10 mg/ml and 20 mg/ml solution for injection
mepivacaine hydrochloride

What Mepivacaine Accord is and what it is used for

Local anesthetic ( local anesthetic ).

This medicine is used for temporary, local anesthesia and pain relief by infiltration and regional nerve block with injection.

Mepivacaine hydrochloride contained in Mepivacaine Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Mepivacaine Accord

Do not use Mepivacaine Accord

  • if you are allergic to mepivacaine hydrochloride or any of the other ingredients (listed in section 6)
  • if you have severe cardiac arrhythmias (severe disorders of the heart’s electrical conduction system)
  • if you have a weak heart muscle that can not be kept under control with treatment ( acute decompensated heart failure )
  • for anesthesia of the cervix ( cervix ) during childbirth (paracervical anesthesia).

In addition, there are certain occasions when epidural anesthesia should not be given. These are

  • increased pressure in the skull
  • acute central nervous system disease (brain or spinal cord) including inflammation , tumors , infectious virus or bacterial disease, narrowing of the open spaces of the spine, ongoing spinal disease (eg spondylitis, tuberculosis and tumor ) and spinal cord injury (eg fracture )
  • septicemia (blood poisoning)
  • infection at the injection site
  • problems with blood coagulation (blood clotting) or treatment with blood thinners) (except low-dose heparin )
  • heart attack and severe blood and fluid loss.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before giving Mepivacaine Accord if you have:

  • kidney or liver disease
  • blocked blood vessels
  • atherosclerosis ( arteriosclerosis )
  • nerve damage due to diabetes
  • porphyria (a disorder of blood formation).

Other medicines and Mepivacaine Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor or pharmacist if you are taking any of the following medicines:

  • Some strong painkillers (eg centrally acting painkillers or opioids)
  • Drugs used in anesthesia (eg ether)
  • Medicines used for muscle relaxation (non-depolarizing muscle relaxation)
  • Drugs used to treat irregular heartbeat ( antiarrhythmics )
  • Other local anesthetics

Pregnancy, breastfeeding and fertility

Based on long-term use, mepivacaine anesthesia is considered relatively safe to use in pregnant women.

Mepivacaine Accord passes through the placenta, but retrospective studies of pregnant women who received local anesthesia during emergency surgery early in pregnancy have not shown that local anesthetics cause malformations.

However, no controlled studies have been performed on pregnant women.

In addition, inadequately studied reproductive studies in animals have been performed with mepivacaine. Therefore, caution should be exercised before giving this anesthetic during early pregnancy.

A possible complication of using Mepivacaine Accord during childbirth is that the mother may have very low blood pressure ( arterial hypotension ).

It is not known if local anesthetics are excreted in breast milk. Because many medicines are excreted in human milk, caution should be exercised when administering Mepivacaine Accord to a breastfeeding woman.

If Mepivacaine Accord needs to be given during breastfeeding, breastfeeding can be resumed approximately 24 hours after the end of treatment.

Driving and using machines

Depending on the dose and how the medicine is given, mepivacaine has a transient effect on mobility and coordination.

The doctor must determine in each case whether the patient can drive a car or use machines when Mepivacaine Accord has been used.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Mepivacaine Accord contains sodium

1 ml Mepivacaine Accord 10 mg / ml solution for injection contains 0.14 mmol (3.2 mg) sodium .

One 10 ml ampoule of Mepivacaine Accord 10 mg / ml solution for injection contains 1.4 mmol (32 mg) sodium .

One 20 ml vial of Mepivacaine Accord 10 mg/ml solution for injection contains 2.8 mmol (64 mg) sodium.

1 ml Mepivacaine Accord 20 mg / ml solution for injection contains 0.12 mmol (2.8 mg) sodium .

One 2 ml ampoule of Mepivacaine Accord 20 mg / ml solution for injection contains 0.24 mmol (5.6 mg) sodium .

One 5 ml ampoule of Mepivacaine Accord 20 mg / ml solution for injection contains 0.60 mmol (14 mg) sodium .

One 10 ml ampoule of Mepivacaine Accord 20 mg / ml solution for injection contains 1.2 mmol (28 mg) sodium .

One 20 ml vial of Mepivacaine Accord 20 mg/ml solution for injection contains 2.4 mmol (56 mg) sodium.

This should be considered by patients on a low-salt diet.

How to use Mepivacaine Accord

You are given Mepivacaine Accord by a doctor. The doctor knows how to take this medicine.

The recommended dose that your doctor gives you depends on the type of pain relief you need and in which part of your body the medicine is to be injected. It also depends on your body weight, age, and health condition.

You are given Mepivacaine Accord as an injection. In which part of the body you get the injection depends on why you are getting Mepivacaine Accord. Your doctor will give you Mepivacaine Accord in one of the following areas:

  • In the skin ( infiltration )
  • Under the skin near a nerve (regional, plexus – or nerve block)
  • Around the spinal cord ( epidural or lumbar anesthesia or caudal anesthesia )

Mepivacaine Accord should be given as a slow injection. The highest recommended dose for a single administration is:

  • Ears Nose Throat ‑ area: 200 mg mepivacaine hydrochloride (3 mg / kg body weight)
  • Intercostal blockade: 300 mg mepivacaine hydrochloride (4 mg / kg body weight)
  • Epidural anesthesia and peripheral blockades: 400 mg mepivacaine hydrochloride (6 mg / kg body weight)
  • Plexus anesthesia: 500 mg mepivacaine hydrochloride (7 mg / kg body weight).
  • For caudal anesthesia in children: 5 mg / kg body weight. Individual differences are possible.
Indications Dosage (ml)
Invoice repositioning 5‑20 ml
Sympathetic nerve block 5‑10 ml
Skin rash (hives) 0.1‑2 ml
Lateral cutaneous nerve at thigh blockage 10 ml
Femoral nerve block 10‑20 ml
Median nerve block 3‑5 ml
Blocked by the obturator nerve 10‑15 ml
Blockage of diaphragmatic nerve 10‑15 ml
Radial nerve block 10‑20 ml
Ulnar nerve blocked 5‑10 ml
Digital nerve block, every nerve 1‑2 ml
The paracervical blockade, each side 6‑10 ml
Paravertebral blockade 5‑10 ml
The pudendal blockade, each side 7‑10 ml
Sacred blockade 10‑30 ml
Tonsillectomy, each tonsil 5‑10 ml
Wound care Up to 30 ml
Intravenous regional anesthesia Up to 40 ml

In the case of epidural anesthesia, adjustment based on age is required

  • 5 year olds: 0.5 ml / segment
  • 10 year olds: 0.9 ml / segment
  • 15-year-olds: 1.3 ml / segment
  • 20 ‑ year olds: 1.5 ml / segment
  • 40 ‑ year olds: 1.3 ml / segment
  • 60 year olds: 1.0 ml / segment
  • 80 ‑ year olds: 0.7 ml / segment

If you use more Mepivacaine Accord than you should 

You may get the following symptoms; restlessness, dizziness, hearing and vision disorders, tingling in the area around the tongue and mouth, slurred speech, nausea, vomiting, tremors ( muscle tremors ), and muscle twitching as signs of imminent seizures, arrhythmias, increased heart rate, high blood pressure, and hemorrhage. An extreme overdose can lead to unconsciousness with respiratory and circulatory arrest.

In case of signs of overdose, the administration of the Mepivacaine Accord must be stopped immediately. The doctor decides what additional treatment measures are required. These may include infusion of a fat emulsion.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

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

The possible side effects after using Mepivacaine Accord are very similar to other local anesthetics. Side effects caused by the drug are difficult to distinguish from the physiological effects of a nerve block (eg drop in blood pressure, slow pulse ) They are also difficult to distinguish from the effects of injection, either directly (eg nerve damage) or indirectly (t (eg abscess at the injection site).

In addition, any abnormal absorption properties or metabolic disorders in the liver or renal excretion disorders must be considered as a possible cause of side effects.

Any side effects ar

Common (may affect up to 1 in 10 people):

  • tingling or numbness
  • dizziness
  • slower pulse
  • low blood pressure *, high blood pressure
  • nausea *, vomiting

Uncommon (may affect up to 1 in 100 people):

  • signs and symptoms of poisoning in the central nervous system , e.g. seizures, tingling around the mouth, numbness in the tongue, hearing or vision disorders, unconsciousness, tremors ( tremor ), tinnitus , speech disorders, inhibition of the functions of the central nervous system

Rare (may affect up to 1 in 1,000 people):

  • allergic reactions
  • life-threatening allergic reaction
  • neuropathy ( peripheral nerve disease)
  • peripheral nerve damage
  • arachnoiditis ( inflammation of one of the membranes surrounding the brain and spinal cord)
  • double vision
  • cardiac arrhythmias
  • cardiac arrest
  • breathing problems

* These side effects were more common after epidural anesthesia.

How to store Mepivacaine Accord

  • Keep this medicine out of the sight and reach of children.
  • No special storage instructions.
  • Do not freeze.
  • Do not use this medicine after the expiry date which is stated on the ampoule , vial and carton after EXP. The expiration date is the last day of the specified month.
  • Do not use this medicine if you notice that the contents are discolored in any way or if there are particles.
  • Mepivacaine Accord is for single use only and should be used immediately after opening.
  • Discard any unused solution.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is mepivacaine hydrochloride.

Mepivacaine Accord 10 mg / ml solution for injection :

1 ml solution contains 10 mg mepivacaine hydrochloride.

One 10 ml ampoule contains 100 mg mepivacaine hydrochloride.

One 20 ml vial contains 200 mg mepivacaine hydrochloride.

Mepivacaine Accord 20 mg/ml solution for injection :

1 ml solution contains 20 mg mepivacaine hydrochloride.

One 2 ml ampoule contains 40 mg mepivacaine hydrochloride.

One 5 ml ampoule contains 100 mg mepivacaine hydrochloride.

One 10 ml ampoule contains 200 mg mepivacaine hydrochloride.

One 20 ml vial contains 400 mg mepivacaine hydrochloride.

The other ingredients are water for injections, sodium chloride and sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).

What the medicine looks like and contents of the pack

Mepivacaine Accord solution for injection is a clear, colorless, sterile solution for injection. It is available as ampoules of clear type I glass and vials of clear type I glass with rubber stopper and flip-off seal.

Mepivacaine Accord 10 mg/ml solution for injection :

10 ml ampoules with red ribbon are delivered in packs of 1 and 5 ampoules

20 ml vials with chlorobutyl rubber stopper and a mist gray flip-off ‑ seal are supplied in packs of 1, 5, and 10 vials

Mepivacaine Accord 20 mg/ml solution for injection :

2 ml ampoules with green ribbon are delivered in packs of 1 and 5 ampoules

5 ml ampoules with red ribbon are delivered in packs of 1, 5, 10, and 50 ampoules

10 ml ampoules with green ribbon are delivered in packs of 1 and 5 ampoules

20 ml vials with chlorobutyl rubber stopper and a lavender flip ‑ off ‑ seal are supplied in packs of 1, 5, and 10 vials

The ampoules are delivered in blister packs or trays.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 kV Utrecht

Netherlands

Manufacturer

Accord Healthcare Limited

Sage House, 319, Pinner Road,

North Harrow, Middlesex

HA1 4HF, UK

Accord Healthcare BV

Winthontlaan 200

3526 kV Utrecht

Netherlands

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Muhammad Nadeem

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