Description:

Ketesse 50mg/2ml is a solution for injection or concentrate for solution for infusion containing dexketoprofen trometamol, a nonsteroidal anti-inflammatory drug (NSAID) of the propionic acid class. It is used for the short-term symptomatic treatment of acute moderate to severe pain (e.g., postoperative pain, renal colic, low back pain, musculoskeletal pain, or dental pain) when oral administration is not appropriate (e.g., due to nausea/vomiting or need for rapid onset).

Prescription:

• Prescription required; administered only by healthcare professionals (intramuscular or intravenous route).

Therapeutic Category:

• Nonsteroidal anti-inflammatory drug (NSAID) / Analgesic (parenteral form for acute pain relief).

Active Ingredients/Composition:

• Dexketoprofen trometamol 73.8 mg per 2 mL ampoule (equivalent to dexketoprofen 50 mg base). Each mL contains 25 mg dexketoprofen (as trometamol). Other ingredients: Ethanol (96%) ~200 mg per 2 mL ampoule, sodium chloride 8 mg, and water for injection (pH 7.0–8.0; osmolarity 270–328 mOsmol/L).

Vitamins: Not present.

Minerals: Not present (trace sodium from sodium chloride).

Variant:

• Standard 50 mg/2 mL (25 mg/mL) solution in ampoules; also available as 25 mg tablets or granules in the Ketesse line, but this is the injectable variant.

Consume Type:

• Parenteral (intramuscular deep injection or intravenous slow injection/infusion).

Directions/Usage:

Administered by a doctor/nurse only.

• Adults: 50 mg (1 ampoule of 2 mL) every 8–12 hours by slow IV injection (over at least 15 seconds), IV infusion (over 10–30 minutes), or deep IM injection.
• If necessary, repeat after minimum 6 hours.
• Maximum daily dose: 150 mg (3 ampoules).
• Duration: Short-term only (maximum 2 days); switch to oral treatment as soon as possible.
• Dilute IV doses in compatible fluid (e.g., 0.9% NaCl or 5% glucose) if needed for infusion.
• Use lowest effective dose for shortest duration.

Common Side Effects:

• Injection site pain/reactions (inflammation, bruising), nausea/vomiting, dyspepsia, abdominal pain, diarrhea, headache, dizziness, vertigo, palpitations, constipation, dry mouth, flatulence, rash, fatigue, or hot flushes. Rare: Serious gastrointestinal bleeding/ulceration, renal impairment, increased blood pressure, or allergic reactions.

Package Type:

• Clear glass ampoule (2 mL) containing 50 mg dexketoprofen; packed in boxes of 1, 5, 6, 10, 20, 50, or 100 ampoules (most common in Ghana: 5 or 10 ampoules per box).

Storage Advice:

• Store below 30°C, protected from light. Do not freeze. Keep in original carton. Use immediately after opening (single-dose ampoule). Keep out of reach of children.

Safety Advice:

• Contraindicated in active peptic ulcer, severe heart failure, severe renal/hepatic impairment, history of NSAID-induced asthma/bleeding/allergic reactions, third trimester of pregnancy (fetal harm), or hypersensitivity. Use caution in elderly, asthma, hypertension, heart disease, or with anticoagulants/antiplatelets (increased bleeding risk). Contains ethanol (up to 200 mg per dose). Avoid alcohol. Monitor for GI bleeding, renal function, and blood pressure. Stop immediately and seek help for black/tarry stools, severe stomach pain, vomiting blood, chest pain, shortness of breath, or swelling. Not for children under 18 years. Pregnancy: Category C (avoid in 3rd trimester). Breastfeeding: Avoid (passes into milk).

Product Substitutes:

• Keral 50 mg/2 mL solution for injection/infusion (Menarini)
• Dexketoprofen 50 mg/2 mL generics (various importers in Ghana)
• Enantyum injection (Menarini brand in some markets)
• Other parenteral NSAIDs: Ketorolac injection 30 mg (for severe pain), Diclofenac injection 75 mg. Consult a doctor/pharmacist for suitable alternatives.

Manufacturer/Marketer:

• Menarini Manufacturing

Country of Origin:

• Spain