Hovid Imipenem + Cilastatin Powder for Solution for Infusion 500mg

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Werkstoffen:

IMIPENEM MONOHYDRATE; CILASTATIN SODIUM

Beschikbaar vanaf:

HOVID BERHAD

INN (Algemene Internationale Benaming):

IMIPENEM MONOHYDRATE; CILASTATIN SODIUM

Eenheden in pakket:

1 Vials

Geproduceerd door:

Brooks Steriscience Limited

Productkenmerken

PAEDIATRIC USE
Hovid Imipenem + Cilastatin is not recommended in children under 1
year of age or paediatric
patients with impaired renal function (serum creatinine >2 mg/dl).
Imipenem + Cilastatin contains sodium which should be taken into
consideration by patients on a
controlled sodium diet.
PREGNANCY AND LACTATION
PREGNANCY:
There are no adequate and well-controlled studies for the use of
imipenem/cilastatin in
pregnant women. The potential risk for humans is unknown.
Hovid Imipenem + Cilastatin should be used during pregnancy only if
the potential benefit justifies
the potential risk to the foetus.
LACTATION: Imipenem and cilastatin are excreted into the mother's milk
in small quantities. Little absorption
of either compound occurs following oral administration. Therefore it
is unlikely that the suckling infant will
be exposed to significant quantities. If the use of Imipenem +
Cilastatin is deemed necessary, the benefit
of breast feeding for the child should be weighed against the possible
risk for the child.
DRUG INTERACTIONS
Generalized seizures have been reported in patients who received
ganciclovir and Hovid Imipenem +
Cilastatin. These medicinal products should not be used concomitantly
unless the potential benefit
outweighs the risks.
Decreases in valproic acid levels that may fall below the therapeutic
range have been reported when
valproic acid was co-administered with carbapenem agents. The lowered
valproic acid levels can lead to
inadequate seizure control; therefore, concomitant use of imipenem and
valproic acid/sodium valproate
is not recommended and alternative antibacterial or anti-convulsant
therapies should be considered.
ORAL ANTI-COAGULANTS:
Simultaneous administration of antibiotics with warfarin may augment
its
anti-coagulant effects.
There have been many reports of increases in the anti-coagulant
effects of
orally administered anti-coagulant agents, including warfarin in
patients who are concomitantly
receiving antibacterial agents. The risk may vary with the underlying
infection, age an