Clindamycin 300mg/2ml solution for injection ampoules

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Clindamycin phosphate

Tilgængelig fra:

Bowmed Ibisqus Ltd

ATC-kode:

J01FF01

INN (International Name):

Clindamycin phosphate

Dosering:

150mg/1ml

Lægemiddelform:

Solution for injection

Indgivelsesvej:

Intravenous; Intramuscular

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 05010600; GTIN: 5060130130300 5060130130447

Indlægsseddel

Realized by:
QUALITY SYSTEM - ISO 9001:2008
ARTWORK
PDF 1.5
ISSUE DATE
20/06/2014
OPERATOR
RI006M
DRAFT
03
SEPARATIONS:
(BLACK)
MEAS. (mm): 210 X 297(FOLD 150X36 MM)
CUTTING PROFILE: ACSI003
TECHNICAL SPECIF.: ACSI001L00
g/sq.mt: 60 GR/M
2
Thikness: 0,065 MM
FONT TYPE: MYRIAD PRO Size: 8 PT
THIS ARTWORK IS PROPERTY OF:
FACTA/ACS DOBFAR
CLIENT APPROVAL
DATE
SIGNATURE
PRODUCT NAME:
I-CLINDAMYCINA 150MG/ML
SOLUTION FOR INJECTION
PRODUCT CODE:
L08GBCLIN06
EURPACK GRAFIFARMA GRAFIFLEX - Aprilia (LT) tel. [phone]
produzione@grafifarma.it - Robecco s/N (MI) tel. [phone]
milano@grafifarma.it
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GRAFIFARMA GRAFIFLEX Srl. v.01-2013
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLINDAMYCIN 150MG/ML, SOLUTION FOR INJECTION
_CLINDAMYCIN PHOSPHATE_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
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Produktets egenskaber

OBJECT 1
CLINDAMYCIN 300MG/2ML SOLUTION FOR INJECTION
AMPOULES (150MG/ML IN 2ML AMPOULES)
Summary of Product Characteristics Updated 21-Dec-2017 | Bowmed
Ibisqus Limited
1. Name of the medicinal product
Clindamycin 150mg/ml, solution for injection
2. Qualitative and quantitative composition
Each ml of solution contains clindamycin phosphate equivalent to 150
mg clindamycin.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection.
Clear, colourless, sterile solution.
4. Clinical particulars
4.1 Therapeutic indications
Antibacterial. Serious infections caused by susceptible Gram-positive
organisms, staphylococci (both
penicillinase- and non-penicillinase-producing), streptococci (except
_Streptococcus faecalis_) and
pneumococci. It is also indicated in serious infections caused by
susceptible anaerobic pathogens such as
_Bacteroides_ spp, _Fusobacterium_ spp, _Propionibacterium_ spp,
_Peptostreptococcus_ spp. and
microaerophilic streptococci.
Clindamycin does not penetrate the blood/brain barrier in
therapeutically effective quantities.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents including
national and local guidelines
4.2 Posology and method of administration
Routes of administration:
Intramuscular injection
Intravenous infusion
Adults:
Serious infections: 600 mg - 1.2 g/day in two, three or four equal
doses.
More severe infections: 1.2 - 2.7 g/day in two, three or four equal
doses.
Single i.m. injections of greater than 600 mg are not recommended nor
is administration of more than 1.2
g in a single one hour infusion.
For more serious infections, these doses may have to be increased. In
life-threatening situations, doses as
high as 4.8 g daily have been given intravenously to adults.
Alternatively, the drug may be administered in the form of a single
rapid infusion of the first dose
followed by continuous IV. infusion.
Renal and/or hepatic insufficiency
The dosage may require reduction in patients with renal and/or hepatic