Pethidine 100mg/2ml solution for injection ampoules

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Pethidine hydrochloride

Prieinama:

Advanz Pharma

ATC kodas:

N02AB02

INN (Tarptautinis Pavadinimas):

Pethidine hydrochloride

Dozė:

50mg/1ml

Vaisto forma:

Solution for injection

Vartojimo būdas:

Intramuscular; Subcutaneous; Intravenous

Klasė:

Schedule 2 (CD)

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 04070200; GTIN: 5099602332799

Pakuotės lapelis

The name of your medicine is Pethidine Hydrochloride 50mg/ml Solution
for Injection
but will be referred to as “Pethidine Injection” throughout the
remainder of this leaflet.
In this leaflet:
1. What Pethidine Injection is and what it is used for
2. Before you are given Pethidine Injection
3. How Pethidine Injection is given to you
4. Possible side effects
5. How to store Pethidine Injection
6. Further information
1.WHAT PETHIDINE INJECTION IS AND WHAT IT IS USED FOR
Pethidine Injection is a type of medicine called an opioid analgesic.
The word opioid
means a substance similar to opium, for instance strong pain relievers
such as
morphine or codeine. An analgesic is a medicine that can be used to
relieve pain.
Pethidine
Injection
is
used
to
relieve
moderate
to
severe
pain.
Including
pain
associated with childbirth, or during an anaesthetic or following an
operation. As well
as relieving pain, pethidine has other effects including a sedative
(calming) effect.
2. BEFORE YOU ARE GIVEN PETHIDINE INJECTION
YOU SHOULD NOT BE GIVEN THIS MEDICINE IF:
• you know that you are allergic to Pethidine Injection or one of
the other ingredients
in this product (listed at the end of this leaflet), or to other
strong pain relievers, such
as morphine
• you have any problems that affect your breathing including chronic
bronchitis or
asthma
• you are taking monoamine oxidase inhibitors (MAOIs) or have been
taking them
within the last two weeks. MAOIs (eg. phenelzine or isocarboxazid) are
medicines
used to treat depression
• you have recently suffered a head injury, have any conditions
associated with raised
pressure in the brain or a tumour of the adrenal gland
(phaeochromocytoma).
Patients in a coma should not be given this medicine.
Speak to your doctor if one of these applies to you before you are
given this medicine.
TAKE SPECIAL CARE AND TELL YOUR DOCTOR IF:
• you have an underactive thyroid gland (which may cause tiredness,
intolerance to
cold,
constipation,
and
puffiness
of
the
face)
or
underactive
adrenal
glands

Prekės savybės

OBJECT 1
PETHIDINE INJECTION BP 50MG/ML
Summary of Product Characteristics Updated 01-Sep-2014 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Pethidine Hydrochloride 50mg/ml Solution for Injection
2. Qualitative and quantitative composition
Each 1ml of solution contains 50mg of Pethidine Hydrochloride B.P.
3. Pharmaceutical form
Clear, colourless, sterile solution intended for parenteral
administration to human beings.
4. Clinical particulars
4.1 Therapeutic indications
Pethidine hydrochloride may be used as an analgesic for the relief of
moderate to severe pain including :
obstetric analgesia; pre-operative medication and analgesia during
anaesthesia; post-operative analgesia.
4.2 Posology and method of administration
Pethidine Injection may be administered by subcutaneous, intramuscular
or slow intravenous injection.
Adults : The following single doses may be used and should not usually
be repeated more frequently than
four hourly; Subcutaneous or intramuscular injection : 25 - 100mg.
Intravenous injection : 25 - 50mg.
Elderly or debilitated patients : The initial dose should not exceed
25mg, because of the particular
sensitivity among elderly or debilitated patients to the central
depressant effects of pethidine.
Children : The usual single dose is 0.5 to 2mg/kg body weight by
intramuscular injection. If necessary,
this dose may be repeated, allowing a minimum of four hours between
doses. Use of a small graduated
syringe is recommended for the accurate administration of dosages in
children. In the absence of
graduated syringes, the solution should be diluted with Water for
Injections before measuring the dose.
4.3 Contraindications
History of hypersensitivity to pethidine.
Coma. It also contra-indicated in conditions associated with raised
intracranial pressure and in head injury
(opioid analgesics interfere with pupillary responses vital for
neurological assessment).
Phaeochromocytoma.
Acute respiratory depression and when there is risk of paralytic ileus
or obstructive airways dis