Depiofen Ampoules

Symptomatic treatment of moderate to high intensity acute pain in cases where oral administration of the drug is not appropriate, for example, postoperative pain, renal colic, and low back pain.

Adults. The recommended dose is 50 mg with an interval of 8–12 hours. If necessary, repeat the dose after 6 hours. The maximum daily dose should not exceed 150 mg. The drug is intended for short-term use, therefore, it should be used only during acute pain (no more than 2 days). Patients should be transferred to oral analgesics whenever possible. Adverse reactions can be reduced by using the smallest effective dose for the shortest possible time necessary to improve the condition. In postoperative pain of moderate or severe severity, the drug can be used according to the indications in the same recommended doses in combination with opioid analgesics.

Elderly patients. Dose adjustment is usually not required. However, through a physiological decrease in renal function, a lower dose is recommended, namely: the maximum daily dose is 50 mg with mild renal impairment.

From the liver. For patients with mild or moderate liver disease (5–9 points on the Child-Pugh scale), the maximum daily dose should be reduced to 50 mg and liver function should be carefully monitored. In severe liver diseases, the drug is contraindicated (10–15 points on the Child-Pugh scale).

From the kidneys. For patients with mild renal function impairment (creatinine clearance of 50–80 ml/min), the maximum daily dose should be reduced to 50 mg. In case of impaired renal function of moderate or severe degree (creatinine clearance <50 ml/min), the drug is contraindicated.

Children and teens. The drug should not be used in children and adolescents due to lack of data on its effectiveness and safety.

Intramuscular injection. The injection should be slowly injected deep into the muscle.

Intravenous infusion.

For infusion, dilute the contents of a 2 ml ampoule in 30–100 ml of a 0.9% sodium chloride solution, glucose solution, or Ringer-lactate solution. The solution for infusion should be prepared under aseptic conditions, avoiding the influence of natural daylight. The prepared solution should be transparent. Infusion should be carried out within 10–30 minutes. Avoid the influence of natural daylight on the prepared solution.

Depiofen, diluted in 100 ml of 0.9% sodium chloride solution or in glucose solution, can be mixed with dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline.

Depiofen cannot be mixed in a solution for infusion with promethazine and pentazocine.

Intravenous injection (bolus injection).

If necessary, administer the contents of 1 ampoule (2 ml of injection) for at least 15 seconds.

The drug can be mixed in small volumes (for example in a syringe) with solutions for injection of heparin, lidocaine, morphine and theophylline.

Depiofen can not be mixed in small volumes (for example in a syringe) with solutions of dopamine, promethazine pentazocine, pethidine and hydrocortisone, since a white precipitate forms.

The drug can be mixed only with the medicines indicated above.

For intramuscular or injectable use, the drug should be immediately administered after it has been drawn from an ampoule. The solution for infusion should be used immediately after its preparation. In the future, the responsibility for the conditions and duration of storage lies with the medical professional. The prepared solution retains its properties for 24 hours at a temperature of 25 °C, provided that it is protected from exposure to daylight.

When storing diluted solutions of the drug in plastic bags or in containers suitable for injection with ethyl vinyl acetate, cellulose propionate, low density polyethylene and polyvinyl chloride, no changes in the content of the active substance due to sorption were observed.

The drug Depiofen is intended for single use, so the remains of the finished solution should be poured. Before administering the drug, make sure that the solution is clear and colorless. A solution containing solid particles cannot be used.

• Hypersensitivity to dexketoprofen, any other non-steroidal anti-inflammatory drug (NSAID) or to the excipients of the drug.
• If substances of similar action, such as acetylsalicylic acid or other NSAIDs, provoke the onset of attacks of asthma, bronchospasm, acute rhinitis or cause the development of nasal polyps, the appearance of urticaria or angioneurotic edema.
• Active phase of ulcer disease or bleeding, suspected or recurrent peptic ulcer disease or bleeding in history (at least two confirmed facts of ulcer or bleeding) or chronic dyspepsia.
• Gastrointestinal bleeding, other bleeding in the active phase or with increased bleeding.
• Gastrointestinal bleeding or perforation associated with previous NSAID therapy.
• Crohn's disease or non-specific ulcerative colitis.
• Bronchial asthma.
• Severe heart failure.
• Medium or severe renal impairment (creatinine clearance <50 ml / min).
• Serious impairment of liver function (10–15 points on the Child-Pew scale).
• Hemorrhagic diathesis and other coagulation disorders.
• 3rd trimester of pregnancy or breastfeeding.
• Use for the purpose of neuro-axial (intrathecal or epidural administration (due to ethanol content).

Active substance: dexketoprofen trometamol;

1 ml of solution contains dexketoprofen trometamol equivalent to dexketoprofen 25 mg (1 ampoule of 2 ml contains dexketoprofen trometamol equivalent to dexketoprofen 50 mg).

Excipients: ethanol 96%, sodium chloride, sodium hydroxide and/or hydrochloric acid, diluted, water for injection.

5 ampoules of dark glass in cartridge and carton.

Store in the original packaging to protect from light. After dilution, store the solution for 24 hours at a temperature of 2 to 8 °C in a dark place. Keep out of the reach of children.

Laboratorios Normon SA, Ronda de Valdecarriso, 6, Tres Cantos, 28760, Madrid, Spain.

No 294 dated 04/30/14

Registration Certificate No. UA / 13589/02/01