Atropine 1mg/5ml solution for injection pre-filled syringes

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Atropine sulfate

Dostępny od:

Martindale Pharmaceuticals Ltd

Kod ATC:

A03BA01

INN (International Nazwa):

Atropine sulfate

Dawkowanie:

200microgram/1ml

Forma farmaceutyczna:

Solution for injection

Droga podania:

Intravenous

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 15010300; GTIN: 5026468000340

Ulotka dla pacjenta

3. HOW ATROPINE SOLUTION FOR INJECTION IS GIVEN
THIS MEDICINE IS AN INJECTION WHICH WILL BE GIVEN TO YOU BY A DOCTOR
OR NURSE.
Your doctor will decide the correct dose you require.
ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS OF AGE:
• 0.5mg into a vein, followed by further doses of 0.5mg if
necessary,
up to a maximum of 3mg.
CHILDREN UNDER 12 YEARS OF AGE:
This medicine is not recommended for children under 12.
IF YOU THINK YOU HAVE BEEN GIVEN TOO MUCH ATROPINE SOLUTION FOR
INJECTION THAN YOU SHOULD BE GIVEN:
This medicine is given to you by your doctor so it is unlikely you
will
receive too much. Your doctor has information on how to recognise and
treat an overdose. If you are concerned about your treatment, please
talk to your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines Atropine Solution for injection can cause side
effects,
although not everybody gets them.
The following side effects have been reported.
CONTACT YOUR DOCTOR OR NURSE IMMEDIATELY IF YOU GET ANY OF THE
FOLLOWING:
• Sudden life – threatening allergic reaction such as rash,
itching or
hives on the skin, swelling of the face, lips, tongue or other parts
of
the body, shortness of breath, wheezing or trouble breathing.
OTHER SIDE EFFECTS INCLUDE:
• blurred vision
• increase in pressure in the eye
• dry mouth
• nausea
• thirst
• dilation of the pupils
• uncomfortable sensitivity to light (photophobia)
• decrease in tears production in the eyes
• flushing
• dryness of the skin
• fast heart beat ( tachycardia)
• palpitations (you are aware of your heart beating)
• difficulty in passing urine
• constipation
• vomiting
• nervousness
• confusion especially in the elderly
• thickening of the phlegm produced while coughing
• restlessness
• hallucinations
• changes in the way the heart beats (arrhythmias)
• severe confusion ( delirium)
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor, pharmacist or nurse:
This
includes any possible side effects not listed in this leaflet. You

Charakterystyka produktu

OBJECT 1
ATROPINE SULFATE 1MG IN 5ML SOLUTION FOR
INJECTION IN PRE-FILLED SYRINGE
Summary of Product Characteristics Updated 18-Jan-2017 | Martindale
Pharma
1. Name of the medicinal product
Atropine Sulfate 1mg in 5ml Solution for injection in pre-filled
syringe.
2. Qualitative and quantitative composition
Each 5 ml syringe contains 1 mg Atropine sulfate
Each 1ml of solution for injection contains 0.2 mg Atropine sulphate
For the full list of excipients, see section 6.1.
.
3. Pharmaceutical form
Solution for injection in pre-filled syringe. Clear and practically
particulate free solution pH 3 - 4.5.
4. Clinical particulars
4.1 Therapeutic indications
Reversal of excessive of bradycardia. The administration is given in
the algorithm for the emergency
treatment of Peri - arrest arrhythmias produced by European
Resuscitation Council's and Resuscitation
Council (UK).
4.2 Posology and method of administration
_Adults and children over 12 years _
Initially 0.5mg by intravenous injection and then increments of 0.5mg
to a maximum of 3mg.
Paediatric population
Not recommended.
_Elderly _
As for Adults.
Method of administration:
Atropine 1mg in 5ml is administered by intravenous injection.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in 6.1
o Closed-angle glaucoma
o Risk of urinary retention because of prostatic or urethral disease
o Myasthenia gravis unless given in conjunction with
anticholinesterase
o Breast-feeding (see section 4.6).
o Achalasia of the oesophagus
4.4 Special warnings and precautions for use
Use with caution in case of:
Prostatic enlargement
Renal or hepatic insufficiency
Cardiac insufficiency, arrhythmias, hyperthyroidism
Chronic obstructive pulrnonary disease, as a reduction in bronchial
secretions may lead to the formation
of bronchial plugs
Paralytic ileus, intestinal atonia in elderly, toxic megacolon
Pyloric stenosis
Fever, or when ambient temperature is high
In the elderly, who are more susceptible to adverse effects.
.
4.5 Interaction with oth