Tafalgin^® (Solution) Instructions for Use

Marketing Authorization Holder

Pharmfirma Sotex, CJSC (Russia)

ATC Code

N02BG (Other analgesics and antipyretics)

Active Substance

Tyrosyl-D-arginyl-phenylalanyl-glycin amide (Grouping name)

Dosage Form

Tafalgin®

Solution for subcutaneous injection 4 mg/1 ml: 1 ml amp. 10, 20, or 30 pcs. or syringes 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for subcutaneous injection transparent, colorless or slightly yellowish.

Excipients: sodium chloride, mannitol, glycine, sodium acetate trihydrate, glacial acetic acid, water for injection.

1 ml – ampoules of light-protective glass (5) – contour cell packs (2) – cardboard packs*.
1 ml – ampoules of light-protective glass (5) – contour cell packs (4) – cardboard packs*.
1 ml – ampoules of light-protective glass (5) – contour cell packs (6) – cardboard packs*.
1 ml – syringes with or without a needle protection device (2) – contour cell packs (5) – cardboard packs*.
1 ml – syringes with or without a needle protection device (2) – contour cell packs (10) – cardboard packs*.

* the pack is sealed on both sides with self-adhesive labels for opening control or without labels.

Clinical-Pharmacological Group

Non-opioid centrally acting analgesic

Pharmacotherapeutic Group

Other analgesics and antipyretics

Pharmacological Action

It selectively binds to receptors in the brain that are responsible for pain relief, responsible for the development of many side effects characteristic of most potent opioid analgesics.

It disrupts the transmission of pain impulses in the nervous system, changes the intensity of pain perception by acting on the higher parts of the brain. With repeated use, the effectiveness of this agent does not decrease.

Indications

For the relief of moderate to severe intensity pain, including in malignant neoplasms.

ICD codes

Dosage Regimen

Administer Tafalgin^® by subcutaneous injection only. Do not administer intramuscularly or intravenously.

The standard initial dose is 4 mg (1 ml) administered two to three times per day. If required, administration every 4 hours is permitted.

Adjust the dosing frequency based on individual patient response and pain control. Titrate the regimen gradually to achieve and maintain adequate analgesia.

The maximum single dose must not exceed 7 mg. The maximum total daily dose must not exceed 42 mg.

For management of chronic pain, administer the drug regularly on a fixed schedule rather than on an as-needed basis. Adjuvant analgesics may be co-administered.

During long-term therapy, periodically reassess the need for continued treatment and review the dosage, potentially using short-term drug holidays.

The duration of therapy is determined solely by the attending physician based on the clinical situation.

Adverse Reactions

Immune system disorders frequency unknown – urticaria, rash, swelling of the eyes, mouth or face, difficulty breathing or itching, which may be symptoms of angioedema and anaphylactic reaction.

Nervous system disorders frequent – hypesthesia, headache, dizziness, head discomfort, peripheral neuropathy, paresthesia, sedative effect, drowsiness, burning sensation; infrequent – slowed thoughts, disorientation, dysphoria, sleep disorder, irritability, hyperesthesia, polyneuropathy, oral hypesthesia, oral paresthesia; frequency unknown – clouding of consciousness, confusion, numbness, seizures, excitability.

Sense organ disorders frequent – eye hyperemia, change in eyelid condition; infrequent – miosis, photophobia, tinnitus.

Cardiovascular system disorders frequent – tachycardia, arterial hypertension; infrequent – bradycardia, hyperemia, decreased blood pressure.

Respiratory system disorders infrequent – nasal congestion.

Digestive system disorders frequent – constipation; vomiting, dry mouth, nausea; infrequent – decreased appetite, diarrhea, increased AST activity.

Skin and subcutaneous tissue disorders frequent – itching; infrequent – dry skin, rash, urticaria.

Musculoskeletal and connective tissue disorders frequent – limb discomfort; muscle weakness, muscle tension; infrequent – arthralgia, flank pain; limb pain, myalgia, musculoskeletal stiffness, musculoskeletal discomfort.

Urinary system disorders frequent – proteinuria; infrequent – hematuria, dysuria, changes in urine, leukocyturia.

Laboratory parameters frequent – proteinuria, eosinophilia, decreased INR, prolonged aPTT; infrequent – increased INR, increased ESR, increased monocyte count, neutropenia, thrombocytopenia, increased lymphocyte count, prolonged prothrombin time, decreased red blood cell distribution width.

General disorders very frequent – asthenia; frequent – hyperthermia, discomfort; feeling of heat; feeling of chest discomfort; infrequent – fatigue.

Contraindications

Hypersensitivity to tyrosyl-D-arginyl-phenylalanyl-glycine amide, poisoning with drugs affecting the nervous system (analgesics, psychotropic or hypnotic drugs), alcohol intoxication, pregnancy, breastfeeding, children and adolescents under 18 years of age.

With caution

Paralytic intestinal obstruction (including history);
Bronchial asthma; tendency to bronchospasm; COPD;
Chronic heart failure class III-IV according to NYHA classification.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

This agent can be used for a long time, the duration of therapy is determined by the attending physician.

When treating chronic pain, this agent is preferably administered regularly according to a fixed schedule. Adjuvant analgesics may be additionally prescribed.

With long-term use, it is also recommended to regularly check the need to continue the use of this agent (for example, by short-term breaks) and review the dose.

Effect on ability to drive vehicles and machinery

This agent may negatively affect the ability to drive vehicles and complex machinery, as it affects the central nervous system. During treatment, the patient should refrain from driving vehicles and working with machinery.

Drug Interactions

If it is necessary to use other drugs, a doctor’s consultation is required.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.