SALACLOVIR POWDER FOR SOLUTION FOR INFUSION 250MGVIAL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Aciclovir sodium 274.4mg eqv. Aciclovir

Available from:

PAN-MALAYAN PHARMACEUTICALS PTE LTD

ATC code:

J05AB01

Dosage:

250 mg/ vial

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

Aciclovir sodium 274.4mg eqv. Aciclovir 250 mg/ vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

LABORATORIO REIG JOFRÉ, S.A

Authorization status:

ACTIVE

Authorization date:

2014-10-07

Summary of Product characteristics

_París 1 - 7, Nave 2, Pol. Ind. Cova Solera, 08191 Rubí - Barcelona
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_Tlf. 93 697 04 12 - Fax [phone] ● diseño&preimpresión:
[e-mail] ● www.graficas-agarcia.com_
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REIG JOFRE
IGAG
Nº 1
Black
02/11/2021
SALACLOVIR 250 mg
RJ-PAN MALAYAN
B1XXXX-01
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140 x 400 mm
35 x 100 mm
_LOMO EN 100 _
Specialprint 40 g
1.
NAME OF THE MEDICINAL PRODUCT
SALACLOVIR 250 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 mg aciclovir (as aciclovir sodium).
After reconstitution
Each ml of solution for infusion contains 25 mg aciclovir.
Excipient with known effect
Each vial contains 45 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
Spongy pastille white or almost white freeze-dried sterile powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SALACLOVIR is indicated in non-immunocompromised patients for the
treatment of
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Severe initial genital herpes.
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Varicella zoster virus infection.
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Herpes simplex encephalitis.
SALACLOVIR is indicated in immunocompromised patients for the
treatment of
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Herpes simplex infection.
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Varicella zoster infection.
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Prophylaxis of herpes simplex infection.
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Herpes simplex encephalitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
A course of treatment with SALACLOVIR usually lasts 5 days, but this
may be adjuste