GLYPRESSIN solution for injection 1 mg8.5 ml

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Terlipressin 0.85 mg/8.5 ml eqv Terlipressin acetate

Διαθέσιμο από:

FERRING PHARMACEUTICALS PRIVATE LIMITED

Φαρμακολογική κατηγορία (ATC):

H01BA04

Δοσολογία:

0.85 mg

Φαρμακοτεχνική μορφή:

INJECTION, SOLUTION

Σύνθεση:

Terlipressin 0.85 mg/8.5 ml eqv Terlipressin acetate 1 mg/8.5 ml

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

ZENTIVA k.s.

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2012-10-04

Φύλλο οδηγιών χρήσης

60-I-SEA-02 

GLYPRESSIN
®
 0.1 MG/ML 

COMPOSITION   
One ampoule of 8.5 ml solution contains 1 mg terlipressin acetate, corresponding to 0.85 mg 
terlipressin free base. The concentration of the solution is 0.1 mg terlipressin free base/ml.   
List of excipients: Sodium chloride, acetic acid, sodium acetate and water for injections 

PHARMACEUTICAL DOSAGE FORM 
Solution for injection 

INDICATIONS   
Bleeding oesophageal varices 

DOSAGE AND ADMINISTRATION 
Adults: 
Initially an i.v. injection of 2 ampoules of GLYPRESSIN
®
 solution for injection (2 mg terlipressin 
acetate,  equivalent  to  1.7  mg  terlipressin)  is  given  every  4  hours.  The  treatment  should  be 
maintained  until  bleeding  has  been  controlled  for  24  hours,  but  up  to  a  maximum  of  48  hours. 
After  the  initial  dose,  the  dose  can  be  adjusted  to  1  ampoule  of  GLYPRESSIN
®
  solution  for 
injection (1 mg terlipressin acetate, equivalent to 0.85 mg terlipressin) i.v. every 4 hours in patients 
with body weight < 50 kg or if adverse effects occur. 

CONTRAINDICATIONS 
Contraindicated in pregnancy. 
Hypersensitivity to terlipressin or to any of the excipients. 

SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
Blood pressure, heart rate and fluid balance should be monitored during treatment. To avoid local 
necrosis  at  the  injection  site,  the  injection  must  be  given  i.v.  Caution  should  be  exercised  in 
treating patients with hypertension or recognised heart disease. 
In patients with septic shock with a low cardiac output terlipressin should not be used. 
Children  and  the  elderly:  particular  caution  should  be  exercised  in  the  treatment  of  children  and 
elder

Αρχείο Π.Χ.Π.

GLYSOL-I-SG-05.01
1.
NAME OF THE MEDICINAL PRODUCT
GLYPRESSIN
®
solution for injection, 1 mg/8.5 ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule of 8.5 ml solution contains 1 mg terlipressin acetate,
corresponding to 0.85 mg
terlipressin free base. The concentration of the solution is 0.1 mg
terlipressin free base/ml.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless liquid
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bleeding oesophageal varices
Treatment of patients with hepatorenal syndrome (HRS) Type 1 who are
actively being considered for
liver transplant.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
BLEEDING OESOPHAGEAL VARICES (BOV)
Posology
Adults:
Initially an i.v. injection of 2 ampoules of GLYPRESSIN
®
solution for injection (2 mg terlipressin acetate,
equivalent to 1.7 mg terlipressin) is given every 4 hours. The
treatment should be maintained until
bleeding has been controlled for 24 hours, but up to a maximum of 48
hours. After the initial dose, the
dose can be adjusted to 1 ampoule of GLYPRESSIN
®
solution for injection (1 mg terlipressin acetate,
equivalent to 0.85 mg terlipressin) i.v. every 4 hours in patients
with body weight < 50 kg or if adverse
effects occur.
Method of Administration
i.v. injection
HEPATORENAL SYNDROME (HRS)
Posology
1 ampoule of GLYPRESSIN
®
solution for injection (1 mg terlipressin acetate, equivalent to
0.85 mg
terlipressin) every 6 to 12 hours by slow intravenous bolus injection
for 7 to 14 days (administered in
association with albumin 20% 100 mL IV twice daily for 7 to 14 days).
If serum creatinine (SCr) has not decreased by at least 30% from the
baseline value after 3 days, the
dose can be increased to a maximum of 2 ampoules of GLYPRESSIN
®
solution for injection (2 mg
terlipressin acetate, equivalent to 1.7 mg terlipressin) every 6
hours.
It is however recommended that the dose not be increased in patients
with severe pre-existing
cardiovascular disease or in the presence of an ongoing significant
adverse event e.g. pulmonary
oedem