Klaricid IV 500mg powder for solution for infusion vials

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Clarithromycin

Saatavilla:

Viatris UK Healthcare Ltd

ATC-koodi:

J01FA09

INN (Kansainvälinen yleisnimi):

Clarithromycin

Annos:

500mg

Lääkemuoto:

Powder for solution for infusion

Antoreitti:

Intravenous

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 05010500; GTIN: 5013158086715

Pakkausseloste

MKP-00709-2017_d5
FRONT
PATIENT INFORMATION LEAFLET ON
®
IV 500 mg
Powder for Concentrate for Solution for
Infusion
Clarithromycin
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor or
your pharmacist.
•
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
•
If you get any side effects talk to your doctor
or pharmacist. This includes any possible side
effects not listed in the leaflet. See section 4.
What is in this leaflet:
1.
What Klaricid IV is and what it is used for
2.
What you need to know before receiving Klaricid IV
3.
How is Klaricid IV given?
4.
Possible side effects
5.
How to store Klaricid IV
6.
Contents of the pack and other information
1. What Klaricid IV is and what it is used for
Klaricid IV contains the active ingredient
clarithromycin. Klaricid belongs to a group of
medicines called macrolide antibiotics. Antibiotics
stop the growth of bacteria (bugs) that cause
infections.
Klaricid IV is used whenever an intravenous (injection
into the vein) antibiotic is required to treat severe
infections or, alternatively, if a patient cannot swallow
Klaricid tablets.
It is used to treat infections such as:
1.
Chest infections such as bronchitis and
pneumonia
2.
Throat and sinus infections
3.
Skin and tissue infections
Klaricid IV is indicated in adults and children 12 years
and older.
2. What you need to know before receiving
Klaricid IV
Do not receive Klaricid IV if you;
• know that you are allergic to
clarithromycin, other macrolide
antibiotics such as erythromycin
or azithromycin, or any of the other
ingredients in Klaricid IV.
•
are taking medicines called ergot alkaloid tablets
(e.g. ergotamine or dihydroergotamine) or use
ergotamine inhalers for migraine.
•
are taking medicines called terfenadine or
astemizole (widely taken for h

Valmisteyhteenveto

OBJECT 1
KLARICID IV 500MG (SMPC)
Summary of Product Characteristics Updated 14-May-2018 | Mylan
Products Limited
1. Name of the medicinal product
Klaricid IV 500 mg, Powder for Concentrate for Solution for Infusion
2. Qualitative and quantitative composition
One vial contains 739.5 mg clarithromycin lactobionate, corresponding
to 500mg clarithromycin
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for Concentrate for Solution for Infusion
White to off-white caked, lyophilized powder
4. Clinical particulars
4.1 Therapeutic indications
Klaricid IV 500 mg is indicated in adults and children 12 years and
older.
Klaricid IV 500 mg is indicated whenever parenteral therapy is
required for treatment of infections caused
by susceptible organisms in the following conditions;
- Lower respiratory tract infections for example, acute and chronic
bronchitis, and pneumonia (see section
4.4 and 5.1 regarding Sensitivity Testing).
- Upper respiratory tract infections for example, sinusitis and
pharyngitis.
- Skin and soft tissue infections (e.g. folliculitis, cellulitis,
erysipelas) (see section 4.4 and 5.1 regarding
Sensitivity Testing).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
For intravenous administration only.
Intravenous therapy may be given for 2 to 5 days in the very ill
patient and should be changed to oral
clarithromycin therapy whenever possible as determined by the
physician.
ADULTS: The recommended dosage of Klaricid IV 500 mg is 1.0 gram
daily, divided into two 500mg
doses, appropriately diluted as described below.
CHILDREN OLDER THAN 12 YEARS: As for adults.
CHILDREN UNDER 12 YEARS: Use of Klaricid IV 500 mg is not recommended
for children younger than 12
years. Use Klaricid Paediatric Suspension.
ELDERLY: As for adults.
RENAL IMPAIRMENT: In patients with renal impairment who have
creatinine clearance less than 30ml/min,
the dosage of clarithromycin should be reduced to one half of the
n