Apresoline

Pajjiż: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Hydralazine hydrochloride 25mg

Disponibbli minn:

AFT Pharmaceuticals Ltd

INN (Isem Internazzjonali):

Hydralazine hydrochloride 25 mg

Dożaġġ:

25 mg

Għamla farmaċewtika:

Tablet

Kompożizzjoni:

Active: Hydralazine hydrochloride 25mg Excipient: Colloidal silicon dioxide Dispersed Yellow 15093, coat Copovidone Hypromellose Macrogol 8000   Magnesium stearate Microcrystalline cellulose   Opacode brown S-1-26593 Povidone   Purified talc   Sucrose   Titanium dioxide Wheat starch

Unitajiet fil-pakkett:

Bottle, plastic, 1 x 100, 100 tablets

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

Sumitomo Chemical Company Limited

Indikazzjonijiet terapewtiċi:

For the treatment of moderate to severe hypertension as an adjunct to other anti-hypertensive agents e.g. beta-blockers and diuretics.

Sommarju tal-prodott:

Package - Contents - Shelf Life: Bottle, plastic, 1 x 100 - 100 tablets - 48 months from date of manufacture stored at or below 30°C

Data ta 'l-awtorizzazzjoni:

1969-12-31

Karatteristiċi tal-prodott

NEW ZEALAND DATA SHEET
1
APRESOLINE
® (20
MG/ML POWDER FOR INJECTION
)
APRESOLINE
®
20 mg/mL powder for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydralazine hydrochloride 20 mg/mL
3
PHARMACEUTICAL FORM
White to yellowish lyophilisate
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertensive crisis, especially during late pregnancy (pre-eclampsia
and eclampsia)
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
ADULTS
The initial dose is 5-10 mg, administered by slow intravenous
injection in order to avoid
precipitous fall in mean arterial pressure with a critical reduction
in cerebral or utero-
placental perfusion. If it is necessary to repeat the injection, this
should be done after an
interval of 20-30 min, throughout which the blood pressure and heart
rate should be
monitored. A satisfactory response can be defined as a decrease in
diastolic blood pressure
to 90-100 mmHg.
Apresoline may also be given by continuous intravenous infusion,
beginning with a flow
rate of 200-300 µg/min. Maintenance flow rates must be determined
individually and are
usually within the range 50-150 µg/min.
Prior to injection, the powdered active substance should be completely
dissolved in 1 mL
distilled water for injection and the freshly prepared solution should
be used immediately.
For the preparation of infusion solutions, this fresh solution should
be diluted with
physiological saline or with 5% sorbitol solution.
CHILDREN
In the rare cases where rapid treatment proves indispensable in a
child, Apresoline
ampoules should be used with extreme caution.
The initial dose is 0.1-0.5 mg/kg body weight administered
intravenously over 1-2 min with
repeat doses every 30-90 min as required, up to a maximum daily dose
of 3.5 mg/kg body
weight.
METHOD OF ADMINISTRATION
Parenteral treatment with Apresoline should always be carried out
cautiously and under
strict medical surveillance (if possible in hospital).
4.3
CONTRAINDICATIONS

Known hypersensitivity to hydralazine or dihydralazine or to any of
the excipients

Idiopathi