1. Name Of The Medicinal Product
Glypressin 0.12 mg/ml solution for injection
2. Qualitative And Quantitative Composition
One ampoule contains 1mg terlipressin acetate in 8.5ml solution for injection.
For excipients, see section 6.1
3. Pharmaceutical Form
Solution for injection.
Clear, colourless liquid.
4. Clinical Particulars
4.1 Therapeutic Indications
Glypressin is indicated in the treatment of bleeding oesophageal varices.
4.2 Posology And Method Of Administration
In acute variceal bleeding, 2mg Glypressin should be administered by intravenous bolus, followed by 1 – 2 mg every 4 – 6 hours until bleeding is controlled, up to a maximum of 72 hours.
Administration is by intravenous injection.
4.3 Contraindications
Contraindicated in pregnancy.
Hypersensitivity to terlipressin or any other excipients of the product.
4.4 Special Warnings And Precautions For Use
Since Glypressin has antidiuretic and pressor activity it should be used with great caution in patients with hypertension, atherosclerosis, cardiac dysrhythmias or coronary insufficiency. Constant monitoring of blood pressure, serum sodium and potassium and fluid balance is essential.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known
4.6 Pregnancy And Lactation
Glypressin® may stimulate contraction of smooth muscle and is therefore contraindicated in pregnancy. There is no data concerning its use in lactation.
4.7 Effects On Ability To Drive And Use Machines
Not applicable
4.8 Undesirable Effects
Glypressin® is only recommended for the short-term treatment of bleeding oesophageal varices, so few side effects have been reported. Those noted have included abdominal cramps, headache, transient blanching and increased arterial blood pressure.
4.9 Overdose
The recommended dose (2mg/4 hours) should not be exceeded as the risk of severe circulatory adverse effects is dose-dependent.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Posterior pituitary lobe hormones (vasopressin and analogues) (H 01 BA 04)
Glypressin® may be regarded as a circulating depot of lysine vasopressin. Following intravenous injection, three glycyl moieties are enzymatically cleaved from the N-terminus to release lysine vasopressin.
The slowly released vasopressin reduces blood flow in the splanchnic circulation in a prolonged manner, thereby helping to control bleeding from ruptured oesophageal varices.
5.2 Pharmacokinetic Properties
Glypressin® is administered by bolus intravenous injection. It shows a biphasic plasma level curve which indicates that a two compartment model can be applied.
The half-life of distribution (T1/2α) is about 8 -10 minutes.
The half-life of elimination (T1/2β) is about 50 -70 minutes.
Lysine vasopressin reaches maximum plasma levels about 1 - 2 hours following intravenous administration and has a duration of activity of 4 - 6 hours.
5.3 Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium chloride
Acetic acid
Sodium acetate
Water for injections
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf Life
2 years
6.4 Special Precautions For Storage
Store in a refrigerator (2-8 °C). Keep the ampoules in the ourter carton in order to protect from light.
6.5 Nature And Contents Of Container
Type I clear glass ampoules.
Pack size: 5 x 8.5ml
6.6 Special Precautions For Disposal And Other Handling
Unused drug and waste should be destroyed in accordance with local requirements.
7. Marketing Authorisation Holder
Ferring Pharmaceuticals Ltd.,
The Courtyard
Waterside Drive
Langley, Berkshire
SL3 6EZ
UK
8. Marketing Authorisation Number(S)
PL 03194/0101
9. Date Of First Authorisation/Renewal Of The Authorisation
11/05/2009
10. Date Of Revision Of The Text
11/05/2009
No comments:
Post a Comment