Septanest with adrenaline 1:200 000

Package leaflet: Information for the user

SEPTANEST WITH ADRENALINE 1:200 000 (40 mg + 0.005 mg)/ml,
solution for injection
SEPTANEST WITH ADRENALINE 1:100 000 (40 mg + 0.01 mg)/ml,
solution for injection
articaine hydrochloride + adrenaline
Please read carefully this leaflet before the administration of the medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your dentist, doctor, or pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your dentist, doctor, or pharmacist. See section 4.

Leaflet contents

1. What Septanest with adrenaline is and what it is used for
2. What you need to know before using Septanest with adrenaline
3. How to use Septanest with adrenaline
4. Possible side effects
5. How to store Septanest with adrenaline
6. Contents of the pack and other information

1. What Septanest with adrenaline is and what it is used for

Septanest with adrenaline is used to anaesthetize the oral cavity during dental procedures.
This medicine contains two active substances:

• articaine, a local anaesthetic agent that prevents the sensation of pain, and
• adrenaline, a vasoconstrictor agent that constricts blood vessels at the injection site, thereby prolonging the effect of articaine and reducing bleeding during the procedure.

Septanest with adrenaline 1:200 000 (40 mg + 0.005 mg)/ml or Septanest with adrenaline 1:100 000 (40 mg + 0.01 mg)/ml is administered to the patient by a dentist.
Septanest with adrenaline is intended for children over 4 years of age (approximately 20 kg body weight), adolescents, and adults.
Depending on the type of dental procedure being performed, the dentist will decide which of the two medicines to use:

• Septanest with adrenaline 1:200 000 (40 mg + 0.005 mg)/ml is usually used for simple and short dental procedures.
• Septanest with adrenaline 1:100 000 (40 mg + 0.01 mg)/ml is more suitable for procedures that are longer or associated with potentially heavier bleeding.

2. Important information before using Septanest with adrenaline

When not to use Septanest with adrenaline
Do not use this medicine if the patient has any of the following conditions:

• The patient is allergic to articaine or adrenaline, or to any of the other ingredients of this medicine (listed in section 6);
• The patient is allergic to other local anaesthetic agents;
• The patient has epilepsy that is not adequately controlled with medication.

Warnings and precautions
Before starting treatment with Septanest with adrenaline, discuss with the dentist if the patient has any of the following conditions:

• Severe heart rhythm disorders (e.g. second- or third-degree atrioventricular block);
• Acute heart failure (severe weakening of the heart, e.g. sudden chest pain at rest or following myocardial infarction (i.e. heart attack));
• Low blood pressure;
• Abnormally rapid heartbeat;
• Myocardial infarction (heart attack) within the last 3–6 months;
• The patient has undergone coronary artery bypass grafting (CABG) within the last 3 months;
• The patient is taking antihypertensive drugs called beta-blockers, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe slowing of heart function (see section "Septanest with adrenaline and other medicines");
• Very high blood pressure;
• The patient is concurrently taking certain medications used to treat depression and Parkinson’s disease (tricyclic antidepressants). These drugs enhance the effects of adrenaline;
• Epilepsy;
• Absence in the patient’s blood of a natural chemical substance called plasma cholinesterase (plasma cholinesterase deficiency);
• Kidney problems;
• Severe liver disease;
• A condition called myasthenia, which causes muscle weakness;
• Porphyria, which may cause neurological complications or skin problems;
• The patient is using other local anaesthetic agents, drugs that cause temporary loss of sensation (including inhaled anaesthetics such as halothane);
• The patient is taking antiplatelet or anticoagulant drugs to prevent narrowing or hardening of blood vessels in arms and legs;
• The patient is over 70 years of age;
• The patient has had or currently has heart disease;
• Uncontrolled diabetes;
• Severe hyperthyroidism (thyrotoxicosis);
• A tumour called a phaeochromocytoma of the adrenal gland;
• A condition called closed-angle glaucoma, which is an eye disease;
• Inflammation or infection at the site of injection;
• Reduced oxygen supply to body tissues (hypoxia), high potassium levels (hyperkalemia), and metabolic disturbances due to excessive acid levels in the blood (metabolic acidosis).

Septanest with adrenaline and other medicines
Inform the dentist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
It is especially important to inform the dentist if the patient is taking any of the following medicines:

• Other local anaesthetic agents, drugs causing reversible loss of sensation (including inhaled anaesthetics such as halothane);
• Sedatives (such as benzodiazepines, opioids), for example, to reduce anxiety before a dental procedure;
• Medicines affecting the heart and lowering blood pressure (such as guanadrel, guanethidine, propranolol, nadolol);
• Tricyclic antidepressants used to treat depression (such as amitriptyline, desipramine, imipramine, nortriptyline, maprotiline, and protriptyline);
• COMT inhibitors used in the treatment of Parkinson’s disease (such as entacapone or tolcapone);
• MAO inhibitors used to treat depressive or anxiety disorders (such as moclobemide, phenelzine, tranylcypromine, linezolid);
• Medicines used to treat irregular heartbeat (e.g. digitalis, quinidine);
• Medicines used to treat migraine attacks (such as methysergide or ergotamine);
• Sympathomimetic vasoconstrictor drugs (such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline) used to raise blood pressure: if these have been used within the last 24 hours, planned dental treatment should be postponed;
• Neuroleptic drugs (e.g. phenothiazines).

Food and Septanest with adrenaline
Avoid eating, including chewing gum, until normal sensation returns, due to the risk of biting the lip, cheek, or tongue, especially in children.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her dentist or doctor before using this medicine.
The dentist or doctor will decide whether the patient may use Septanest with adrenaline during pregnancy.
Breastfeeding may be resumed 5 hours after administration of the anaesthetic.
No effect on fertility is expected following doses used during dental procedures.

Driving and operating machinery
If adverse effects occur, such as dizziness, blurred vision, or fatigue, the patient should not drive or operate machinery until feeling normal again (usually within 30 minutes after the dental procedure).

Septanest with adrenaline contains sodium and sodium metabisulfite.

• Sodium: less than 23 mg of sodium per cartridge, meaning the medicine is considered "sodium-free".
• Sodium metabisulfite: in rare cases, may cause severe allergic reactions and breathing problems (bronchospasm). If there is a risk of an allergic reaction, the dentist will choose an alternative anaesthetic.

3. How to use Septanest with adrenaline

Only doctors or dentists who have appropriate training may administer Septanest with adrenaline.
The dentist will decide whether to use Septanest with adrenaline 1:200,000 or Septanest with adrenaline 1:100,000 and will determine the appropriate dose, taking into account the patient's age, body weight, general health condition, and the dental procedure being performed.
The lowest effective dose required to achieve adequate anaesthesia should be used.
This medicine is administered by slow injection into the oral cavity.

Use of a higher than recommended dose of Septanest with adrenaline
It is unlikely that a patient would receive an excessive dose of this medicine, but if the patient experiences any discomfort, they should inform the dentist immediately. Symptoms of overdose may include severe weakness, pale skin, headache, feeling of excitation or hyperactivity, disorientation, loss of balance, involuntary tremors or convulsions, dilated pupils, blurred vision, difficulty focusing the eyes clearly on an object, speech disturbances, dizziness, seizures, stupor, loss of consciousness, hiccups, yawning, abnormally slow or rapid breathing which may lead to temporary respiratory arrest, and ineffective heart contractions (known as circulatory arrest).

If you have any further doubts regarding the use of this medicine, consult your dentist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone experiences them.
While the patient is in the dental office, they will be closely monitored by the dentist for the effects of Septanest with adrenaline.
You should immediately inform the dentist, doctor or pharmacist if any of the following serious side effects occur in the patient:

• swelling of the face, tongue or throat, difficulty swallowing, hives or breathing problems (angioedema)
• rash, itching, throat swelling and breathing difficulties: these may be symptoms of an allergic reaction (hypersensitivity)
• combination of drooping eyelid and constricted pupil ( Horner's syndrome )
  These side effects may occur rarely (may affect up to 1 in 1,000 patients). Other side effects not listed above may also occur in some patients.

Common side effects: may occur in more than 1 in 10 patients:

• gingivitis
• neuropathic pain – caused by nerve damage
• tingling or reduced sensation to touch in the mouth and around the mouth
• metallic taste, taste disturbances or loss of taste sensation
• increased sensitivity to touch
• increased sensitivity to heat
• headache
• abnormally fast heartbeat
• abnormally slow heartbeat
• low blood pressure
• swelling of the tongue, lips and gums

Uncommon side effects: may occur in more than 1 in 100 patients:

• burning sensation
• high blood pressure
• inflammation of the tongue and oral cavity
• nausea, vomiting, diarrhoea
• rash, pruritus
• neck pain or pain at the injection site

Rare side effects: may occur in more than 1 in 1,000 patients:

• nervousness, anxiety
• facial nerve disorders (facial nerve paralysis)
• drowsiness
• involuntary eye movements
• double vision, temporary blindness
• drooping eyelid and constricted pupil (Horner’s syndrome)
• displacement with downward displacement of the eyeball into the orbit ( enophthalmos )
• ringing in the ears, hearing hypersensitivity
• palpitations
• hot flushes
• wheezing (bronchospasm), asthma
• breathing difficulties
• peeling and ulceration of the gums
• peeling at the injection site
• urticaria
• minor muscle twitching, involuntary muscle contractions
• fatigue, weakness
• chills

Very rare side effects: may occur in more than 1 in 10,000 patients:

• prolonged loss of sensation, prolonged tingling or loss of taste

Frequency not known: frequency cannot be estimated from available data

• extremely elevated mood (euphoria)
• heart rhythm coordination disorders (conduction disturbances, atrioventricular block)
• increased blood flow to a body part, leading to stasis in blood vessels
• dilation or constriction of blood vessels
• hoarseness
• difficulty swallowing
• cheek swelling and local swelling
• burning mouth syndrome
• skin redness (flush)
• abnormally excessive sweating
• exacerbation of neuromuscular symptoms of Kearns-Sayre syndrome
• sensation of heat or cold
• bruxism (teeth grinding)

Reporting of side effects
If any adverse effects occur in the patient, including any adverse effects not listed in this leaflet, they should be reported to the dentist, doctor or pharmacist.
Side effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw,
Tel.: +48 22 49 21 301
Fax: +48 22 40 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps to provide more information on the safety of medicinal products.

5. How to store Septanest with adrenaline 1:100 000

The medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the blister and outer packaging after EXP.
The expiry date refers to the last day of the stated month.
The abbreviation “Lot” indicates the batch number.
Store below 30°C.
Do not freeze.
Store ampoules in the outer packaging to protect from light.
Do not use this medicine if the solution appears cloudy or discoloured.
Ampoules are for single use only. The solution should be used immediately after opening.
Any unused portion of the solution must be discarded.
Medicines must not be disposed of via wastewater or household waste. Your dentist knows
how to properly dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the packaging and other information

What Septanest with adrenaline contains

• The active substances are articaine hydrochloride and adrenaline (as adrenaline bitartrate).
  o Each 1.7 ml cartridge of Septanest with adrenaline 1:200,000 (40 mg + 0.005 mg)/ml contains 68 mg of articaine hydrochloride and 8.5 micrograms of adrenaline (as adrenaline bitartrate).
  o 1 ml of Septanest with adrenaline 1:200,000 (40 mg + 0.005 mg) contains 40 mg of articaine hydrochloride and 5 micrograms of adrenaline (as adrenaline bitartrate).
  o Each 1.7 ml cartridge of Septanest with adrenaline 1:100,000 (40 mg + 0.01 mg)/ml contains 68 mg of articaine hydrochloride and 17 micrograms of adrenaline (as adrenaline bitartrate).
  o 1 ml of Septanest with adrenaline 1:100,000 (40 mg + 0.01 mg) contains 40 mg of articaine hydrochloride and 10 micrograms of adrenaline (as adrenaline bitartrate).
• Other ingredients: sodium chloride, sodium metabisulfite (E223), sodium hydroxide, and water for injections.

What Septanest with adrenaline looks like and contents of the pack
Septanest with adrenaline is a clear, colourless solution.
It is supplied in single-dose glass cartridges sealed with a movable rubber stopper at the base and a rubber plug secured with an aluminium seal at the top.
Packaging:

• Carton containing 50 glass cartridges of 1.7 ml.
• Carton containing 50 glass cartridges with auto-aspiration of 1.7 ml.
• Package containing 4 cartons with 50 glass cartridges of 1.7 ml each.
• Package containing 8 cartons with 50 glass cartridges of 1.7 ml each.
  Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
SEPTODONT
58, rue du Pont de Créteil
94100 Saint Maur des Fossés
France

These medicinal products are authorised for marketing in the European Economic Area under the following names:
Austria: Septanest mit Epinephrin 1:200.000 40 mg/ml + 5 Mikrogramm/ml, Injektionslösung
Septanest mit Epinephrin 1:100.000 40 mg/ml + 10 Mikrogramm/ml, Injektionslösung
Belgium: Septanest Normal 40 mg/mL+ 5 microgrammes/mL, solution injectable
Septanest Special, 40 mg/mL+ 10 microgrammes/mL, solution injectable
Bulgaria: Септанест 1/200 000, 40 mg/ml+5 микрограма /ml инжекционен разтвор
Септанест 1/100 000, 40 mg/ml+10 микрограма /ml инжекционен разтвор
Croatia: Septanest 40 mg/ml + 0.005 mg/ml otopina za injekciju
Septanest Forte 40 mg/ml + 0.01 mg/ml otopina za injekciju
Cyprus: Septanest, 40 mg/ml + 5 micrograms/ml, ενέσιμο διάλυμα
Septanest Forte, 40 mg/ml + 10 micrograms/ml, ενέσιμο διάλυμα
Czech Republic: Septanest s adrenalinem 1:200 000, 40 mg/ml + 5 mikrogramů/ml, injekční roztok
Septanest s adrenalinem 1:100 000, 40 mg/ml + 10 mikrogramů/ml, injekční roztok
Denmark: Septanest, 40 mg/ml + 5 mikrogram/ml, injektionsvæske, opløsning
Septocaine, 40 mg/ml + 10 mikrogram/ml, injektionsvæske, opløsning
Estonia: Septanest, 40 mg/ml + 5 mikrogrammi/ml, süstelahus
Septanest Forte, 40 mg/ml + 10 mikrogrammi/ml, süstelahus
Finland: Septocaine, 40 mg/ml + 5 mikrogrammaa/ml, injektioneste, liuos
Septocaine Forte, 40 mg/ml + 10 mikrogrammaa/ml, injektioneste, liuos
France: Septanest 40 mg/mL Adrénalinée au 1/200 000, solution injectable à usage dentaire
Septanest 40 mg/mL Adrénalinée au 1/100 000, solution injectable à usage dentaire
Germany: Septanest mit Epinephrin 1:200.000 - 40 mg/ml + 0.005 mg/ml, Injektionslösung
Septanest mit Epinephrin 1:100.000 - 40 mg/ml + 0.01 mg/ml, Injektionslösung
Greece: Septanest Articaine 4% υδροχλωριούχο με επινεφρίνη 1/200000 Οδοντικές αμπούλες Ενέσιμη λύση
Septanest Articaine 4% υδροχλωριούχο με επινεφρίνη 1/100000 Οδοντικές αμπούλες Ενέσιμη λύση
Hungary: Septanest 40 mg/ml + 10 mikrogramm/ml, injekciós oldat
Italy: Septanest 40 mg/ml + 5 microgrammi/ml soluzione iniettabile con adrenalina
Septanest 40 mg/ml + 10 microgrammi/ml soluzione iniettabile con adrenalina
Latvia: Septanest 40 mg/ml + 5 mikrogrami/ml šķīdums injekcijām
Septanest Forte 40 mg/ml + 10 mikrogrami/ml šķīdums injekcijām
Lithuania: Septanest 40 mg/ml + 5 mikrogramai/ml, injekcinis tirpalas
Septanest Forte 40 mg/ml + 10 mikrogramai/ml, injekcinis tirpalas
Luxembourg: Septanest Normal, 40 mg/ml+ 5 microgrammes/ml, solution injectable
Septanest Spécial, 40 mg/ml+ 10 microgrammes/ml, solution injectable
Malta: Septanest with adrenaline 1/200,000, 40 mg/ml + 5 mikrogrammi/ml, soluzzjoni għall-injezzjoni
Septanest with adrenaline 1/100,000, 40 mg/ml + 10 mikrogrammi/ml, soluzzjoni għall-injezzjoni
Netherlands: Septanest N 40 mg/ml + 5 microgram/ml, oplossing voor injectie
Septanest SP 40 mg/ml + 10 microgram/ml, oplossing voor injectie
Norway: Septocaine 40 mg/ml+5 mikrog/ml, injeksjonsvæske, oppløsning
Septocaine Forte 40 mg/ml+10 mikrog/ml, injeksjonsvæske, oppløsning
Poland: SEPTANEST Z ADRENALINĄ 1:200 000 (40 mg+0.005mg)/ml, roztwór do wstrzykiwań
SEPTANEST Z ADRENALINĄ 1:100 000 (40 mg+0.01mg)/ml, roztwór do wstrzykiwań
Portugal: Septanest 1/200,000, 40 mg/ml + 5 microgramas/ml, solução injetável
Septanest 1/100,000, 40 mg/ml + 10 microgramas/ml, solução injetável
Romania: SEPTANEST CU ADRENALINĂ 1/200000 40 mg/0.005 mg/ml soluție injectabilă
SEPTANEST CU ADRENALINĂ 1/100000 40 mg/0.01 mg/ml soluție injectabilă
Slovakia: Septanest 40 mg/ml + 5 mikrogramov/ml injekčný roztok
Septanest Forte 40 mg/ml + 10 mikrogramov/ml injekčný roztok
Slovenia: Septanestepi 40 mg/0.005 mg v 1 ml raztopina za injiciranje
Septanestepi 40 mg/0.01 mg v 1 ml raztopina za injiciranje
Spain: Septanest con adrenalina 40 mg/ml + 5 microgramos/ml solución inyectable
Septanest con adrenalina 40 mg/ml + 10 microgramos/ml solución inyectable
Sweden: Septocaine 40 mg/ml + 5 mikrogram/ml, injektionsvätska, lösning
Septocaine Forte 40 mg/ml + 10 mikrogram/ml, injektionsvätska, lösning

Other sources of information
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products (http://www.urpl.gov.pl/pl).

Information intended exclusively for healthcare professionals:

Dosage
The lowest effective dose should be used in all patient populations. The required dose must be determined individually.
For routine procedures in adults, one cartridge is usually administered, but less than the full cartridge content may suffice to achieve effective anaesthesia. In more extensive procedures, multiple cartridges may be required, without exceeding the maximum recommended dose; the decision is made by the dentist.

For most routine dental procedures, Septanest with adrenaline 1:200,000 (40 mg + 0.005 mg)/ml is preferred. For more complex dental procedures requiring enhanced haemostasis, Septanest with adrenaline 1:100,000 (40 mg + 0.01 mg)/ml is preferred.

Concomitant use of sedatives to reduce patient anxiety:
In patients receiving sedative medication, the maximum safe dose of local anaesthetic may be reduced due to additive central nervous system depression.

Children and adolescents (aged 12 to 18 years)
In adults and adolescents, the maximum dose of articaine is 7 mg/kg body weight, with an absolute maximum dose of 500 mg of articaine. The maximum dose of 500 mg articaine corresponds to the dose for a healthy adult weighing over 70 kg.

Children (aged 4 to 11 years)
The safety of Septanest with adrenaline has not been established in children under 4 years of age. No data are available.
The amount of drug to be injected should be determined based on the child's age, body weight, and the extent of the procedure. The average effective dose of articaine is 2 mg/kg body weight for simple procedures and 4 mg/kg body weight for complex procedures. The lowest effective dose ensuring adequate dental anaesthesia should be used. In children aged 4 years and older (or weighing ≥20 kg), the maximum dose of articaine is 7 mg/kg body weight, with an absolute maximum dose of 385 mg articaine in a healthy child weighing 55 kg.

Special patient groups
Elderly patients and patients with renal impairment:
Due to lack of clinical data, particular caution should be exercised, using the lowest effective dose required to achieve adequate anaesthesia in elderly patients and those with renal impairment.
Increased plasma concentrations of the drug may occur, especially after repeated administration. If repeat injection is necessary, the patient should be closely monitored for signs of relative overdose.

Patients with hepatic impairment:
Particular caution should be exercised to use the lowest effective dose required to achieve adequate anaesthesia in patients with hepatic impairment, despite the fact that 90% of articaine undergoes first-pass inactivation by non-specific plasma esterases in tissues and blood.

Patients with plasma cholinesterase deficiency:
Elevated plasma concentrations of the drug may occur in patients with plasma cholinesterase deficiency or those receiving acetylcholinesterase inhibitors, as the drug is inactivated by plasma esterases in approximately 90% of cases. Therefore, the lowest effective dose required to achieve adequate anaesthesia should be used.

Method of administration
Injectable infiltration and peripheral nerve block administration in the oral cavity.
Local anaesthetics should be administered cautiously in the presence of inflammation and/or infection at the injection site. The injection rate should be very slow (1 ml/min).

Precautions to be taken before using or administering the medicinal product
This medicinal product should be used only by physicians or dentists with adequate training and experience in recognizing and managing systemic toxic reactions, or under their supervision. Before administering local anaesthesia, ensure that resuscitation equipment and medications are available for immediate management of any emergency involving the airway or cardiovascular system. After each injection of a local anaesthetic, the patient's level of consciousness should be monitored.
When using Septanest with adrenaline for infiltration or nerve block anaesthesia, injection must always be performed slowly and preceded by aspiration.

Special warnings
Adrenaline may impair blood flow in the gums, potentially leading to local tissue necrosis.
Very rare cases of prolonged or irreversible nerve damage and taste disturbances have been reported following nerve block anaesthesia.

Precautions for use
Hazards associated with accidental intravascular injection:
Accidental intravascular injection may result in sudden high systemic concentrations of adrenaline and articaine. This may lead to severe adverse effects such as seizures, followed by central nervous system and cardiovascular/respiratory depression, unconsciousness progressing to respiratory and circulatory arrest.
Therefore, prior to injection, aspiration should be performed to ensure the needle is not within a blood vessel. However, the absence of blood in the syringe does not guarantee avoidance of intravascular injection.

Hazards associated with intraneural injection:
Accidental injection into a nerve may cause retrograde spread of the drug along the nerve.
To avoid intraneural injection and prevent nerve injury associated with nerve block, the needle should always be gently withdrawn if the patient experiences an electric shock-like sensation during insertion or if the injection is particularly painful. In case of nerve injury, neurotoxic effects may be intensified due to the potential chemical neurotoxicity of articaine and the presence of adrenaline, which may impair perineural blood flow and prevent local washout of articaine.

Management of overdose
Before administering local anaesthesia with a local anaesthetic, ensure that resuscitation equipment and medications are available for immediate management of any airway or cardiovascular emergencies.
The severity of overdose symptoms should prompt physicians/dentists to initiate protocols ensuring timely airway protection and respiratory support.
After each injection of a local anaesthetic, the patient's level of consciousness should be monitored.
In case of acute systemic toxic reaction, administration of the local anaesthetic must be immediately discontinued. If necessary, reposition the patient into a supine position.
CNS symptoms (seizures, CNS depression) should be promptly managed with appropriate airway management, respiratory support, and administration of anticonvulsants.
Ensuring optimal oxygen delivery, respiratory and circulatory support, and treatment of acidosis may prevent cardiac arrest.
In case of circulatory depression (hypotension, bradycardia), consider appropriate treatment with intravenous fluids, vasopressors, and/or inotropic agents. Doses for children should be age- and weight-appropriate.
In case of cardiac arrest, immediate cardiopulmonary resuscitation must be initiated.

Special precautions for disposal and preparation of the medicinal product for use
Do not use this medicinal product if the solution is cloudy or discoloured.
To avoid infection risk (e.g. transmission of hepatitis), syringes and needles used to withdraw the solution must always be fresh and sterile.
Cartridges are for single use only. If only part of the cartridge content is used, the remainder must be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.