NeoKay 1mg capsules

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Phytomenadione

Disponible des:

Neoceuticals Ltd

Codi ATC:

B02BA01

Designació comuna internacional (DCI):

Phytomenadione

Dosis:

1mg

formulario farmacéutico:

Oral capsule

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 09060600; GTIN: 5060256720065 5060256720072

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEOKAY 1MG CAPSULES
PHYTOMENADIONE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or healthcare
professional.
•
If you notice any side effects not listed in this leaflet, please tell
your doctor or healthcare professional.
IN THIS LEAFLET:
1. What Neokay is and what it is used for
2. Before you use Neokay
3. How to use Neokay
4. Possible side effects
5. How to store Neokay
6. Further information
1. WHAT NEOKAY IS AND WHAT IT IS USED FOR
Neokay contains phytomenadione, a synthetic Vitamin K, which is
essential in the body for blood to
clot. Newborn babies can have too little Vitamin K and so may develop
a serious, but rare condition that
causes bleeding. Neokay is used to prevent your baby from developing a
tendency to bleed due to a
deficiency in vitamin K.
2. BEFORE YOU USE NEOKAY
DO NOT USE NEOKAY:
•
if your baby is showing any signs of an allergic reaction to Neokay or
any of its ingredients
(listed in section 6).
•
if your baby is not well enough to be fed within a few hours of birth
•
if the baby’s mother is taking carbamazepine, phenobarbital,
phenytoin, rifampicin or warfarin.
TAKE SPECIAL CARE WITH NEOKAY:
•
if your baby has protein C or protein S deficiency and/or is
currently taking warfarin. Do not give Neokay to your baby
unless specifically advised to do so by their consultant.
•
If your baby has a bleed (eg from the cord stump) or shows
signs of bruising consult your doctor immediately.
3. HOW TO USE NEOKAY
Always use Neokay exactly as your doctor has told you.
You should check with your doctor or helalthcare professional if
you are not sure.
HEALTHY NEWBORN BABIES, INCLUDING HEALTHY PREMATURE BABIES:
The contents of a single Neokay capsule should be given.
Cut the narrow tip off the capsule and squeezing the liquid into
the baby’s mouth, as shown in the picture. Another dose should
be given if the first dose

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Neokay 1mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft gelatin capsule contains 1mg phytomenadione.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, soft
The dark brown soft capsule contains a clear, odourless pale yellow
liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Neokay is indicated for the prevention of vitamin K deficiency
bleeding in
babies
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Oral prophylaxis in healthy neonates, including healthy preterm
babies: _
The contents of a single Neokay capsule should be administered by
cutting the
narrow tubular tip off the capsule and squeezing the liquid into the
baby’s
mouth. Another dose should be given if the first dose is spat out or
the baby is
sick within three hours of the dose being given.
_Unwell babies and babies of mothers taking carbemazepine,
phenobarbital, _
_phenytoin, rifampicin or warfarin at the time of delivery: _
Babies who are not well enough to be fed within a few hours of birth
and
babies whose mothers are taking any of the above drugs should be
treated with
an intramuscular formulation of vitamin K at birth.
_Exclusively breast fed babies: _
The administration of 1mg Neokay by mouth at birth protects healthy
term
babies from the risk of bleeding due to vitamin K deficiency in the
first week
of life. Evidence to date suggests that for babies who are being
exclusively
breast-fed, a dose of 1mg once weekly for 12 weeks offers the best
protection
against late vitamin K deficiency bleeding.
4.3
CONTRAINDICATIONS
Do not give further doses of Neokay to any baby showing evidence of
hypersensitivity to any of the constituents.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Take expert advice before giving Neokay to any baby with protein C or
protein S deficiency currently on treatment with warfarin.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Vitamin K acts as an antidote to the anticoagulant drug