Desmopressin-PH&T

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Osta kohe

Laadi alla Toote omadused (SPC)
21-12-2010

Toimeaine:

Desmopressin acetate trihydrate 0.2mg equivalent to Desmopressin 0.178 mg;  

Saadav alates:

AFT Pharmaceuticals Ltd

INN (Rahvusvaheline Nimetus):

Desmopressin acetate trihydrate 0.2 mg (equivalent to Desmopressin 0.178 mg)

Annus:

200 mcg

Ravimvorm:

Tablet

Koostis:

Active: Desmopressin acetate trihydrate 0.2mg equivalent to Desmopressin 0.178 mg   Excipient: Lactose monohydrate Magnesium stearate Maize starch Povidone

Ühikuid pakis:

Bottle, plastic, HDPE with PP CRC, 30 tablets

Klass:

Prescription

Retsepti tüüp:

Prescription

Valmistatud:

Bachem Americas Inc

Toote kokkuvõte:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP CRC - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with PP CRC - 90 tablets - 36 months from date of manufacture stored at or below 25°C

Loa andmise kuupäev:

2006-07-14

Toote omadused

                                DESMOPRESSIN-PH&T 
_DESMOPRESSIN TABLETS 0.1MG AND 0.2MG _
 
PRESENTATION 
Desmopressin-PH&T 0.1mg tablets are round, white, scored tablets, debossed “0.1” 
on one side. Each tablet contains 0.1mg of desmopressin acetate equivalent to 0.089 
mg  desmopressin and typically weighs 200mg. 
Desmopressin-PH&T 0.2mg tablets are round, white, scored tablets, debossed “0.2” 
on one side. Each tablet contains 0.2mg of desmopressin acetate equivalent to 
0.178mg desmopressin and typically weighs 200mg. 
 
USES 
_ACTIONS _
Desmopressin is a synthetic analogue of vasopressin. The difference lies in the 
desamination of cysteine and substitution of L-arginine by D-arginine. These 
structural differences with vasopressin result in a significant increase of the anti-
diuretic activity, while the vasopressor activity is reduced considerably. The duration 
of the anti-diuretic activity is extended considerably. After oral administration, 
duration of the effect of 6 to 14 hours is to be expected.  
Clinical trials with desmopressin tablets in the treatment of nocturia showed the 
following (p<0.001): 
•  A reduction of not less than 50% in the mean number of nocturnal voids was 
obtained in 39% of patients with desmopressin compared with 5% of patients with 
placebo 
•  The mean number of voids per night decreased by 44% with desmopressin 
compared with 15% with placebo 
•  The mean duration of first undisturbed sleep period increased by 64% with 
desmopressin compared with 20% with placebo 
•  The mean duration of first undisturbed sleep period increased by 2 hours with 
desmopressin compared with 31 minutes with placebo. 
EFFECT OF TREATMENT WITH INDIVIDUAL ORAL DOSE OF DESMOPRESSIN BETWEEN 0.1 AND 
0.4 MG DURING 3 WEEKS COMPARED WITH PLACEBO (POOLED DA
                                
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