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Product Line:

Anti-inflammatory and Pain Line

Patient Product Information

Formulation:
BLOKIUM 50 mg: Each coated tablet contains: sodium diclofenac 50 mg; Excipients  q.s; BLOKIUM 75 mg: Each coated tablet contains: sodium diclofenac 75 mg; Excipients  q.s; BLOKIUM 100 mg: Each extended release coated tablet contains: sodium diclofenac 100 mg; Excipients  q.s; BLOKIIUM Injectable: Cada ampoule contains: sodium diclofenac 75 mg; Excipients  q.s

Therapeutic Action:
analgesic and anti-inflammatory. Antirheumatic.

Indications:
inflammatory and degenerative rheumatisms: rheumatoid arthritis, degenerative osteoarthritis, ankylosing spondylitis, gouty arthropathy. Extra-articular rheumatism and periarticular affections such as bursitis, tendinitis, synovitis or tenosynovitis, scapulohumeral periarthritis.
Acute musculoeskeletical inflammatory processes. Post-traumatic and post-surgical pain.  Gynecological painful and/ or inflammatory affections such as primary dysmenorrhea, anexitis, etc. Otorhynolaryngologic inflammatory processes (pharyngoamygdalitis, otitis, etc.) and dental processes.

Dosage
BLOKIUM 50: usual dose: 1 tablet twice or three times a day according to medical judgement. Coated tablets should be taken in one piece with liquids preferably before meals.
BLOKIUM 75: usual dose is 1 to 2 tablets per day according to medical criteria. In the case of greater intensity of symptoms at night or early in the morning the administration of BLOKIUM 75 is recommended to be given at night . the Blokium 75 tablets should be taken in one piece with liquids preferably before meals. Due to the elevated dose BLOKIUM 75 is not indicated in children.
BLOKIUM 100:  usual dose, 1 extended released tablet per day. The tablets have to be ingested in one piece with liquids and with the food. BLOKIUM 100 is not adequate for pediatric usage.
Injectable BLOKIUM: adults: the BLOKIUM ampoules should not be administered for more than two consecutive days; in the necessary case it should be followed by BLOKIUM tablets. Intramuscular injection: the usual dosage is one ampoule of of 75 mg given profound intra gluteus. Only exceptionally can 2 injections daily can be given with an interval of various hours between them  and changing buttock.It can also be combined 1 ampoule of 75 mg with BLOKIUM tablet up to a maximal dose of 150 mg per day. Intravenous injection: BLOKIUM ampoules can not be administered as an intravenous bolus injection.  Previous to its intravenous injection  the BLOKIUM ampoule has to be diluted in 0.9% saline solution or 5% glucose solution buffered with sodium bicarbonate according to instructions. For the treatment of moderate or intense  postoperative pain, 75 mg should be infused in a continuous manner for a period of 30 minutes to 2 hours. In case it is necessary treatment can be repeated in several hours without surpassing the maximum dose of 150 mg in 24 hours. For the prevention of postoperative pain a charge dose of 25 to 50 mg should be infused after the surgical procedure over a period of 15 minutes to 1 hour, followed by the continuous infusion of 5 mg for 1 hour up to a maximal dose of 150 mg. Instructions for use: according to the anticipated duration for the infusion, mix 100 to 500 ml of isotonic saline solution (sodium chloride solution at 0,9%)or glucose solution at 5% with an injectable solution of sodium bicarbonate(0,5 ml of a solution at 8,4% or 1 ml of a 4,2% solution or a the corresponding volume of a different solution); add to this solution the content of an ampoule of BLOKIUM.
If the prepared solution has precipitates or crystals it will not be used for infusion. Only a clear solution should be employed. Intravenous infusions should be used immediately after prepared. Solutions for infusion should not be preserved.
Children: BLOKIUM ampoules are not recommended to be used in children.
Incompatibilities: as a general rule, BLOKIUM solution for injection should not be mixed with other injectable solutions. Solutions for infusion, sodium chloride solution at 0,9% or glucose solutions at 5%, that are not buffered with sodium bicarbonate are at risk of over-saturation with the probability of crystal or precipitate formation.           

Contraindications:
hypersensibility to the active substance. Acute gastritis or gastroduodenal ulcer.
As with other non-steroidal anti-inflammatory drugs, BLOKIUM 50 (Sodium diclofenac) is contraindicated for asthmatic people who had suffered asthma attacks, urticaria or acute rhinitis due to the administration of acetylsalicylic acid and other drugs inhibiting the prostaglandin synthesis.

How Supplied
BLOKIUM 50:  packs containing 15, 30 and 100 coated tablets.
BLOKIUM 75: packs containing 15 and 30 coated tablets.
BLOKIUM 100: packs containing 15 extended release coated tablets.
BLOKIUM Inyectable: packs containing 3 and 5 ampoules.