Patient leaflet - ISOKET 1 MG / ML CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION
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22290104 / 4024055
6
32462
22290104 ISOKET 1mg
16/02/2022
UK & IE
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AESICA
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Isoket ® 1 mg/ml _____
Concentrate for solution for injection or infusion
Isosorbide dinitrate 50 ml bottle
Isoket ® 1 mg/ml
Concentrate for solution for injection or infusion
Isosorbide dinitrate
10ml ampoule
Package leaflet: Information for the patient
Read all of this leaflet carefully before you start using 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 you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
- In this leaflet, Isoket 1 mg/ml concentrate for solution for injection or infusion will be called Isoket.
What is in this leaflet:
1. What Isoket is and what it is used for
2. What you need to know before you use Isoket
3. How to use Isoket
4. Possible side effects
5. How to store Isoket
6. Contents of the pack and other information
1. what isoket is and what it is used for
Isoket belongs to a group of medicines called organic nitrates. Organic nitrates work by widening the blood vessels in your heart to allow an increased amount of blood to flow to areas which need it. Isoket is used to treat heart failure (heart problems that can cause shortness of breath or ankle swelling) and angina pectoris.
Angina usually feels like a tight pain in the chest, neck or arm area.
It is also used sometimes during surgical procedures on the heart.
2. what you need to know before you use isoket
ARTWORK
Norgine Item No.:
Proof No.:
Change Control No.:
Product Name (including flavour):
Date:
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Manufacturing Site:
Technical Drawing No.:
Dimensions (mm):
Pharmacode:
Material Number:
Variable data prompts information:
22290104 / 4024055
6
32462
22290104 ISOKET 1mg
16/02/2022
UK & IE
PIL
AESICA
NOR-LFT105-V1 (PTTI001PIL-003/06)
140 × 520mm
4559
PTTI001PIL-003/06
N/A
Pre-printed (as part of artwork) Printed on-line
Schawk Job No.:
106576684 / 402691270 0230
Black
Technical Info Profile
Fonts used:
SCK
100% 50%
■
95% 5%
SP Gill Alt One OT-Bold
SP Gill Alt One OT-Regular
Average Text Size (Body Text):
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SGK is a Matthews International Corporation
Page 2 of 2
Example of admixture preparation
To obtain a dose of 6 mg per hour, add 50 ml of Isoket 1 mg/ml to 450 ml of a suitable vehicle, under aseptic conditions. The resultant admixture (500 ml) contains 100 pg/ml (1 mg/10 ml) isosorbide dinitrate. An infusion rate of 60 ml per hour (equivalent to 60 paediatric microdrops per minute or 20 standard drops per minute) will deliver the required dose of 6 mg per hour.
Should it be necessary to reduce fluid intake, 100 ml of Isoket 0.1% may be diluted to 500 ml using a suitable vehicle. The resultant solution now contains 200 pg/ml (2 mg/10 ml) isosorbide dinitrate. An infusion rate of 30 ml per hour equivalent to 30 paediatric microdrops per minute), will deliver the required dose of 6 mg per hour.
A dilution of 50% is advocated to produce a solution containing 0.5 mg/ml where fluid intake is strictly limited.
This leaflet was last revised in January 2022
4024055 22290104 12/464 4559
Isoket contains sodium
Isoket 1 mg/ml contains 3.54 mg/ml of sodium and may not be suitable for people on a controlled sodium diet. Tell your doctor or nurse before taking Isoket if this applies to you.
3. how to use isoket
lmportant:Your doctor will choose the dose that is right for you. If you have any questions ask your doctor.
Isoket is a concentrate for intravenous infusion (injected into a vein) and intracoronary injection (injected directly into the artery serving the heart). Isoket is a concentrate and must be diluted before use. Your doctor or nurse will dilute Isoket with either saline (salt water) or glucose solution before it is given to you.
Adults
- When this medicine is given intravenously (injected into a vein), the usual dose will be between 2 mg and 12 mg per hour, although sometimes as much as 20 mg per hour is necessary.
- When used during surgical procedures on the heart the usual dose is 1 mg injected directly into the heart. Further doses may be given if your doctor thinks it necessary.
As this medicine is used in hospital, your heart beat (pulse) and blood pressure will be carefully monitored whilst you are being given Isoket. This is to make sure that your medicine is working properly and that the dose you are taking is right for you.
Use in children
This medicine is not suitable for children.
If you think you have been given too much Isoket
As this medicine will be given to you by a doctor or nurse, it is unlikely that you will be given too much or too little.
An overdose of Isoket may cause your blood pressure to be too low resulting in paleness, sweating, weak pulse, fast heartbeat, light-headedness on standing, headache, weakness, dizziness, feeling sick, being sick and diarrhoea. If you have any concerns about this tell your doctor or nurse.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and seek immediate medical help if you have any of the following symptoms:
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* Swelling of the face or throat, causing difficulty in breathing or wheezing
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* Fainting or collapse
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* Swelling or blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).
Speak to your doctor or nurse if you have any of the following symptoms:
Very common ( may affect more than 1 in
10 people)
- headache
Common (may affect up to 1 in 10 people)
- dizziness
- drowsiness
- have a faster heart beat (tachycardia)
- weakness
- light-headedness on standing
Uncommon (may affect up to 1 in 100 people)
- feeling sick
- vomiting
- a reduced blood flow to the brain and heart, causing you to feel faint or dizzy
- symptoms of angina (chest pain) may be increased
- skin rash or flushing
Very rare (may affect up to 1 in 10,000 people)
- heartburn
Not known (frequency cannot be estimated from the available data) red or scaly skin (exfoliate dermatitis)
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
United Kingdom
Yellow Card Scheme
Website: or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
HPRA Pharmacovigilance
Website:
By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store isoket
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions when it is unopened.
Once opened the product should be used immediately. Do not throw awayany medicines via wastewater or household waste. Ask your nurse how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information what isoket contains
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– The active substance is isosorbide dinitrate. Isoket
What Isoket looks like and contents of the pack
Isoket is a concentrate for solution for infusion and injection. It is a clear solution.In Ireland
Isoket 1 mg/ml comes in 10 ml glass ampoules and 50 ml glass bottles.
Each ampoule contains 10 mg of isosorbide dinitrate in 10 ml of solution.
Each bottle contains 50 mg of isosorbide dinitrate in 50 ml of solution.
In the UK
Isoket 1 mg/ml comes in 10 ml glass ampoules and 50 ml & 100 ml glass bottles.
Each ampoule contains 10 mg of isosorbide dinitrate in 10 ml of solution.
The bottles contain either 50 mg of isosorbide dinitrate in 50 ml of solution or 100 mg isosorbide dinitrate in 100 ml of solution. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ireland
Merus Labs Luxco II S.a.R.L.
26–28, rue Edward Steichen
L-2540 Luxembourg
United Kingdom
Norgine Pharmaceuticals Limited
Norgine House, Widewater place, Moorhall Road, Harefield, Middlesex, UB9 6NS, UK
Manufacturer
Aesica Pharmaceuticals GmbH,
Alfred-Nobel-StraBe 10, 40789 Monheim, Germany
This leaflet was last revised in January 2022
If this leaflet is difficult to see or read or you would like it in a different format, please contact: Ireland: Merus Labs Luxco II S.a.R.L.
26–28, rue Edward Steichen
L-2540 Luxembourg
United Kingdom: Norgine Pharmaceuticals Limited
Norgine House, Widewater place, Moorhall Road,
Harefield, Middlesex, UB9 6NS, UK
NORGINE
4024055 22290104 12/464 4559