Zedbac 500mg powder for solution for infusion vials

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Azithromycin dihydrate

Fáanlegur frá:

Aspire Pharma Ltd

ATC númer:

J01FA10

INN (Alþjóðlegt nafn):

Azithromycin dihydrate

Skammtar:

500mg

Lyfjaform:

Powder for solution for infusion

Stjórnsýsluleið:

Intravenous

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 05010500; GTIN: 5060209731056

Upplýsingar fylgiseðill

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, pharmacist or nurse.
•
If you get any side effects talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See
section 4.
What is in this leaflet:
1 What Zedbac is and what it is used for
2 What you need to know before you are
given Zedbac
3 How to use Zedbac
4 Possible side effects
5 How to store Zedbac
6 Contents of the pack and other information
1. WHAT ZEDBAC IS AND
WHAT IT IS USED FOR
Zedbac belongs to a group of antibiotics called
macrolides. It is used to treat localized infections
caused by bacteria in many different parts of
the body.
WHICH DISEASES ARE TREATED WITH ZEDBAC?
Zedbac is indicated for treatment of
serious infections or when oral treatment
cannot be used. It is used for treatment of
pneumonia (lung infection), and pelvic infections
(infection of the reproductive organs) caused by
susceptible organisms.
2. WHAT YOU NEED TO KNOW BEFORE YOU
ARE GIVEN ZEDBAC
DO NOT USE ZEDBAC
•
if you are allergic to azithromycin or any of the
ingredients of this medicine (listed in section 6).
•
if you are allergic (hypersensitive) to any
other macrolide antibiotic (such as
erythromycin or clarithromycin) or ketolide
(macrolide derivatives).
•
if you are taking any ergot derivatives such
as ergotamine (used to treat migraine) as
these medicines should not be taken together
with azithromycin.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before
using Zedbac
•
if you have an allergic reaction such as red
or white spots on the skin, itching and skin
irritation, swelling of the skin, larynx (throat)
or tongue, and difficulty in breathing, in which
case you should stop treatment with Zedbac.
•
if you have or have had kidney problems.
•
if you have or have had liver problems: your
doctor may need to mon

Vara einkenni

OBJECT 1
ZEDBAC 500MG POWDER FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 06-Feb-2018 | Aspire Pharma
Ltd
1. Name of the medicinal product
Zedbac 500 mg powder for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 500 mg of azithromycin (equivalent to 524.03 mg of
azithromycin dihydrate), which
after reconstitution results in a 100 mg/ml azithromycin solution. The
concentrate should be further
diluted to 1 mg/ml or 2 mg/ml.
Excipient(s) with known effect:
This medicinal product contains 7.31 mmol (168.2 mg) sodium per vial.
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Powder for solution for infusion.
Free white powder, with small aggregates.
4. Clinical particulars
4.1 Therapeutic indications
Azithromycin as powder for solution for infusion is indicated for the
treatment of community-acquired
pneumonia due to susceptible microorganisms, (see Section 5.1) in
adult patients where initial
intravenous therapy is required.
Azithromycin as powder for solution for infusion is indicated for the
treatment of pelvic inflammatory
disease (PID) due to susceptible microorganisms (see Section 5.1), in
patients where initial intravenous
therapy is required.
Consideration should be given to official guidance regarding the
appropriate use of antibacterial agents.
4.2 Posology and method of administration
Posology
The recommended dose of Azithromycin (azithromycin as powder for
solution for infusion) for the
treatment of adult patients with community-acquired pneumonia due to
the indicated susceptible
microorganisms is of 500 mg administered as a single intravenous daily
dose for at least two consecutive
days. The intravenous therapy should be followed by the oral
administration of azithromycin in a single
daily dose of 500 mg up to 7 to 10 days of treatment. Transition to
oral therapy should be carried out
when indicated by the doctor and according to the clinical response.
The recommended dose of Azithromycin (azithromycin as powder for
solut