Erythrocin IV Lactobionate 1 g Powder for Concentrate for Solution for Infusion

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Erythromycin

זמין מ:

Amdipharm Limited

קוד ATC:

J01FA; J01FA01

INN (שם בינלאומי):

Erythromycin

כמות:

1 gram(s)

טופס פרצבטיות:

Powder for concentrate for solution for infusion

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

Macrolides; erythromycin

מצב אישור:

Marketed

תאריך אישור:

1980-01-28

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ERYTHROCIN
®
IV LACTOBIONATE 1 G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
(ERYTHROMYCIN LACTOBIONATE)_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 pharmacist or
nurse.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Erythrocin IV Lactobionate 1 g Powder for
Concentrate for
Solution for Infusion (will be referred to Erythrocin IV Lactobionate
throughout this
leaflet).
WHAT IS IN THIS LEAFLET
1.
What Erythrocin IV Lactobionate is and what it is used for
2.
What you need to know before you are given Erythrocin IV Lactobionate
3.
How Erythrocin IV Lactobionate will be given to you
4.
Possible side effects
5.
How to store Erythrocin IV Lactobionate
6.
Contents of the pack and other information
1.
WHAT ERYTHROCIN IV LACTOBIONATE IS AND WHAT IT IS USED FOR
Erythrocin IV Lactobionate belongs to a group of drugs called
antibiotics, and is used in
adults
and
children
to treat
infections
which
are
caused
by
bacteria.
Erythrocin
IV
Lactobionate may be used if you cannot swallow erythromycin tablets or
are at particular
risk of developing an infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ERYTHROCIN IV LACTOBIONATE
DO NOT BE GIVEN ERYTHROCIN IV LACTOBIONATE:
•
If you are allergic to erythromycin or any of the other ingredients of
this medicine
(listed in section 6).
•
If you are allergic to macrolide antibiotics such as clarithromycin or
azithromycin.
•
If you are currently taking a medicine called
-
ergotamine or dihydroergotamine (used to treat migraines) while taking
erythromycin as this may cause serious side effects;
-
terfenadine
or
astemizole
(widely
taken
for
hayfever
and
allergies),
cisapride (for stomach disorders) or pimozide (

מאפייני מוצר

Health Products Regulatory Authority
27 March 2023
CRN00DG0D
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Erythrocin IV Lactobionate 1 g Powder for Concentrate for Solution for
Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains erythromycin lactobionate equivalent to 1 g of
erythromycin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (Powder for sterile
concentrate).
A white to off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Erythrocin IV Lactobionate is indicated in adults and children for the
prophylaxis and treatment of infections caused by
erythromycin sensitive organisms.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, children and neonates:
Severe and immunocompromised infections;
50 mg/kg/day, preferably by continuous infusion, (equivalent to 4g per
day for adults).
Mild to moderate infections (oral route compromised); 25 mg/kg/day.
Elderly:
No special dosage recommendations.
Hepatic impairment
Erythromycin should be used with caution in patients with impaired
hepatic function (see sections 4.4 & 5.2).
Method of administration
BOLUS INJECTION (IV PUSH) IS CONTRAINDICATED
Continuous infusion of erythromycin lactobionate is preferred due to
the slower infusion rate and lower concentration of
erythromycin; however, intermittent infusion at intervals not greater
than every six hours is also effective.
Erythromycin lactobionate must be administered by continuous or
intermittent intravenous infusion only.
Intravenous erythromycin should be replaced by oral erythromycin as
soon as possible.
PREPARATIONS FOR ADMINISTRATION:
For Intermittent Infusion of 1 gram dose:
Step 1 - add 20 ml of Water for Injections BP to the 1 g vial.
Step 2 - add 20 ml of Step 1 solution to 200-250 ml of Sodium Chloride
Intravenous Infusion BP (0.9% Saline). This provides a
0.5%-0.4% solution.
Health Products Regulatory Authority
27 March 2023
CRN00DG0D
Page 2 of 9
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