Atropin Abboxia 0,5 mg/ml Injektionsvätska, lösning

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

atropinsulfat (monohydrat)

Tillgänglig från:

Abboxia AB

ATC-kod:

A03BA01

INN (International namn):

atropine sulfate (monohydrate)

Dos:

0,5 mg/ml

Läkemedelsform:

Injektionsvätska, lösning

Sammansättning:

atropinsulfat (monohydrat) 0,5 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Ampull, 5 x 1 ml; Ampull, 10 x 1 ml; Ampull, 20 x 1 ml; Ampull, 50 x 1 ml; Ampull, 100 x 1 ml

Bemyndigande status:

Godkänd

Tillstånd datum:

2022-02-04

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATROPIN ABBOXIA 0,5 MG/ML SOLUTION FOR INJECTION
ATROPIN ABBOXIA 1 MG/ML SOLUTION FOR INJECTION
atropine sulphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Atropin Abboxia is and what it is used for
2.
What you need to know before you use Atropin Abboxia
3.
How to use Atropin Abboxia
4.
Possible side effects
5.
How to store Atropin Abboxia
6.
Contents of the pack and other information
1.
WHAT ATROPIN ABBOXIA IS AND WHAT IT IS USED FOR
Atropin Abboxia belongs to a group of medicines which are called
anticholinergics. Atropine sulphate,
the active substance in Atropin Abboxia, temporarily blocks some nerve
endings. This decreases
glands secreting, makes some muscles (such as in the gut) relax and
speeds up the heart. Atropin
Abboxia is used for:
-
relaxation of muscles in the gastro-intestinal tract during cramps
-
to reduce saliva, fluid in the lungs and/or gastric juice
-
to treat a slow heartbeat
-
as medication during surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ATROPIN ABBOXIA
DO NOT USE ATROPIN ABBOXIA
-
if you are allergic to atropine sulphate or any of the other
ingredients of this medicine (listed in
section 6)
-
if you have troubles passing urine (i.e. if you are a man and have an
enlarged prostate)
-
if you have increased pressure in the eye (glaucoma)
-
if you have blockage in the intestines or paralysis of the bowel
-
if you suffer from severe inflammation of the colon (ulcerative
colitis) or complication of colonic
inflammation
These contraindications do not apply in the event of life-threatening
situations.
WARNINGS AND PRECAUTIONS
Talk to your doctor before your are given Atropin Abboxia

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atropin Abboxia 0,5 mg/ml solution for injection
Atropin Abboxia 1 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains 0,5 mg atropine sulphate.
1 ampoule á 1 ml contains 0,5 mg atropine sulphate.
1 ml solution for injection contains 1 mg atropine sulphate.
1 ampoule á 1 ml contains 1 mg atropine sulphate.
Excipient with known effect
1 ml solution for injection contains 3,5 mg sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atropin Abboxia is indicated in children and adults for:
• Spastic contractions in the gastrointestinal tract
• Hypersecretion of saliva, bronchial fluid and/or gastric acid.
• Bradycardia.
• Per operative medication.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Spastic contractions in the gastrointestinal tract, hypersecretion:
Administered in optimal effective dose which is titrated individually
and with moderate mouth dryness
as a sign of achievement of an optimal dose.
Bradycardia: 0,5–1 mg intravenously.
Per operative medication in adults: 0,5 mg subcutaneously.
_Pediatric population_
Per operative medication to children:
3–10 kg
0,10–0,15 mg
10–12 kg
0,15 mg
12–15 kg
0,20 mg
2
15–17 kg
0,25 mg
17–20 kg
0,30 mg
20–30 kg
0,35 mg
30–50 kg
0,40–0,50 mg
Subcutaneous injection should be given 1 hour before surgery. In case
of narrow timelines, an
emergency dose 0,75 of the recommended subcutaneous dose may be
injected intravenously 10-15
minutes before initiation of anesthesia. The effect though becomes
worse.
Elderly
Dose reduction may be necessary in elderly.
Method of administration
Atropin Abboxia 0,5 mg/ml is used for both intravenous and
subcutaneous administration.
Atropin Abboxia 1 mg/ml is used for intravenous administration.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to atropine sul