administered intravenously. Hemorrhage or gastric ulceration should be considered. Vitamin K is prescribed in cases of hypoprothrombinemia.
In case of overdose, seek immediate medical attention at the nearest hospital or poison control center.

Store in a dry and ventilated place at a temperature of 15 and 30°C. Keep out of reach of children.

24 months. Do not use after the expiration date printed on the package.