Anti-Inflammatory (internal use and injection) / Musculoskeletal System

Maxi Diclofenac 75 mg / 3 ml 5’s solution for injection in ampoules

Brands: Plethico (India)

$4.90

Quantity

Maxi Diclofenac 75 mg / 3 ml 5's solution for injection in ampoules quantity

Add to cart

Add to wishlist

Sku:

62820166fa12

Brands:: Plethico (India)

Description

The instruction for medical use

of MAKSI™-75 medicine

the Trade name
of Maksi™-75

the International unlicensed
name Sodium Diclofenac

the Dosage form
Solution for intramuscular injections of 75 mg / 3 ml

Structure
of 1 ml of solution contains
active agent – diclofenac of sodium of 25 mg,
excipients: methylparaben, dinatrium hydrophosphate, dinatrium edetat, PEG-400, propylene glycol, benzyl alcohol, polysorbate-80, sodium hydroxide, water for injections.

Description
Transparent colourless or yellowish solution

Pharmacotherapeutic group
Non-steroidal anti-inflammatory drugs.
Acetic acid derivatives.
The code of automatic telephone exchange M01AB05

the Pharmacological

Pharmacokinetics Diclofenac properties is well soaked up after intramuscular introduction. Time of achievement of the maximum concentration of diclofenac in plasma after intramuscular introduction is 20 minutes. Linking with proteins of plasma makes 99.5%, mainly with albumine. Diclofenac gets into synovial fluid where high concentrations of drug can be maintained even after decrease in plasma concentration. In insignificant quantity gets into breast milk. Diclofenac is actively metabolized to a number of phenolic components. The main metabolite is 4-hydroxy-derivative diclofenac. Plasma elimination half-life makes 1-2 hours, of synovial fluid of 3-6 hours. Diclofenac is removed from an organism in the form of a glucuronide and sulphatic conjugates, mostly with urine (about 65%), and with bile (about 35%).
The pharmacodynamics
of Maksi™-75 is non-steroidal anti-inflammatory drug with the significant analgetic and moderate febrifugal activity. Shows the action by cyclooxygenase enzyme suppression that causes considerable decrease in level of prostaglandins in the inflammation center. Drug reduces hypostasis, inflammation and morbidity of joints in a pseudorheumatism, but does not make long impact on a course of the disease. In injuries and postoperative pains drug reduces inflammatory hypostasis and pains both at the movement, and in a condition of rest. Suppresses aggregation of thrombocytes and extends a bleeding time. Drug does not affect function of kidneys at healthy people, but can worsen renal function if it depends on vasodilating E2 prostaglandin (for example, in arterial hypertension, diabetes, cirrhosis and other states).

Indications
– a pseudorheumatism
– the osteoarthrosis ankylosing a spondylitis
– the tendinitis, sinoviit, a bursitis
– stretchings, dislocations
– neuralgia, myalgias
– gout attacks
– postoperative pains
– renal colic
– at orthopedic, dental and other small surgical interventions

appoint the Route of administration and doses of the Injection for initial treatment a short course at acute conditions and at aggravation of chronic processes.
To adults and children 18 years are more senior: the single dose makes 75 mg, frequency rate of introduction – once a day. Duration of treatment is 2-3 days. The maximum daily dose – 150 mg.
Instructions on use.
The injection is carried out deeply intramusculary (vnutriyagodichno) to an upper external quadrant. The interval between injections has to make several hours and the following injection it is necessary to enter into other buttock.

Side effects
– pain and burning sensation in the injection site of drug
– nausea, vomiting, pains in epigastriums, diarrhea
– dizziness, a headache
– a disorientation, excitement, insomnia, irritability, fatigue
– hypersensitivity reactions, a multiformny erythema,
a Lyell’s disease, Stephens-Johnson’s syndrome, anaphylactic reactions, including
shock
– anemia, a leukopenia, thrombocytopenia, an agranulocytosis
– a renal failure
– the hair loss
Is rare
– digestive tract erosive cankers, zheludochno –
intestinal bleedings, pseudomembranous colitis
– abscess and necrosis of fabrics in the injection site

of the Contraindication
– hypersensitivity to drug components
– a peptic ulcer of a stomach and duodenum, gastrointestinal bleedings
– the bronchial asthma caused by intake of non-steroidal anti-inflammatory drugs
– a concomitant use of other non-steroidal anti-inflammatory drugs or anticoagulants
– moderate and heavy renal failures (plasma creatinine more than 160 µmol/l), a hypovolemia, dehydration, disturbances of a hemopoiesis in the anamnesis, disturbance of cerebral circulation, before surgical intervention at patients with high risk of bleeding
– a porphyria
– children’s and teenage age up to 18 years
– pregnancy, the lactation period

Medicinal interactions
Pharmakodinamichesky interaction
Maxi-75 can suppress effect of diuretics, but potassium – the preserving diuretics strengthens action therefore observation of potassium level in plasma is necessary. It was reported about nephrotoxic reactions at the patients receiving at the same time cyclosporine and Maxi-75. At reception with other NPVS (non-steroidal anti-inflammatory drugs) and steroids the risk of development of side effects increases. Interaction between hinolonovy drugs and Maxi-75 can lead to spasms, especially at patients with epilepsy and appearance of spasms in the anamnesis.
By results of several researches it is revealed that drug has no significant impact on action of oral antihyperglycemic and anticoagulating means.
Pharmacokinetic interaction
Drug increases plasma concentration of lithium by decrease in its renal excretion. Also increases plasma concentration of digoxin, but clinical manifestations of overdose were not noted. At use of diclofenac together with a methotrexate within 24 hours the increase in plasma concentration of a methotrexate in this connection, emergence of toxic reactions is not excluded is possible.
Drug reduces concentration of salicylates in blood plasma.

Special instructions
Though diclofenac does not interact with oral glucose-lowering drugs, control of glycemia level at patients with diabetes is necessary.
With care drug is appointed to patients with a renal failure, chronic heart failure, an arterial hypertension, at intake of diuretics, before big operations because of danger of reduction of a renal blood-groove.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Considering side effects of drug (dizziness, a headache) it is necessary to be careful at control of transport or other potentially dangerous mechanisms.

Overdose
Symptoms: dizziness, a headache, myoclonic encephalopathy, consciousness disturbance, nausea, vomiting, pains in epigastriums, gastrointestinal bleeding, perforation of ulcers at patients with a peptic ulcer of a stomach and duodenum, developing of erosive cankers of digestive tract, increase in level of transaminases and bilirubin in blood, an oliguria, an anury.
Treatment: at overdose it is necessary to cancel drug. In hard cases – a hemodialysis or hemoperfusion.

A form of release and packing
On 3 ml of drug in an ampoule. On 5 and 10 ampoules in a cardboard pack with the instruction for medical use.

To Store storage conditions in dry, protected from light. the place, at a temperature not above 25ºС.
To store out of children’s reach!

3 years
not to apply a period of storage after an expiration date.

Prescription status
According to the prescription

of Proizvoditel Pletkhiko Pharmasyyutikalz Ltd / Plethico Pharmaceuticals Ltd
the location Address:
Dharavara, Kalariya – 453,001, Indore (L. S.), India
the Legal address:
37/37A, Indastrial Isteyt, Polograund, Indore (L. S.), 452,015, India
the Address of the organization accepting in the territory of the Republic of Kazakhstan consumers on quality a produktsiipredstavitelstvo in RK Rezlov LTD LLP, Karaganda, Ermekov St. 116 A, office 10. Ph. +7 (212) 442220, fax + 7 (212) 442221. E-mail address of rezlov_ltd@mail.ru

Additional information