PK Merz Infusion 0.4mg/ml

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

AMANTADINE SULFATE

Saadav alates:

Merz Pharmaceuticals GmbH Eckenheimer Landstrasse 100, D-60318 Frankfurt am Main, Germany

ATC kood:

N04BB01

INN (Rahvusvaheline Nimetus):

AMANTADINE SULFATE 0.4 mg/ml

Ravimvorm:

SOLUTION FOR INFUSION

Koostis:

AMANTADINE SULFATE 0.4 mg/ml

Retsepti tüüp:

POM

Terapeutiline ala:

ANTI-PARKINSON DRUGS

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2006-11-07

Infovoldik

Instruction for use please read carefully!
Composition:
One infusion bottle of 500 ml contains:
Active ingredient: Amantadine Sulphate 200 mg.
Excipients: Sodium chloride and water for injection.
Indications:
For the intensive and initial treatment of severe and life-threatening
cases of Parkinson’s
disease. For temporary relief of oral therapy.
To increase vigilance and clarify consciousness, in cases of
unconsciousness, e. g., after
cranio-cerebral traumata and in case of retarded awakening phase after
anaesthesia. Against
concomitant neuralgia in herpes zoster.
Contra-indications:
PK-Merz infusion must not be used in patients with:
– hypersensitivity to amantadine or to any of the other constituents
of the medicinal product,
– severe non compensated heart insufficiency (stage NYHA IV),
– cardiomyopathies and myocarditis (disease of the cardiac muscles),
– grade II or III AV-block,
– existing bradycardia under 55 beats/min,
– known prolonged QT interval or discernible U-waves,
– congenital QT syndrome in the family anamnesis,
– history of serious ventricular arrhythmias including torsades de
pointes and
– low blood level of calcium and magnesium.
PK-Merz infusion must not be used in patients simultaneous treatment
with budipine or other
drugs that prolong the QT interval (see interactions).
PK-Merz infusion should not be used in patients with:
– severe renal impairment (creatinine clearance < 10 ml/min).
PK-Merz infusion may be used only with particular caution in patients
with:
– prostate hypertrophy,
– narrow angle glaucoma,
– renal failure (of varying severity) see “precautionary
measures”
– anamnestic or existing states of agitation or confusion and
– delirious syndromes or exogenous psychosis in the anamnesis.
PK-Merz infusion should not be administered simultaneously with
memantine (see “inter-
actions”).
Pregnancy and lactation period:
During pregnancy, PK-Merz infusion should only be used after careful
assessment of the risks
and benefits and only where absol

Toote omadused

Page 1 of 11 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 
PK-Merz Infusion 0.4 mg/ml 
Solution for infusion 

2.  
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Active substance: amantadine sulphate.  
One infusion bottle of 500 ml solution for infusion
contains 200 mg of amantadine sulphate.  

Excipients: sodium chloride: see also chapter 4.4 

For a full list of excipients, see section 6.1. 

3.  
PHARMACEUTICAL FORM 
Solution for infusion  

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 
Intensive care and initial treatment of akinetic crisis in
acute exacerbations of parkinsonian 
symptoms. 
Decreased vigilance in post-comatose states of varying
aetiology within a holistic concept under 
hospital conditions. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
DOSAGE WITH SINGLE AND DAILY DOSES: 

An ECG (50 mm/s) should be recorded before and 1 and 3 weeks
after commencing treatment and 
the Bazett frequency-corrected QT time (QTc) determined
manually. Such an ECG should also be 
recorded before and 2 weeks after any subsequent dose
increase. Further ECG check-ups should 
then take place at least
once a year. Treatment must be avoided or discontinued in
patients who 
show baseline QTc values above 420 ms, an increase of more
than 60 ms during treatment with PK-
Merz infusion, or a QTc time in excess of 480 ms during
treatment with PK-Merz infusion, and in 
patients who show discernible U waves. By following the above
precautions and taking the 
contraindications listed in section 4.3 into account, the very
rare, but life-threatening, undesirable 
effect torsade de pointes can be prevented. 

Page 2 of 11 
PARKINSONIAN SYNDROMES 
In the event of an acute exacerbation in parkinsonian
symptoms in the sense of an akinetic crisis, 
intravenous doses of 200 mg amantadine sulphate in 500 ml of
sol