Composition

Blokium B12 Injection Form:Each ampoule with solvent contains:

• Diclofenac potassium — 75.00mg

• Betamethasone sodium phosphate — 2.63mg

• Benzyl alcohol — 0.06mg

• Anhydrous disodium phosphate — 4.98mg

• Sodium hydroxide — q.s. pH 8.4

• Methylparaben — 2.4mg

• Propylparaben — 0.45mg

• Propylene glycol — 576mg

• Water for injection — q.s. 3.0ml

Each lyophilized vial-ampoule contains:

• Hydroxocobalamin — 10.00mg

• Excipients: Mannitol — 87.00mg

Indications

• Acute inflammatory manifestations of rheumatism;

• Lumbosciatalgia;

• Cervical brachialgia;

• Polyradiculoneuropathy.

Contraindications

• Hypersensitivity to the active substance of the preparation;

• Hypersensitivity to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs);

• Active gastroduodenal ulcer;

• Acute renal failure;

• Hepatic failure;

• Severe decompensated heart failure;

• Arterial hypertension;

• Systemic mycosis;

• Active tuberculosis;

• Gout;

• Hepatitis A, B, and non-A-B and other viral infections;

• Anticoagulant treatment;

• Pregnancy and lactation period.

Dosage and Method of Administration

1-2 vials per day, only via deep intramuscular injection. The contents of the ampoule must be mixed with the vial and shaken slightly.

The duration of treatment depends on the patient's reaction and medical criteria. It should be emphasized that during corticosteroid therapy prolonged for more than 2 weeks, there is a risk of developing adrenocortical insufficiency, which is manifested by the inhibition of ACTH secretion and adrenal atrophy. In case of long-term treatment, the dose should be reduced progressively to avoid the aforementioned complications. It is not recommended to use Blokium B12 injections for more than 3 days.

Pregnancy and Lactation Period

Unless there is a special indication, Blokium B12 is not used during pregnancy, especially during the last trimester of gestation, as diclofenac may inhibit uterine contractions and cause premature closure of the ductus arteriosus. Corticosteroids pass into breast milk, which is why their use is not recommended at this time.

Possible Side Effects

The following reactions were revealed during the parenteral use of the drug:

• Hyperpigmentation or hypopigmentation, cutaneous and subcutaneous atrophy, sterile abscesses;

• Individual cases of acute renal failure, hematuria, and proteinuria;

• Individual cases of leukopenia, hemolytic anemia, and agranulocytosis;

• Arterial hypertension, congestive heart failure, and palpitations;

• Sodium retention, edema, potassium excretion, and hypokalemic alkalosis;

• Muscle weakness, steroid myopathy, reduction of muscle mass, osteoporosis, vertebral compression fractures, fractures of the femoral or humeral head, pathological fractures of long bones;

• Menstrual disorders, Cushingoid state, growth retardation in children, adrenal insufficiency, which especially develops during stressful situations such as trauma, surgery, or systemic diseases.

• Reduced carbohydrate tolerance, increased requirement for insulin and oral hypoglycemic drugs in diabetic patients;

• Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos, and tinnitus;

• Negative nitrogen balance caused by protein catabolism.

Overdose

In case of overdose, gastric lavage by inducing vomiting is necessary.

Packaging

5 vial-ampoules of lyophilized powder and 5 ampoules of solvent.

Storage Rules

Store in a cool and dry place, at a temperature of 15-25°C, out of reach of children.

Dispensing Method

Pharmaceutical product group II, dispensed by prescription form N3.

Produced in Argentina by Laboratorios Casasco, Buenos Aires.Email: info@casasco.com.ar