Prenoxad 2mg/2ml solution for injection pre-filled syringes

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Naloxone hydrochloride

Dostupno od:

Martindale Pharmaceuticals Ltd

ATC koda:

V03AB15

INN (International ime):

Naloxone hydrochloride

Doziranje:

1mg/1ml

Farmaceutski oblik:

Solution for injection

Administracija rute:

Intramuscular

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 19020700; GTIN: 5026468663361

Uputa o lijeku

IN THIS LEAFLET:
1. What Prenoxad Injection is and what it is used for
2. Before Prenoxad Injection is given
3. How Prenoxad Injection will be given
4. Possible side effects
5. Storing Prenoxad Injection
6. Contents of the Pack and other information
1. WHAT PRENOXAD INJECTION IS AND WHAT IT IS USED FOR
Prenoxad Injection contains the medicine naloxone. Naloxone belongs to
a
group of medicines that reverse the action of opioid drugs e.g.
diamorphine
(heroin), methadone, dextropropoxyphene, nalbuphine, pentazocine.
This medicine is used to:
• reverse the action of opioid drugs e.g. if you have been given or
taken an
overdose of these drugs.
• if you are at risk of an opioid overdose you should always carry
your Prenoxad
Injection with you. It is designed as an emergency rescue treatment
but you
should still get medical attention as soon as possible.
2. BEFORE PRENOXAD INJECTION IS GIVEN
THIS MEDICINE IS OFTEN USED IN CIRCUMSTANCES WHERE IT IS NECESSARY TO
ACT
VERY RAPIDLY. YOU SHOULD NOT BE INJECTED WITH THIS MEDICINE UNLESS IT
IS IN
THE CIRCUMSTANCES THAT WERE EXPLAINED WHEN YOU WERE GIVEN THE PRENOXAD
INJECTION.
Prenoxad Injection will only be made available once the prescriber has
assessed
the suitability and ability of a client or a representative to
administer naloxone in
the appropriate circumstances.
YOU SHOULD NOT BE GIVEN PRENOXAD INJECTION IF:
• you are allergic (hypersensitive) to Naloxone or to any other
ingredients in this
medicine, listed in section 6 of this leaflet.
BEFORE GIVING YOU THE PRENOXAD INJECTION YOUR PRESCRIBER WILL HAVE
CONSIDERED WHETHER SPECIAL CARE NEEDS TO BE TAKEN IF:
• you have kidney or liver problems
• you have heart problems.
If you have any of these problems you should make your doctor aware or
remind him.
TAKING OTHER MEDICINES
If you are able, you must tell your doctor if you are taking or have
recently
taken any medicines, including those obtained without a prescription.
PREGNANCY AND BREAST-FEEDING
Prenoxad Injection should not be used if you are pregnant or
breas

Svojstava lijeka

OBJECT 1
PRENOXAD 1MG/ML SOLUTION FOR INJECTION IN A PRE-
FILLED SYRINGE
Summary of Product Characteristics Updated 15-Feb-2018 | Martindale
Pharma
1. Name of the medicinal product
Prenoxad 1mg/ml Solution for Injection in a pre-filled syringe
2. Qualitative and quantitative composition
The active substance is Naloxone Hydrochloride 1 mg/ml
1 ml of solution - contains 1 mg of naloxone hydrochloride.
For a full list of excipients, see section 6.1.
Excipients with known effect:
Each 2 ml of solution contains 0.018g of sodium chloride
3. Pharmaceutical form
Solution for injection/infusion in a pre-filled syringe
Sterile, clear and colourless liquid with a pH of 3.0-4.0 and
osmolarity 270 to 300 mOsmol/L.
4. Clinical particulars
4.1 Therapeutic indications
Prenoxad Injection is intended for emergency use in the home or other
non-medical setting by appropriate
individuals or in a health facility setting for the complete or
partial reversal of respiratory depression
induced by natural and synthetic opioids, including methadone,
diamorphine (diacetylmorphine (INN))
and certain other opioids such as dextropropoxyphene and certain mixed
agonist/antagonist analgesics:
nalbuphine and pentazocine. For this reason Prenoxad Injection should
be carried by persons at risk of
such events. It may also be used for the diagnosis of suspected acute
opioid overdose.
4.2 Posology and method of administration
Prenoxad Injection may only be made available once the prescriber has
assessed the suitability and
competence of a client or representative to administer naloxone in the
appropriate circumstances.
Prenoxad Injection is for administration by intramuscular injection.
Prenoxad Injection is administered as a part of a resuscitation
intervention in suspected overdose
casualties, where opioid drugs may be involved or suspected. It may
need to be used in a non-medical
setting. Therefore, the prescriber should take appropriate steps to
ensure that the patient thoroughly
understands the indications and use of Prenoxad Injection. The
prescri