FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 pre-filled syringe (0.7 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Latvian: 1 pilnšļirce (0,7 ml) ar pievienotu adatu ar adatas aizsargu un 2 spirta salvetes.
English: 1 pre-filled syringe (0.8 ml) with pre-assembled needle with needle guard and 2 alcohol swabs Multipack: 4 (4 packs of 1) pre-filled syringes (0.8 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: 1 pilnšļirce (0,8 ml) ar pievienotu adatu ar adatas aizsargu un 2 spirta salvetes Daudzdevu iepakojums: 4 (4 iepakojumi pa 1) pilnšļirces (0,8 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: EU/1/16/1124/004 1 pre-filled pen EU/1/16/1124/015 4 pre-filled pens (4 packs of 1) EU/1/16/1124/016 6 pre-filled pens (6 packs of 1) EU/1/16/1124/063 4 pre-filled pens (1 pack of 4) EU/1/16/1124/064 12 pre-filled pens (3 packs of 4)
Latvian: EU/1/16/1124/004 1 pildspalvveida pilnšļirce EU/1/16/1124/015 4 pildspalvveida pilnšļirces (4 iepakojumi pa 1) EU/1/16/1124/016 6 pildspalvveida pilnšļirces (6 iepakojumi pa 1) EU/1/16/1124/063 4 pildspalvveida pilnšļirces (1 iepakojums pa 4) EU/1/16/1124/064 12 pildspalvveida pilnšļirces (3 iepakojumi pa 4)
English: EU/1/16/1124/003 1 pre-filled pen EU/1/16/1124/013 4 pre-filled pens (4 packs of 1) EU/1/16/1124/014 6 pre-filled pens (6 packs of 1) EU/1/16/1124/061 4 pre-filled pens (1 pack of 4) EU/1/16/1124/062 12 pre-filled pens (3 packs of 4)
Latvian: EU/1/16/1124/003 1 pildspalvveida pilnšļirce EU/1/16/1124/013 4 pildspalvveida pilnšļirces (4 iepakojumi pa 1) EU/1/16/1124/014 6 pildspalvveida pilnšļirces (6 iepakojumi pa 1) EU/1/16/1124/061 4 pildspalvveida pilnšļirces (1 iepakojums pa 4) EU/1/16/1124/062 12 pildspalvveida pilnšļirces (3 iepakojumi pa 4)
English: EU/1/16/1124/041 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/042 6 pre-filled syinges (6 packs of 1) EU/1/16/1124/054 12 pre-filled syringes (12 packs of 1)
Latvian: EU/1/16/1124/041 4 pilnšļirces (4 iepakojumi pa 1) EU/1/16/1124/042 6 pilnšļirces (6 iepakojumi pa 1) EU/1/16/1124/054 12 pilnšļirces (12 iepakojumi pa 1)
English: EU/1/16/1124/013 4 pre-filled pens (4 packs of 1) EU/1/16/1124/014 6 pre-filled pens (6 packs of 1) EU/1/16/1124/062 12 pre-filled pens (3 packs of 4)
Latvian: EU/1/16/1124/013 4 pildspalvveida pilnšļirces (4 iepakojumi pa 1) EU/1/16/1124/014 6 pildspalvveida pilnšļirces (6 iepakojumi pa 1) EU/1/16/1124/062 12 pildspalvveida pilnšļirces (3 iepakojumi pa 4)
English: EU/1/16/1124/044 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/045 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/055 12 pre-filled syringes (12 packs of 1)
Latvian: EU/1/16/1124/044 4 pilnšļirces (4 iepakojumi pa 1) EU/1/16/1124/045 6 pilnšļirces (6 iepakojumi pa 1) EU/1/16/1124/055 12 pilnšļirces (12 iepakojumi pa 1)
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.5 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: Daudzdevu iepakojums: 12 (12 iepakojumi pa 1) pilnšļirces (0,5 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.5 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: Daudzdevu iepakojums: 6 (6 iepakojumi pa 1) pilnšļirces (0,5 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: Hepatobiliary disorders (see section 4.4)
Latvian: Aknu un/vai žults izvades sistēmas traucējumi (skatīt 4.4. apakšpunktu)
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.7 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: Daudzdevu iepakojums: 12 (12 iepakojumi pa 1) pilnšļirces (0,7 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: Nordimet 17.5 mg solution for injection in pre-filled syringe methotrexate
Latvian: Nordimet 17,5 mg šķīdums injekcijām pildspalvveida pilnšļircē Methotrexatum
English: Nordimet 12.5 mg solution for injection in pre-filled syringe methotrexate
Latvian: Nordimet 12,5 mg šķīdums injekcijām pildspalvveida pilnšļircē Methotrexatum
English: 1 pre-filled syringe (0.4 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Latvian: 1 pilnšļirce (0,4 ml) ar pievienotu adatu ar adatas aizsargu un 2 spirta salvetes.
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.7 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: Daudzdevu iepakojums: 6 (6 iepakojumi pa 1) pilnšļirces (0,7 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: 1 pre-filled syringe (1 ml) with pre-assembled needle with needle guard and 2 alcohol swabs Multipack: 4 (4 packs of 1) pre-filled syringes (1.0 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: 1 pilnšļirce (1 ml) ar pievienotu adatu ar adatas aizsargu un 2 spirta salvetes Daudzdevu iepakojums: 4 (4 iepakojumi pa 1) pilnšļirces (1 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: SC 20 mg / 0.8 ml
Latvian: Šķīdums injekcijām20 mg/0,8 ml
English: 4 pre-filled pens (0.4 ml) with pre-assembled needle and 4 alcohol swabs.
Latvian: 4 pildspalvveida pilnšļirces (0,4 ml) ar pievienotu adatu un 4 spirta salvetes.
English: 1 pre-filled syringe (0.6 ml) with pre-assembled needle with needle guard and 2 alcohol swabs Multipack: 4 (4 packs of 1) pre-filled syringes (0.6 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: 1 pilnšļirce (0,6 ml) ar pievienotu adatu ar adatas aizsargu un 2 spirta salvetes Daudzdevu iepakojums: 4 (4 iepakojumi pa 1) pilnšļirces (0,6 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: Nordimet 20 mg solution for injection in pre-filled syringe methotrexate
Latvian: Nordimet 20 mg šķīdums injekcijām pildspalvveida pilnšļircē Methotrexatum
English: 1 pre-filled syringe (0.3 ml) with pre-assembled needle with needle guard and 2 alcohol swabs Multipack: 4 (4 packs of 1) pre-filled syringes (0.3 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: 1 pilnšļirce (0,3 ml) ar pievienotu adatu ar adatas aizsargu un 2 spirta salvetes Daudzdevu iepakojums: 4 (4 iepakojumi pa 1) pilnšļirces (0,3 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.3 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: Daudzdevu iepakojums: 6 (6 iepakojumi pa 1) pilnšļirces (0,3 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.3 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: Daudzdevu iepakojums: 12 (12 iepakojumi pa 1) pilnšļirces (0,3 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: Nordimet 22.5 mg solution for injection in pre-filled syringe methotrexate
Latvian: Nordimet 22,5 mg šķīdums injekcijām pildspalvveida pilnšļircē Methotrexatum
English: Nordimet 15 mg solution for injection in pre-filled syringe methotrexate
Latvian: Nordimet 15 mg šķīdums injekcijām pildspalvveida pilnšļircē Methotrexatum
English: Cardiac disorders Rare: Pericarditis, pericardial effusion, pericardial tamponade.
Latvian: Sirds funkcijas traucējumi Reti: perikardīts, izsvīdums perikardā, perikarda tamponāde.
English: Nordimet 10 mg solution for injection in pre-filled syringe methotrexate
Latvian: Nordimet 10 mg šķīdums injekcijām pildspalvveida pilnšļircē Methotrexatum
English: If you develop any of the following side effects, contact your doctor immediately: - inflammation of the lungs (symptoms may be general illness, dry, irritating cough, shortness of breath, breathlessness at rest, chest pain, or fever) - spitting or coughing blood - severe peeling or blistering of the skin - unusual bleeding (including vomiting blood) or bruising - severe diarrhoea - ulcers in mouth - black or tarry stools - blood in the urine or stools - tiny red spots on the skin - fever - yellowing of the skin (jaundice) - pain or difficulty in passing urine - thirst and/or frequent urination - fits (convulsions) - loss of consciousness - blurred or decreased vision
Latvian: - čūlas mutes dobumā; - melni vai darvai līdzīgi izkārnījumi; - asinis urīnā vai izkārnījumos; - sīki, sarkani plankumi uz ādas; - drudzis; - dzeltenīga āda (dzelte); - sāpes urinējot vai apgrūtināta urinācija; - slāpes un/vai bieža urinācija; - krampju lēkmes (krampji); - samaņas zudums; - neskaidra vai pavājināta redze.
English: Your doctor will carry out blood and urine tests to make sure that any side effects are identified quickly.
Latvian: Lai tās savlaicīgi konstatētu, ārsts regulāri nozīmēs Jums asins un urīna analīzes.
English: Nordimet 7.5 mg solution for injection in pre-filled syringe methotrexate
Latvian: Nordimet 7,5 mg šķīdums injekcijām pilnšļircē Methotrexatum
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.8 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: Daudzdevu iepakojums: 6 (6 iepakojumi pa 1) pilnšļirces (0,8 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.8 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: Daudzdevu iepakojums: 12 (12 iepakojumi pa 1) pilnšļirces (0,8 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.4 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: Daudzdevu iepakojums: 12 (12 iepakojumi pa 1) pilnšļirces (0,4 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.6 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: Daudzdevu iepakojums: 12 (12 iepakojumi pa 1) pilnšļirces (0,6 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.4 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: Daudzdevu iepakojums: 6 (6 iepakojumi pa 1) pilnšļirces (0,4 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: 1 pre-filled syringe (0.4 ml) with pre-assembled needle with needle guard and 2 alcohol swabs Multipack: 4 (4 packs of 1) pre-filled syringes (0.4 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: 1 pilnšļirce (0,4 ml) ar pievienotu adatu ar adatas aizsargu un 2 spirta salvetes Daudzdevu iepakojums: 4 (4 iepakojumi pa 1) pilnšļirces (0,4 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.6 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: Daudzdevu iepakojums: 6 (6 iepakojumi pa 1) pilnšļirces (0,6 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: Nordimet 25 mg solution for injection in pre-filled syringe methotrexate
Latvian: Nordimet 25 mg šķīdums injekcijām pildspalvveida pilnšļircē Methotrexatum
English: 1 pre-filled pen (0.8 ml) with pre-assembled needle and 1 alcohol swab Multipack: 4 (4 packs of 1) pre-filled pens (0.8 ml) with pre-assembled needle and alcohol swabs Multipack: 4 (1 pack of 4) pre-filled pens (0.8 ml) with pre-assembled needle and alcohol swabs Multipack: 6 (6 packs of 1) pre-filled pens (0.8 ml) with pre-assembled needle and alcohol swabs Multipack: 12 (3 packs of 4) pre-filled pens (0.8 ml) with pre-assembled needle and alcohol swabs
Latvian: 1 pildspalvveida pilnšļirce (0,8 ml) ar pievienotu adatu un 1 spirta salvete Daudzdevu iepakojums: 4 (4 iepakojumi pa 1) pildspalvveida pilnšļirces (0,8 ml) ar pievienotu adatu un spirta salvetes
English: 1 pre-filled pen (0.5 ml) with pre-assembled needle and 1 alcohol swab Multipack: 4 (4 packs of 1) pre-filled pens (0.5 ml) with pre-assembled needle and alcohol swabs Multipack: 4 (1 pack of 4) pre-filled pens (0.5 ml) with pre-assembled needle and alcohol swabs Multipack: 6 (6 packs of 1) pre-filled pens (0.5 ml) with pre-assembled needle and alcohol swabs Multipack: 12 (3 packs of 4) pre-filled pens (0.5 ml) with pre-assembled needle and alcohol swabs
Latvian: 1 pildspalvveida pilnšļirce (0,5 ml) ar pievienotu adatu un 1 spirta salvete Daudzdevu iepakojums: 4 (4 iepakojumi pa 1) pildspalvveida pilnšļirces (0,5 ml) ar pievienotu adatu un spirta salvetes
English: Multipack: 12 (12 packs of 1) pre-filled syringes (1.0 ml) with pre-assembled needle with needle guard and alcohol swabs
Latvian: Daudzdevu iepakojums: 12 (12 iepakojumi pa 1) pilnšļirces (1 ml) ar pievienotu adatu ar adatas aizsargu un spirta salvetes
English: 1 pre-filled pen (0.9 ml) with pre-assembled needle and 1 alcohol swab Multipack: 4 (4 packs of 1) pre-filled pens (0.9 ml) with pre-assembled needle and alcohol swabs Multipack: 4 (1 pack of 4) pre-filled pens (0.9 ml) with pre-assembled needle and alcohol swabs Multipack: 6 (6 packs of 1) pre-filled pens (0.9 ml) with pre-assembled needle and alcohol swabs Multipack: 12 (3 packs of 4) pre-filled pens (0.9 ml) with pre-assembled needle and alcohol swabs
Latvian: 1 pildspalvveida pilnšļirce (0,9 ml) ar pievienotu adatu un 1 spirta salvete Daudzdevu iepakojums: 4 (4 iepakojumi pa 1) pildspalvveida pilnšļirces (0,9 ml) ar pievienotu adatu un spirta salvetes
English: For Orlistat 60 mg capsules:
Latvian: Orlistata 60 mg kapsulām:
English: The capsule should be swallowed with water.”
Latvian: Kapsula jānorij, uzdzerot ūdeni.”
English: Symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage on your right hand side), sometimes with loss of appetite.”
Latvian: Simptomi var būt dzeltenīga āda un acis, nieze, tumšas krāsas urīns, sāpes vēderā un jutīgas aknas (par ko liecina sāpes zem ribu loka priekšējā daļā labajā pusē), dažreiz arī ēstgribas zudums.
English: “[Product name] can be taken immediately before, during a meal or up to one hour after a meal.
Latvian: KĀ LIETOT [ZĀĻU NOSAUKUMS] “[zāļu nosaukums] var lietot tieši pirms ēšanas, ēšanas laikā vai 1 stundas laikā pēc ēdienreizes.
English: For Orlistat 120 mg capsules: “[Product name] is not recommended for people taking acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).”
Latvian: Orlistata 120 mg kapsulām: “ [zāļu nosaukums] neiesaka cilvēkiem, kuri lieto akarbozi (zāles, ko lieto 2.tipa cukura diabēta ārstēšanai).”
English: [Product name] is not recommended for people taking acarbose.”
Latvian: [zāļu nosaukums] nav ieteicams cilvēkiem, kuri lieto akarbozi”
English: “Other medicines and [Product name]”
Latvian: PIRMS [ZĀĻU NOSAUKUMS] LIETOŠANAS “Citas zāles un un [zāļu nosaukums]
English: • “- acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).
Latvian: • “akarbozi (pretdiabēta līdzekli, ko ieto 2. tipa cukura diabēta ārstēšanai.
English: • “oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones).
Latvian: • oksalātu nefropātija (kalcija oksalāta daudzuma palielināšanās, kas var radīt nierakmeņus).
English: SECTION 4 - POSSIBLE SIDE EFFECTS
Latvian: IESPĒJAMĀS BLAKUSPARĀDĪBAS
English: • “Hepatitis (inflammation of the liver).
Latvian: • “hepatīts (aknu iekaisums).
English: Section 4.8 “Hepatitis that may be serious”
Latvian: “Hepatīts, kas var būt smags
English: See Chapter 2, take extra care with [Product name]”
Latvian: Skatīt 2. apakšpunktu Īpaša piesardzība, lietojot [zāļu nosaukums”]
English: The following wording should be included in the SmPC of the marketing authorisations to be varied, as relevant:
Latvian: ZĀĻU APRAKSTS (ZA) Veicot reģistrācijas apliecību izmaiņas, zāļu aprakstā attiecīgi iekļaujams šāds formulējums:
English: The following wording should be included in the package leaflet of the marketing authorisations to be varied, as relevant:
Latvian: Veicot reģistrācijas apliecību izmaiņas, lietošanas instrukcijā attiecīgi iekļaujams šāds formulējums:
English: ANNEX III AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCTS CHARACTERISTICS AND PACKAGE LEAFLET
Latvian: GROZĪJUMI, KAS IEKĻAUJAMI ZĀĻU APRAKSTA UN LIETOŠANAS INSTRUKCIJAS ATTIECĪGAJOS APAKŠPUNKTOS
English: Strength Pharmaceutical Form Route of Administration Packaging
Latvian: Ievadīšanas veids Iepakojums
English: The European Commission issued a decision on 27 February 2017.
Latvian: Eiropas Komisija pieņēma lēmumu 2017. gada 27. februārī.
English: What is gentamicin?
Latvian: Kas ir gentamicīns?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 February 2017
Latvian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2017. gada 27. februāris EMA/144816/2017
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/117)
Latvian: Saskaņā ar Direktīvas 2001/82/EK 35. pantu (EMEA/V/A/117) veiktās reģistrācijas pārskatīšanas procedūras rezultāti.
English: In veterinary medicine gentamicin is used mainly as a solution for injection for cattle, pigs, horses, cats and dogs.
Latvian: Veterinārmedicīnā gentamicīnu galvenokārt lieto injekciju šķīduma veidā liellopiem, cūkām, zirgiem, kaķiem un suņiem.
English: Gentamicin is an aminoglycoside antibiotic indicated for the treatment of a variety of bacterial infections.
Latvian: Gentamicīns ir aminoglikozīdu grupas antibiotika, ko indicē dažādu bakteriālu infekciju ārstēšanai.
English: Proprietary data and scientific references on residue depletion were provided by the marketing authorisation holders.
Latvian: Reģistrācijas apliecību īpašnieki iesniedza patentētu informāciju un zinātniskās atsauces par atlieku izdalīšanos.
English: Belgium noted that there are different approved withdrawal periods for cattle and pigs for veterinary medicinal products containing gentamicin presented as solutions for injection across the European Union, e.g. cattle meat and offal from 28 days to 210 days; cattle milk from 2 to 7 days, with some of the products stating ‘do not use in cows whose milk is intended for human consumption'; and pig meat and offal from 28 days to 150 days.
Latvian: Beļģijas aģentūra norādīja, ka Eiropas Savienībā ir pieejami dažādi apstiprināti ierobežojumu periodi liellopu un cūku produkcijas izmantošanā gentamicīnu saturošām veterinārajām zālēm injekciju šķīduma veidā, piemēram, liellopu gaļai un blakusproduktiem no 28 dienām līdz 210 dienām, govs pienam no 2 līdz 7 dienām (dažiem produktiem norādīts nelietot govīm, kuru piens paredzēts lietošanai pārtikā), kā arī cūkgaļai un tās blakusproduktiem no 28 dienām līdz 150 dienām.
English: The CVMP was requested to review all available residue depletion data and recommend withdrawal periods for cattle (meat and milk) and pigs (meat and offal).
Latvian: Veterināro zāļu komitejai lūdza pārskatīt visus pieejamos datus par atlieku izdalīšanos un ieteikt ierobežojumu periodus liellopiem (gaļai un pienam) un cūkām (gaļai un blakusproduktiem).
English: On 8 January 2016, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs, due to concerns related to the withdrawal periods set for the aforementioned products.
Latvian: Beļģijas aģentūra 2016. gada 8. janvārī uzsāka procedūru saskaņā ar Direktīvas 2001/82/EK 35. pantu attiecībā uz gentamicīnu saturošajām veterinārajām zālēm injekciju šķīduma veidā liellopiem un cūkām saistībā ar bažām par iepriekš minētajām zālēm noteiktajiem ierobežojumu periodiem.
English: On 10 November 2016, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods for cattle (meat and milk) and pigs (meat and offal) for veterinary medicinal products containing gentamicin presented as solutions for injection.
Latvian: Eiropas Zāļu aģentūra (turpmāk tekstā - Aģentūra) 2016. gada 10. novembrī pabeidza pārskatu par patērētāju drošību saistībā ar ierobežojumu periodiem liellopiem (gaļai un pienam) un cūkām (gaļai un blakusproduktiem), kam lieto gentamicīnu saturošās veterinārās zāles injekciju šķīduma veidā.
English: Based on the evaluation of the currently available data, the CVMP concluded that the overall benefitrisk balance for veterinary medicinal products containing gentamicin presented as solutions for injection is positive and agreed that the withdrawal periods for cattle (meat and milk) and pigs (meat and offal) should be amended to provide assurance for consumer safety and also agreed that the subcutaneous route should no longer be recommended for cattle and pigs since the depletion kinetics from the injection site remain unknown.
Latvian: Ņemot vērā pašreiz pieejamo datu novērtējumu, CVMP secināja, ka gentamicīnu saturošo veterināro zāļu injekciju šķīduma veidā ieguvumu un riska vispārējais līdzsvars ir pozitīvs, un apstiprināja, ka ierobežojumu periodi liellopiem (gaļai un pienam) un cūkām (gaļai un blakusproduktiem) produkcijas izmantošanā ir jāmaina patērētāju drošības garantēšanai, kā arī apstiprināja, ka vairs nav ieteicama subkutāna ievadīšana liellopiem un cūkām, jo izdalīšanās kinētika no injekcijas vietas nav zināma.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for veterinary medicinal products containing gentamicin presented as solutions for injection is positive and recommended amendments to withdrawal periods for cattle and pigs to provide assurance for consumer safety.
Latvian: Aģentūras Veterināro zāļu komiteja (CVMP) nolēma, ka gentamicīnu saturošo veterināro zāļu injekciju šķīdumu veidā ieguvumu un riska vispārējais līdzsvars ir pozitīvs, un ieteica mainīt ierobežojumu periodu liellopiem un cūkām patērētāju drošības garantēšanai.
English: The CVMP recommended that the marketing authorisations for veterinary medicinal products containing gentamicin presented as solutions for injection should be varied in order to amend the product information accordingly.
Latvian: CVMP ieteica gentamicīnu saturošo veterināro zāļu injekciju šķīduma veidā reģistrācijas apliecībās veikt grozījumus, lai attiecīgi veiktu izmaiņas zāļu aprakstā.
English: Why were veterinary medicinal products containing gentamicin presented as solutions for injection reviewed?
Latvian: Kāpēc pārskatīja gentamicīnu saturošās veterinārās zāles injekciju šķīduma veidā?
English: 75009 Paris
Latvian: 75009 Paris Francija
English: Based on the finding that:
Latvian: Pamatojoties uz konstatējumiem, ka:
English: Cancers found up to the age of:
Latvian: Vēzis atrasts sievietēm vecumā līdz:
English: ATC code: G 03 AA 07
Latvian: ATĶ kods: G 03 AA 07
English: ANNEX II SCIENTIFIC CONCLUSIONS PRESENTED BY THE EMEA
Latvian: PIELIKUMS II EMEA IESNIEGTIE ZINĀTNISKIE SECINĀJUMI
English: How to delay or shift a period:
Latvian: Kā aizkavēt vai mainīt menstruāciju sākuma dienu:
English: Tablets should never be delayed for longer than 7 days.
Latvian: Tablešu lietošanu nekad nedrīkst pārtraukt ilgāk par 7 dienām.
English: SCIENTIFIC CONCLUSIONS OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RIGEVIDON (see Annex I)
Latvian: RIGEVIDON ZINĀTNISKĀ NOVĒRTĒJUMA VISPĀRĒJAIS KOPSAVILKUMS (skatīt Pielikumu I)
English: Changes usually remain within the normal laboratory reference range.
Latvian: Izmaiņas parasti paliek laboratorijas rādītāju normas ietvaros.
English: This risk increases with age and with the extent of smoking and is particularly marked in women over 35 years of age.
Latvian: Šis risks paaugstinās ar vecumu un smēķēšanas intensitāti un ir sevišķi izteikts sievietēm pēc 35 gadu vecuma.
English: These studies do not present evidence for a causal relationship.
Latvian: Šie pētījumi nepierāda cēloņsakarību.
English: Laboratory tests
Latvian: Laboratoriju testi
English: - Obesity (body mass index above 30 kg/m²).
Latvian: Aptaukošanos (ķermeņa masas indekss virs 30 kg/m²).
English: All women who use oral contraceptives should be strongly advised not to smoke.
Latvian: Visām sievietēm, kuras lieto orālus kontracepcijas līdzekļus, ir stingri ieteikts nesmēķēt.
English: For long-term users of these medicinal products, use of other contraceptives should be advised.
Latvian: Šo zāļu ilgtermiņa lietotājiem ieteicams lietot citus kontraceptīvos līdzekļus.