Stragen Nordic

Solution for injection in a pre-filled syringe 0.1 mg/ml 
(clear, colorless)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Adrenalin Stragen is and what it is used for 
2. What you need to know before you receive Adrenalin Stragen 
3. How Adrenalin Stragen is given 
4. Possible side effects 
5. How to store Adrenalin Stragen 
6. Contents of the packaging and other information 

1. What Adrenaline Stragen is and what it is used for

Adrenaline Stragen belongs to a group of drugs called adrenergic and dopaminergic drugs.

This medicine is used for:

  • treatment of cardiac arrest (that cardiac function and respiration unexpectedly cease and unconsciousness),
  • treatment of acute anaphylaxis in adults (severe shock or collapse due to a severe allergic reaction ).

What You Need to Know Before You Get Adrenaline Stragen

You must not be given Adrenaline Stragen

If you are allergic to any of the excipients in this medicine (listed in section 6), you must not be given Adrenaline Stragen if an alternative form of adrenaline or another antihypertensive agent is available.

Warnings and cautions

Adrenaline Stragen is used in acute treatment. Uninterrupted medical monitoring is required after administration.

Caution

The risk of side effects increases if you:

  • have previously had hyperthyroidism (a disease of the thyroid gland),
  • have severe kidney failure,
  • suffers from hypercalcemia (increased calcium concentration in the blood),
  • suffer from hypokalaemia (too low potassium concentration in the blood),
  • have diabetes mellitus,
  • have heart disease or high blood pressure,
  • has a brain injury or atherosclerosis in the cerebral artery s,
  • have glaucoma (increased pressure in the eye),
  • have any prostate disease,
  • is older,
  • is pregnant.

Other medicines and Adrenaline Stragen

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

Drugs that may affect or be affected by Adrenaline Stragen include:

  • volatile halogens for anesthesia (gas used in anesthesia),
  • certain antidepressants,
  • medicines to treat high blood pressure and heart disease,
  • drugs for the treatment of diabetes.

Pregnancy and breastfeeding

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

Driving and using machines

Driving ability and use of machines are not affected by Adrenaline Stragen.

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.

Adrenaline Stragen contains sodium

This medicine contains 35.4 mg of sodium (the main ingredient in common table salt) per syringe. This corresponds to 1.77% of the recommended maximum daily intake for an adult.

How Adrenaline Stretches Are Given

Adrenaline Stragen is administered to you by a doctor, nurse, or healthcare professional. They must decide on the right amount for you and when and how this should be given.

In case of life-threatening allergic reactions ( acute anaphylaxis ):

Adults: A dose of 0.05 mg (0.5 ml adrenaline 0.1 mg/ml solution), which is repeated as needed until the desired response is achieved.

In cardiac arrest:

Adults: 1 mg (10 ml adrenaline 0.1 mg/ml solution) is given into a vein or bone at 3-5 minute intervals until the heart starts beating.

Children over 5 kg: 10 micrograms / kg (0.1 ml / kg adrenaline 0.1 mg / ml solution) is given into a vein or bone at 3−5 minute intervals until the heart starts beating.

This medicine is not suitable for delivery in a dose of less than 0.5 ml and should therefore not be used in newborns and infants for whom the body weight is less than 5 kg.

4. Possible side effects

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

The following side effects have been reported:

  • anxiety,
  • dyspnoea (difficulty breathing),
  • nervousness,
  • fear,
  • sweating,
  • palpitation er (irregular or faster heartbeat),
  • tachycardia (increased heart rate),
  • pallor,
  • shaking,
  • weakness,
  • dizziness,
  • headache,
  • nausea,
  • vomiting,
  • cold arms and legs,
  • hallucinations,
  • fainting,
  • hyperglycemia (high blood sugar levels),
  • hypokalaemia (low potassium levels in the blood),
  • metabolic acidosis (increased acidity in the blood),
  • mydriasis (dilated pupils ).

At high doses to patients who are sensitive to adrenaline, the side effects are:

  • cardiac dysrhythmia (irregular heartbeat / cardiac arrest),
  • hypertension (with the risk of cerebral hemorrhage),
  • vasoconstriction (narrowing of blood vessels, eg under the skin, in arms and legs or kidneys),
  • acute angina attacks,
  • risk of acute myocardial infarction.

Repeated local injections can cause necrosis (tissue damage) at the injection sites due to vascular constriction (blood vessels constrict).

In all cases, medical monitoring is required after administration of AdrenalineStragen.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Adrenaline Stragen

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. The expiration date (EXP) is the last day of the specified month. The doctor or nurse will check this.

Store in the aluminum bag to protect against light and oxygen.

Do not store above 25 ° C

Do not open the aluminum bag until the product is to be used.

Once the bag has been opened, the product must be used immediately.

Do not freeze.

Do not use sharp instruments to open the bag.

You should not be given Adrenaline Stragen if the pre-filled syringe is partially used or shows signs of visible damage.

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.

6. Contents of the packaging and other information

Content declaration

The active substance is adrenaline tartrate:

Each ml of solution for injection contains adrenaline tartrate equivalent to 0.1 mg adrenaline.

Each 10 ml pre-filled syringe contains adrenaline tartrate equivalent to 1 mg adrenaline.

The other ingredients are sodium chloride, hydrochloric acid , sodium hydroxide, water for injections.

What the medicine looks like and the contents of the pack

Adrenaline Stragen is a clear, colorless solution in a 10 ml pre-filled syringe of polypropylene, individually packaged in a transparent blister and wrapped in an aluminum bag.

The pre-filled syringes are available in cartons of 1 and 10 syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Stragen Nordic A / S

Helsingørsgade 8C

3400 Hillerød

Denmark

Manufacturer :

Aguettant Laboratory

1 rue Alexander Fleming

69007 Lyon

FRANCE

This leaflet was last amended on 2019-04-03

Further information about this medicine is available on the Medical Products Agency’s website http://www.lakemedelsverket.se.

The following information is intended for healthcare professionals only:

Intravenous adrenaline should only be given to those who have experience with the use and titration of vasopressors in their normal clinical practice.

Cardiopulmonary rescue

10 ml of 0.1 mg/ml solution (1 mg) of adrenaline by intravenous or intraosseous administration, repeated at 3-5 minute intervals until spontaneous circulation returns.

Endotracheal use should only be used as a last resort if no other route of administration is available, with a dose of 20 to 25 ml of 0.1 mg/ml solution (2 to 2.5 mg).

In cardiac arrest after cardiac surgery, Adrenaline Stragen is administered intravenously in doses of 0.5 ml or 1 ml of 0.1 mg/ml solution (50 or 100 micrograms) very gently and titrated to effect.

Acute anaphylaxis

Titrate adrenaline intravenously with bolus doses of 0.5 ml 0.1 mg / ml solution (0.05 mg) according to response.

Adrenaline Stragen 0.1 mg/ml, solution for injection in a pre-filled syringe is not recommended for intramuscular use in acute anaphylaxis. For intramuscular administration, 1 mg/ml solution should be used.

Pediatric population

This medicine is not suitable to deliver a dose of fewer than 0.5 ml and should therefore not be used intravenously or intraosseously in neonates and infants for whom the body weight is less than 5kg.

Cardiac arrest in children

Intravenous or intraosseous administration (in children over 5 kg): 0.1 ml / kg 0.1 mg / ml solution (10 micrograms / kg) to a maximum single dose of 10 ml 0.1 mg / ml solution (1 mg), repeated at 3-5 minute intervals until spontaneous circulation returns.

Endotracheal use (regardless of weight) should only be used as a last resort if no other route of administration is available, with a dose of 1 ml/kg 0.1 mg/ml solution (100 micrograms/kg) to a maximum single dose of 25 ml of 0, 1 mg/ml solution (2.5 mg).

Strictly respect the following protocols:

The pre-filled syringe is for single patient use only. Discard the syringe after use.

Do not reuse.

The product should be inspected visually for particulate matter and discoloration prior to administration. The only clear and colorless solution, free from particles or precipitates, should be used.

The product should not be used in the bag or blister pack has been opened or if the tamper-proof seal on the syringe (the plastic film at the base of the end cap) is broken.

1) Tear up the aluminum bag by hand using only the perforations.Do not use sharp instruments to open the bag.
2) Remove the pre-filled syringe from the sterile blister pack.
3) Press the piston to release the latch. The sterilization process may have caused the latch to attach to the syringe body.

4) Unscrew the end cap to break the seals. Do not touch the exposed Luer coupling so that contamination can be avoided.

5) Check that the syringe end seal is completely removed. If not, replace the cover and turn again.

6) Exhale the air by gently pressing on the piston.

7) Connect the syringe to a vascular access device or cannula.
Press the plunger to inject the required volume.
Any unused product or waste material should be disposed of in accordance with local requirements

Muhammad Nadeem

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