Apresoline Ampoules 20 mg Powder for concentrate for solution for injection or infusion

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

HYDRALAZINE HYDROCHLORIDE

から入手可能:

Amdipharm Limited

ATCコード:

C02DB; C02DB02

INN（国際名）:

HYDRALAZINE HYDROCHLORIDE

投薬量:

20 milligram(s)

医薬品形態:

Powder for concentrate for solution for injection/infusion

処方タイプ:

Product subject to prescription which may not be renewed (A)

治療領域:

Hydrazinophthalazine derivatives; hydralazine

認証ステータス:

Not marketed

承認日:

1979-04-01

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR PATIENT
APRESOLINE AMPOULES 20MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION OR INFUSION
HYDRALAZINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist or
nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
Your medicine is called Apresoline Ampoules 20mg Powder for
concentrate for solution for
injection or infusion and will be called Apresoline Ampoules 20 mg
throughout the rest of this
leaflet.
WHAT IS IN THIS LEAFLET
1.What Apresoline Ampoules 20 mg are and what they are used for
2.What you need to know before you use Apresoline Ampoules 20 mg
3.How to use Apresoline Ampoules 20 mg
4.Possible side effects
5.How to store Apresoline Ampoules 20 mg
6.Contents of the pack and other information
1.WHAT APRESOLINE AMPOULES 20 MG ARE AND WHAT THEY ARE USED FOR
Apresoline Ampoules 20 mg contain 20mg hydralazine hydrochloride.
Hydralazine is an anti-
hypertensive – it is used to treat high blood pressure. It works by
relaxing blood vessels and
increasing the supply of blood and oxygen to the heart.
Apresoline is used to treat very high blood pressure, particularly
when this condition occurs in
pregnancy (pre-eclampsia and toxaemia of pregnancy) or in patients
with kidney disease.
2.WHAT YOU NEED TO KNOW BEFORE YOU USE APRESOLINE AMPOULES 20 MG
DO NOT USE APRESOLINE AMPOULES 20MG IF :
- you are allergic to hydralazine or any of the other ingredients of
this medicine (allergic
reactions include mild symptoms such as itching and/or rash. More
severe symptoms include
swelling of the face, lips, tongue and/or throat with dif

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Apresoline Ampoules 20 mg Powder for concentrate for solution for
injection or infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Apresoline Ampoules contain 20 mg Hydralazine Hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for injection or infusion. (Powder
for sterile concentrate)
2 ml, Type 1, Ph. Eur. clear glass ampoules containing a yellowish
crystalline powder for reconstitution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of hypertensive emergencies, including pre-eclampsia
and toxaemia of pregnancy, and in hypertension
with renal complications.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY:_
_ADULTS:_
Hypertension: The dose should be adjusted to the individual
requirements of the patient. Treatment should begin with
low doses of Apresoline which, depending on the patient’s response
should be increased stepwise to achieve optimal
therapeutic effect whilst keeping unwanted effects to a minimum.
_PAEDIATRIC POPULATION_
Not recommended
_USE IN THE ELDERLY_
Clinical evidence would indicate that no special dosage regimen is
necessary but concurrent hepatic and renal
insufficiency should be taken into account.
Method of administration:
Parenteral: Initially 5 to 10 mg by slow intravenous injection, to
avoid precipitous decreases in arterial pressure with a
critical reduction in cerebral or utero-placental perfusion. If
necessary a repeat injection can be given after an interval
of 20-30 minutes, throughout which blood pressure and heart rate
should be monitored. A satisfactory response can be
defined as a decrease in diastolic blood pressure to 90/100 mm Hg. The
contents of the vial should be reconstituted by
dissolving in 1ml of Water for Injection. This should then be further
diluted with 10 ml of Sodium Chloride Injection
0.9% and be administered by slow intravenous injection. The injection
must be given immediately and any remainder
d