Declophen 75 mg/3 ml solution for intramuscular or intravenous injection 3 ampoules

Declophen 75 mg/3 ml solution for intramuscular or intravenous injection 3 ampoules

Composition:

Each 3 ml ampoule contains:
Diclofenac sodium — 75 mg.
Excipients:
Sodium metabisulfite.
Disodium edetate.
Sodium hydroxide.
Benzyl alcohol.
Propylene glycol.
Ethanol.
Nicotinamide.
Water for injection.

Product Description:

Declophen is a non‑steroidal anti‑inflammatory drug (NSAID) with pronounced antirheumatic, analgesic, anti‑inflammatory, and antipyretic properties.
It effectively relieves pain, inflammation, and swelling in rheumatic diseases, colic, acute gout attacks, and post‑traumatic or postoperative conditions.

Indications for Use:

• Rheumatoid arthritis, osteoarthritis.
• Vertebral pain syndromes, ankylosing spondylitis, spondyloarthritis.
• Extra‑articular rheumatism.
• Renal and hepatic colic.
• Acute gout attacks.
• Pain, swelling, and inflammation after trauma or surgery.

Method of Administration and Dosage:

• For intramuscular injection only; other routes are not permitted.
• Administer deeply into the gluteal muscle.
• Adults: 1 ampoule once daily.
• In cases of colic or severe pain: up to 2 injections per day (interval 2–3 hours).
• Do not exceed 2 injections per day.
• Maximum duration of therapy: 2 days.
• If continued treatment is required, switch to oral or rectal forms.
• Total daily dose of diclofenac must not exceed 150 mg.

Contraindications:

• Pediatric use.
• Hypersensitivity to diclofenac sodium, sodium bisulfite, or excipients.
• Severe cardiac, hepatic, or renal insufficiency.
• Bradycardia, marked hypotension.
• Gastrointestinal bleeding.
• Pregnancy and lactation.
• Patients with asthma, angioedema, urticaria, or rhinitis induced by aspirin, ibuprofen, or other NSAIDs.

Precautions:

• Discontinue if hepatic disorders develop.
• Patients with cardiovascular disease must be monitored during therapy.
• Frail, elderly, or low‑weight patients should receive minimal effective doses.
• Clinical evaluation required for patients with peptic ulcers, GI bleeding history, liver or kidney disease, or hypertension.
• In asthma, hay fever, respiratory diseases, or nasal polyps, treatment may provoke asthma attacks.

Adverse Reactions / Side Effects:

• Rare: abscesses at injection site.
• Headache, dizziness, vertigo.
• Tachycardia/bradycardia, hypertension, arrhythmia, heart failure.
• Abdominal pain, vomiting, cramps, flatulence, nausea, diarrhea, dyspepsia.
• Fluid retention, edema.
• Rash, angioedema.
• Local injection site reactions.

Pregnancy and Lactation:

Contraindicated during pregnancy and breastfeeding.

Storage Conditions:

Store at temperatures not exceeding 30 °C, out of reach of children.

Packaging:

Cardboard box containing 3 clear glass ampoules of 3 ml each, with leaflet.