Persantin 10mg/2ml solution for injection ampoules

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Dipyridamole

Disponible depuis:

Boehringer Ingelheim Ltd

Code ATC:

B01AC07

DCI (Dénomination commune internationale):

Dipyridamole

Dosage:

5mg/1ml

forme pharmaceutique:

Solution for injection

Mode d'administration:

Intravenous

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 02090000; GTIN: 5012816012424

Notice patient

PACKAGE LEAFLET:
INFORMATION FOR THE USER
PERSANTIN
® AMPOULES
10 MG/2 ML SOLUTION
FOR INFUSION
(dipyridamole)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects gets troublesome or
serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What PERSANTIN Ampoules are and what they
are used for
2. Before you receive PERSANTIN Ampoules
3. How PERSANTIN Ampoules will be given
4. Possible side effects
5. How to store PERSANTIN Ampoules
6. Further information
1. WHAT PERSANTIN AMPOULES ARE AND WHAT THEY ARE USED FOR
The name of your injection is PERSANTIN
Ampoules 10 mg / 2 ml Solution for Infusion
(called PERSANTIN Ampoules in this leaflet).
• It contains a medicine called dipyridamole. This
belongs to a group of medicines called
‘coronary vasodilators’
• It works by opening up (dilating) the blood
vessels in the heart
PERSANTIN Ampoules are used instead of
exercise during scans to assess heart conditions.
2. BEFORE YOU RECEIVE PERSANTIN AMPOULES
YOU SHOULD NOT BE GIVEN PERSANTIN AMPOULES
IF:
• You are allergic (hypersensitive) to dipyridamole
or any of the other ingredients of PERSANTIN
Ampoules (listed in Section 6 below)
• You have heart problems such as a recent heart
attack (within the last 4 weeks), angina (chest
pain) at rest, irregular heart beat, heart block
(this usually causes a slow heart beat), heart
failure or a problem affecting the heart valves
• You have low blood pressure or have recently
fainted (within the last 4 weeks) for no apparent
reason
• You have had a stroke or something called a
‘transient ischaemic attack’ (a temporary stroke
that lasts less than 24 hours)
• You have breathing probl

Résumé des caractéristiques du produit

PERSANTIN AMPOULES 10 MG/2 ML SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 02-Mar-2015 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
Persantin Ampoules 10 mg / 2 ml Solution for Infusion
2. Qualitative and quantitative composition
Dipyridamole 5 mg/ml. Each 2 ml ampoule contains 10 mg dipyridamole.
For excipients, see 6.1.
3. Pharmaceutical form
Solution for infusion.
2ml glass ampoules containing a clear, yellow-coloured solution.
4. Clinical particulars
4.1 Therapeutic indications
_Adults:_
As an alternative to exercise stress in thallium-201 myocardial
imaging, particularly in patients unable to
exercise or in those for whom exercise may be contraindicated.
_Children:_
As an alternative to exercise stress in myocardial perfusion imaging,
particularly in children unable to
exercise or in those for whom exercise may be contraindicated. More
specifically, this may include
children with Kawasaki disease complicated by coronary artery
involvement, or those with congenitally
abnormal coronary circulations.
4.2 Posology and method of administration
The dose of intravenous PERSANTIN as an adjunct to thallium myocardial
perfusion imaging should be
adjusted according to the weight of the patient. The recommended dose
is 0.142 mg/kg/minute (0.567
mg/kg total) infused over 4 minutes.
Thallium-201 should be injected within 3-5 minutes following the
4-minute infusion of PERSANTIN.
4.3 Contraindications
Hypersensitivity to any of the components of the product.
Patients with dysrhythmias, second- or third degree atrioventricular
block or with sick sinus syndrome
should not receive intravenous PERSANTIN (unless they have a
functioning pacemaker). Patients with
baseline hypotension (systolic blood pressure < 90 mmHg), recent
unexplained syncope (within 4 weeks)
or with recent transient ischaemic attacks are not suitable candidates
for dipyridamole testing.
Patients with severe coronary artery disease, including unstable
angina and recent myocardial infarction
(within 4 weeks), left ventricu