Adrenaline (base) 1mg/1ml (1 in 1,000) solution for injection ampoules

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Kauptu það núna

Vara einkenni Vara einkenni (SPC)
08-06-2018

Virkt innihaldsefni:

Adrenaline acid tartrate

Fáanlegur frá:

base) 1mg/1ml (1 in 1,000) solution for injection ampoules (hameln pharma Ltd

ATC númer:

C01CA24

INN (Alþjóðlegt nafn):

Adrenaline acid tartrate

Skammtar:

1mg/1ml

Lyfjaform:

Solution for injection

Stjórnsýsluleið:

Subcutaneous; Intramuscular

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 03040300; GTIN: 5016386000249

Upplýsingar fylgiseðill

                                1. What Adrenaline (epinephrine) 1 in 1000
Injection is and what it is used for
Adrenaline is used in life-threatening emergencies
such as
ACUTE ALLERGIC REACTIONS.
It is an active
CHEMICAL PRODUCED
in the
BODY
.
Adrenaline acts on receptors in the body and can
increase the speed and force of heart muscle
contractions,
relieve
narrowing
of
the
lungs
passages helping breathing and relieve some of
the symptoms of acute allergic reaction.
2. What you need to know before you use
Adrenaline (epinephrine) 1 in 1000 Injection
DO NOT USE ADRENALINE (EPINEPHRINE) 1 IN
1000 INJECTION:
• if you are
ALLERGIC
to adrenaline or any of the
other
ingredients
of
this
medicine
(listed
in
section 6).
WARNINGS AND PRECAUTIONS:
TALK TO YOUR DOCTOR, PHARMACIST OR NURSE
BEFORE USING ADRENALINE (EPINEPHRINE) 1
IN 1000 INJECTION:
• if you are in
SHOCK
or have lost a lot of blood.
• if you have any
HEART DISEASE or
long standing
chest disease like asthma or emphysema.
• if you have
PHAEOCHROMOCYTOMA
(a tumour
on the adrenal gland).
• if you have low blood levels of
POTASSIUM
or
high blood levels of
CALCIUM
.
• if you are suffering from
GLAUCOMA
(increased
pressure in the eye).
• if you are going to have an
OPERATION
under
general anaesthetic.
• if you are a
DIABETIC
.
• if you are suffering from
HIGH BLOOD PRESSURE
.
• if you have had a
SPINAL CORD INJURY
and are
suffering
from
over-activity
of
the
involuntary
nervous
system
which
causes
your
BLOOD
PRESSURE TO BE UNCONTROLLED.
• if you have an ENLARGED PROSTATE
or have
DIFFICULTY URINATING
.
• if you have any
PSYCHOLOGICAL DISORDERS
.
OTHER
MEDICINES
AND
ADRENALINE
(EPINEPHRINE) 1 IN 1000 INJECTION:
Tell your doctor, pharmacist or nurse if you are
taking, have recently taken or might take
ANY OTHER
MEDICINES
, including medicines obtained without
a prescription. This is especially important with
the following medicines as they may interact with
your Adrenaline (epinephrine) 1 in 1000 Injection:
• Other medicines to treat
HIGH BLOOD PRESSURE
or
A HEART CONDITION.

                                
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Vara einkenni

                                OBJECT 1
ADRENALINE (EPINEPHRINE) INJECTION BP 1 IN 1000
Summary of Product Characteristics Updated 18-Dec-2015 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Adrenaline (Epinephrine) Injection BP 1 in 1000.
2. Qualitative and quantitative composition
Each ml of solution for injection contains 1 mg of adrenaline
(epinephrine) as the acid tartrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Sterile Injection.
4. Clinical particulars
4.1 Therapeutic indications
Adrenaline Injection BP 1 in 1000 may be used in the treatment of
acute allergy and anaphylactic shock.
4.2 Posology and method of administration
The INTRAMUSCULAR ROUTE is the preferred choice for most individuals
who have to be given adrenaline
for the management of an anaphylactic reaction. The generally accepted
dosage of adrenaline in this
indication is 0.01mg/kg body weight. An additional dosage table
according to age is presented below.
Dose of INTRAMUSCULAR injection of Adrenaline (Epinephrine) Injection
BP 1 in 1000 for a severe
anaphylactic reaction
Age
Dose
Volume of adrenaline
1 IN 1000
(1mg/ml)
Under 6 months
0.01 mg/kg IM
0.01 ml/kg
6 months – 6 years
0.15 mg IM
0.15 ml
Child 6 – 12 years
0.3 mg IM
0.3 ml
Child > 12 years
0.5 mg IM
0.5 ml
Adult
0.5 mg IM
0.5 ml
If necessary, these doses may be repeated several times at 5 – 15
minute intervals according to blood
pressure, pulse, and respiratory function. A small volume syringe
should be used.
4.3 Contraindications
Hypersensitivity to adrenaline, sodium metabisulfite or any of the
other ingredients.
Adrenaline 1 in 1000 should not be used in fingers, toes, ears, nose
or genitalia owing to the risk of
ischaemic tissue necrosis.
4.4 Special warnings and precautions for use
Adrenaline should be used with caution in patients with:
• hyperthyroidism, psychoneurosis, phaeochromocytoma, narrow angle
glaucoma, diabetes mellitus,
hypokalaemia or hypercalcaemia.
• severe renal impairment, prostatic hypertrophy or urination
difficulty
• cerebrovascular d
                                
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