CLAVENIR 1 G.

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AMOXICILLIN AS SODIUM; CLAVULANIC ACID AS POTASSIUM

Available from:

BIOAVENIR LTD, ISRAEL

ATC code:

J01CR02

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJ/INF

Composition:

AMOXICILLIN AS SODIUM 1000 MG/VIAL; CLAVULANIC ACID AS POTASSIUM 200 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

LABORATORY REIG JOFRE,S.A., SPAIN

Therapeutic area:

AMOXICILLIN AND ENZYME INHIBITOR

Therapeutic indications:

Indicated for the treatment of the following infections in adults and children: severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms), acute exacerbations of chronic bronchitis (adequately diagnosed), community acquired pneumonia. cystitis, pyelonephritis, Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis, bone and joint infections, in particular osteomyelitis, intra-abdominal infections, female genital infections. Prophylaxis against infections associated with major surgical procedures in adults, such as those involving the: gastrointestinal tract, pelvic cavity, head and neck, biliary tract surgery.

Authorization date:

2020-11-30

Patient Information leaflet

Mercurio 13 - Pol. Ind. “Coherman”
28970 Humanes (Madrid)
T. 91 697 65 02 - F. 91 697 18 03
[e-mail]
PRUEBA N.º: 3
FECHA: 9.2.2011
CLIENTE: REIG JOFRE
CÓDIGO: 229294/1101
SUSTITUYE A: /0801
PROSPECTO:
CLAVENIR 1G
TAMAÑO: 120 x 620 mm
PLEGADO: 120 x 40 mm
Nº DE COLORES: 1/1
COLOR: Negro - Negro
COD. BARRAS: N/A
PAPEL: Offset blanco 50 g/m
2
TIPOGRAFÍA
Helvetica
Tamaño: 9 pt.
CORRECCIONES
APROBADO
Fecha y Firma
_Anverso / Front_
CLAVENIR 1G
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT
Clavenir 1G
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxicillin (INN) (sodium salt).............................1g
Clavulanic Acid (INN) (potassium salt)........200 mg
Excipients, see 6.1. List of excipients
3. PHARMACEUTICAL FORM
Powder for solution for injection.
4. CLINICAL DATA
4.1 THERAPEUTIC INDICATIONS
Clavenir 1G is indicated for short-term treatment of bacterial
infections
in the following areas when it is suspected that they are caused by
betalactamase-producing, amoxicillin-resistant stocks. In other situa-
tions, amoxicillin alone should be considered.
Mixed infections caused by amoxicillin-sensitive germs and betalacta-
mase-producing germs sensitive to amoxicillin / clavulanic acid can be
treated with Clavenir 1G. These infections do not require an
additional
antibiotic stable to betalactamase action.
Infections of the upper respiratory tract (including ORL2), in
particular
sinusitis, otitis media and recurrent tonsillitis. These infections
are of-
ten produced by _Streptococcus pneumoniae, Haemophilus influenzae*,_
_Moraxella catarrhalis* and Streptococcus pyogenes_.
Infections of the lower respiratory tract, in particular acute
exacerbation
of chronic bronchitis (especially if considered to be serious),
bronchop-
neumonia. These infections are often caused by _Streptococcus_ _pneu-_
_moniae, Haemophilus influenzae* and Moraxella catarrhalis*._
Infections of the genitourinary tract and abdominal infections, in
par-
ticular cystitis (especially when it is recurrent

Summary of Product characteristics

Clavenir 1G
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT
Clavenir 1G
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains:
Amoxicillin ( as amoxicillin sodium).............................1g
Clavulanic acid (as potassium clavulanate)...........200 mg
Each vial contains approximately 2.74 mmol of sodium (63 mg) and 1.0
mmol of
potassium (39.2 mg).
For the full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White or almost white powder.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Clavenir 1G is indicated for the treatment of the following infections
in adults and
children (see sections 4.2,4.4 and 5.1):
• Severe infections of the ear, nose and throat (such as
mastoiditis, peritonsillar
infections, epiglottitis, and sinusitis when accompanied by severe
systemic signs and
symptoms)
• Acute exacerbations of chronic bronchitis (adequately diagnosed)
• Community acquired pneumonia
• Cystitis
• Pyelonephritis
• Skin and soft tissue infections in particular cellulitis, animal
bites, severe dental
abscess with spreading cellulitis
• Bone and joint infections, in particular osteomyelitis
• Intra-abdominal infections
• Female genital infections.
Prophylaxis against infections associated with major surgical
procedures in adults,
such as those involving the:
Gastrointestinal tract
Pelvic cavity
Head and neck
Biliary tract surgery.
4.2 Posology and method of administration
Clavenir 1G must only be administered intravenously.
Dosage
Doses are expressed throughout in terms of amoxicillin/clavulanic acid
content except
when doses are stated in terms of an individual component.
The dose of Clavenir that is selected to treat an individual infection
should take into
account:
• The expected pathogens and their likely susceptibility to
antibacterial agents (see
section 4.4)
• The severity and the site of the infection
• The age, weight and renal function of the patient as shown below.
This Clavenir powder for solution fo