Description:

Tranexamic acid injection 500mg/5ml VEGAGEN UK is a sterile antifibrinolytic (anti-hemorrhagic) solution used to prevent or treat excessive bleeding caused by increased fibrinolysis (breakdown of blood clots). It is indicated for conditions such as heavy menstrual bleeding (menorrhagia), gastrointestinal bleeding, hemorrhagic urinary disorders (e.g., post-prostate surgery), epistaxis (nosebleeds), traumatic hyphema, obstetric/gynecological bleeding, dental procedures in hemophiliacs, and peri/post-operative bleeding (including cardiac, orthopedic, or ENT surgery). It works by competitively inhibiting plasminogen activation and fibrinolysis, stabilizing clots.

Prescription: Prescription-only (Rx). Administered by healthcare professionals (IV/IM/slow injection) in hospitals, clinics, or under medical supervision due to risks like thrombosis and need for monitoring.

Therapeutic Category:

Antifibrinolytic / Antihemorrhagic agent / Haemostatic.

Active Ingredients/Composition:

Each 5 ml ampoule contains: Tranexamic acid BP 500 mg (100 mg/ml). Excipients: Water for injections (sterile, non-pyrogenic); no preservatives in most formulations.

Vitamins: None.

Minerals: None.

Variant: 500 mg/5 ml (100 mg/ml) strength in ampoules (standard adult dose; often in packs of 10 ampoules; UK-sourced generic).

Consume Type:

Parenteral (intravenous slow injection or infusion; can be intramuscular in some cases; not oral—tablets exist separately).

Directions/Usage: Administered only by trained healthcare professionals with monitoring.

• Standard dose: 0.5 g (5 ml, 1 ampoule) to 1 g (10 ml or 2 ampoules) by slow IV injection (max 1 ml/min or 100 mg/min) 2-3 times daily.
• For acute haemorrhage: Often 1 g IV initially, repeated as needed (e.g., every 6-8 hours).
• In surgery (e.g., cardiac): Peri-operative doses per protocol (e.g., 10-15 mg/kg IV).
• For menorrhagia or other: Short-term use (e.g., 1 g 3 times daily). Dilute for infusion if required; rate slow to avoid hypotension. Adjust in renal impairment (reduce dose/frequency). Follow specialist instructions; not for self-administration.

Common Side Effects:

• Nausea, vomiting, diarrhoea
• Injection site reactions (pain, phlebitis)
• Hypotension (if injected too rapidly)
• Headache, dizziness, fatigue
• Rare: Allergic reactions (rash, anaphylaxis), visual disturbances (color vision changes with high/prolonged doses), seizures (high doses). Serious: Thromboembolic events (e.g., DVT, PE—rare but risk in predisposed patients), convulsions.

Package Type:

Glass ampoules of 5 ml each, typically in packs of 10 ampoules (tray or box packaging; sterile, single-use).

Storage Advice: Store at room temperature (below 25-30°C), protected from light. Do not freeze. Keep in original packaging. Use immediately after opening; discard unused portion. Keep out of reach of children.

Safety Advice:

• Slow IV injection only (rapid can cause hypotension, bradycardia).
• Contraindicated in active thromboembolic disease, subarachnoid haemorrhage (increased cerebral edema risk), or hypersensitivity.
• Caution in renal impairment (dose reduction), history of thrombosis, DIC (disseminated intravascular coagulation), or visual disturbances (monitor color vision).
• Screen for risk factors before use (e.g., oral contraceptives increase thrombosis risk).
• Pregnancy: Use if clearly needed (Category B; preferred in postpartum haemorrhage per guidelines). Breastfeeding: Generally compatible.
• Monitor for thrombosis signs; avoid in hematuria from upper urinary tract without specialist advice.
• Report yellow card (UK) or FDA Ghana adverse events.

Product Substitutes: Other tranexamic acid 500mg/5ml injections: Cyklokapron (original Pfizer), generic versions (e.g., from Accord-UK, Stragen UK, Focus Pharma, or importers like Vega/Vegagen in Ghana), or local brands (e.g., Ginex a, Prexam, Tranex). Alternatives: Aminocaproic acid (less common), or oral tranexamic acid tablets 500 mg for non-acute use—consult doctor per condition (e.g., Ghana protocols for postpartum hemorrhage favor tranexamic acid IV).

Manufacturer/Marketer:

VEGAGEN UK LIMITED (UK-based pharmaceutical supplier/marketer; products sourced from GMP-approved European sites).

Country of Origin:

United Kingdom (marketed by VEGAGEN UK LTD, Chesterfield, UK; commonly imported to Ghana and available in pharmacies like Meldinpharma .