Diclofenac-Darnitsa solution for injections of 25 mg/ml in ampoules of 3 ml, 10 pcs — Made in Ukraine — Free Delivery
(Diclofenac-Darnitsa)
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Description Diclofenac-Darnitsa solution for injections of 25 mg/ml in ampoules of 3 ml, 10 pcs — Made in Ukraine — Free Delivery
Indication
The medicinal product for intramuscular administration is intended for the treatment of:
- inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, vertebral pain syndrome, non-articular rheumatism;
- acute attacks of gout;
- renal and biliary colic;
- pain and swelling after injuries and operations;
- severe migraine attacks.
The medicinal product when administered as an intravenous infusion is intended for the treatment or prevention of postoperative pain.
Contraindications
Hypersensitivity to the active substance, sodium metabisulfite or to any other components of the medicinal product.
Like other nonsteroidal anti-inflammatory preparations (NSAIDs), diclofenac is also contraindicated in patients in whom the use of ibuprofen, acetylsalicylic acid, or other NSAIDs provokes an asthma attack, angioedema, urticaria, acute rhinitis, nasal polyps, or allergy-like symptoms.
History of gastrointestinal bleeding or perforation associated with previous NSAID treatment.
Active peptic ulcer/bleeding or a history of recurrent peptic ulcer/bleeding (two or more separate episodes of established ulceration or bleeding).
Inflammatory bowel diseases (for example, Crohn's disease or ulcerative colitis).
Liver failure.
Kidney failure.
Congestive heart failure (II-IV functional class according to the NYHA - New York Heart Association classification).
Ischemic heart disease in patients (angina, previous myocardial infarction).
Cerebrovascular diseases in patients who have suffered a stroke or have episodes of transient ischemic attacks.
Diseases of peripheral arteries.
Treatment of perioperative pain in coronary artery bypass grafting (or the use of an artificial blood circulation device).
There is a high risk of postoperative bleeding, blood clotting disorders, hemostasis disorders, hematopoietic disorders or cerebrovascular bleeding.
III trimester of pregnancy.
In this dosage form, the preparation is contraindicated for children.
Intravenous infusions are contraindicated in:
- simultaneous use of NSAIDs or anticoagulants (including low doses of heparin);
- hemorrhagic diathesis in the anamnesis or confirmed/suspected cerebrovascular bleeding in the anamnesis;
- surgical interventions with a high risk of bleeding;
- history of bronchospasm and bronchial asthma;
- moderate or severe renal failure (creatinine level in blood serum > 160 mmol/l);
- hypovolemia or dehydration of various genesis.
Features of the use of the preparation
Undesirable effects can be minimized by using the minimum effective dose for the shortest possible time required to control symptoms.
The use of the preparation with systemic NSAIDs, including selective inhibitors of cyclooxygenase-2, should be avoided due to the lack of any synergistic benefit and the possibility of the development of additional side effects.
Care should be taken when prescribing the preparation to elderly patients. In particular, the lowest effective doses should be used for elderly patients in poor health and for patients with low body mass index.
As with the use of other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid, may also occur when using diclofenac. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can cause myocardial infarction. A symptom of such a reaction may be chest pain that occurs in combination with an allergic reaction to diclofenac.
Like other NSAIDs, diclofenac, due to its pharmacodynamic properties, can mask the signs and symptoms of infection.
Сomposition
active substance: diclofenac;
1 ml of solution contains:
diclofenac sodium 25 mg;
excipients: mannitol (E 421), sodium metabisulfite (E 223), benzyl alcohol, propylene glycol, sodium hydroxide, water for injections.
Method of application and dosage
The preparation should be used in the smallest recommended doses for the shortest period of time, taking into account the goal of therapy for each patient individually.
Do not use for more than 2 days. If necessary, the treatment can be continued with Diclofenac-Darnitsa tablets.
Intramuscular injection.
To prevent damage to nerves or other tissues at the site of an intramuscular injection, the following recommendations should be followed.
The dose is usually 75 mg (1 ampoule) per day, which should be administered by deep injection into the upper outer sector of the gluteus maximus muscle. In severe cases, the daily dose can be increased to 2 injections of 75 mg, between which an interval of several hours should be maintained (1 injection in each buttock). Alternatively, 75 mg can be combined with other dosage forms of the preparation Diclofenac-Darnitsa (for example, tablets) up to a total maximum total daily dose of 150 mg.
In the conditions of a migraine attack, clinical experience is limited to cases with the initial use of 1 ampoule of 75 mg. The total daily dose should not exceed 175 mg on the first day. There are no available data on the use of the preparation for the treatment of migraine attacks for more than 1 day.
Intravenous infusions
Diclofenac-Darnitsa, solution for injection, should not be administered as an intravenous bolus injection.
Immediately before starting the intravenous infusion of Diclofenac-Darnitsa, depending on its required duration, 1 ampoule of the preparation should be diluted in 100-500 ml of 0.9% sodium chloride solution or 5% glucose solution, buffered with sodium bicarbonate solution for injections (0.5 ml of 8.4% or 1 ml of 4.2% solution, or the corresponding volume of another concentration), which was taken from a newly opened container. Only clear solutions can be used. If there are crystals or sediment in the solution, it cannot be used for infusion.
Two alternative dosing regimens of Diclofenac-Darnitsa, a solution for injection, are recommended:
For the treatment of moderate to severe postoperative pain, 75 mg should be administered continuously over 30 minutes to 2 hours. If necessary, the treatment can be repeated after 4-6 hours, but the dose should not exceed 150 mg per day.
For the prevention of postoperative pain, a loading dose of 25-50 mg should be administered 15 minutes to 1 hour after surgery, after which a continuous infusion of approximately 5 mg per hour should be used up to a maximum daily dose of 150 mg.
Elderly patients
Although in elderly patients, the pharmacokinetics of the preparation does not deteriorate to a clinically significant degree, NSAIDs should be used with special caution in such patients, who, as a rule, are more prone to the development of adverse reactions. In particular, for debilitated elderly patients or for patients with a low body weight, it is recommended to use the lowest effective doses (see also the section "Peculiarities of use"); also, patients should be examined for gastrointestinal bleeding during NSAID treatment.
The recommended maximum daily dose of Diclofenac-Darnitsa is 150 mg.
Each ampoule is intended for single use only. The solution should be used immediately after opening the ampoule. Any unused amount must be disposed of.
Children
Diclofenac-Darnitsa in the medicinal form of a solution for injections is contraindicated for use in children.
Overdose
Symptoms There is no typical clinical picture of the consequences of an overdose of diclofenac. Overdose may cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhea, dizziness, disorientation, agitation, coma, drowsiness, tinnitus, loss of consciousness, or convulsions. In case of severe poisoning, acute kidney failure and liver damage are possible.
Treatment. Within 1 hour of using a potentially toxic amount of the preparation orally, the use of activated charcoal may be appropriate. Additionally, for adults, gastric lavage should be considered for 1 hour after administration of a potentially toxic amount of the preparation. Diazepam should be administered intravenously in case of frequent or prolonged convulsions. Depending on the clinical condition of the patient, other measures may be indicated. Treatment is symptomatic.
Incompatibility
Diclofenac-Darnitsa, a solution for injections, cannot be mixed with other solutions for injections in the same container.
0.9% sodium chloride solution and 5% glucose solution without sodium bicarbonate as additives pose a risk of oversaturation, which may lead to the formation of crystals or precipitate.
Other solutions for infusion should not be used.
Storage conditions
Store in the original packaging at a temperature not higher than 25 °C. Do not freeze.
Keep out of the reach of children.
Tags: Diclofenac
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