Document: Ketamin Abcur solution for injection ENG PL change

• Ketamin Abcur solution for injection PL
• Ketamin Abcur solution for injection ENG PL

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Package leaflet: Information for the user

Ketamin Abcur 10 mg/ml solution for injection

Ketamin Abcur 50 mg/ml solution for injection

ketamine

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.

What is in this leaflet

1. What Ketamin Abcur is and what it is used for

2. What you need to know before you are given Ketamin Abcur

3. How you are given Ketamin Abcur

4. Possible side effects

6. Contents of the pack and other information

This medicine contains ketamine which belongs to a group of medicines called anaesthetic agents, which are used to put you to sleep during an surgery. Ketamin Abcur may be used in both routine and emergency surgery. Ketamin Abcur can be given alone or in combination with other anaestehtic agents.

You must not be given Ketamin Abcur:

- if you are allergic to ketamine or any of the other ingredients of this medicine (listed in section 6).

- if you are suffering from any condition in which an increase in blood pressure may be harmful to you or have suffered in the past from a medical condition which may have been caused/worsened by an increase in blood pressure.

- if you have been pregnant and during that pregnancy have suffered from a condition called eclampsia or pre-eclampsia

Warnings and precautions

Talk to your doctor or nurse before using Ketamin Abcur:

• if you are dehydrated or have decreased blood volume

• if you have a heart disease

• if you have mild to moderately high blood pressure and disturbed, high, heart rhythm

• if you have increased pressure in the brain, injury or disease in the central nervous system.

• if you have increased pressure in the eye (glaucoma) or have had an eye examination or surgery

• if you have a history or current drug abuse or addiction

• if you have longterm or acute abundant intake of alcohol

• if you have a current mental or a history of mental health problems (e.g. schizophrenia and acute psychosis)

• if you have porphyria (an inherited disease that affects the blood)

• if you have an overactive thyroid gland or undergo treatment with thyroid products

• if you have a lung or upper respiratory tract infection

• if you have had an injury to your head, or damage to the eyeball

• if you have any injury inside your head or the pressure in the head is higher than it normally should be (hydrocephalus)

• if you have liver cirrosis or impaired liver function

Outpatient care

After outpatient anaesthesia you should be accompanied home and should not drink alcohol for the next 24 hours.

Other medicines and Ketamin Abcur

Tell your doctor if you are using, have recently used or might use any other medicines.

Ketamin Abcur may affect or be affected by other medicines:

• Ketamine Abcur should not be used together with
  - teophylline (medicine for treatment of respiratory diseases)

• any muscle relaxant

• diazepam (used as sedative, tranquilizer and anticonvulsants)

• vasopressin (diuretics)

• thyroid replacement hormones

• thiopental (used for anesthesia)

• barbiturates (used as sedatives and in treatment of epilepsia), narcotics or alcohol

• medicines used for treatment of high blood pressure

• opioids

• antibiotics and medicines used for treatment of fungus infection (itraconazole, fluconazole, clarithromycin, erythromycin)

• verapamil and diltiazem (used as calcium antagonist)

• phenytoin, carbamazepin (used in epilepsia)

• St John´s Wort

Ketamin Abcur with food, drink and alcohol

As with other anaesthetics you should not eat or drink for 4-6 hours before you are given Ketamin Abcur.

You should not drink alcohol for at least 24 hours after your surgery.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before your are given this medicine.

Pregnancy

Ketamin passes the placenta. This medicine should not be used during pregnancy except during delivery.

Breast-feeding

Ketamine is excreted in the breast milk.This medicine should not be used during breast-feeding.

Driving and using machines

Caution should be taken when driving or operating machines following treatment with Ketamin Abcur. You should not drive or operate machines for at least 24 hours after you operation.

Ketamin Abcur 10 mg/ml contains sodium

Ketamin Abcur 10 mg/ml contains less than 1 mmol sodium (23 mg) ml, i.e. essentially ‘sodium- free’.

Ketamin Abcur will be given to you in a hospital by, or under supervision of, an anaesthetist (a specialist in anaesthetics). The dose will be determined individually for you.

It will be given as an injection or slower infusion, into, a vein (intravenously) or in a muscle (intramuscularly). It can be given alone or in combination with other anaesthetic agents,

If you have further questions ask your doctor, nurse or anaesthetists.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 10 in 100 people):

• hallucinations, abnormal dreams, nightmares, agitation, confusion, irrational behaviour

• muscle cramps

• involuntary eye movements

• double vision

• increased blood pressure and increased heart rate

• breathing more quickly

• nausea, vomiting

• excessive secretion of saliva

• skin inflammation/rash

Uncommon side effects (may affect up to 1 in 100 people)

• anorexia

• anxiety

• increased pressure in the eye

• slowing heart rate, changes in heart rhythm

• low of blood pressure

• breathing more slowly or inhibition of breathing, narrowing of the voice box leading to difficulty breathing

• skin rash (exanthem)

• increased muscle tones

• pain or skin rash at the injection site

Rare side effects (may affect up to 1 in 1000 people):

• allergic reaction (‘anaphylaxis’) such as breathing problems, swelling and rash

• drifting in and out of consciousness (with feeling of confusion and hallucinations), flashbacks, feeling ill at ease, sleeplessness, feeling disorientated

• affect on the reflexes which keep your airways clear, resulting in temporary inability to breathe

Side effect where the occurrence is not known (frequency cannot be estimated from the available data)

• abnormal results in liver function tests

• liver damage caused by the medicine (reported only after prolonged use or drug abuse)

During awakening of the anaesthesia you may experience vivid dreams, hallucinations and feeling of confusion.

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 the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ketamin Abcur

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 label after EXP. The expiry date refers to the last day of that month.

It is recommended that the product is used as soon as possible after it is mixed with solvent, although it may be stored if the instructions at the end of the leaflet are strictly followed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

What Ketamin Abcur contains

10 mg/ml: Each ml solution for injection contains ketamine hydrochloride equivalent to 10 mg ketamine

50 mg/ml: Each ml solution for injection contains ketamine hydrochloride equivalent to 50 mg ketamine

50 mg/ml: water for injections

What Ketamin looks like and contents of the pack

Ketamin Abcur is a clear colourless solution for injection (injection).

Ketamine Abcur 10 mg/ml: 5 ml glass ampoules in boxes of 5, 10, 20, 50 or 100 ampoules

Ketamine Abcur 50 mg/ml 5 ml glass ampoules in boxes of 5, 10, 20, 50 or 100 ampoules

10 ml glass ampoules in boxes of 5, 10, 20, 50 or 100 ampoules

Marketing Authorisation Holder

Abcur AB

Box 1452

251 14 Helsingborg

Sweden

Manufacturer

Laboratoire Renaudin
Z.A. Errobi
F-64 250 Itxassou

France

This leaflet was last revised in 22 December 2015

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The following information is intended for healthcare professionals only.

Ketamin Abcur should only be administrated by or under supervision of medically qualified anaesthetists. Equipment to ensure the vital functions should be available.

Incompatabilities

Ketamine is chemically incompatible with barbiturates and diazepam because of formation of precipitate. Therefore, these should not be mixed in the same syringe or infusion fluid.

Shelf life

Before opening: 3 years

After opening: Chemical and physical in-use stability has been demonstrated for 48 hours at 25 °C. From microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Special precautions for handling

Ketamin Abcur can be diluted with 50 mg/ml (5%) glucose solution and 9 mg/ml (0,9 %) sodium chloride.