Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - recarbrio

Document Subject

Generated Narrative: MedicinalProductDefinition mp0f7d092ba8e4ed3275cffe67db6bbcc7

identifier: http://ema.europa.eu/identifier/EU/1/19/1420/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Recarbrio 500 mg/500 mg/250 mg powder for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-0f7d092ba8e4ed3275cffe67db6bbcc7

identifier: http://ema.europa.eu/identifier/EU/1/19/1420/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - recarbrio

Attesters

What is in this leaflet

1. What Recarbrio is and what it is used for
2. What you need to know before you are given Recarbrio
3. How you are given Recarbrio
4. Possible side effects
5. How to store Recarbrio
6. Contents of the pack and other information

Recarbrio is an antibiotic. It contains the active substances imipenem, cilastatin, and relebactam. Recarbrio is used in adults to treat:

certain bacterial infections of the lungs (pneumonia)

infections of the blood associated with the infections of the lung mentioned above

infections caused by bacteria that other antibiotics may not be able to kill Recarbrio is used in patients 18 years or older.

You should not be given Recarbrio if:

you are allergic to imipenem, cilastatin, relebactam or any of the other ingredients of this medicine (listed in section 6)

you are allergic to carbapenem antibiotics

you ever had a severe allergic reaction to penicillin antibiotics or cephalosporin antibiotics You should not be given Recarbrio if any of the above apply to you. If you are not sure, talk to your doctor or nurse before being given Recarbrio. Warnings and precautions Talk to your doctor or nurse before being given Recarbrio if:

you are allergic to any medicines - especially antibiotics

you have ever had convulsions (seizures or fits)

you have ever had confusion or muscle twitches with a medicine

you are taking a medicine containing valproic acid

you have had diarrhoea while taking antibiotics in the past

you have kidney problems your doctor may lower your dose Tell your doctor right away if you have an allergic reaction, convulsions (seizures or fits), diarrhoea, or develop kidney problems while receiving Recarbrio (see section 3). Children and adolescents Recarbrio should not be used in children or adolescents who are under 18 years of age. This is because it is not known if the medicine is safe to use in these patients. Other medicines and Recarbrio Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. Tell your doctor about all the medicines you take, especially if you take:

medicines that contain ganciclovir, used for treating some viral infections

medicines that contain valproic acid or divalproex sodium, usually used for treating epilepsy, bipolar disorder, or migraine

medicines to control blood clotting, such as warfarin Pregnancy and breastfeeding If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. Driving and using machines Recarbrio may make you feel dizzy, shaky, or cause convulsions or seizures. This may affect your ability to drive or use machines. Recarbrio contains sodium This medicine contains approximately 37.5 mg of sodium (main component of cooking/ table salt) in each vial. This is equivalent to about 2 % of the adult recommended maximum amount of sodium you should take daily, and needs to be taken into account if you are on a low-salt diet.

The usual dose is one vial (containing 500 mg imipenem, 500 mg cilastatin, and 250 mg relebactam) every 6 hours. If you have kidney problems, your doctor may lower your dose. It is given as a drip directly into a vein ( intravenous infusion ). The infusion will last 30 minutes. The course of treatment usually lasts from 5 up to 14 days, depending on the type of infection you have and how you respond to treatment. If you are given more Recarbrio than you should Recarbrio will be given to you by a doctor or a nurse, so it is unlikely you will be given the wrong dose. If you think you have been given too much Recarbrio, tell your doctor or nurse right away. If you miss a dose of Recarbrio Tell your doctor or nurse right away if you think you were not given your dose of Recarbrio. If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Tell your doctor right away if you notice any of the following serious side effects - the medicine must be stopped:

allergic reactions the signs may include hives, swelling of the face, lips, tongue or throat, difficulty in breathing or swallowing

severe skin reactions (e.g., severe rash, skin peeling or blistering) Other side effects Common: (may affect up to 1 in 10 people)

nausea, being sick (vomiting), diarrhoea

blood test results that may show changes in the liver

blood test results that may show an increase in the number of some types of blood cells called eosinophils

blood test results that may show an increase in some white blood cells

rash

inflammation and pain caused by a blood clot in the vein Uncommon: (may affect up to 1 in 100 people)

hives

skin itchiness

convulsions (fits) and nervous system problems like tremor

confusion

seeing, hearing or feeling something that is not there (hallucinations)

dizziness, sleepiness

low blood pressure

blood test results that may show changes in the kidney

blood test results that may show a decrease in the number of red blood cells, white blood cells, and blood cells called platelets

blood test results that may show an increase in the number of some blood cells called platelets

abnormal kidney, liver, and blood function detected by blood tests

pain or redness or formation of a lump where the medicine was injected

fever

blood test (called a Coombs test) results showing antibodies that can cause anaemia by destroying red blood cells Rare: (may affect up to 1 in 1,000 people)

fungal infection (candidiasis)

changes in taste

disease of the brain, tingling sensation (pins and needles), localised tremor

hearing loss

staining of the teeth and/or tongue

inflammation of the colon with severe diarrhoea (colitis)

low number of white blood cells which may make it difficult for your body to fight infections

inflammation of the liver

liver failure

inability of the kidney to perform normal function

changes in the amount of urine, changes in urine color

swelling of the skin

painful rash with flu-like symptoms

redness and scaling of the skin Very rare: (may affect up to 1 in 10,000 people)

inflammation of stomach or intestine (gastro-enteritis)

anaemia due to destruction of red blood cells, leading to symptoms like tiredness, pale skin

headache

worsening of a rare disease associated with muscle weakness (aggravation of myasthenia gravis)

a spinning sensation (vertigo)

ringing in the ears (tinnitus)

irregular heartbeat, the heart beating forcefully or rapidly

chest discomfort, difficulty breathing, abnormally fast and superficial breathing, pain in the upper spine

pain in the throat

flushing, bluish discoloration of the face and lips, changes in skin texture, excessive sweating

increase in the production of saliva

inflammation of intestine with bloody diarrhoea (haemorrhagic colitis)

stomach pain

heartburn

red swollen tongue, overgrowth of the normal projections on the tongue giving it a hairy appearance

severe loss of liver function due to inflammation (fulminant hepatitis)

pain in several joints

itching of the vulva in women

weakness, lack of energy Not known: (frequency cannot be estimated from the available data)

agitation

abnormal movements

jaundice (yellowing of your skin and eyes)

blood tests showing an increase in a substance called lactic dehydrogenase (LDH) which may be a sign of tissue damage 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.

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 container. The expiry date refers to the last day of that month. Keep this medicine in the outer carton to protect from light. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Recarbrio contains

The active substances are imipenem, cilastatin, and relebactam. Each vial contains 500 mg imipenem, 500 mg cilastatin, and 250 mg relebactam.

The other ingredient is sodium hydrogen carbonate. What Recarbrio looks like and contents of the pack Recarbrio is a white to light yellow powder supplied for solution for infusion in glass vials. Pack size is 25 vials. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Manufacturer Merck Sharp & Dohme B.V. Waarderweg 2031 BN Haarlem The Netherlands FAREVA Mirabel Route de Marsat, Riom 63963, Clermont-Ferrand Cedex 9 France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien MSD Belgium T l/Tel: +32(0)27766dpoc_belux@merck.com Lietuva UAB Merck Sharp & Dohme Tel: + 370 5 278 02 msd_lietuva@merck.com

: +359 2 819 3info-msdbg@merck.com Luxembourg/Luxemburg MSD Belgium T l/Tel: +32(0)27766dpoc_belux@merck.com

esk republika Merck Sharp & Dohme s.r.o. Tel: +420 233 010 dpoc_czechslovak@merck.com Magyarorsz g MSD Pharma Hungary Kft. Tel: +36 1 888 5hungary_msd@merck.com

Danmark MSD Danmark ApS Tlf: + 45 4482 4dkmail@merck.com Malta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@merck.com

Deutschland MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) e-mail@msd.de Nederland Merck Sharp & Dohme B.V. Tel: 0800 9999(+31 23 5153153) medicalinfo.nl@merck.com

Eesti Merck Sharp & Dohme O Tel.: +372 6144 msdeesti@merck.com Norge MSD (Norge) AS Tlf: +47 32 20 73 msdnorge@msd.no

MSD . . . . . : +30 210 98 97 dpoc_greece@merck.com sterreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 dpoc_austria@merck.com Espa a Merck Sharp & Dohme de Espa a, S.A. Tel: +34 91 321 06 msd_info@merck.com Polska MSD Polska Sp. z o.o. Tel: +48 22 549 51 msdpolska@merck.com France MSD France T l: + 33 (0) 1 80 46 40 Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465inform_pt@merck.com Hrvatska Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 croatia_info@merck.com Rom nia Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 msdromania@merck.com Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfo_ireland@merck.com Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386 1 5204 msd.slovenia@merck.com sland Vistor hf. S mi: + 354 535 7Slovensk republika Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282dpoc_czechslovak@merck.com Italia MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) medicalinformation.it@msd.com Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 info@msd.fi

Merck Sharp & Dohme Cyprus Limited : 800 00 673 (+357 22866700) cyprus_info@merck.com Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700medicinskinfo@merck.com Latvija SIA Merck Sharp & Dohme Latvija Tel: + 371 67364msd_lv@merck.com United Kingdom (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfoNI@msd.com This leaflet was last revised in {MM/YYYY}. Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu <------------------------------------------------------------------------------------------------------------------------> The following information is intended for healthcare professionals only: Recarbrio is supplied as a dry powder in a single-dose vial that must be constituted and further diluted using aseptic technique prior to intravenous infusion as outlined below:

To prepare the infusion solution, contents of the vial must be transferred to 100 mL of an appropriate infusion solution: 9 mg/mL (0.9 %) sodium chloride. In exceptional circumstances where 9 mg/mL (0.9 %) sodium chloride cannot be used for clinical reasons 5 % glucose may be used instead.

Withdraw 20 mL (10 mL times 2) of diluent from the appropriate infusion bag and constitute the vial with 10 mL of the diluent. The constituted suspension must not be administered by direct intravenous infusion.

After constitution, shake vial well and transfer resulting suspension into the remaining 80 mL of the infusion bag.

Add the additional 10 mL of infusion diluent to the vial and shake well to ensure complete transfer of vial contents; repeat transfer of the resulting suspension to the infusion solution before administering. Agitate the resulting mixture until clear.

Constituted solutions of Recarbrio range from colorless to yellow. Variations of color within this range do not affect the potency of the product.

For patients with renal insufficiency, a reduced dose of Recarbrio will be administered according to the patient's CrCl, as determined from the table below. Prepare 100 mL of infusion solution as directed above. Select the volume (mL) of the final infusion solution needed for the appropriate dose of Recarbrio as shown in the table below. Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if discoloration or visible particles are observed. Preparation of Recarbrio Doses Creatinine Clearance (mL/min) Dosage of Recarbrio (imipenem/cilastatin/relebactam) (mg) Volume (mL) of Solution to be Removed and Discarded from Preparation Volume (mL) of Final Infusion Solution Needed for Dosage Greater than or equal to 500/500/N/A Less than to greater than or equal to 400/400/Less than to greater than or equal to 300/300/Less than to greater than or equal to or ESRD on haemodialysis 200/200/Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Compatible medicinal products The physical compatibility of Recarbrio with selected injectable medicinal products was evaluated in two commonly available diluents at a Y-infusion site. Compatible medicinal products with the corresponding compatible diluent (i.e., 5 % Dextrose Injection or 0.9 % Sodium chloride Injection) are listed below. Recarbrio should not be co-administered through the same intravenous line (or cannula), with other medicinal products not listed below, as no compatibility data are available. Refer to the respective prescribing information of the co-administered medicinal product(s) to confirm compatibility of simultaneous co-administration. This medicinal product must not be mixed with other medicinal products except those mentioned below. List of Compatible Injectable Medicinal Products for use with 5 % Dextrose or 0.9 % Sodium chloride Injection as Diluents dexmedetomidine dopamine epinephrine fentanyl heparin midazolam norepinephrine phenylephrine Compatible intravenous bags and infusion set materials Recarbrio is compatible with the following intravenous container bags and infusion set materials. Any intravenous bags or infusion set materials not listed below should not be used. Intravenous Container Bag Materials Polyvinyl chloride (PVC) and polyolefin (polypropylene and polyethylene) Intravenous Infusion Set Materials (with tubing) PVC + Di-(2-ethylhexyl)phthalate (DEHP) and polyethylene (PE)-lined PVC Incompatible medicinal products Recarbrio for solution for infusion is physically incompatible with propofol in 5 % Dextrose (also named Glucose) or 0.9 % Sodium chloride. After constitution and dilution Diluted solutions should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed two hours.