Konakion MM Paediatric 2mg/0.2ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Phytomenadione

Available from:

Neon Healthcare Ltd

ATC code:

B02BA01

INN (International Name):

Phytomenadione

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Oral; Intravenous; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060600; GTIN: 5000471004502

Patient Information leaflet

1
uk-pl-konakion-clean-180227-2mg-0.2ml-amps
PATIENT INFORMATION LEAFLET
UK
KONAKION MM PAEDIATRIC 2 MG/0.2 ML
ROCHE
solution for injection or oral administration
Phytomenadione (vitamin K
1
)
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR BABY OR CHILD IS
GIVEN THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask the doctor, nurse or midwife.

This medicine has been prescribed for your child. Do not pass it on to
others. It may harm them even if
their symptoms are the same.

If any of the side effects become serious or troublesome, or if you
notice any side effects not listed in this
leaflet, please tell the doctor, nurse or midwife.
IN THIS LEAFLET:
1. What Konakion MM Paediatric is and what it is used for
2. Before your baby or child is given Konakion MM Paediatric
3. How Konakion MM Paediatric is given
4. Possible side effects
5. How Konakion MM Paediatric is stored
6. Further information
1.
WHAT KONAKION MM PAEDIATRIC IS AND WHAT IT IS USED FOR
Konakion MM Paediatric contains a medicine called phytomenadione. This
is a man-made vitamin called
vitamin K
1
. Konakion MM Paediatric is used for the following:

Babies who do not have enough vitamin K in their bodies. Giving
Konakion MM Paediatric
PREVENTS
and
TREATS
bleeding caused by a lack of vitamin K. This is called ‘vitamin K
deficiency bleeding’
(VKDB). This is a serious, but rare condition. All newborn babies are
given vitamin K
1
with their
parent’s permission.

Babies and young children who may have had too much of certain
medicines to thin their blood (called
anticoagulants). Konakion MM Paediatric is normally used to treat
these children after advice from a
specialist haematologist (blood doctor).
Konakion MM Paediatric works by helping your body make blood clotting
factors. These blood clotting
factors help stop bleeding.
2.
BEFORE YOUR BABY OR CHILD IS GIVEN KONAKION MM PAEDIATRIC
YOUR CHILD MUST NOT BE GIVEN KONAKION MM PAEDIATRIC IF THEY ARE
ALLERGIC (HYPERSENSITIVE

Summary of Product characteristics

OBJECT 1
KONAKION MM PAEDIATRIC 2 MG/0.2 ML
Summary of Product Characteristics Updated 04-Jun-2018 | Roche
Products Limited
1. Name of the medicinal product
Konakion MM Paediatric 2mg/0.2ml
2. Qualitative and quantitative composition
Each ampoule contains 2mg phytomenadione in 0.2ml.
3. Pharmaceutical form
The ampoule solution is clear to slightly opalescent, pale yellow in
colour and contains the active
constituent in a mixed micelles vehicle of glycocholic acid and
lecithin.
4. Clinical particulars
4.1 Therapeutic indications
Konakion MM Paediatric is indicated for the prophylaxis and treatment
of vitamin K deficiency bleeding
(VKDB) in neonates and infants.
Konakion MM Paediatric can be used, following specialist advice from a
haematologist, as an antidote to
anticoagulant drugs of the coumarin type in infants and children. For
use as an antidote to anticoagulant
drugs of the coumarin type in adolescents and adults, refer to
Konakion MM Ampoules 10mg/ml.
4.2 Posology and method of administration
_PROPHYLAXIS OF VITAMIN K DEFICIENCY BLEEDING (VKDB)_
_Healthy neonates of 36 weeks gestation and older: _
Either:
- 1 mg administered by intramuscular injection at birth or soon after
birth
or
- 2 mg orally at birth or soon after birth. The oral dose should be
followed by a further dose of 2 mg at 4-7
days of age. A further 2 mg oral dose should be given at 1 month after
birth. In exclusively formula fed
infants the third oral dose can be omitted
_Preterm neonates of less than 36 weeks gestation weighing 2.5 kg or
greater, and term neonates at _
_special risk_ _(e.g. prematurity, birth asphyxia, obstructive
jaundice, inability to swallow, maternal use of _
_anticoagulants or antiepileptics):_ 1 mg IM or IV at birth or soon
after birth. The amount and frequency of
further doses should be based on coagulation status.
_Preterm neonates of less than 36 weeks gestation weighing less than
2.5 kg:_ 0.4 mg/kg (equivalent to 0.04
ml/kg) IM or IV at birth or soon after birth. This parenteral dose
should not be exceeded. The amo