Ismelin 10mg/1ml solution for injection ampoules

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Guanethidine monosulfate

Dostupné s:

Amdipharm Plc

ATC kód:

C02CC02

INN (Mezinárodní Name):

Guanethidine monosulfate

Dávkování:

10mg/1ml

Léková forma:

Solution for injection

Podání:

Intramuscular

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 02050300; GTIN: 5060064170663

Charakteristika produktu

OBJECT 1
ISMELIN AMPOULES 10 MG/ML
Summary of Product Characteristics Updated 30-Sep-2014 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Ismelin® ampoules l0mg/ml
Guanethidine monosulphate Ampoules 10mg/ml
2. Qualitative and quantitative composition
Guanethidine monosulphate Ph.Eur. 10mg/ml
3. Pharmaceutical form
A colourless solution in a clear glass l ml ampoule, for intramuscular
administration.
4. Clinical particulars
4.1 Therapeutic indications
Control of hypertensive crises, and to obtain more rapid blood
pressure control.
4.2 Posology and method of administration
_Adults:_
Ismelin should be given by intramuscular injection. One injection of
10 to 20mg will generally cause a
fall in blood pressure within 30 minutes which reaches a maximum in
one to two hours and is maintained
for four to six hours. If a further dose of 10 to 20mg is deemed
necessary, then three hours should be
allowed to elapse between doses.
In hypertensive patients with moderate renal insufficiency, the
intervals between dosing should be
extended or the dosage reduced to avoid accumulation as the drug is
renally excreted. (For patients with
renal failure, see Section 4.3, "Contra-indications").
_Children: _not recommended.
_Elderly: _Clinical evidence would indicate that no special dosage
regime is necessary, but concurrent
coronary or cerebral insufficiency should be taken into account.
4.3 Contraindications
Cases of phaeochromocytoma and patients previously treated with
monoamine oxidase inhibitors (see
Section 4.5, "Interactions with other medicaments and other forms of
interaction"); in such cases, Ismelin
may lead to the release of large quantities of catecholamines, which
may cause a hypertensive crisis.
Patients with known hypersensitivity to guanethidine and related
derivatives. Heart failure due to causes
other than hypertension. Renal failure (creatinine clearance 10 to
40ml/min).
4.4 Special warnings and precautions for use
Heat and physical exertion may increase the antihypertensive effect of
Ismel