Potassium chloride 20% (potassium 13.3mmol/5ml) solution for infusion 5ml ampoules

Country: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Potassium chloride

Disponibbli minn:

potassium 13.3mmol/5ml) solution for infusion 5ml ampoules (Martindale Pharmaceuticals Ltd

Kodiċi ATC:

B05XA01

INN (Isem Internazzjonali):

Potassium chloride

Dożaġġ:

200mg/1ml

Għamla farmaċewtika:

Solution for infusion

Rotta amministrattiva:

Intravenous

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 09020201; GTIN: 5014124170322

Fuljett ta 'informazzjoni

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
WHAT STERILE POTASSIUM CHLORIDE CONCENTRATE
CONTAINS
• The active substance is potassium chloride.
- Sterile Potassium Chloride Concentrate 10%:
each 1ml (millilitre) of solution contains 0.1g
of potassium chloride in a sterile solution for
injection
- Sterile Potassium Chloride Concentrate 15%:
each 1ml (millilitre) of solution contains 0.15g
of potassium chloride in a sterile solution for
injection
- Sterile Potassium Chloride Concentrate 20%:
each 1ml (millilitre) of solution contains 0.2g
of potassium chloride in a sterile solution for
injection
• The other ingredients are dilute hydrochloric
acid, potassium hydroxide and water for
injections.
WHAT STERILE POTASSIUM CHLORIDE CONCENTRATE
LOOKS LIKE AND CONTENTS OF THE PACK
Sterile Potassium Chloride Concentrate is a
clear, colourless solution supplied in clear glass
ampoules. Each carton contains 10 ampoules.
- Sterile Potassium Chloride Concentrate 10% is
available in ampoules containing 5ml, 10ml or
50ml of solution
- Sterile Potassium Chloride Concentrate 15% is
available in ampoules containing 10ml or 20ml
of solution
- Sterile Potassium Chloride Concentrate 20% is
available in ampoules containing 5ml or 10ml of
solution
MARKETING AUTHORISATION HOLDER AND
MANUFACTURER
Martindale Pharmaceuticals
Bampton Road
Harold Hill
Romford
Essex
RM3 8UG
United Kingdom
IF YOU WOULD LIKE ANY MORE INFORMATION, OR
WOULD LIKE THE LEAFLET IN A DIFFERENT FORMAT,
PLEASE CONTACT MEDICAL INFORMATION AT THE
ABOVE ADDRESS.
PRODUCT LICENCE NUMBERS:
PL 01883/6154R
PL 01883/6186R
PL 01883/6185R
This leaflet was last revised in August 2013
WHAT IS IN THIS LEAFLET
1. What Sterile Potassium Chloride Concentrate is,
and what it is used for
2. What you need to know before you are given
Sterile Potassium Chloride Concentrate
3. How Sterile Potassium Chloride Concentrate is
given
4. Possible side effects
5. How to store Sterile Potassium Chloride
Concentrate
6. Contents of the pack and other information
1. WHAT STERILE POTASSIUM CHLORIDE
CON

Karatteristiċi tal-prodott

OBJECT 1
STERILE POTASSIUM CHLORIDE 20% W/V CONCENTRATE
FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 18-Feb-2015 | Martindale
Pharma
1. Name of the medicinal product
Sterile Potassium Chloride 20% w/v Concentrate for Solution for
Infusion
2. Qualitative and quantitative composition
Potassium Chloride 20% w/v
Each 5ml of solution contains 1000 mg of potassium chloride,
equivalent to approximately 13 mmol
potassium ions
Each 10ml of solution contains 2000 mg of potassium chloride,
equivalent to approximately 26 mmol
potassium ions
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Concentrate for Solution for Infusion
A clear, colourless solution
pH: 4.5 – 7.5
4. Clinical particulars
4.1 Therapeutic indications
Electrolyte imbalance.
4.2 Posology and method of administration
Method of administration: slow intravenous infusion, as a dilute
solution
Dilute by adding to an appropriate volume of a suitable infusion fluid
and mix well before use, to produce
a potassium concentration of 20 mmol per litre and not more than 40
mmol per litre. Infuse at a rate not
exceeding 20 mmol potassium per hour.
In the treatment of severe hypokalaemia or diabetic ketoacidosis, the
higher concentration and a higher
infusion rate may be required. In this case the infusion should be
into a high blood flow vein and
continuous ECG monitoring is advisable.
_Adults and the elderly_
Up to 6g (80 mmol) daily, after dilution to a concentration of 20
mmol/litre and no greater than 40
mmol/litre.
_Infants and children_
Up to 3 mmol per kg per day, after dilution to a concentration of 20
mmol/litre.
4.3 Contraindications
Potassium Chloride is contraindicated in patients with:
– Hyperkalaemia
– Impaired renal function with oliguria, anuria or azotaemia
– Hyperchloraemia
– Addison's disease
– Acute dehydration and heat cramps
4.4 Special warnings and precautions for use
This product must not be injected undiluted. It must be diluted with
sodium chloride intravenous infusion
0.9% w/v or other suitabl