Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Alliance Pharma (Ireland) Limited, United Drug Distributors, United Drug House, Magna Business Park, Magna Drive, Citywest, Dublin 24, Ireland
Treatment of bleeding oesophageal varices.
The administration of terlipressin serves the emergency care for acute bleeding oesophageal varices until endoscopic therapy is available. Afterwards the administration of terlipressin for the treatment of oesophageal varices is usually an adjuvant therapy to the endoscopic haemostasis.
Initially 1‑2 mg terlipressin acetate (equivalent to 1-2 vials of Haemopressin) are administered.
Depending on the patient’s body weight the dose can be adjusted as follows:
After the initial injection, the dose can be reduced to 1 mg every 4 to 6 hours.
Theapproximate value for the maximum daily dose of Haemopressin is 120 microgram/kgbody weight.
Haemopressin should only be used with caution in patients over 70 years (see section 4.4).
Haemopressin is not recommended in children and adolescents due to insufficient experience on safety and efficacy (see section 4.4)
Haemopressin should only be used with caution in patients with chronic renal failure (see section 4.4).
A dose adjustment is not required in patients with liver failure.
The therapy is to be limited to 2–3 days in adaptation to the course of the disease.
Haemopressin is dissolved with the accompanying solvent and is applied intravenously. The intravenous injection should be given during the period of one minute. For further dilution see section 6.6.
The recommended dose should not be exceeded in any case, since the risk of severe circulatory adverse effects is dose-dependent.
An acute hypertensive crisis, especially in patients with recognized hypertension can be controlled with a vasodilator-type alpha-blocker, e.g. 150 microgram clonidine intravenously.
Bradycardia requiring treatment should be treated with atropine.
Unopened: 2 years.
After reconstitution with solvent ampoule: Use immediately.
From a microbiological point of view, the product should be used immediately.
Do not store above 25°C.
Keep the vial in the outer carton in order to protect from light. For storage of the reconstituted medicinal product, see section 6.3.
Powder:
Colourless, type I glass vials, closed with bromobutyl rubber stopper and sealed with aluminium flip-off cap. Each vial contains 11 mg powder.
Solvent:
Colourless, type I glass ampoules, sealed by fusion. Each ampoule contains 5 ml solvent.
Pack sizes:
1 vial with powder and 1 ampoule of solvent.
5 vials with powder and 5 ampoules of solvent.
Not all pack sizes may be marketed.
Reconstitute the powder only in the solvent provided.
The entire contents of the solvent ampoule should be slowly added to the powder vial and the vial rolled gently until the powder is completely dissolved. The powder should dissolve within 10 seconds. A clear colourless solution results.
A further dilution to 10 ml with sterile sodium chloride 9 mg/ml (0.9%) solution for injection is possible.
For single use only. Discard any unused solution.
The solution should be inspected visually for particles and discolouration prior to administration.
Do not use Haemopressin if you notice
Any unused product or waste material should be disposed of in accordance with local requirements.
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