Konakion MM 10mg/1ml solution for injection ampoules

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Phytomenadione

Предлага се от:

Neon Healthcare Ltd

АТС код:

B02BA01

INN (Международно Name):

Phytomenadione

дозиране:

10mg/1ml

Лекарствена форма:

Solution for injection

Начин на приложение:

Intravenous

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 09060600; GTIN: 5000471004137

Листовка

1
uk-pl-konakion-tracked-160927-10mg
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KONAKION
® MM AMPOULES 10MG/ML
ROCHE
solution for injection
Phytomenadione (vitamin K
1
)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or nurse.

If any of the side effects become serious or troublesome, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or nurse.
WHAT IS IN THIS LEAFLET:
1. What Konakion MM is and what it is used for
2. What you need to know before you are given Konakion MM
3. How Konakion MM is given
4. Possible side effects
5. How to store Konakion MM
6. Contents of the pack and further information
1.
WHAT KONAKION MM IS AND WHAT IT IS USED FOR
Konakion MM contains a medicine called phytomenadione. This is a
man-made vitamin called vitamin K
1.
Konakion MM is used for the following:

To prevent and treat bleeding after the use of certain medicines to
thin the blood (called anti-
coagulants).

To treat children (aged 1 year and older) who have liver disease or
low levels of vitamin K in their body
because of illness. Konakion MM is normally used to treat these
children after advice from a specialist
haematologist (blood doctor).
Konakion MM works by helping your body make blood clotting factors.
These blood clotting factors help
stop bleeding.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN KONAKION MM
YOU MUST NOT BE GIVEN KONAKION MM IF YOU ARE ALLERGIC (HYPERSENSITIVE)
TO PHYTOMENADIONE or any of
the other ingredients of Konakion MM (listed in Section 6: Further
information).
If you are not sure if this applies to you, talk to your doctor or
nurse before having Konakion.
WARNINGS AND PRECAUTIONS
Check with your doctor or nurse before having Konakion MM if:

You have severe problems with your liver.

You have an artificial heart valve.
OTHER MEDICINES AND KONAKION MM
Please tell

Данни за продукта

OBJECT 1
KONAKION MM 10MG/ML
Summary of Product Characteristics Updated 05-Oct-2016 | Roche
Products Limited
1. Name of the medicinal product
Konakion MM.
2. Qualitative and quantitative composition
Each Konakion MM Ampoule contains 10.0 mg vitamin K
1
(phytomenadione) Ph. Eur in 1 ml.
3. Pharmaceutical form
Amber glass ampoules containing 10 mg phytomenadione in 1 ml. 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 is indicated as an antidote to anticoagulant drugs of the
coumarin type in the treatment of
haemorrhage or threatened haemorrhage, associated with a low blood
level of prothrombin or factor VII.
4.2 Posology and method of administration
Konakion MM ampoules are for i.v. injection.
_ADULTS_
_SEVERE OR LIFE-THREATENING HAEMORRHAGE, E.G. DURING ANTICOAGULANT
THERAPY:_ The coumarin anticoagulant
should be withdrawn and an intravenous injection of Konakion MM given
slowly (over at least 30
seconds) at a dose of 5 - 10 mg together with prothrombin complex
concentrate (PCC). Fresh frozen
plasma (FFP) may be used if PCC is not available. The patient's INR
should be estimated three hours later
and, if the response has been inadequate, the dose should be repeated.
Not more than 40 mg of Konakion
MM should be given intravenously in 24 hours. Coagulation profiles
must be monitored on a daily basis
until these have returned to acceptable levels; in severe cases more
frequent monitoring is necessary.
_Dose recommendations for vitamin K_
_1_
_ therapy in patients with major and life threatening bleeding:_
Anticoagulant
Condition
Intravenous
vitamin
K
1
Concomitant therapy
Warfarin
Major bleeding
5.0 mg
PCC
1
Life threatening bleeding
5.0 to 10.0 mg
PCC
1
PCC, prothrombin complex concentrate
1
Fresh frozen plasma (FFP) may be used if PCC is not available.
LESS SEVERE HAEMORRHAGE:
Treatment of asymptomatic patients with elevated IN