Deksakort %0.4

Deksakort %0.4

Product Group:Hormones
Pharmaceutical Form:Solution for Injection
Active Ingredient:Dexamethasone Sodium Phosphate
Target Type:Cattle, Horse
Package Form:50 ml

For Animal Use Only

For Animal Use Only

 

DEKSAKORT %0.4

Solution for Injection

Veterinary Anti-inflammatory, Antiallergic

 

COMPOSITION

Deksakort 0,4 % Solution for Injection per ml: clear, colorless, sterile injectable solution containing 4 mg Dexamethasone 21 Sodium Phosphate, equivalent to 3 mg Dexamethasone base.

 

PHARMACOLOGICAL PROPERTIES

Deksakort 0,4 % Solution for Injection has high anti-inflammatory, anti-allergic and anaphylactic activity thanks to dexamethasone, a synthetic analogue of hydrocortisone it contains. It is a safe glucocorticoid with a long duration of 36-72 hours even at low doses. Glucocorticoids (Corticosteroids) suppress acute and chronic inflammation cases that develop due to different factors (microorganism, chemical substances and mechanical factors). These antirheumatic and anti-inflammatory activities are due to their inhibition of fibroblast activity and granuloma formation. Thus, the inflammatory phenomenon is prevented by stabilizing the lysosomal membrane and preventing the spread of lysosomal proteolytic enzymes, which are caused by their breakdown and have a large share in the formation of inflammation, to the damaged cell and its surroundings. It moderately corrects hypoglycemia in dairy animals with ketosis; It raises the blood glucose level and decreases the glucose utilization in the periphery. 8-10 hours after glucocorticoid use, blood glucose level returns to normal rapidly. Within 24 hours, the animal's appetite is increased, and the milk yield, which decreases the next day, begins to increase.

It is rapidly absorbed following parenteral administration and reaches its peak plasma level. Plasma binding in cattle is 74%. The drug is hydrolyzed in serum 10 minutes after the injection. It is converted in the liver by hydroxylation mainly to the 6-hydroxy and 2-dihydroxy dexamethasone metabolites. Within 24 hours, 44% of the dose is excreted in the urine and feces.

AREA OF USE / INDICATIONS

Deksakort 0,4 % Solution for Injection is an anti-inflammatory and antirheumatic medication used in the treatment of bovine ketosis, especially osteoarthritis, synovitis, bursitis, edema, injury, nonspecific dermatitis and summer eczema, snake bite, insect bite, drug and toxic substance poisoning, circulatory collapse, shock, dermatitis, urticaria, eczema.

 It is used as antiallergic and/or anaphylactic in asthma, pruritus and light sensitivity.

Deksakort 0,4 % Solution for Injection can also be used to support the main treatment in cases such as acute mastitis, metritis, umbilical toxemia, traumatic gastritis, pyelonephritis, transplant disease, operational stress, pneumonia, joint inflammations and lameness, retention, fatigue, exhaustion, influenza.

 

USAGE AND DOSAGE

The therapeutic dose should be determined by considering the severity of clinical cases, the sensitivity of the animal to the drug, and the duration of steroids treatment.

Pharmacological Dose: as a single dose, intramuscularly or intravenously and locally (intra-articularly); in ruminants 5-40 mcg/kg. b.w., in horses 10 mcg/kg b.w. applied with active ingredient calculation.

If no other form is recommended by the veterinarian, the Practical Dosage Table is shown below.

Cattle - Buffalo5 ml / 500 kg b.w.
Calf - Heifer - Buffalo Calf2 ml / 200 kg b.w.
Baby cow1 ml / 100 kg b.w.
Horse1 ml / 400 kg b.w.

 

Although the above single doses are usually sufficient in early cases, the dose can be repeated at 48-hour intervals if necessary. The maximum dose in cattle is 10 ml. A dose of 2-3 ml is recommended in the treatment of shock in horses.

SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES

For the occurrence of abortion in cows, 5 ml can be administered as a single dose intramuscularly after the 240th day of pregnancy. If abortion does not occur within 48-72 hours, the dose can be repeated.

Deksakort 0,4 % Solution for Injection can be used in the treatment of arthritis, bursitis, tendosynovitis in horses under sterile conditions (into the inflamed joint or sac after the fluid content is removed from the inflamed joint as much as the volume of medication to be given) as a support for the main treatment. Since the anti-inflammatory effect of corticosteroids can hide the signs of infection, animals that have been administered the drug should be closely monitored. In order to control acute and chronic infections, the drug should be administered with an appropriate antibacterial therapy. The use of corticosteroids depends on the dose, duration, and drug properties, and inhibition of endogenous steroid production may occur following discontinuation of the drug. Use in the first and last trimesters of pregnancy may cause fetal death, abortion, retention of secundinarium and metritis.

 

UNDESIRABLE EFFECTS

It can delay wound healing, weaken body immunity and resistance, or exacerbate infection outbreaks. In the presence of viral infection, it can accelerate the development of the disease. It can reduce milk yield in dairy animals. Such side effects as elevation of SAP and SGPT, weight loss, loss of appetite, increased urination and frequent urination (in dogs), occasional vomiting and bloody diarrhea (in cats), lameness (in horses), osteoporosis, gastrointestinal destruction and ulceration, increased clotting probability and tendency to thrombosis, increased blood sugar, potassium loss, loss of fur and hair characteristics, restlessness and muscle weakness have been reported.

 

DRUG INTERACTIONS

Incompatible with acetazolamides and diuretics (risk of hypokalemia increases), antidiabetics (Antihypoglycemic effect), barbiturates (risk of potassium loss and corticosteroid metabolism increase), NSAIDs (risk of gastrointestinal ulceration increases), metoclopramides (aggression may occur). Since dexamethasone is incompatible with pentobarbital, primidone, phenytoin, carbamazepine, proclopromazine, ephedrine, rifampicin and vancomycin, it cannot be used together with these drugs.

 

SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE

The recommended dose of Dexamethasone should not be exceeded. There is no antidote. In long-term use, it can cause Cushing's Syndrome, which includes changes in carbohydrate, protein, fat and mineral metabolism. It can cause muscle weakness and osteoporosis. In horses, doses higher than recommended may cause temporary lethargy and drowsiness.

 

RESIDUAL WARNINGS FOR FOOD PRODUCING ANIMALS

Drug Residue Elimination Period: During the treatment and 21 days after the last application, animals cannot be sent to slaughter. The milk obtained during 3 days (6 milkings) cannot be offered for human consumption.

 

CONTRAINDICATIONS

As with all other corticosteroids, it is contraindicated for animals with congestive heart, liver and kidney failure and chronic nephritis, in cases of hyper corticalism (Cushing's syndrome), peptic ulcer, tuberculosis, diabetes and osteoporosis, for pregnant animals (in the first and last third of pregnancy), during the viremic stage in viral infections, acute infections (as its anti-inflammatory effects can mask the symptoms of infection).

Use during pregnancy: It should not be used in the first and last 1/3rds of pregnancy.

 

GENERAL PRECAUTIONS

Can only be used by veterinarians.

Keep out of reach of children.

Keep away from foodstuff.

Consult your veterinarian in case of unexpected effect.

Do not buy or use products with damaged packaging.

 

PRECAUTIONS TO BE TAKEN AND RECOMMENDATIONS FOR PHYSICIANS

The application should be administered with gloves and the specified precautions should be strictly followed.

 

STORAGE CONDITIONS AND SHELF LIFE

Shelf life is 2 years when stored at room temperature (15 -25oC), protected from light. The opened package should be consumed within 1 month.

 

END-OF-USE DISPOSAL AND WARNINGS FOR NON-TARGET SPECIES

Used packaging should be disposed of by burying it in the ground, as it may harm the environment and ecosystem.

 

TRADE DRESS

Deksakort 0,4 % Solution for Injection is offered for sale in transparent colored glass bottles of 20 ml, 50 ml and 100 ml in cardboard boxes.

 

PLACE AND CONDITIONS FOR SALE

Sold in veterinary offices and pharmacies with a veterinary prescription (VHR).

PROSPECTUS APPROVAL DATE: 27.03.2013

T.R. MINISTRY OF AGRICULTURE AND FORESTRY MARKETING PERMISSION DATE AND NO: 26.12.2003-12/096

 

NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.

Malıköy Başkent OSB Mah. 26. Cad. No: 34/A - Sincan - ANKARA - TÜRKİYE

 

MANUFACTURER COMPANY NAME AND ADDRESS

ALBAFARMA İLAÇ SAN. TİC. A.Ş.

İTOSB (İstanbul Tuzla Organize Sanayi Bölgesi) 8. Cad. No: 11 Tuzla-İSTANBUL

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