Pitressin 20 PU/ml Solution for Injection

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Argipressin

Доступна с:

Mercury Pharmaceuticals Ltd

код АТС:

H01BA; H01BA06

ИНН (Международная Имя):

Argipressin

дозировка:

20 unit(s)/millilitre

Фармацевтическая форма:

Solution for injection

Тип рецепта:

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

Терапевтические области:

Vasopressin and analogues; argipressin

Статус Авторизация:

Not marketed

Дата Авторизация:

1979-04-01

тонкая брошюра

1
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
{CARTON 10 X 1ML AMPOULE}
1.
NAME OF THE MEDICINAL PRODUCT
Pitressin 20 PU/ml Solution for Injection
Argipressin
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
_ _
Each ml contains 20 international pressor units of synthetic
argipressin (as synthetic vasopressin).
3.
LIST OF EXCIPIENTS
Glacial Acetic Acid and Water for Injection.
4.
PHARMACEUTICAL FORM AND CONTENTS
Solution for injection. 10 x 1 ml ampoules
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
For dosage, indications, contraindications, warnings etc,
Read the package leaflet before use.
For intravenous, intramuscular or subcutaneous use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
9.
SPECIAL STORAGE CONDITIONS
Store in a refrigerator (2

C – 8

C).
Do not freeze.
Store in the original outer packaging to protect from light.
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Once opened use immediately.
If only part used, discard the remaining solution.
Use only as prescribed by a physician
2
11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Mercury Pharmaceuticals Ltd.,
Capital House, 85 King William Street,
London EC4N 7BL, UK
12.
MARKETING AUTHORISATION NUMBER(S)
PA 899/1/1
13.
BATCH NUMBER<, DONATION AND PRODUCT CODES>
_ _
14.
GENERAL CLASSIFICATION FOR SUPPLY
_ _
POM
15.
INSTRUCTIONS ON USE
For single use only
16.
INFORMATION IN BRAILLE

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pitressin 20 PU/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 0.4 mg of synthetic vasopressin (50 pressor unit
per mg) which is equivalent to argipressin 20
pressor units.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, sterile, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in diabetes insipidus, when this is not of nephrogenic origin
and control of bleeding from oesophageal varices.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
DIABETES INSIPIDUS:
A dose of 0.25ml to 1ml (5 to 20 units) by subcutaneous or
intramuscular injection every four hours.
OESOPHAGEAL VARICES:
For the initial control of variceal bleeding Pitressin should be given
intravenously. Pitressin, 20 units diluted in 100ml
dextrose 5% w/v may be infused over a 15 minute period.
ELDERLY (OVER 65 YEARS):
As for adults, no clinical or pharmacokinetic data specific to this
age group are available. However, the drug has been
used successfully at normal dosage in the elderly.
PATIENTS WITH RENAL IMPAIRMENT:
Pitressin should not be used in patients with chronic nephritis with
nitrogen retention (see Section 4.3).
PAEDIATRIC POPULATION:
Not recommended in children below 18 years.
Method of administration
Subcutaneous, intravenous or intramuscular injection.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Anaphylaxis to the active substance or to any of the excipients listed
in section 6.1.
Patient with coronary artery disease, or those intended to receive
halogenated anaesthetic agents.
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